RT-PCR
Visby Medical Nabs FDA EUA for POC Respiratory Panel Test
The assay detects and differentiates between SARS-CoV-2, influenza A, and influenza B in nasopharyngeal swab specimens.
FDA Grants EUAs to Lucira Health Molecular COVID/Flu Test; Azure Biotech, CorDx COVID Antigen Tests
FDA said Lucira's test is the first molecular COVID-19 test to receive FDA authorization following collaboration with NIH's Independent Test Assessment program.
PerkinElmer Nabs Authorization for Molecular SCID/SMA Test in Newborns
The firm said its assay for spinal muscular atrophy and severe combined immunodeficiency can aid early identification and treatment of those potentially fatal diseases.
Virax Biolabs, Cosmos Holdings Ink Distribution Deal for Monkeypox PCR Test
Cosmos will have exclusive distribution rights for Greece and Cyprus with the opportunity to nonexclusively distribute the tests across Europe.
Helix Diagnostics SARS-CoV-2 Test Nabs FDA EUA for Serial Testing
The RT-PCR test is authorized for use only at the Michigan company's lab with samples collected by a healthcare provider or self-collected under the supervision of a healthcare provider.