NEW PRODUCTS

FDA Watch: Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]

FDA Watch

Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]

Industry Buzz

Lab Companies Scramble to Bring Coronavirus Detection Tests to Market

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

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

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

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

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

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

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

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...]


(-00000g2)