Binx Health said that when it received FDA CLIA waiver, it already had a strategic partner for sales of its POC platform and chlamydia and gonorrhea tests.
The firm said it believes that the results of a recent study are representative of the broader utility of the test and its potential for broad application to diagnose concussions.
DARPA program managers said they are developing different testing modalities that are crucially linked in their objective to facilitate more comprehensive and faster testing.
Bio-Techne expects the acquisition will provide it with a basis to build out its IVD presence, given Asuragen's diagnostic tests and regulatory expertise.
The European firm said it has developed a multiplex test in part to lessen concerns that confirmed variants could reduce the accuracy of its current PCR assays for SARS-CoV-2.
Diagenode already sells more than 30 real-time PCR tests that are CE-marked for the detection of bacteria, parasites, and viruses for multiple infectious diseases.
The firm said it is drawing up plans for its business in a post-pandemic world, planning the introduction of new testing panels and enhancing its respiratory panel.
The firm's CEO said that the deprioritization of its submission for a standalone SARS-CoV-2 assay running on its Verigene I molecular diagnostic instrument is puzzling.
Reuters reports that France is to recommend that people under 55 who received one dose of AstraZeneca's SARS-CoV-2 vaccine receive a different vaccine for their second dose.
