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The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.
The firm's technology can perform in-droplet centrifugation, 10-second cell lysis, and sound wave-based PCR on the surface of an inexpensive polymer chip.
The startup, which was founded by two Washington University researchers and a Wharton MBA, is looking to take a big bite out of Cologuard's market.
The assay's CE marking permits its use for the early diagnosis of HIV-1 in infants and for measuring viral load and disease progression using dried blood spot samples.
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.
In a letter, about two dozen researchers criticize the World Health Organization investigation into the origins of SARS-CoV-2 and call for a new inquiry, the Wall Street Journal reports.
National Geographic reports that nine great apes at the San Diego Zoo have been vaccinated against SARS-CoV-2.
Janet Woodcock, the acting commissioner of the US Food and Drug Administration, speaks with NPR about SARS-CoV-2 testing and vaccines in the US.
In Science this week: genetic study of kidney fibrosis implicates the SOX9-NAV3-YAP1 axis.