Here is a sampling of 2020 media coverage of the Association for Diagnostics & Laboratory Medicine (formerly AACC), its journals Clinical Chemistry and The Journal of Applied Laboratory Medicine, and its former patient health site, www.labtestsonline.org. (Lab Tests Online is no longer an Association for Diagnostics & Laboratory Medicine program.)
In-office blood test results in six minutes
DEC.29.2020 // Israel21c
To learn more about PixCell Medical’s technology, read Bransky’s paper in The Journal of Applied Laboratory Medicine.
How Long Does a Flu Test Take and When Can You Expect Results?
DEC.22.2020 // Healthline
According to the American Association of Clinical Chemistry, rapid antigen tests are about 50 to 70 percent accurate, although the Food and Drug Administration (FDA) has required more recent tests to make changes to improve their results.
AI opportunities abound in clinical labs -- but prep work is key
DEC.22.2020 // Lab Pulse
But despite the promise of machine learning in clinical labs, there have been overexpectations. In addition, there are barriers to adoption, according to a session at the recent American Association for Clinical Chemistry (AACC) virtual meeting.
AACC 2020: COVID-19 Paved Way For ‘Retailization,’ Innovation In Point-Of-Care Testing, Now What?
DEC.21.2020 // Medtech Insight
A panel of experts at the recent American Association for Clinical Chemistry meeting, which focused on disruptive technologies in POC testing, agreed that the landscape for diagnostic testing is rapidly changing.
MeMed Developing Inflammatory Biomarker Tests for Use in Guiding COVID-19 Treatment
DEC.18.2020 // 360Dx
MeMed, an Israeli company with a focus on developing assays that gauge immune response to infectious diseases, is developing two new tests that could help select treatments for COVID-19 patients.
Quick decisions, expertise kept Wash. lab afloat during 1st COVID-19 hotspot
DEC.18.2020 // Lab Pulse
Baird discussed the lab's experience in a December 17 session of the American Association for Clinical Chemistry (AACC) virtual meeting.
Pediatric testing platform is producing accolades for Durham startup Baebies
DEC.17.2020 // WRAL Tech Wire
This week, the Durham-based biotech startup received the AACC Disruptive Technology Award at the 2020 American Association for Clinical Chemistry’s annual scientific meeting and clinical lab expo.
COVID-19 challenges the landscape of rapid testing for infectious diseases
DEC.17.2020 // Lab Pulse
The future is bright for rapid testing of infectious diseases, but the COVID-19 pandemic has raised a number of challenges that must be addressed, according to speakers at a December 15 session of the American Association for Clinical Chemistry (AACC) virtual meeting.
AACC 2020 Disruptive Tech Award-Winning Diagnostic Testing Platform Could Detect COVID-19 in 14 Minutes
DEC.17.2020 // HospiMedica
A COVID-19 test is being developed on a near-patient testing platform that won the Disruptive Technology Award at the 2020 AACC virtual meeting and could perform rapid reverse transcription polymerase chain reaction (RT-PCR) to generate results in as little as 14 minutes.
HHS' Adm. Brett Giroir expounds on national COVID testing strategy at AACC
DEC.16.2020 // Modern Healthcare
Adm. Brett Giroir, the coordinator of the US COVID-19 testing efforts for HHS addressed attendees of the American Association of Clinical Chemistry Laboratory Expo — held virtually this year due to the pandemic — in a special session on Tuesday evening, expounding on federal efforts to stimulate COVID-19 test development, maintain the supply chain, and coordinate with manufacturers and labs.
HHS' Adm. Brett Giroir expounds on national COVID testing strategy at AACC
DEC.16.2020 // 360Dx
Adm. Brett Giroir, the coordinator of the US COVID-19 testing efforts for HHS addressed attendees of the American Association of Clinical Chemistry Laboratory Expo — held virtually this year due to the pandemic — in a special session on Tuesday evening, expounding on federal efforts to stimulate COVID-19 test development, maintain the supply chain, and coordinate with manufacturers and labs.
Bottlenecks in testing supplies short-circuit U.S. COVID-19 response
DEC.16.2020 // Lab Pulse
Supply shortages have plagued the U.S. response to COVID-19 testing, and the federal government is open to new ideas for solutions, according to a presentation by White House COVID-19 testing lead Admiral Dr. Brett Giroir in a speech at the American Association for Clinical Chemistry (AACC) annual meeting.
Inflammatory biomarkers help quickly size up COVID-19 patients
DEC.16.2020 // Lab Pulse
Rapid blood tests for interferon gamma-induced protein 10 (IP-10) and calprotectin could help in the assessment and triage of COVID-19 patients, according to poster presentations reported by test developers at the annual American Association for Clinical Chemistry (AACC) meeting.
AACC Panelists Take Lessons for Future From COVID-19 Pandemic Testing Challenges
DEC.15.2020 // 360Dx
During a virtual session at this week's American Association of Clinical Chemistry annual meeting on the role of clinical and public health labs in addressing COVID-19, panelists recounted the struggles they had faced in ramping up testing this spring and presented ideas for how the country could avoid similar issues in the future.
What have labs learned from the COVID-19 pandemic?
DEC.15.2020 // Lab Pulse
If you had the chance to do it all over again, what would you do differently? Representatives from clinical labs pondered that question as it relates to the COVID-19 pandemic in a December 14 session at the American Association for Clinical Chemistry (AACC) virtual meeting, offering guidance on how labs could respond to the next global health emergency.
Low-volume test platform from Baebies wins 'disruptive tech' award at AACC
DEC.15.2020 // Lab Pulse
A diagnostic testing platform designed specifically for infants that requires a smaller blood sample beat products from two other companies to win the Disruptive Technology Award at the American Association for Clinical Chemistry (AACC) virtual annual meeting.
AACC 2020: Roche Panel Discusses How Pandemic Ushered In New Era For Diagnostics Ecosystem
DEC.15.2020 // Medtech Insight
“The global pandemic is a huge tidal wave and as it recedes, the landscape will be changed,” said William Morice, president of Mayo Clinic Laboratories, during a panel discussion with Roche Diagnostics Corp. executives at the virtual American Association for Clinical Chemistry (AACC) meeting on 14 December.
Roche sees alignment between COVID-19 tests, vaccines in 2021
DEC.15.2020 // Lab Pulse
Diagnostic tests and COVID-19 vaccines should work beneficially together, according to executives from Roche during a press briefing at the virtual American Association for Clinical Chemistry (AACC) meeting.
First-of-Its-Kind Rapid Test Could Identify Which COVID-19 Patients Are Responding to Drug Treatments
DEC.15.2020 // HospiMedica
The findings on the study by researchers at the Rabin Medical Center (Petah Tikva, Israel) using a blood test from MeMed Diagnostics (Haifa, Israel) were presented at the virtual 2020 AACC Annual Scientific Meeting & Clinical Lab Expo.
Blood Test for Calprotectin Could Predict Which COVID-19 Patients Are at Risk of Decline
DEC.15.2020 // HospiMedica
The findings of the test that could predict COVID-19 severity were presented at the virtual 2020 AACC Annual Scientific Meeting & Clinical Lab Expo.
6 trends to watch at AACC 2020
DEC.14.2020 // Lab Pulse
Although this year's meeting of the American Association for Clinical Chemistry (AACC) is virtual, it is probably more important than ever. The industry is at the forefront of worldwide efforts to combat the COVID-19 disease.
Coronavirus update: A green light for the Pfizer vaccine, dashed hopes for a new aid bill
DEC.11.2020 // Consumer Affairs
Researchers have found that a rapid COVID-19 test could identify which patients are responding to drug treatments and which patients are in need of more aggressive help. Their study was presented at the virtual 2020 AACC Annual Scientific Meeting & Clinical Lab Expo.
Stigma Is Still a Key Hurdle Against HIV
DEC.1.2021 // Media Planet supplement in USA Today
“A significant proportion of individuals with HIV are unaware that they have the virus and continue to spread it as a result,” explained Dr. David Grenache, president of the American Association for Clinical Chemistry.
Does THC Make Alcohol Stronger, or Vice Versa?
NOV.19.2020 // Westword
According to a study from the American Association for Clinical Chemistry, simultaneous use of cannabis and alcohol produces “significantly higher” concentrations of THC in the blood, while limited research from the ’90s shows that cannabis can delay the body’s absorption of alcohol, therefor slowing its effects.
New delays for COVID test results, possible at-home solution
NOV.18.2020 // Good Morning America
"We're starting to deal with staff shortages in the laboratory. Because of the rising case numbers, people are having exposures and now they can't come to work and so we're short staffed." - AACC President Dr. David Grenache
Labs brace for impact of infection, COVID-19 testing surge as Thanksgiving looms
NOV.18.2020 // ABC News
"I can't believe we're months into this and we are currently back to where we were this spring and early summer," Dr. David Grenache, president of the American Association for Clinical Chemistry, told ABC News. "Cases rising very quickly, limited supplies and reagents. But our biggest resource and our most precious resource are the scientists, the clinical laboratory scientists that perform the test."
Joe Biden's COVID-19 testing plans energize scientists, but lack price tag or specifics
NOV.13.2020 // ABC News
"It's absolutely essential that we get a handle on ramping up testing," Dr. David Grenache, president of the American Association for Clinical Chemistry, said. "I can't believe that we're 10, 11 months into this, and we're currently back to where we were this spring and early summer, with cases rising very quickly. And laboratories still have capacity issues."
Laboratory Stakeholders Weigh In On Biden Administration Priorities
NOV.12.2020 // 360Dx
American Association for Clinical Chemistry Past President Carmen Wiley said the current rates of and guidance around reimbursement for SARS-CoV-2 were okay, but that she hoped there would be no cuts in the rates as the Biden administration takes over.
Faulty DNA paternity test results bring decades of heartbreak, families say
NOV.5.2020 // WFAA - Local Dallas ABC-affiliate
But the American Association for Clinical Chemistry estimates 13 billion lab tests are performed each year in the U.S., so even a conservative error rate of just 0.005% amounts to 650,000 botched tests each year, or 650,000 father-son relationships that could've been.
Could Pernicious Anemia Be the Reason You're So Tired?
NOV.3.2020 // Shape
This is because roughly half of those with pernicious anemia don't have detectable intrinsic factor antibodies, according to the American Association for Clinical Chemistry.
Clinical Laboratories Need Creative Staffing Strategies to Keep and Attract Hard-to-Find Medical Technologists, as Demand for COVID-19 Testing Increases
NOV.2.2020 // Dark Daily
In fact, according to an American Association for Clinical Chemistry (AACC) Coronavirus Testing Survey, 56% of labs surveyed in September said staffing the lab is one of the greatest challenges. That is up from 35% in May.
Mass Spec Struggles to Demonstrate Utility as Platform for SARS-CoV-2 Dx
OCT.22.2020 // 360Dx
Filkins and colleagues published a commentary in Clinical Chemistry looking at the MALDI assay developed by the Chilean researchers.
Someone to Run the Tests
OCT.14.2020 // GenomeWeb
David Grenache, the chief scientific officer at TriCore Reference Laboratories and president of the American Association for Clinical Chemistry, tells the Journal that recruiting additional lab technologists is not necessarily simple.
Help Wanted at Covid-19 Testing Labs
OCT.13.2020 // Wall Street Journal
“They’ve been working really hard, and people are getting burned out,” said David Grenache, chief scientific officer at TriCore Reference Laboratories in New Mexico and president of the American Association for Clinical Chemistry. “I can replace hardware and I can manage not having enough reagents, but I can’t easily replace a qualified technologist.”
Labs squeezed for staff to meet COVID-19 testing demand
OCT.13.2020 // Becker's Hospital Review
In August, 58 percent of labs said staffing was an issue, up from 35 percent in May, according to a survey from the American Association for Clinical Chemistry cited by the Journal.
Nobel Prize Winners in Chemistry and Physics Discuss Shattering Gender Norm, Redefining Women’s Roles
OCT.10.2020 // Forbes
On Doudna’s and Charpentier’s win, Dr. Patricia Jones, Clinical Director of Chemistry at Children’s Medical Center of Dallas and former president of American Association for Clinical Chemistry said the CRISPR work is “huge and very promising.” “It makes me happy to see these two women win the Nobel Prize because again it shows what women are capable of doing and are doing on a daily basis now.”
CMS Streamlines CLIA Certification to Expand COVID-19 Testing
SEP.30.2020 // Revcycle Intelligence
The shortages are impacting nearly half of all clinical laboratories, the American Association for Clinical Chemistry (AACC) recently reported.
Florida Hospitals Grapple With Lack Of Testing Agents
SEP.29.2020 // CBS Miami
But an August survey by the American Association of Clinical Chemistry indicated that 67 percent of laboratories were having issues getting reagents and COVID-19 testing kits, the highest percentage of reported difficulties since May when the group, which represents commercial, hospital and public-health laboratories, began surveying its members.
COVID-19 or the flu? Kansas prepares for confusion and testing demand this winter
SEP.27.2020 // The Wichita Eagle
An August survey by the American Association for Clinical Chemistry found 52 percent of labs reported being unable to obtain supplies needed to run COVID-19 tests in the week before the survey.
FDA warns of teen misuse of Benadryl sparked by 'dangerous' TikTok challenge, asks app to remove videos
SEP.27.2020 // Media Entertainment Arts WorldWide (MEAWW)
According to the American Association for Clinical Chemistry (AACC), one to four teaspoons of nutmeg can cause dry mouth, agitation, hypothermia, hallucinations, among others — and in some cases, coma and death.
Faster, cheaper COVID-19 tests in danger of creating blindspot in data collection
SEP.23.2020 // ABC News
There's no straightforward answer about whether rapid tests are counted, said ... the American Association for Clinical Chemistry.
Supply shortages continue to plague COVID-19 testing
SEP.23.2020 // Axios
Two-thirds of labs are struggling to get enough reagents and test kits, according to a survey done last month by the American Association for Clinical Chemistry.
COVID-19 Testing Is Hampered by Shortages of Critical Ingredient
SEP.22.2020 // Wall Street Journal
According to a survey last month by the American Association for Clinical Chemistry, which represents commercial, hospital and public-health laboratories, 67% of labs are having issues getting both reagents and test kits—the highest level since the group started querying labs in May.
POLITICO Playbook PM: McConnell plows ahead
SEP.22.2020 // Politico
According to a survey last month by the American Association for Clinical Chemistry, which represents commercial, hospital and public-health laboratories, 67% of labs are having issues getting both reagents and test kits—the highest level since the group started querying labs in May.
Health systems still limiting COVID-19 tests due to supply shortages
SEP.22.2020 // Becker's Hospital Review
In a survey conducted by the American Association for Clinical Chemistry in August, 67 percent of labs reported having issues getting both reagents and test kits, the Journal reported.
AACC Calls on Congress to Fund Clinical Lab Training Programs
SEP.17.2020 // 360Dx
The American Association for Clinical Chemistry is calling on Congress to provide funding for clinical laboratory training programs.
AACC urges Congress to prepare for future pandemics
SEP.17.2020 // LabPulse
The American Association for Clinical Chemistry (AACC) issued a statement on September 17 that urges Congress to provide more funding for clinical laboratory training programs as a way to prepare for future public health emergencies like the COVID-19 pandemic.
Diagnostic firms confident about COVID-19 rapid testing capacity despite growing demand
SEP.15.2020 // Modern Healthcare
David Grenache, the American Association of Clinical Chemistry's president, also noted the supply chain issues. A survey conducted in August by the organization found 67% of labs are having issues getting reagents and test kits for COVID-19 assays, the highest number since monthly surveying began in May.
Ultra-sensitive antigen testing could help identify patients at risk for severe COVID-19
SEP.9.2020 // BioWorld
A recent study published in Clinical Chemistry found a high correlation between blood levels of S1 – a protein that is part of the SARS-CoV-2 viral structure – and admissions to the intensive care unit (ICU).
COVID-19 antigen assay set to triple US testing capacity
SEP.3.2020 // Chemical & Engineering News
“But in order for home tests to be even remotely useful, there’s going to have to be some requirement around the frequency of testing,” Grenache says.
Plenty of coronavirus tests are available, but they're not being used
AUG.26.2020 // CNN
But David Grenache, president of the American Association for Clinical Chemistry, described the decline in testing as "unusual and inconsistent" across the country.
Trump Administration Blocks FDA From Regulating Many New Medical Tests
AUG.21.2020 // NPR
The Health and Human Services Department says labs no longer have to seek authorization from the FDA before they start using their tests. [The] move is being welcomed by some, like David Grenache of the American Association for Clinical Chemistry.
New Zealand’s renewed COVID crisis: Why scientists say the virus is hard to contain
AUG.18.2020 // ABC News
"With a novel virus like this, you have lots to learn," says Dr. David Grenache, president of the American Association for Clinical Chemistry.
The Push to Deploy At-Home Antigen Tests for COVID-19
AUG.17.2020 // The Scientist
There are real benefits to increasing the availability of tests for COVID-19, says biomedical scientist David Grenache, the chief scientific officer at TriCore Reference Laboratories.
COVID-19 patient with repeatedly undetectable SARS-CoV-2 antibodies
AUG.10.2020 // News Medical
A recent case study published in the Journal of Applied Laboratory Medicine in August 2020 illustrates this with its finding of persistent seronegativity in a patient confirmed to be SARS-CoV-2 positive.
AACC Survey Finds Almost Half of Labs Lack Supplies for SARS-CoV-2 Testing
JUL.28.2020 // 360Dx
Almost half of laboratories surveyed by the American Association for Clinical Chemistry reported they still do not have the supplies necessary to run SARS-CoV-2 tests, the association said on Tuesday.
What is pooled testing for COVID-19 and how can it help fight the virus?
JUL.24.2020 // Reuters
“This type of testing works really well when you have an asymptomatic patient population or you’re doing some contact tracing where the likelihood of the prevalence of someone having the SARS-CoV virus is rather low, because you could test multiple groups and get tons of negatives,” said Carmen Wiley, president of the American Association for Clinical Chemistry (AACC).
Mitch with Dr. Carmen Wiley, President, American Association of Clinical Chemistry
JUL.21.2020 // KRLD News
The President of the American Association of Clinical Chemistry talks about COVID-19 testing.
Trump claims the U.S. has the world's best coronavirus testing. Experts disagree.
JUL.17.2020 // Q107 (from The Associated Press)
“I feel a bit like a broken record — nothing has really changed,” said Dr. Carmen Wiley, president of the American Association of Clinical Chemistry. “There’s a huge disconnect between what the task force indicates is happening and what we are truly experiencing in the field.”
Could COVID-19 end standoff on tests developed in laboratories?
JUL.15.2020 // The Science Advisory Board
The American Association for Clinical Chemistry (AACC) urged Congress to exempt the many national and regional clinical laboratories that are separate from the public health system, but that also have the expertise and capacity to develop and perform coronavirus tests.
Long delays in getting test results hobble coronavirus response
JUL.12.2020 // The Washington Post
One of those groups, the American Association for Clinical Chemistry, said it raised those same concerns last month in a call with Giroir, who said he had designated an official in each state to oversee the test supply chain and promised to give the organizations a list of those officials so they could direct pleas for help to them.
Lab groups ask Trump admin for more transparency into COVID-19 testing supply allocation
JUL.10.2020 // Medtech Dive
The lab stakeholder groups, including the American Association for Clinical Chemistry, the Association of Public Health Laboratories, and the Association for Molecular Pathology, called on the Trump administration to better manage the supply chain as labs are continuing to experience difficulty obtaining testing supplies.
Laboratory Stakeholders Including AMP, AACC Ask White House to Address COVID-19 Supply Chain Issues
JUL.10.2020 // 360Dx
The organizations, including the American Association for Clinical Chemistry, the Association of Public Health Laboratories, the Association for Molecular Pathology, the College of American Pathologists, and the American Society for Microbiology, requested the names and contact information for individuals in each state responsible for overseeing supply chains for testing supplies and personal protective equipment to facilitate communication between labs and equipment distributors.
Survey: resources for covid-19 testing still limited months later
JUL.1.2020 // Univision
A survey conducted by the American Association for Clinical Chemistry found that more than 50% of labs were still unable to obtain enough supplies in May, such as swabs, chemical reagents and testing kits. To discuss this UNews spoke to Dr. Carmen Wiley, the president of the American Association for Clinical Chemistry.
Hospitals Can't Get Enough COVID-19 Tests
JUN.29.2020 // WGBH - Boston's Local NPR Station
The shortages are an issue across the country. In a national survey by the American Association for Clinical Chemistry, half of the labs that responded said they were having trouble getting reagents or swabs.
AACC to Senate: 4 steps to prepare for next pandemic
JUN.26.2020 // LabPulse
The American Association for Clinical Chemistry (AACC) sent a letter to the U.S. Senate health committee leadership detailing four steps the government should take to ready the country for the next pandemic.
Survey shows resources for COVID-19 diagnostic testing still limited months later
JUN.20.2020 // ABC News
"We surveyed over 100 laboratories and asked them multiple questions to try to find out where people were struggling, thinking that supply issues have likely been managed but in fact they were not," Dr. Carmen Wiley, AACC's president, told ABC News.
AACC taps Golden as CEO to succeed retiring Kreizman
JUN.19.2020 // CEO Update
Veteran association leader Mark Golden has been hired as CEO of the $23 million-revenue Washington, D.C.-based American Association of Clinical Chemistry, effective Aug. 17.
Stakes are High for Reopening as COVID Testing Challenges Remain
JUN.19.2020 // TrialSiteNews
“The new normal is going to involve making do with less revenue,” said Dr. Carmen Wiley, president of the American Association of Clinical Chemistry (AACC). In an interview, she explained this will be a major challenge faced by clinical labs.
People in the News: Michael Hunkapiller, Susan Barnes, Jack Schuler, Mark Golden
JUN.12.2020 // GenomeWeb
Mark Golden has been appointed the CEO of the American Association for Clinical Chemistry, effective Aug. 17.
Trade Show Organizers Want Answers From City, State On When And Whether They Can Hold Events At McCormick Place
JUN.10.2020 // CBS Chicago
“Everyone’s optimistic,” said Dr. David Grenache of the American Association of Clinical Chemistry. That group already rescheduled its show from July to mid-December.
How summer camps will become testing sites for coronavirus tests
JUN.9.2020 // Good Morning America
AACC President-Elect Dr. David Grenache: "I could see some parents thinking, 'well, I'll have my child get an antibody test, and if it's positive, then they're safe,' but that's not necessarily true."
AACC Launches Competition to Support Diagnostic Research
JUN.8.2020 // 360Dx
The American Association for Clinical Chemistry announced Monday it has launched a new competition to support research to improve diagnostic testing.
AACC launches research contest, will award deidentified blood samples
JUN.8.2020 // LabPulse
The American Association for Clinical Chemistry (AACC) is set to award large sets of deidentified blood samples to lab medicine teams who demonstrate innovation in diagnostic testing research.
Fat: Death in the Time of COVID-19
JUN.7.2020 // Psychology Today
Remarkably, and despite heroic efforts, "not a single nation" has managed to reduce the prevalence of obesity in the past 20 years. (Aleksandrova et al, Clinical Chemistry, 2018)
Other news to note for June 5, 2020
JUN.5.2020 // BioWorld
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American Association for Clinical Chemistry, Avita Medical, Extherid Biosciences, Insulet, Mednax, Perfectus Biomed.
AACC Revises Guidance on Management of Point-of-Care Testing
JUN.4.2020 // 360Dx
The American Association for Clinical Chemistry on Thursday announced that it has issued a guidance document that describes best practices for hospitals and other healthcare institutions running point-of-care testing (POCT) programs.
Should You Get Tested for Covid-19 After Protesting?
JUN.2.2020 // Medium Coronavirus Blog
“In this situation, CDC guidelines should be followed for SARS-CoV-2 diagnostic testing,” Carmen Wiley, PhD, of the American Association for Clinical Chemistry tells the Medium Coronavirus blog. “If you found yourself in a situation where you could not maintain social distancing or were in a situation where people were coughing and you feel you may have increased risk of exposure, you can opt to self-isolate and monitor for signs of illness."
Antibody Tests Aren't Accurate, But You Can Still Buy One
JUN.1.2020 // Bloomberg
While the FDA was too slow to greenlight those tests, now, “the pendulum swung in the other direction,” says David Grenache, chief science officer for TriCore Reference Laboratories in New Mexico and incoming president of the American Association of Clinical Chemistry. The FDA opened the floodgates for antibody tests, requiring companies to do some accuracy testing but not reviewing their data.
Guidelines shed light on serology, antibody testing for COVID-19
JUN.1.2020 // Healio
In its recent guidance on serology and antibody testing for SARS-CoV-2, the American Association for Clinical Chemistry said that only specific tests should be used and only in certain instances.
Experts worry about false COVID-19 antibody test results
MAY.29.2020 // Futurity
In a new paper in the journal Clinical Chemistry, Neil Anderson, an assistant professor of pathology and immunology at Washington University School of Medicine in St. Louis and the assistant medical director of the Clinical Microbiology Laboratory at Barnes-Jewish Hospital, and Christopher Farnsworth, an instructor of pathology and immunology at the School of Medicine, emphasize the importance of the appropriate use of antibody tests.
AACC asks U.S. Senate to prioritize COVID-19 testing
MAY.28.2020 // LabPulse
The American Association for Clinical Chemistry (AACC) has sent a letter to U.S. Senate leadership with five recommendations to improve testing for the novel coronavirus.
AACC Sends Testing Recommendations to Senate For SARS-CoV-2 Relief Bill
MAY.28.2020 // 360Dx
The American Association for Clinical Chemistry sent a letter to US Senate leadership Wednesday offering recommendations for improving SARS-CoV-2 testing capacity that it says should be included in the newest coronavirus relief bill.
A negative test result isn’t proof you don’t have COVID-19
MAY.23.2020 // Times-Standard
At the moment, polymerase chain reaction, or PCR, tests are the most widely used test to detect severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2, the virus which causes COVID-19, because they’re highly accurate, said American Association for Clinical Chemistry President Dr. Carmen Wiley in a video.
CDC flags shortcomings of antibody tests in reopening guidelines
MAY.21.2020 // LabPulse
In a statement provided on May 20 to LabPulse.com, the AACC noted that on average, 366,278 diagnostic tests per day had been conducted in the prior week, according to the COVID Tracking Project. That comes pretty close to the 400,000 tests per day of current U.S. capacity estimated by the White House recently, but it still falls short, AACC President Carmen Wiley, PhD, commented.
AACC objects to FDA's at-home virus kit clearance, following go-ahead for Everlywell
MAY.21.2020 // LabPulse
The American Association for Clinical Chemistry (AACC) has notified the U.S. Food and Drug Administration (FDA) that it objects to the agency's recent emergency use authorization (EUA) of an "unproven" at-home coronavirus collection kit.
Buyer beware? What to know about direct-to-consumer antibody tests
MAY.20.2020 // ABC News
"Antibodies are markers of an infection you had," Dr. David Grenache, president-elect of American Association for Clinical Chemistry and chief scientific officer of TriCore Reference Laboratories, told ABC News.
Other news to note for May 19, 2020
MAY.19.2020 // BioWorld
The American Association for Clinical Chemistry, based in Washington, D.C., has released a statement on COVID-19 antibody testing, urging organizations to only use tests that are FDA-authorized or that were developed by a laboratory licensed by CMS to in-house tests.
YNMG & COVID: A Test You Can't Study For
MAY.13.2020 // KUNM - Albuquerque's Local NPR Station
Dr. David Grenache, TriCore chief scientific officer and president-elect of the American Association for Clinical Chemistry tells us about the development of COVID-19 antibody tests, and the importance of social distancing no matter what the results of an antibody test are.
COVID-19 testing problems started early, U.S. still playing from behind
MAY.11.2020 // Modern Healthcare
American Association for Clinical Chemistry President Carmen Wiley said in an interview that supply issues were a major problem for AACC members, and some labs have started validating alternate transport media and are using 3-D printers to manufacture nasopharyngeal collection swabs.
FDA Sets Standards for Coronavirus Antibody Tests in Crackdown on Fraud
MAY.5.2020 // Wall Street Journal
Dr. Grenache spoke to the saleswoman’s supervisor, who promised to relay his concerns about the two potential violations to Premier. He then forwarded the email to the FDA on April 25, urging the agency to stop allowing test-makers to sell serology tests without gaining at least an emergency authorization from the agency.
Quest and LabCorp Are Offering Coronavirus Antibody Testing—But Should You Really Get One?
MAY.4.2020 // Health
Some antibodies are protective, while others merely serve as markers of disease, David Grenache, PhD, president-elect of the American Association for Clinical Chemistry (AACC) and chief scientific officer of TriCore Reference Laboratories in Albuquerque, New Mexico, tells Health.
TriCore Reference Labs begins COVID-19 antibody testing
MAY.4.2020 // KOB
The blood test is designed to detect those antibodies. The catch, Dr. Grenache said, is that health experts still don’t know if those antibodies provide immunity at all.
FDA policy change may put an end to 'Wild West' of coronavirus antibody tests
MAY.4.2020 // LabPulse
The American Association for Clinical Chemistry (AACC) is among the organizations and experts that have been speaking out about commercial serology tests and calling for more oversight by the FDA.
Questions remain as NM begins antibody testing
APR.29.2020 // Albuquerque Journal
It’s unclear what finding antibodies will mean, exactly, because scientists are unsure whether having them will stave off a future infection, Grenache said.
TriCore to start testing certain people for COVID-19 antibodies
APR.29.2020 // KRQE
“All we know is that if you have an antibody to the coronavirus, you have been exposed in the past or you were known to have the illness,” TriCore Chief Scientific Officer David Grenache said. “You had a diagnosis, and you have recovered and your immune system has antibodies, but we don’t know yet if the antibodies mean you are immune from getting sick again.”
Pay it 4ward: M'Tucci's recognizes TriCore lab employees for their hard work
APR.29.2020 // KOB
"If there's a silver lining to this pandemic, it's that it has raised awareness of the role that laboratory professionals play in patient care," said David Grenache of Tricore Reference Laboratories.
Smaller labs report critical shortage of testing supplies
APR.28.2020 // CNN
Smaller labs and hospitals are reporting a critical shortage of Covid-19 testing supplies as President Donald Trump touts that there are enough tests to reopen the country.
Big commercial labs given priority for coronavirus testing equipment by feds
APR.28.2020 // CNN
Three major groups representing labs -- the Association of American Medical Colleges, the Association of Public Health Laboratories and the American Association for Clinical Chemistry -- have warned that supply shortages are growing critical.
L.A. is using a streamlined coronavirus test. But it has potential risks and rewards.
APR.28.2020 // LA Times
"We've not seen anything like this," Carmen Wiley, president of the American Assn. for Clinical Chemistry, said of the scramble by the nation's labs to provide the tests.
Labs say the White House needs to beef up swab production
APR.26.2020 // National Journal
Laboratories would have to make sure that a new kind of swab didn’t alter the result of the coronavirus test, said Carmen Wiley, president of the American Association of Clinical Chemistry, which represents clinical laboratories.
House Dems investigating unproven Covid-19 antibody tests
APR.24.2020 // CNN
House Democrats are citing flaws in federal policy that have led to unproven and fraudulently marketed coronavirus antibody tests being sold in the US, according to a memo shared exclusively with CNN.
Question: ‘What seems to be the holdup?’
APR.24.2020 // Antelope Valley Press
“It is a little bit insane,” David Grenache, the lab director at TriCore Reference Laboratories in Albuquerque, N.M., said. “Everyone is running around trying to get as much as they can from every vendor. Laboratories are competing with each other to get needed resources.”
New Mexico pushing for antibody tests to get clearer picture of COVID-19
APR.23.2020 // KRQE
“We know there’s intense interest in getting these tests available, we’ve been working on it for several weeks. I am far more committed to making sure we offer a test that’s very reliable and very accurate than I am trying to meet someone’s timeline,” said Chief Scientific Officer at TriCore Dr. David Grenache.
When will we know if COVID-19 antibodies prevent reinfection?
APR.22.2020 // ABC News
"It's going to take people who have known antibodies to COVID-19 to be re-exposed and find out if their protective antibodies come back to elevated levels and protect them -- or not," Dr. Carmen Wiley, president of the American Association for Clinical Chemistry, told ABC News.
Novel Covid 19 experimental test may deliver results in half an hour
APR.22.2020 // Medical Dialogues
Researchers at Karolinska Institutet in Sweden along with researchers in China have developed new diagnostic test for COVID-19 that can be performed without advanced laboratory equipment and deliver the result in about half an hour.The study has been published in the journal Clinical Chemistry.
Alone, low vitamin D does not cause osteoporotic fractures
APR.22.2020 // Medical Xpress
While low blood levels of vitamin D are associated with osteoporotic fractures, the link is not causative, according to the results of an analysis published online April 7 in Clinical Chemistry.
Trump Thinks Governors’ Pleas for More Coronavirus Tests Are Fake News
APR.21.2020 // Vanity Fair
“It is a little bit insane. Everyone is running around trying to get as much as they can from every vendor,” David Grenache, the lab director at TriCore Reference Laboratories in Albuquerque, told the Journal about private labs’ attempts to get necessary testing supplies, noting that “laboratories are competing with each other to get needed resources” and often fail to get what they need.
Lab group urges White House to provide "access to vital supplies" for testing
APR.20.2020 // CNN
“At this point, the biggest barrier to testing is not capacity, but access to vital supplies,” wrote Carmen Wiley, the president of the American Association for Clinical Chemistry in an April 16 letter to Dr. Deborah Birx, who sits on the White House coronavirus task force.
Coronavirus Testing Hampered By Disarray, Shortages, Backlogs
APR.20.2020 // Kaiser Health News
“It is a little bit insane. Everyone is running around trying to get as much as they can from every vendor,” said David Grenache, the lab director at TriCore Reference Laboratories in Albuquerque, N.M. “Laboratories are competing with each other to get needed resources,” he said, and often coming up short.
The nutmeg challenge is going viral again on TikTok, and the platform is struggling to remove the dangerous trend
APR.20.2020 // Insider
It takes five to 20 grams, or one to four teaspoons, of ground nutmeg to become intoxicated, according to the American Association for Clinincal Chemistry (AACC).
Opening the magic box: Lab professionals reveal their value during COVID-19
APR.20.2020 // LabPulse
The American Association for Clinical Chemistry's (AACC) online community, AACC Artery, has been crackling briskly with discussions on these topics as clinical laboratory professionals start to confront a mountain of questions related to serology.
Massive coronavirus testing ramp-up needed for US to reopen: report
APR.20.2020 // Medtech Dive
The American Association for Clinical Chemistry on Friday issued a similarly dire statement in response to the White House plan for the reopening of the country, warning that labs face severe supply shortages to conduct COVID-19 tests, including swabs, viral transport media, reagents, pipettes and personal protective equipment.
U.S. reopening plans shine light on testing supply shortages
APR.20.2020 // LabPulse
In a statement on April 17, the American Association for Clinical Chemistry (AACC) called on the federal government to correct supply chain problems that are resulting in shortages of nasal swabs and other vital products needed to ramp up testing to high volumes.
Coronavirus Testing Hampered by Disarray, Shortages, Backlogs
APR.19.2020 // The Wall Street Journal
“It is a little bit insane. Everyone is running around trying to get as much as they can from every vendor,” said David Grenache, the lab director at TriCore Reference Laboratories in Albuquerque, N.M. “Laboratories are competing with each other to get needed resources,” he said, and often coming up short.
Coronavirus Updates: New York To Allow Marriage Bureau Clerks To Perform Ceremonies On Video
APR.18.2020 // Gothamist
AACC president Carmen Wiley said, "The only entity in this crisis with the power to source the necessary supplies on a large scale and route them to those areas where they are most needed — whether an N95 mask, testing reagents, or a testing swab — is the federal government."
US COVID-19 total tops 700,000; cases spike in Russia, parts of Asia
APR.18.2020 // University of Minnesota's CIDRAP News
Meanwhile, the American Association for Clinical Chemistry in a statement yesterday said supply chain issues, such as personal protective equipment, swabs, and reagents are obstacles to scaled-up testing and that the White House is in the best position to coordinate resources.
Amid the push to reopen, states and businesses plead for more federal testing help
APR.17.2020 // The Washington Post
“The only entity in this crisis with the power to source the necessary supplies on a large scale and route them to those areas where they are most needed — whether an N95 mask, testing reagents, or a testing swab — is the federal government,” Carmen Wiley, [AACC's] president, said in a statement.
Research Shows Vitamin D Supplements Do Not Prevent Osteoporotic Fractures
APR.15.2020 // Pharmacy Times
Low vitamin D levels alone do not cause osteoporotic fractures, according to a new study published in the American Association for Clinical Chemistry (AACC)'s Clinical Chemistry journal.
Test makers, FDA struggling with shift from molecular to serology testing for SARS-CoV-2
APR.14.2020 // BioWorld
David Grenache, president-elect of the American Association for Clinical Chemistry, told BioWorld that a clinical lab’s choice of testing often hinges on the types of equipment that lab has installed.
AACC responds to reports of bad blood tests for coronavirus
APR.14.2020 // LabPulse
The American Association for Clinical Chemistry (AACC) has acknowledged problems with some commercial serology tests for the novel coronavirus, while also advocating for a hands-off regulatory approach when it comes to assays developed by CLIA-certified labs.
The Next Pandemic: Excess testing capacity essential, but cost question not yet answered
APR.8.2020 // BioWorld
Wiley, president of AACC, told BioWorld that the existing instrument types are up to the job, but that surge capacity is needed, and that it is not clear how the cost of that capacity will be handled.
Fausses-couches à répétition : la qualité des spermatozoïdes en cause
APR.6.2020 // Marie Claire (French)
“Traditionnellement, en cas de fausses couches récurrentes, les médecins ont concentré leur attention sur les femmes”. C’est ce que dénonce une étude publiée dans la revue Clinical Chemistry et menée par une équipe de scientifiques de l'Imperial College London, dirigée par le docteur Channa Jayasena, qui tente de déconstruire les clichés autour de la responsabilité seule et unique des femmes dans le cas d’une fausse couche.
Can the Reality of Coronavirus Antibody Tests Live Up to Hype?
APR.6.2020 // LabPulse
Grenache proposed an online forum for labs to exchange information about which tests work and which ones don't to the American Association for Clinical Chemistry. Very quickly, the online forum was up and running.
White House Data Request Highlights Coordinated Response Concerns
APR.2.2020 // Modern Healthcare
After receiving a request by Vice President Mike Pence to submit daily reports on COVID-19 testing within their facilities, hospitals with in-house labs are struggling to figure out exactly how to do it.
New York City Hospitals Struggle To Get Virus Testing Online Amid Patient Surge
APR.1.2020 // WGBH - Boston's Local NPR Station
A voluntary list of COVID-19 testing laboratories maintained by the American Association for Clinical Chemistry, a clinical laboratory trade group, includes only one New York City hospital location: New York-Presbyterian/Columbia University Medical Center.
STUDY: When Mothers Receive Fentanyl Epidurals During Labor, the Fentanyl Gets Passed on to Their Babies
MAR.27.2020 // AllOnGeorgia
Breaking research in AACC’s The Journal of Applied Laboratory Medicine shows that the fentanyl in epidurals can pass on to babies during labor.
Fentanyl during moms' labor shows up in babies' urine
MAR.25.2020 // Lab Pulse
Fentanyl administered to pregnant women during labor may be passed on to their babies and show up in neonatal urine samples, researchers reported in the Journal of Applied Laboratory Medicine on March 24.
Putin dons hazmat suit, as Russia admits virus numbers likely far higher
MAR.24.2020 // ABC 11
The Russian test itself also appears to be significantly less sensitive than those used elsewhere -- according to the president of the American Association for Clinical Chemistry, perhaps as much as 10-16 times less.
Need For Speed: Corporate Education Must Pick Up Its Pace
MAR.23.2020 // Forbes
For example, as COVID-19 created shockwaves around the globe, a team at my firm worked with subject matter experts who wanted to deliver free COVID-19 education modules: the first one for medical and laboratory professionals and, a few days later, a version targeted for laypeople at companies. Within a week, we went from ideation to launch using AACC Learning Lab.
Why is Russia reporting so few COVID-19 cases? Some say it's a cover-up
MAR.21.2020 // ABC News
“That would mean it’s about 10-16 times less sensitive than what’s available in the U.S.,” Carmen Wiley, president of the American Association of Clinical Chemistry, told ABC News by a phone. At such a level, she said there was a risk the Russians were missing cases, in particular where people were asymptomatic.
National COVID-19 response: US raises health alert to highest level and 9 other notes
MAR.20.2020 // Becker's Hospital Review
The American Association for Clinical Chemistry launched a COVID-19 testing directory for healthcare workers. The directory includes all U.S. clinical labs that are or will be testing for COVID-19 cases.
Testing supply shortage limits who can get a COVID-19 test
MAR.19.2020 // Wink News (CBS Affiliate)
Wiley, who is also President for the American Association of Clinical Chemistry, said all credentialed laboratories and hospitals in the United States have emergency preparedness plans.
Coronavirus Testing in the U.S.: What You Need to Know
MAR.19.2020 // Elemental Medium
The CDC has since sent new test kits to all 50 states and Washington, D.C., but tests are still in short supply in many places. “The availability is variable,” Carmen Wiley, PhD, president of the American Association for Clinical Chemistry, tells Elemental.
New FDA COVID-19 Testing Guidelines Cause Concern for Insurance Coverage
MAR.19.2020 // Pharmacy Times
However, the FDA’s updated guidelines drew concern from organizations such as the American Association for Clinical Chemistry (AACC), which feels that the Families First Coronavirus Response Act does not provide coverage for COVID-19 testing unless the tests are performed under an EUA.
Coronavirus: testing in US accelerates as companies step in where government failed
MAR.18.2020 // South China Morning Post
“That really doesn’t work well in an emerging disease state like this,” said Carmen Wiley, president of the American Association for Clinical Chemistry, a lab testing group. “But once some of those restrictions were loosened, it allowed labs to do what labs do best,” including designing and manufacturing tests quickly, she added.
Coronavirus: testing in US accelerates as companies step in where government failed
MAR.18.2020 // Yahoo News
“That really doesn’t work well in an emerging disease state like this,” said Carmen Wiley, president of the American Association for Clinical Chemistry, a lab testing group. “But once some of those restrictions were loosened, it allowed labs to do what labs do best,” including designing and manufacturing tests quickly, she added.
DIY nasal swabs, drive-thrus and labs in overdrive: Americans are desperate for more coronavirus testing
MAR.17.2020 // The Washington Post
Carmen Wiley, president of the American Association for Clinical Chemistry, said that the FDA requires swabs made by a single manufacturer and that some labs are running low.
Are rapid diagnostic tests as reliable for patients as lab cultures?
MAR.16.2020 // The Washington Post
As with any medical tests, RDTs need to be performed properly for the best results, experts say. Food and Drug Administration regulations require that detailed instructions be provided with each test. These include guidance on how to read test results, says Carmen L. Wiley, president of the American Association for Clinical Chemistry.
Biotin Interference Still an Albatross For Labs, Diagnostics Developers
MAR.16.2020 // 360Dx
Then in January, the American Association for Clinical Chemistry issued a guidance instructing clinicians, lab professionals, and patients how to prevent biotin from interfering with test results.
Vendors, labs scramble to meet needs of coronavirus outbreak
MAR.13.2020 // Lab Pulse
"Many of our member labs are highly complex labs already approved by CLIA to develop and run their own tests," said Carmen Wiley, PhD, president of the American Association for Clinical Chemistry (AACC). "Their main objective right now is to get them up and running so that we can start doing surveillance of the coronavirus."
Revival of VALID Act draws mixed response
MAR.9.2020 // Lab Pulse
The American Association for Clinical Chemistry (AACC) believes the VALID Act "introduces new and redundant regulatory hurdles" for labs for many diseases and conditions that are not public health emergencies, according to a March 6 press statement.
FDA Provides SARS-CoV-2 Test Validation Guidance for High-Complexity Labs Seeking EUA
MAR.3.2020 // GenomeWeb
The Association of Public Health Labs and the American Association of Clinical Chemistry had been urging FDA to expand its authorization to allow labs to develop tests.
FDA issues guidance for expanded development of coronavirus diagnostic tests
MAR.3.2020 // Modern Healthcare
"I'm thrilled that the FDA is allowing high-complexity laboratories to do this testing," said Carmen Wiley, president of AACC.
FDA Allows High-Complexity CLIA-Certified Labs to Perform Coronavirus Testing
FEB.29.2020 // GenomeWeb
The American Association of Clinical Chemistry also sent a letter to the agency last week in support of APHL's request to allow other labs, particularly those with the expertise and capacity to develop and perform coronavirus tests, to perform them.
AACC to FDA: Let labs run in-house coronavirus tests
FEB.28.2020 // Lab Pulse
The American Association for Clinical Chemistry (AACC) has asked permission from the U.S. Food and Drug Administration (FDA) to allow all qualified local and state clinical laboratories to run their own in-house tests for the novel coronavirus without review by the agency.
Confronting the coronavirus
FEB.27.2020 // The Washington Post
The current dearth of accurate coronavirus tests clearly shows how additional FDA regulation of LDTs could negatively affect patient care by delaying or preventing development of these tests when they are needed most.
Coronavirus and the race to distribute reliable diagnostics
FEB.19.2020 // Nature
Meanwhile, a group at Hong Kong University have developed two one-step quantitative RT reverse transcription PCR tests targeting both the open reading frame 1b (ORF1b) and the N regions of the viral genome.
Five-Minute Fentanyl Assay in Development Takes Aim at Opioid Crisis
FEB.6.2020 // 360Dx
Wang along with her colleagues completed a study published last week in Clinical Chemistry that describes the development and clinical validation of the test.
As Worries Grow Over Novel Coronavirus, Dx Industry Jumps Into Action
FEB.4.2020 // GenomeWeb
Researchers have developed two single-step quantitative real-time reverse-transcription PCR assays to detect two different regions of the viral genome, as described in a recent Clinical Chemistry study.
Wuhan coronavirus RT-PCR tests deliver results fast
FEB.4.2020 // Lab Pulse
Scientists in Hong Kong and China have developed rapid reverse transcription polymerase chain reaction (RT-PCR) tests that may be used to identify and confirm the 2019 novel coronavirus (2019-nCoV), with results available in about an hour. Their experience with the tests was published in the journal Clinical Chemistry on January 31.
Two new rapid tests that could help contain Coronavirus epidemic
FEB.1.2020 // Medical Dialogues
Researchers have developed two new tests that accurately diagnose coronavirus infection in about 1 hour. The research has been published in AACC's Journal of Clinical Chemistry.
Should You Trust a Rapid Diagnostic Test?
JAN.20.2020 // Consumer Reports
As with any medical tests, RDTs need to be performed properly for the best results, experts say. Food and Drug Administration regulations require that detailed instructions be provided with each test. These include guidance on how to read test results, says Carmen L. Wiley, Ph.D., president of the American Association for Clinical Chemistry.
AACC Issues Guidance on Biotin Interference in Lab Tests
JAN.14.2020 // 360Dx
The American Association for Clinical Chemistry has issued a guidance instructing clinicians, lab professionals, and patients how to prevent biotin from interfering with test results.
AACC guides on biotin interference: Communication is key
JAN.13.2020 // Lab Pulse
The American Association for Clinical Chemistry (AACC) has released a new guidance document for tackling the risk of interference from biotin (vitamin B7) in lab test results that stresses interdisciplinary communication.
Analysis of commercial DNA tests finds inconsistent coverage
JAN.7.2020 // Reuters
A sampling of a dozen tests from each of three commercial laboratories has found they often fail to adequately analyze large segments of DNA that could be contributing to disease, researchers report this week in the journal Clinical Chemistry.
New blood test to improve triage for elderly concussion patients
JAN.7.2020 // Medical Device Network
According to a research paper published in January issue of AACC’s The Journal of Applied Laboratory Medicine, the blood test was 100% accurate at identifying who did not have brain tissue damage.
New blood test can improve triage for elderly concussion patients
JAN.6.2020 // Philly Voice
The blood test used in the study, published in the American Association for Clinical Chemistry's Journal of Applied Laboratory Medicine, is the first to evaluate mild traumatic brain injury or concussion in patients who may have intracranial bleeding.
Vitamin K Deficiency: Bleeding In This Body Part Could Be A Warning Sign
JAN.4.2020 // International Business Times
Newborns whose mothers have been taking certain drugs during pregnancy might also put them at risk of this vitamin deficiency. This can lead to excessive bleeding and bruising and in severe cases, even cause fatal brain bleeding, says Lab Tests Online.
How long does it take to become nicotine-free?
JAN.3.2020 // Inverse
The American Association for Clinical Chemistry reports that it can take more than two weeks for cotinine blood levels to completely drop, compared to those of a non-tobacco user, once someone completely stops using tobacco and nicotine products.
Testing drivers for cannabis is hard. Here's why
JAN.2.2020 // CNN
In July, Clinical Chemistry published the findings of a University of California-San Francisco study that showed THC could be detected in breath for up to three hours after smoking and that there's a correlation between THC concentrations and blood concentrations for that initial period.