510(k)

Applied Biocode intends to have panel for identifying 18 gastrointestinal pathogens on the clinical market by the end of the year.

Gencurix aims to achieve US FDA 510(k) clearance for its GenesWell BCT breast cancer prognostic test next year.

The test, which runs directly from a patient nasopharyngeal swab, is the fifth assay on the firm's sample-to-result molecular diagnostics platform.

The list includes "high throughput DNA sequence analyzer," "DNA genetic analyzer," and "mass spectrometer for clinical multiplex test systems." 

The RNA-based blood test takes less than five hours to detect the presence or absence of infection in patients who may have sepsis.

The assay has been available outside the US since November and runs on the Liaison MDX benchtop instrument. 

GenMark's CEO said that the firm continues to focus on growing the ePlex instrument's global reach and expanding its menu. 

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.

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Researchers suggest that genetic variations could influence the side effects people experience when using synthetic cannabinoids, the International Business Times reports.

An analysis has examined the makeup of researchers on Twitter and what they share, Nature News reports.

At Stat News, Jim Kozubek argues that the Broad Institute is pushing the boundary of what a nonprofit is.

In PNAS this week: gut microbes may affect honeybee weight, phenotype and gene expression changes in DiGeorge syndrome, and more.