National Lab Companies Move Quickly to Market Fujirebio’s Lumipulse for Earlier Alzheimer’s Detection
The new blood-based assay avoids painful lumbar punctures and may quicken Alzheimer’s diagnoses
FDA-dtet
FDA Approves Teal Wand as First At-Home Cervical Cancer Screening
Teal Health, the company manufacturing and distributing the test, says thousands of women are already on a waiting list for the assay
Diagnostics Pipeline: FDA Approves Visby Medical’s Over-The-Counter Women’s Sexual Health Test
It’s the first PCR-based sexually transmitted infection test platform for at-home use
FDA Watch: Expanded Label Clearance Opens Cologuard to a Younger Market
September was an eventful month for one of the hottest products on the consumer genetic test market, the Cologuard multi-target stool DNA test (mtSDNA) for colorectal cancer screening produced by Exact Sciences. The month started badly with the release of a CMS-sponsored research report finding Cologuard “less effective and considerably more costly” than alternatives. Although Exact Sciences quickly criticized the report and its analytical methodology, its stock took a beating.
FDA Watch: Agency Issues New Guidance on Biotin Interference Testing
From - Diagnostic Testing & Emerging Technologies
On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform…
FDA Greenlights Assays Using New Test Model for Lyme Disease Diagnosis
...
Already a member? Log in here
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
FDA Issues Warning for ‘Over Reliance’ on Rupture of Membrane Tests
...
Already a member? Log in here
FDA Considering Self-Collection Sample Regulation
...
Already a member? Log in here
FDA Medical Device User Fees Rise as Part of Reauthorization
...
Already a member? Log in here
Kellison Award goes to FDA’s Dr. Alberto Gutierrez
From - Laboratory Industry Report
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after…