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nucleic acid amplification

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 agency updated its guidance for samples tested using nucleic acid testing, saying the technology has improved detection for the viruses.

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.

Recent action from the FDA to reclassify certain point-of-care flu diagnostics means the agency will keep a closer eye on the tests' sensitivity and specificity.

The updated guidance comes on the heels of new data suggesting that for some individuals, antibodies to the Zika virus may stay in the body for months after infection. 

The Medicare contractor proposed coverage for several cancer assays, but would not cover molecular respiratory virus assays or a test for inflammatory bowel disease.

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