BEVERLY, Mass.--(BUSINESS WIRE)-- BioHelix Corporation has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s first molecular diagnostic assay, the IsoAmp® HSV Assay. The diagnostic test is intended for the detection of Herpes Simplex Virus (HSV1 & HSV2) in genital and oral lesion specimens from symptomatic patients. This is the first FDA cleared product in the company’s growing portfolio of simple, molecular nucleic acid amplification assays for infectious diseases. The device is not FDA cleared for the use with cerebral spinal fluid (CSF), does not differentiate between HSV-1 and HSV-2, and is not intended to be used for prenatal screening.
“Our mission is to improve the quality of patient care by equipping clinicians and laboratories with simple and cost-effective molecular diagnostic tests that provide rapid solutions to support infectious disease diagnosis,” commented Huimin Kong, President and CEO of BioHelix. “FDA clearance of our IsoAmp® HSV Assay represents an important product development milestone and is another step toward realizing our goal to commercialize our proprietary HDA isothermal amplification platform for improved disease detection and patient management.”
The IsoAmp® platform consists of proprietary Helicase-Dependent Amplification (HDA) technology and a single use handheld disposable detection device. The IsoAmp® HSV molecular test consists of:
1) simple sample preparation (one step dilution);
2) isothermal nucleic acid amplification; and
3) instrument-free detection of the amplification products with a disposable handheld cassette.
Results are available within 1.5 hours of obtaining the specimens. Because there is no requirement for instrumentation, the IsoAmp® technology enables broad market access to the benefits of molecular diagnostic testing, providing faster results as compared to viral culture methods.
About Herpes Simplex Virus (HSV)
Herpes simplex viruses (HSV-1 and HSV-2) are common and contagious viruses that cause blistering and sores on the mouth, lips or genitals. They are the cause of genital herpes, one of the most prevalent sexually transmitted diseases (STDs). Most genital herpes is caused by HSV-2. Nationwide, it is estimated that about one out of six people 14 to 49 years of age have genital HSV-2 infection.* Most of these individuals have minimal or no signs of infection. Despite this, genital herpes can be associated with illness, psychological problems and even mortality.1,2 Once a positive diagnosis has been made, antiviral medications can be taken to shorten and prevent outbreaks. In addition, daily suppressive therapy for symptomatic herpes can reduce transmission to partners.
About BioHelix Corporation
BioHelix’s is a molecular diagnostic company focused on improving the quality of healthcare through the development of simple molecular diagnostic tests for the near patient setting, wherein rapid solutions are required for prompt medical intervention. The company’s strategy is to develop and disseminate simple, rapid molecular tests to a broad market of laboratory settings through the use of proprietary isothermal amplification technology combined with simple and low cost detection device platforms that require little or no investment in equipment. BioHelix’s first product line is based on the IsoAmp® system, which combines proprietary Helicase Dependent Amplification (HDA) technology with an instrument-free detection device to enable laboratories to perform molecular diagnostic test with random-access flexibility and minimal capital expenditures. More information about the company can be found at www.biohelix.com.
1.Centers for Disease Control & Prevention (CDC) Genital Herpes - CDC Fact Sheet
2.Looker KJ, Garnett GP, Schmid GP. An estimate of the global prevalence and incidence of herpes simplex virus type 2 infection. Bulletin of the World Health Organization. Volume 86, Number 10, October 2008, 737-81.
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