Group A streptococcus | GenomeWeb

Group A streptococcus

The firm said that molecular product sales were up 103 percent, driven by the launch of the Solana Group A Strep assay earlier this year.

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

A month after Brexit fears pushed the GenomeWeb Index down half a percent, companies rallied on news of an acquisition and better than expected Q2 performances.

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.

The company issued the Class I recall in February because poor lamination between sample reaction wells led to inaccurate results, but has since resolved the issue.

With recent and impending launches of POC MDx platforms, some industry observers believe the technology could replace some POC immunoassays in a few years.

A number of firms now have FDA-approved Group A Strep assays, but end users may be hesitant to adopt them until Infectious Disease Society of America guidelines are updated.

The test is the second to be waived for use on the Alere i isothermal nucleic acid amplification platform, and detects Group A Strep DNA in eight minutes or less.

Solana leverages the helicase-dependent amplification technology that also underpins Quidel's AmpliVue molecular technology.

The firm received CLIA waiver of a strep A assay on its Liat platform yesterday, and a favorable evaluation of its influenza A/B assay was published last week.

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