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 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.
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 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.