The FDA said it is the first test authorized to test for M. genitalium, a slow-growing bacteria that is difficult to detect with traditional laboratory methods.
The assay, which was CE marked last month, qualitatively detects group B Streptococcus nucleic acid from 18- to 24-hour Lim broth enrichments.
Clinical research has shown that the assay exhibited 100 percent sensitivity compared to culture-based testing methods, Hologic said.
In Life Sciences, CEO Thomas Joyce noted a strong performance by Beckman Coulter, while in Diagnostics, he said Cepheid grew 25 percent year over year.
The British-based firm says that its assay detects hepatitis C via a single-use, disposable cartridge within 90 minutes of testing.
The grant is specifically intended to support the development of noninvasive, rapid tests that can be used at the point of care in developing country settings.
The firm's life science segment grew revenues 8 percent, but revenues from its diagnostics segment saw revenues retreated 4 percent.
The CE-marked test enables health professionals to distinguish between HIV-1 and HIV-2, and runs on the fully automated Cobas 6800/8800 systems.
The test is the first to be approved for the company's second-generation molecular detection system, but can also be run using the first-generation system alongside other existing assays.
The Medicare contractor proposed coverage for several cancer assays, but would not cover molecular respiratory virus assays or a test for inflammatory bowel disease.
A federal judge has ruled that drug companies, device manufacturers, and universities need to provide missing clinical data from hundreds of trials to a federal website, ScienceInsider reports.
A genetic analysis suggests red pandas might actually belong to two different species, New Scientist reports.
NPR reports that the US Centers for Disease Control and Prevention has fixed the problem with some of its SARS-CoV-2 testing kits.
In Nature this week: epigenetic factors that prevent healthy aging and more.