BioHelix’ IsoAmp Near-Patient HSV Diagnostic Gets FDA 510(k) Clearance

BioHelix received FDA 510(k) clearance for its first molecular diagnostic, the IsoAmp® HSV Assay. The test is designed to detect herpes simplex virus type 1 and 2 in genital and oral lesion specimens from symptomatic patients. The firm notes the test is not cleared for use with cerebrospinal fluid specimens, and doesn’t differentiate between HSV-1 and HSV-2, nor is it intended for use in prenatal screening.

BioHelix’ IsoAmp platform combines a helicase-dependent amplification (HDA) technology and single-use handheld detection device. The overall technology carries out sample preparation (one step dilution), isothermal nucleic acid amplification, and instrument-free detection of the amplification products on the disposable cassette. Results are available within 1.5 hours.

“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," comments Huimin Kong, president and CEO.

BioHelix is exploiting two isothermal amplification technologies: the in-house developed target-based HDA platform, and the primase-based whole-genome amplification platform (pWGA) licensed from Harvard University. The HAD platform is being used in the development of molecular diagnostics for near-patient testing, while the pWGA technology is being leveraged for a range of potential applications including the detection of trace quantities of contaminating DNA in biopharmaceuticals, vaccines, and enzymes used in clinical diagnostics.

In March the firm was awarded a BioHelix two-year phase 1 SBIR Advanced Technology grant from the NIH to develop a rapid malaria diagnostic based on the IsoAmp platform, in collaboration with Tulane University School of Public Health and Tropical Medicine.