GEN Exclusives

More »

GEN News Highlights

More »
Oct 17, 2011

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.


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Climate Change and Disease

Are the incursions of dengue fever and West Nile virus into North America just the tip of the iceberg of insect-borne diseases that are migrating due to a warming planet?