regulatory approval
FDA Approves GSK's Jemperli With Ventana CDx for dMMR Endometrial Cancer
The FDA also approved the Ventana MMR RxDx panel as a companion diagnostic to select endometrial cancer patients for treatment with dostarlimab.
Roche Elecsys SARS-CoV-2 Serology Test Receives Health Canada Approval
The test measures the level of antibodies to the spike protein of the virus and can be used to establish immunity and vaccine efficacy.
Guardant Health Receives New York State Approval for Guardant Reveal MRD Test
The assay is Guardant Health’s first commercially available product for clinical management of early-stage tumors and is initially focused on colorectal cancer.
Delfi Diagnostics Starts Prospective Lung Cancer Screening Trial
The company is planning to commercialize its cancer early detection technology initially in lung cancer and is working with NYU researchers to explore future expansions.
Binx Health Chlamydia and Gonorrhea Test CLIA Waived
The 30-minute test can be used on samples from males and females in settings operating under a CLIA certificate of waiver.