Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
EliTechGroup Obtains CE Mark for Saliva Use With SARS-CoV-2 Test
The PCR-based test was originally released in September for use with nasopharyngeal, nasal, and oropharyngeal swabs.
FDA Grants EUAs for SARS-CoV-2 Tests From Thermo Fisher Scientific, Phase Scientific International
Thermo Fisher's molecular test uses targets across three genomic regions to ensure accurate detection, while Phase Scientific's antigen test can be used at the point of care.
NYU Langone Health Gets FDA Clearance for Solid Tumor Gene Sequencing Test
The test uses next-generation sequencing to detect cancer-linked mutations in 607 genes to help guide patient treatment.
Cepheid Nabs CE Mark for PCR-Based HIV-1 Tests
Both tests run on any of the firm's GeneXpert systems and add second targets for HIV detection and early identification.
Scope Fluidics Obtains CE Mark for PCR-Based SARS-CoV-2 Panel
The firm said many testing locations could benefit from the system’s performance, including medical centers and places frequented by the public.