Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic solutions, announced today that it received the CE Mark for its Quidel Molecular Direct HSV 1+2/VZV assay for the differentiation and detection of herpes simplex viruses 1 and 2 (HSV 1+2) and varicella-zoster virus (VZV) in active lesions.
Quidel's new PCR assay kit distinguishes between three infectious diseases: HSV 1, the virus responsible for most cold sores and some genital herpes transmissions; HSV 2, the virus primarily responsible for most genital herpes and some cold sores; and VZV, the virus responsible for chicken-pox in children and shingles among adults.
"The Centers for Disease Control and Prevention (CDC) estimates that there are almost 800,000 new cases of herpes in the United States each year, and about 1 in 6 Americans aged 14 to 49 have a genital HSV 2 infection,"1 said Dr. Timothy Stenzel, M.D., Ph.D., chief scientific officer of Quidel. "Although the classical signs of herpes are easy enough to recognize, the majority of patients present with atypical lesions that can be misinterpreted or confused among these three or other infections. For this reason, the introduction of a fast and accurate molecular test that distinguishes between HSV 1, HSV 2 and VZV is not only desirable, but is also consistent with recently issued European guidelines on managing genital herpes."2
The Quidel Molecular Direct HSV 1+2/VZV assay is part of Quidel's expanding line of molecular diagnostics products. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers. These reagents provide attractive features that include refrigerated storage instead of freezing, ready-to-use reagents, a short time to result, and other benefits that favorably affect diagnostic test outcome.
The Quidel Molecular Direct HSV 1+2/VZV assay kit includes an extraction-free, three-step sample preparation process that requires no heat step, no timed step, and no centrifugation as added benefits. This fast and easy direct-to-amplification procedure allows the assay to generate a result in under an hour.
"We are pleased to receive the CE Mark for our fifth Quidel Molecular assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our Quidel Molecular Direct HSV 1+2/VZV assay allows us to offer a molecular complement to our best-selling ELVIS cell-based assay for herpes detection. Hospital workers will now have the ability to quickly diagnose similar herpes diseases in children and adults through the characterization of samples obtained from lesions."
Quidel offers other CE Marked and 510(k)-cleared molecular tests in the Real-Time PCR format for Influenza A+B, hMPV, RSV + hMPV and C. difficile.
1. http://www.cdc.gov/std/Herpes/STDFact-Herpes.htm
2. http://www.iusti.org/regions/europe/pdf/2010/Euro_Guideline_2010_herpes.pdf