antibody-based diagnostics
The UCLA-led research team used synthetic peptides and a machine learning-developed algorithm to create a test for the detection of Lyme disease antibodies in serum samples.
HHS, Steven & Alexandra Cohen Foundation Award $2M to Lyme Disease Dx Projects
Ten teams participated in a virtual accelerator designed to help them refine their concepts for detecting active Lyme disease infections.
MedMira Gets FDA 510(k) Clearance for HIV-2 Claims for HIV-1/2 Test
The firm is also seeking CLIA-waived status to expand access to its HIV-1/2 test that can be used to detect a broader range of HIV subtypes circulating in the US.
GrapheneDx, Sapphiros, General Graphene Ink Deal on Diagnostic Biosensors
Sapphiros will manufacture biosensor technology for GrapheneDx using graphene from General Graphene, and help commercialize tests through other partners.
QuidelOrtho COVID-19 Serology Tests Gain FDA Marketing Authorization
The tests are intended for prescription use for the detection of IgG antibodies to SARS-CoV-2 in human serum and plasma samples.