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Quidel

The FDA go-ahead marks Quidel's fourth MDx test to receive 510(k) clearance for the Solana platform.

The test runs on the company's Solana instrument, which can process up to 12 patient samples in a 45-minute run.

The rapid molecular test showed 98 percent sensitivity and 97 percent specificity on more than 1,000 throat swabs prospectively collected at four US sites.

Sales of Sofia rapid immunoassay platforms and diagnostic kits led the increase in revenues.

NEW YORK (GenomeWeb) — Researchers at Johns Hopkins University have performed the first validation of the Cepheid Xpert Flu assay in a population of emergency room patients with acute undifferentiated respiratory illness.

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