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Madeleine covers PCR, nucleic acid amplification, and sample prep technologies for GenomeWeb.
More than a dozen studies have been published to date directly comparing molecular diagnostic COVID-19 tests, with some detecting differences, mostly in sensitivity.
A handful of recently published trials suggest that use of the pneumonia panel could lead to more targeted therapy delivered more quickly than standard methods.
The acquisition will round out BD's molecular portfolio and be complementary to the firm's Veritor immunoassay system, according to executives.
With the US now awash in positive samples, assay developers seeking authorization will no longer be allowed to use contrived samples.
The firm has characterized the new product as a way to seize an opportunity, rather than a shift from its ID-AST focus.
The agency will now require commercial antibody test manufacturers to meet certain sensitivity and specificity thresholds.
With few FDA Emergency Use Authorized serology tests and little independent validation, US labs must choose among 100 assays of unknown quality.
The partners received Emergency Use Authorization last week for a test that uses oral fluids, and the lab has capacity to test up to 10,000 samples per day.
The agency plans to work with a number of partners to develop codes that will describe tests and results to standardize data collection.
MBS has developed a compact endpoint PCR system which can test more than 22,000 patient samples per day by performing eight-minute thermal cycling.