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Cepheid's Xpert Xpress SARS-CoV-2 rapid molecular diagnostic test can be used in high- and moderate-complexity labs and at the point of care in certain settings.
The deal is part of a wider collaboration between the companies to develop molecular diagnostic tests using their respective platforms.
A recent study established high sensitivity and specificity for three CLIA waived point-of-care molecular flu tests in pediatric samples.
A handful of rapid 2019-nCoV assays are in the works which could help triage patients more effectively and avoid unnecessary quarantines.
In one of two clearances in October, DiaSorin got the nod to market its Liaison XL Zika Capture IgM II test for the detection of Zika virus IgM antibodies.
The company's life sciences revenues were up 6 percent while its diagnostics business grew almost 7 percent.
The FDA gave the nod to Shenzhen Bioeasy Biotechnology for two lateral flow immunoassays that provide preliminary results in detecting marijuana in urine.
The in vitro diagnostic test can deliver molecular results from whole blood samples in less than three hours, the company said.
The company said its test is faster, more precise, and cheaper than the current gold standard Cepheid GeneXpert test.
The test is the first near-patient assay for M. genitalium, and can also guide treatment by detecting antibacterial resistance markers.