Along with an urgent public health challenge, the outbreak of the novel 2019-nCoV coronavirus in Wuhan, China, first reported on Dec. 31, has created a strategic opportunity for makers of lab tests. … [Read more...]
NEW PRODUCTS
FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
January 14, 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...]
FDA Watch: Agency Clears the Way for Approval of Blood-Based PSA Test
December 3, 2019
The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening. The reason it doesn’t directly recommend testing for all men in this age group is … [Read more...]
NEW PRODUCTS
FDA Watch: New Process for Simultaneous Review IVD Tests Used in Cancer Drug Trials
October 31, 2019
Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, the FDA issued final … [Read more...]
FDA WATCH
FDA Watch: New NGS Data Guidance May Ease Antiviral Drugs & Companion Test Approvals
October 21, 2019
A new FDA Technical Specifications document (Tech Doc) lists recommendations for sponsors on use of next generation sequencing data to secure approval of new antiviral drugs and related diagnostic … [Read more...]
INDUSTRY BUZZ
FDA Watch: Agency Okays EIA Technology-Based Lyme Assays
September 30, 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...]
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On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform biotin interference testing and communicate testing results to labs, clinicians …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...]
