Business, Policy & Funding
Breaking news on Diagnostics business, policy & funding.
In Brief This Week: PerkinElmer, Chembio, Becton Dickinson, Fulgent Genetics, and More
News items for the in vitro diagnostic industry for the week of Sept. 20, 2021.
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.
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
Zymo Research Gets CE Mark for DNA Methylation Kit
Sep 22, 2021
Sep 17, 2021