Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Devyser Fetal RHD Screening Test Receives IVDR Certification
The qPCR-based test can help determine the rhesus D antigen status of the fetus in a pregnant woman.
PixCell Medical's CBC Analyzer Receives IVDR Certification
The HemoScreen instrument is a point-of-care five-part differential complete blood count analyzer that is used for rapid testing from a drop of blood.
Qiagen QiAcuityDx Digital PCR System Gets Regulatory Clearance in Australia, New Zealand
The system is currently available with research-use assays, and the firm expects to launch precision cancer tests in the future.
Called the Coalition for Effective Diagnostics, the organization has called on lawmakers to pass legislation revamping diagnostics regulation, including oversight of LDTs.
FDA Approves Roche CDx Test for Use With Jazz Pharmaceuticals Drug in Biliary Tract Cancer
The approval is for a new indication for Roche's existing Pathway HER2 (4B5) test and is intended to identify patients with HER2-positive biliary tract cancer.