Analyst Research

Report Title Price
Provider: Streetwise Reports
$69.00
Provider: Reuters Investment Profile
$20.00
Provider: Reuters Investment Profile
$20.00
Provider: Ford Investor Services, Inc.
$12.00

NYSE and AMEX quotes delayed by at least 20 minutes. NASDAQ delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.

Roche Holding AG Receives FDA Clearance For Herpes Simplex Virus Type 1 And 2 Tests


Tuesday, 4 Sep 2012 11:00am EDT 

Roche Holding AG announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IgG Antibody to herpes simplex virus (HSV) types 1 and 2 assays for use on cobas modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection. The Elecsys HSV-1 IgG and HSV-2 IgG assays are for the in-vitro qualitative determination of IgG class antibodies to HSV-1 and HSV-2 in human serum or plasma. The immunoassays are intended for use with Roche's electrochemiluminescence (ECL) technology, a sensitive light detection system that provides low-end sensitivity and broad dynamic measuring ranges. The tests are approved for use on the Elecsys 2010, cobas e 411, cobas e 601, cobas e 602 and MODULAR ANALYTICS E170 analyzers. Herpes Simplex Virus Type 1 is mainly transmitted via social contacts during childhood and is generally prevalent in 70-90% of the population. Herpes Simplex Virus Type 2 is usually transmitted sexually and has a prevalence of approximately 17-25% in the general population. HSV Type 1 is most commonly associated with oral herpes, causing infections (sores) of the mouth and lips. HSV Type 2 is primarily associated with genital herpes. Type-specific HSV IgG detection is fundamental to helping healthcare providers manage patients and develop strategies to prevent transmission to partners and babies. 

Company Quote

36.19
-0.03 -0.08%
4:00pm EDT