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...]
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
LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
September 16, 2019
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict patients' responses to medications. It began in 2018, when the FDA warned consumers and … [Read more...]
FDA
Inside Washington: What’s Going on with Regulation of LDTs?
September 9, 2019
Although things appear to be quiet, progress is actually being made in the quest to create workable regulation of Laboratory Developed Tests (LDTs) developments. Here's a rundown of the latest … [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On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform biotin interference testing and communicate testing results to labs, clinicians …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...]
EMERGING TESTS
Nonculture Molecular Tests Speed Diagnosis of Bloodstream Infections
August 19, 2019
The T2Bacteria Panel (T2Biosystems; Lexington, Mass.) can rapidly and accurately diagnoses bloodstream infections (BSIs) caused by five common bacteria, according to a study published May 14 in the … [Read more...]
FDA
FDA Watch: Agency Issues New Guidance on Biotin Interference Testing
August 6, 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...]
INDUSTRY BUZZ
FDA Watch: First Zika Assay Gets Green Light for Marketing
July 22, 2019
Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did something it had never done before: It … [Read more...]
