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
January 3, 2020
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
November 16, 2019
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
November 16, 2019
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
October 17, 2019
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
September 24, 2019
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
September 24, 2019
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
September 3, 2019
On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform biotin interference testing and communicate testing results to labs, clinicians …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
August 28, 2019
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
April 15, 2019
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...]
