Organization
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.
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.
Geisinger Wins $5M NIH Grant to Develop Point-of-Care Genetic Diagnostic Tool
The proposed "High Impact Phenotype Identification System" aims to reduce time to diagnosis of 13 high-impact genetic conditions.
Sep 22, 2021
Sep 17, 2021
UK Opens Consultation on New Diagnostics Regulations
Sep 16, 2021
Hong Kong-Based Prenetics to go Public via SPAC
Sep 15, 2021
Sep 2, 2021