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...]
INDUSTRY BUZZ
FDA Watch: Agency Okays EIA Technology-Based Lyme Assays
September 3, 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...]
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...]
INDUSTRY BUZZ
FDA Watch: Agency Approves New STD Screening Assay Applications
July 1, 2019
The FDA broke new ground by clearing a pair of STD screening assays for detecting chlamydia and gonorrhea for use with extragenital specimens, specifically from the throat and rectum. The tests, … [Read more...]
INDUSTRY BUZZ
FDA Watch: New Warning Letter May Signal Resurgence of LDT Enforcement Activity
April 29, 2019
After a couple of years of dormancy, the FDA laboratory developed test (LDT) enforcement volcano stirred on April 4, when the agency issued a warning letter to Inova Genomics Laboratory (Inova) for … [Read more...]
NEWS
FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform
April 22, 2019
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for new devices and diagnostic tests. But last week, the … [Read more...]
INDUSTRY BUZZ
FDA Watch: Gottlieb Resignation Costs Lab Industry a Valuable Frenemy
March 27, 2019
Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he's held since 2017. Although his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry … [Read more...]
NEWS
Gottlieb Resigns as FDA Chief: Lab Industry Loses a Good Frenemy
March 25, 2019
Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he's held since 2017. But while his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry … [Read more...]
INDUSTRY BUZZ
FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results
February 25, 2019
On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to market. Under the "Safety and Performance Based Pathway" (new Pathway), new product … [Read more...]
