The 71st AACC Annual Scientific Meeting & Clinical Lab Expo attracted some 20,000 professionals from around the globe August 4-8 in Anaheim, California. The program offered a window into the extraordinary changes shaping the future of laboratory medicine, from direct-to-consumer testing, artificial intelligence, and extremely rapid molecular diagnostics to point-of-care and core lab innovations that are empowering laboratory medicine professionals to have an even greater impact on patient care.
The AACC Clinical Lab Expo also featured 835 exhibitors—the most in AACC’s history. Dynamic exhibits featured hundreds of product launches and included groundbreaking tests and medical systems in mobile health, molecular diagnostics, mass spectrometry, automation, chemistry, immunoassays, and many other disciplines.
And in a competition to win AACC’s second annual Disruptive Technology Award, biotech innovators presented novel technologies that could help more patients get accurate diagnoses. Inflammatix won with its rapid HostDx Sepsis test that measures the expression of multiple immune system genes to determine if a patient has or is likely to develop the deadly condition sepsis. The seven Disruptive Technology Award finalists and 10 other unique diagnostic developers presented in the new AACC Innovation Zone, which featured special content curated by Clinical Laboratory News.
In Anaheim, an editorial board of eight AACC members followed the science at the meeting for CLN Daily, the official publication of the AACC Annual Scientific Meeting & Clinical Lab Expo, which was produced and distributed on-site. Read the full stories highlighted in this special section at www.aacc.org/publications/cln/cln-daily.
Translational Medicine: A Clinical Pull or a Technological Push?
By Alec Saitman, PhD
In developing a new diagnostic test, which comes first, the technology or the clinical need? Over the years, clinical laboratorians have witnessed the emergence of and improvements in a staggering number of new diagnostic tests, with the exponential growth of technology seeming to drive this growth. But there may be a problem with always putting technology first.
David Walt, PhD, in his plenary talk, “Biomarker Discovery: From Technology Development to Clinical Applications,” helped to answer those questions. Walt is considered an innovation pioneer and was inducted this year into the National Inventors Hall of Fame. Specifically, he is being recognized for his work in the development of microwell arrays that transformed the field of genetic testing.
In this presentation, Walt described how currently, the biomarker discovery process tends to emphasize technology before clinical application. He argued that this paradigm may not be effective at providing new clinically relevant and useful diagnostic tests, and explained that innovation does not necessarily guarantee improvements in patients’ clinical workups. “Many technology developers do not fully understand the clinical application and select biomarkers that are inappropriate for the particular disease,” he noted.
What’s Next for Consumer Genomics?
By Khushbu Patel, PhD
Since completion of the Human Genome Project, advances in molecular technologies have led to an explosion of consumer genetic testing that is revolutionizing the patient-doctor relationship.
During a special session, “Consumer Genomics, Direct-to-Consumer Genetic Testing, and Patient Empowerment,” moderated by broadcast journalist Cathy Wurzer, two experts discussed how consumer genetic testing fits into the current paradigm of healthcare. They tackled everything from the differences among testing options to the regulations that can either speed up or slow down the proliferation of these tests.
Jill Hagenkord, MD, drew from her experience leading two prominent genetic testing companies, 23andMe and Color Genomics. She covered the evolution and outlook of the consumer genetic testing space. Direct-to-consumer genetics now includes many data points beyond just the traditional assessment of disease risks, from ancestry and trait testing to nutrigenetics and exercise genetics, she emphasized.
But with hype also comes harm, said Theodora Ross, MD, PhD. The flip side of patient empowerment is that the importance of medical counseling can be undervalued. “It is a double-edged sword, and the risks of the lack of information are undersold,” Ross said, noting that even clinicians often have a difficult time understanding and interpreting genetic test results.
Implementing High-sensitivity Troponin Assays
Jumoke Oladipo, MD
The AACC University session, “AACC/IFCC Clinical Laboratory Practice Recommendations for Use of High-Sensitivity Cardiac Troponin (hs-cTn) Assays,” featured four speakers—Fred Apple, PhD; Brad Karon MD, PhD; Judd Hollander, MD; and Allan Jaffe, MD—who have all participated in hs-cTn assay research and also implemented these tests clinically. They shared evidence-based background with the audience about why it’s smart to switch from current generation tests to hs-cTn assays and practical tips about how to incorporate hs-cTn results independent of which assay (cTnT or cTnI) is being implemented.
Apple discussed the recommendations in the IFCC/AACC guidelines with the important message being “to know your assay,” as all assays are not the same. Karon discussed laboratories’ experiences in using high sensitivity assays for the past year, and one thing stood out: platform-to-platform variability, as well as calibrations that also can lead to variability in the assays.
Organizations face two major challenges during implementation. The first involves a change in reporting units. Second, hs-cTn assays should have sex-specific rather than total 99th percentile figures. Overcoming these challenges boils down to proper education among and communication between laboratorians and clinicians. Hollander, an emergency medicine physician, emphasized the importance of clinicians working together with laboratorians in implementing these fifth-generation troponin assays.
The Rise of Tailored Therapies in Breast Cancer
Tina Lockwood, PhD
It seems self-evident that cancer treatment should selectively seek out rogue, cancer-promoting molecules exclusively in tumor cells rather than indiscriminately killing all dividing cells. This is precisely the premise that Virginia Kaklamani, MD, DSc, described in her plenary session, “Using Biomarkers to Tailor Treatment for Breast Cancer.” She noted that the goal of targeted or tailored therapies is to specifically stop proteins that promote tumor cell proliferation and survival.
Keeping track of the many different therapies and biomarkers used to treat breast cancer can be daunting. Kaklamani’s primary objective is for people to recognize that precision medicine is progressing in breast cancer such that treatment “can now be individualized for patients based on their genetic and genomic makeup.”
One reason for the array of tailored therapies is that breast cancer isn’t a single entity. The many distinct types of cancer require that tumor subtype be known to tailor treatment for each patient.
The availability of multiple tailored treatments means that oncologists must identify which patients will benefit from each. Guess who they turn to in this venture? In Kaklamani’s view, “the laboratory is more and more important” for selecting which patients are candidates for specific treatment types. Oncologists rely on multiple pathology specialties, including anatomic pathology as well as hematology, chemistry, immunology, and genomics laboratories, to create comprehensive and tailored treatment plans.
There’s an App for That
Laura Smy, PhD, MLS
In our technology-forward times, healthcare and technology are blending in ways that go beyond electronic medical records or lab information systems. Shannon Haymond, PhD, and David Grenache, PhD, joined forces to present the scientific session, “Digital Medicine and the Connected Health Consumer: What You Need to Know.”
This symposium highlighted how people are generating their own data through digital tools and wearables and sharing this information through social media. Haymond discussed how people are using their devices, social media, and apps to access healthcare information. Upwards of 50% of patients now have online access to their health information via portals. When polled, 82% of the audience indicated their institutions offer patient portals, but only 56% reported having input into how lab information was presented.
Grenache focused on the “quantifiable self” achieved through wearable devices, digital dashboards, and direct-to-consumer testing. Consumers have embraced healthcare wearables with 33% wearing a device in 2018. Grenache covered how dashboards like Apple’s iPhone Health app enable users to view health trends in easy-to-understand formats. Key considerations for consumers in using these tools include the ease of data entry, how data are presented, and how well their privacy is protected.
A New Resource for Biotin Best Practices
Sarah Hackenmueller, PhD
As most clinical laboratorians now know, the high doses of biotin some patients take have the potential to interfere with laboratory testing and results. The session, “Beautiful Skin but Erroneous Lab Results: The AACC Academy’s Guidance Document on Biotin Interference,” not only provided background information on biotin interference but also explained the new AACC best practice recommendations for laboratories to address this potential interference. The guidance document is currently under review for publication.
“The exclusive use of assays that do not exhibit biotin interference has been suggested, but this is not always possible or feasible,” said Patrick Kyle, PhD, who moderated the session. When suspicious of interference, laboratories can take a number of steps focused on determining the presence of biotin and mitigating its interference. “Another option might include the analysis of a second specimen at a later time point if available. Laboratories should work to educate patients and their clinical providers,” Kyle emphasized.
Angela Ferguson, PhD, highlighted several case reports related to biotin interference in laboratory assays, and the impact this issue had on patient follow-up and additional testing. Ferguson also reviewed published literature evaluating the degree of biotin interference in different assays across many manufacturers.
The AACC Academy has recently developed a process to publish expert opinion guidance documents related to emerging areas of interest to the laboratory community. Topics and authors are selected by the AACC Academy Council, and all guidance documents undergo peer review and a public comment period prior to acceptance and publication.