FDA clearance
FDA Authorizes Visby Medical At-Home MDx Test for Chlamydia, Gonorrhea, Trichomoniasis
The 30-minute test detects three sexually transmitted infections from a vaginal swab at home.
FDA Clears Qiagen QiaStat-Dx Mini Gastrointestinal Panel
The assay detects five pathogens that cause acute gastrointestinal illness, complementing the firm's 16-target test.
FDA Clears Qiagen QiaStat-Dx Meningitis/Encephalitis Panel
The panel is the fourth FDA-cleared test on Qiagen's rapid syndromic QiaStat-Dx system.
Devyser Fetal Abnormality Test Nabs China Approval; Firm, Thermo Fisher Collaborate on FDA Approval
The fetal abnormality test measures the most common chromosomal abnormalities, including Down syndrome, via a single-tube PCR process.
FDA Approves Thermo Fisher Oncomine Dx Target Test as CDx for Servier's Voranigo Brain Cancer Drug
The approval expands the clinical indications for the test, which was previously approved as a CDx for non-small cell lung cancer, thyroid cancer, and bile duct cancer drugs.