GENETIC TESTING

FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review

On Dec. 30, 2019, the U.S. Food and Drug Administration (FDA) published a final order exempting dozens of Class I and Class II medical devices that previously required 510(k) submission from 510(k) … [Read more...]

GENETIC TESTING

FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval

Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to … [Read more...]

EMERGING TESTS

Zika Antibody Detection Tests Go from Emergency to Commercial Clearance

 Over the past several years, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did … [Read more...]

EMERGING TESTS

Emerging Tests: New Genetic Tests May Be Better than PSA Screening in Assessing Prostate Cancer Risk

The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening based on their specific circumstances. The reason that the USPTF does not directly … [Read more...]

GENETIC TESTING

FDA Watch: Expanded Label Clearance Opens Cologuard to a Younger Market

September was an eventful month for one of the hottest products on the consumer genetic test market, the Cologuard multi-target stool DNA test (mtSDNA) for colorectal cancer screening produced by … [Read more...]

FDA WATCH

Emerging Tests: FDA Breaks New Ground by Clearing EIA Technology-Based Lyme Assays

Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against Borrelia burgdorferi, the bacteria that causes the disease, in a patient's blood. Traditional testing uses … [Read more...]

GENETIC TESTING

LDTs: FDA Cracks Down on Marketing of Non-Approved PGx Medication Response Tests

Laboratory Developed Tests (LDTs) are back in the FDA's enforcement crosshairs. This time the target is marketing claims related to the medication predictive qualities of pharmacogenetics (PGx) tests … [Read more...]

FDA

FDA Watch: Agency Issues New Guidance on Biotin Interference Testing

On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform biotin interference testing and communicate testing results to labs, clinicians … [Read more...]

EMERGING TESTS

FDA Greenlights Assays Using New Test Model for Lyme Disease Diagnosis

Lyme disease is on the increase. And so is the number of products cleared for detecting it. In fact, products for detecting tickborne diseases have been reaching the U.S. market at a dramatically … [Read more...]

COMPLIANCE

Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]


(-00000g2)