FDA clears BioHelix IsoAmp HSV molecular diagnostic assay

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.

“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.”

"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.