Even before the pandemic began, concerns over the marketing of fraudulent home testing kits had been a sore spot with the FDA. So, when the agency first began to roll out its liberalized clearance … [Read more...]
Industry Buzz
COVID-19 Relief Bill Leaves Labs Out in the Cold
March 30, 2020
Labs who have answered the call to mobilize beyond capacity so that people can be tested for COVID-19 can be forgiven for thinking nobody in Washington “CARES” about them. What else are they supposed … [Read more...]
FDA
FDA Watch: Agency Finalizes CLIA Waiver Guidance for New IV Devices
March 6, 2020
On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here are the highlights. CLIA Waivers The first guidance … [Read more...]
NEW PRODUCTS
FDA Watch: Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
February 8, 2020
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
January 30, 2020
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...]
DEALS
Industry Buzz: The 10 Biggest DX Mergers of 2019
January 14, 2020
Conspicuous by its absence from the list is the proposed $1.2 billion Illumina takeover of Pacific Biosciences which suddenly seems to be in major trouble. Here are the 10-highest value M&A … [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...]
