Quidel | GenomeWeb

Quidel

The GenomeWeb Index, which fell nearly 9 percent in October, rebounded to a 1 percent gain in November, but still underperformed the Dow and Nasdaq.

The test is the fifth assay on the Solana platform to obtain clearance, and expands the firm's offerings in the women's health market. 

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.

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

The test uses the helicase-dependent amplification technology that underpins Quidel's AmpliVue line of molecular assays.

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.

Sales of the firm's infectious disease and women's health products were credited with driving the year-over-year increase in revenues.

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.

New products and a more normal 2016-17 flu season could accelerate revenues for Quidel, the investment bank said.

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