NEW YORK (GenomeWeb News) – BioHelix today announced that the US Food and Drug Administration has given 510(k) clearance for its assay for the detection of herpes simplex virus.
The IsoAmp HSV Assay is BioHelix's first FDA-cleared molecular diagnostic test and is for detecting the virus in genital and oral lesion specimens from symptomatic patients. The device is not FDA-cleared for use with cerebrospinal fluid, the Beverly, Mass.-based firm said. It added the test does not differentiate between HSV-1 and HSV-2 and is not for use for prenatal screening.
The IsoAmp platform is in the form of a single-use handheld detection device and is based on helicase-dependent amplification (HDA) technology. The IsoAmp test consists of a one-step dilution sample preparation method, isothermal nucleic acid amplification, and instrument-free detection of the amplification products with a disposable handheld cassette.
Test results can be achieved within one-and-a-half hours, said 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," Huimin Kong, president and CEO of BioHelix, said in a statement.
While the test is the first FDA-cleared molecular diagnostic test from the company, BioHelix has been in the space for several years. In 2009 it forged a deal with Quidel to jointly develop and commercialize in vitro MDx tests, and the year before Qiagen licensed BioHelix's HDA technology.