FDA clearance
LetsGetChecked Nabs FDA Marketing Authorization for Chlamydia, Gonorrhea Test
The assay is the first test for chlamydia and gonorrhea with at-home sample collection to receive marketing authorization, according to the agency.
FDA Grants Marketing Authorization for Invitae Hereditary Cancer DNA Sequencing Test
The Invitae Common Hereditary Cancers Panel is the first test of its kind to obtain FDA marketing authorization, creating an easier pathway for similar tests.
Streck Quality Controls for DiaSorin's Luminex Sepsis Tests Receive FDA Clearance
The quality controls are designed to verify the performance of the Luminex Verigene Blood Culture Gram-Positive and Gram-Negative tests.
FDA Clears 23andMe BRCA1/2 Consumer Health Risk Report for 41 Additional Variants
The 510(k) clearance will allow 23andMe to offer breast, ovarian, prostate, and pancreatic cancer risk assessments for a broader range of populations.
Hologic Nabs FDA 510(k) Clearance for Respiratory Assay
The multiplex real-time RT-PCR test for SARS-CoV-2, influenza A and B, and RSV is designed for use on the firm's high-throughput Panther Fusion instrument.