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Quidel gets FDA 510(k) clearance for new rapid molecular diagnostic test

MDBR Staff Writer Published 26 October 2016

Quidel has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its new rapid molecular diagnostic test, Solana Strep Complete Assay.

The assay can be used for the rapid and qualitative detection and differentiation of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) and Streptococcus dysgalactiae (pyogenic Group C and G beta-hemolytic Streptococcus) nucleic acids isolated from throat swab specimens obtained from symptomatic patients.

The specimens do not require additional testing by culture, if they are identified as negative by the Solana assay.

The test requires no upfront extraction of DNA and provides result in around 25 minutes. It will accurately differentiate pyogenic Group A from pyogenic Group C or G.

Healthcare professionals can process up to 12 patient samples in each 25-minute run with the assay in moderately complex settings.

Solana molecular platform is said to leverage Helicase-Dependent Amplification (HDA) technology, which is part of firm’s AmpliVue molecular product line.

Solana Influenza A+B secured 510(k) clearance in September, while Solana Trichomonas assay received 510(k) clearance in August and Solana Group A Strep assay was cleared in June last year.

Quidel president and CEO Douglas Bryant said: "We are very pleased to receive FDA clearance for a definitive, comprehensive diagnostic for Streptococcal infections, and along with our recently-cleared Solana Influenza A+B Assay, comes just in time for the upcoming respiratory disease season.

“With the Solana system, we've given moderately complex labs what they want: a platform that provides definitive test results quickly, and in a scalable connected format with a low total cost of ownership.”


Image: Scanning electron micrograph of Streptococcus pyogenese bacteria (yellow) bound to a human neutrophil (blue). Photo: courtesy of National Institutes of Health (NIH).