FDA Approves Breath Test to Aid in Diagnosis of Delayed Gastric Emptying

The Food and Drug Administration has approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test designed by Advanced Breath Diagnostics to aid in the diagnosis of delayed gastric emptying, known as gastroparesis. Gastroparesis is a disorder that slows or stops the movement of food from the stomach to the small intestine and is a complication of diseases such as Parkinson’s, multiple sclerosis, and diabetes. Current tests used to diagnose gastroparesis typically involve the use of a small amount of radioactive material or imaging equipment, so testing must be conducted in specialized outpatient centers. In contrast, the GEBT does not require radioactive material and healthcare professionals administering it do not need to undergo special training, enabling the test to be used in broader settings.

The GEBT is designed to show how fast the stomach empties solids by measuring carbon dioxide in a patient’s breath. Patients have baseline breath tests conducted at the beginning of the test. They then eat a test meal that includes Spirulina platensis, a type of protein that has been enriched with carbon-13. Both carbon-12 and a very small amount of carbon-13 are normally found in exhaled carbon dioxide. The GEBT determines how fast the stomach empties the test meal by measuring the ratio of carbon-13 to carbon-12 collected in breath samples at multiple time points after the meal is consumed compared to baseline.

FDA, CMS Form Task Force on Lab Developed Tests

The Food and Drug Admin­istration (FDA) announced that it is establishing an interagency task force with the Centers for Medicare and Medicaid Services (CMS) to deal with concerns that FDA’s proposed oversight framework for laboratory developed tests (LDTs) will unnecessarily duplicate the current regulation of LDTs by CMS under CLIA. In a joint statement, Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, and Patrick H. Conway, MD, chief medical officer of CMS, write that the goals of the FDA/CMS Task Force on LDT Requirements include identifying similarities between the FDA and CLIA regulations to avoid extraneous agency oversight, and clarifying responsibilities for laboratories that fall under the purview of both agencies, as well as differences in terminology used by FDA and CMS.

The task force invites members of the healthcare community to send any feedback to LDTFramework@fda.hhs.gov. In addition to forming this task force, FDA is currently reviewing the public comments it has received on its LDT draft guidance.

FDA Clears Expanded Bruker MALDI Biotyper CA System

Bruker has received 510(k) clearance from the Food and Drug Administration for a library and methods expansion for the MALDI Biotyper CA System. First cleared in November 2013, the MALDI Biotyper CA system classifies and identifies microorganisms using proteomic fingerprinting by high-throughput matrix assisted laser desorption ionization time-of-flight mass spectrometry. The original platform included a library of 40 clinically relevant aerobic Gram negative bacterial species or species groups, as well as MALDI Biotyper instrumentation, software, reagents, and standard operating procedures. The clearance of this expansion now adds 170 species and species groups to the system that represent clinically relevant species of aerobic Gram positive, fastidious Gram negative, and anaerobic bacteria, Enterobacteria­ceae, and yeasts. This will enable the MALDI Biotyper CA System to identify more than 98% of the bacteria clinical microbiology laboratories typically encounter. In addition, customers will have new specimen preparation options to further optimize workflows.

Great Basin Scientific Receives FDA Clearance for Molecular Group B Strep Test

The Food and Drug Administra­tion has granted clearance to Great Basin Scientific for its molecular diagnostic test for group B Streptococcus (GBS). According to the Centers for Disease Control and Prevention (CDC), GBS remains the leading infectious cause of morbidity and mortality among newborns in the U.S. Approximately 10 to 30% of all pregnant women are colonized with GBS in the genitourinary tract, which can be transferred to the infant during labor and delivery. GBS-colonized mothers are often asymptomatic, however, and therefore the CDC recommends pregnant women get screened for GBS at 35 to 37 weeks of gestation. Using a specimen from enriched Lim broth, the Great Basin GBS assay provides results in approximately 90 minutes by targeting a highly conserved region of the GBS CAMP factor gene. This will enable healthcare providers to make a more rapid diagnosis of a mother’s GBS colonization status than with standard culture-based testing, which may take up to 48 hours.

FDA Gives Nod to Focus Diagnostics’ Molecular Strep Test

Focus Diagnostics, the clinical-laboratory products business of Quest Diagnostics, has received FDA clearance for its Simplexa Group A Strep Direct kit. This is a real-time PCR assay for the detection of group A Streptococcus bacteria directly from throat swabs. Using a proprietary chemistry technique that eliminates the nucleic acid extraction process typical of molecular diagnostics, it can produce results in an hour, compared to culture-based testing methods that can have a time-to-result of up to 2 days. Clinical studies also found the Simplexa Group A Strep Direct to have 97.4% sensitivity and 95.2% specificity compared to culture. This test is intended for use in patients with signs and symptoms of pharyngitis, such as sore throat. It has also received CLIA moderate-complexity categorization, enabling some physician offices, community hospitals, health clinics, and integrated delivery networks to perform the test.

Sophia Genetics Granted CE Mark for BRCA1, BRCA2 Test

Sophia Genetics has obtained the CE mark for its algorithm to detect DNA copy number variations (CNVs) in the BRCA1 and BRCA2 genes. The BRCA1 and BRCA2 genes act as tumor suppressors by maintaining genomic integrity through DNA repair and cell cycle control, and the presence of mutations in these genes such as CNVs can increase the risk of breast cancer by about 70% and the risk for ovarian cancer by about 50%.

The algorithm developed by Sophia directly detects CNVs in BRCA1 and BRCA2 from data generated by next-generation sequencing (NGS). This will be integrated into the solution featured on the company’s Data Driven Medicine platform that covers the identification and characterization of all types of variants (single nucleotide polymorphisms, insertions, deletions, and CNVs) for the BRCA1 and BRCA2 genes in a single NGS experiment. The data Sophia submitted for CE approval came from a multicenter double blind study on more than 500 samples from four different labs. The results showed an analytical performance and sensitivity of up to 96.2%.