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FDA approves BioHelix molecular diagnostic assay

The US Food Drug Administration (FDA) has granted 510(k) approval for BioHelix's molecular diagnostic assay - IsoAmp HSV Assay.

The molecular diagnostic assay is used to detect Herpes Simplex Virus (HSV1 & HSV2) in genital and oral lesion from symptomatic patients specimens and results are obtained within1.5 hours.

The IsoAmp platform utilizes proprietary Helicase-Dependent Amplification (HDA) technology and a single use handheld disposable detection device.

The IsoAmp HSV molecular test consists of simple sample preparation (one step dilution); isothermal nucleic acid amplification; and instrument-free detection of the amplification products with a disposable handheld cassette.

BioHelix president and CEO Huimin Kong said FDA clearance of their IsoAmp HSV Assay is another step toward realizing their goal to commercialize their proprietary HDA isothermal amplification platform for improved disease detection and patient management.

The company said 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.