Roche nabs FDA clearance for quick strep test

The cobas Liat System--Courtesy of Roche

Roche ($RHHBY) is on course to expand its diagnostics offerings with a new test that aims to cut down the time it takes to diagnose strep throat.

The FDA granted 510(k) clearance for the test, which delivers results in just 15 minutes. The product is expected to hit the market by year's end.

The Swiss company says its molecular point of care diagnostic--dubbed the cobas Strep A--is the first of its kind. Strep A, or group A streptococcus bacteria, causes a common infection that can lead to strep throat as well as certain skin infections, scarlet fever and toxic shock syndrome.

Using DNA taken from throat swab specimens, the test runs on the cobas Liat System diagnostic, which is slated to launch later this year.

Conventional rapid strep tests, or rapid antigen detection tests, can sometimes be unreliable. Anywhere between 5% to 30% of these tests fail to detect strep bacteria when they're actually present. Companies like Becton Dickinson ($BDX) and Quidel ($QDEL) sell these rapid strep tests.

The new cobas Strep A test adds to Roche's growing portfolio of assays designed for the cobas Liat System, which the company acquired in a $450 million deal back in April with IQuum. An influenza A/B assay is also available for the compact diagnostic system.

Roche said it expects to begin selling the system and two assays later this year.

- see the press release

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