FDA Clears Roche Tests

The US Food & Drug Administration (FDA) recently cleared Roche Holdings Ltd.’s ( RHHBY ) IgG Antibody to herpes simplex virus (HSV) types 1 and 2 assays for use on cobas modular platforms. The immunoassays will be used with Roche’s patented and highly innovative Electrochemiluminescence (ECL) technology.

Roche’s new tests are designed to help the presumptive diagnosis of HSV-1 and HSV-2 infection in sexually active individuals and expectant mothers. The FDA approved the tests for use on the Elecsys 2010, cobas e 411, cobas e 601, cobas e 602 and Modular Analytics E170 analyzers.

As per the company the HSV type 1 is prevalent in around 70-90% of the population where as the HSV type 2 is prevalent in approximately 17-25% of the population.

We remind investors that in July this year, the FDA also cleared a fully automated vitamin D test for use on Roche’s cobas modular platforms. As per the company, around one billion people world over suffer from vitamin D deficiency.

We note that vitamin D testing is increasing rapidly in the US and the test will open up a good market opportunity for Roche. Roche’s vitamin D test is also available in the EU.

In July, Roche also expanded its blood screening portfolio with an integrated serology testing offering. This serology offering also utilizes the company’s ECL technology. The new serology testing offering is now available to blood and plasma screening laboratories on the modular cobas 4000, 6000 and 8000 analyzer series.

Roche, headquartered in Basel, Switzerland, carries a Zacks #4 Rank (Sell rating) in the short run.