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July 7, 2011
BioHelix announces FDA 510(k) submission of IsoAmp HSV Assay for rapid detection of Herpes Simplex Virus in genital and oral lesions.

Beverly, MA (July 7, 2011) – BioHelix Corporation announced today that it filed for U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s first molecular diagnostic test. The IsoAmp® HSV Assay is intended for the rapid detection of Herpes Simplex Virus Type 1 (HSV-1) and Herpes Simplex Virus Type 2 (HSV-2) in genital and oral lesion specimens from symptomatic patients.  The IsoAmp® HSV assay will run on BioHelix’s IsoAmp® system, which uses Helicase-Dependent Amplification technology to detect HSV-1 and HSV-2 DNA in clinician collected oral and genital lesion specimens. The total turn around time of the new IsoAmp® HSV assay is less than two hours as compared a minimum of one day for existing culture methods.

The IsoAmp® platform consists of BioHelix’s proprietary isothermal nucleic acid amplification technology and a disposable detection device. No special instrument is needed for performing the IsoAmp® assay other than a heating block, which allows broad market access of molecular diagnostic tests. IsoAmp® HSV Assay is the first product submitted to FDA, and the company is developing a growing portfolio of simple, rapid nucleic acid amplification tests for infectious diseases.
 
“The FDA submission of IsoAmp® HSV Assay is an important step toward BioHelix’s commitment to commercialize HDA technology for disease detection and patient management,” commented Huimin Kong, CEO and President of BioHelix. “Our mission is to improve the quality of patient-care by providing clinicians and laboratories with simple and cost-effective molecular diagnostic tests at near patient settings, wherein rapid solutions are necessary for prompt medical intervention.”

For more information on IsoAmp® HSV Assay

 
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