The US Food & Drug Administration (FDA) recently cleared
Roche Holdings Ltd.
) 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
Roche, headquartered in Basel, Switzerland, carries a Zacks #4
Rank (Sell rating) in the short run.
(RHHBY): ETF Research Reports
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