510(k) | GenomeWeb

510(k)

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

The point-of-care test delivers results in 13 minutes or less and will be available for the 2016-2017 respiratory season.   

The point-of-care test detects and distinguishes influenza A and B as well as respiratory syncytial virus in about 20 minutes.

Despite the array of tests available, some lab directors are still seeking broader functionalities and capabilities from the systems they purchase.  

The recent approvals underscore the usefulness of procalcitonin as a sepsis biomarker, even as newer molecular approaches to diagnosing the condition hit the market.

The technique aims to enable physicians to more precisely locate where to biopsy, and as a result patients would require fewer biopsies.

The device, the ORAcollectDx, is an alternative to buccal swabs and provides higher DNA yields, according to the firm.

The two-hour assay detects DNA of multiple species of Staphylococcus as well as the mecA drug-resistance gene in positive blood cultures.

The new PCR-based test is designed to detect Shiga toxin-producing Escherichia coli (STEC) and serotype O157 directly from patient specimens.

The firm has also submitted three other assays for special 510(k) clearance on the Torch system.

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In PNAS this week: genes involved in histone deacetylation in Arabidopsis, effects of pathogenic presenilin-1 mutations, and more.

After a study finds DNA from antibiotic-resistant bacteria in Beijing smog, residents there worry, according to the New York Times.

Canada begins its search for a chief government science advisor, Nature News reports.

A company is using facial recognition tools to identify genetic disorders from pictures, Technology Review reports.