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
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On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform biotin interference testing and communicate testing results to labs, clinicians …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...]
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...]
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...]
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...]
INDUSTRY BUZZ
FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review
January 28, 2019
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]
INDUSTRY BUZZ
FDA Watch: First NGS Residual Cancer Detection Test Wins Approval
December 31, 2018
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute … [Read more...]
INDUSTRY BUZZ
FDA Watch: Changes to CBER Email Policy May Affect Your Lab
November 19, 2018
Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use. The agency changed its email communications policy on … [Read more...]
