North America
FDA Grants Emergency Use Authorization for Northeastern University SARS-CoV-2 Test
The RT-PCR-based test was developed by Northeastern University's Life Sciences Testing Center.
The test measures a panel of proteins in patient blood to determine if they have a bacterial or viral infection, or if they have a bacterial-viral co-infection.
FDA Revises SARS-CoV-2 Test Emergency Use Authorization Requirements to Account for Variants
The agency is requiring test developers to monitor emerging mutations and their potential impact on the performance of authorized SARS-CoV-2 tests.
OraSure Technologies Nabs $13.6M BARDA Funding
The funding will support OraSure's efforts to obtain 510(k) clearance and CLIA waiver for the InteliSwab rapid SARS-CoV-2 antigen test.
Kephera Diagnostics Wins $300K NIH Grant for Chagas Disease Test
The test will be designed in both laboratory-based and point-of-care formats to address the needs of clinical and field settings.
Sep 23, 2021
Sep 22, 2021