Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
FDA Grants Emergency Use Authorization to Xtrava Health SARS-CoV-2 Point-of-Care Antigen Test
Earlier this year, Xtrava Health won funding from the National Institutes of Health to develop a SARS-CoV-2 antigen test that can be used at the point of care.
FDA Classifies Abbott SARS-CoV-2 Molecular Test Recall as Class I Due to False Positives
Last month, the agency alerted users to the potential of false positives due to overflow of the PCR reaction mixture into neighboring wells of the assay reagent tray.
Biopix-T Gets CE Mark for Point-of-Care Platform, Molecular SARS-CoV-2 Test
The Greek molecular diagnostic company's Pebble analysis device relies on real-time quantitative colorimetric loop-mediated isothermal amplification.
FDA Approves Agilent Technologies CDx for Breast Cancer Drug Verzenio
The CDx is the first FDA-approved immunohistochemistry assay to measure Ki-67 protein expression in the context of treatment with Eli Lilly's abemaciclib (Verzenio).
FDA Grants EUAs for Cleveland Clinic COVID-19 PCR Test, Quest Diagnostics Sample Self-Collection Kit
The Cleveland Clinic's test uses self-collected nasal swab specimens, while Quest's kit is used to self-collect nasal specimens for molecular testing.