First Molecular Test Cleared for HSV-1 and HSV-2

Emma Hitt, PhD

May 24, 2010

May 24, 2010 — The US Food and Drug Administration (FDA) has granted 510(k) market clearance for a herpes simplex virus (HSV) 1 and HSV-2 polymerase chain reaction (PCR) kit.

The test, the MultiCode-RTx, manufactured by EraGen Biosciences, Inc, is the first such test cleared for the virus and will distinguish between HSV-1 and HSV-2 in vaginal lesion specimens from symptomatic female patients.

"[C]linical laboratories can now provide PCR-based, qualitative detection of HSV types 1 or 2 as indicated in the package insert in approximately 4 hours utilizing a common nucleic acid extraction system and real-time PCR instrument," noted Maria Foster, EraGen's vice president of commercial operations, in a company news release.

According to the press release, the kit has excellent sensitivity and specificity, produces rapid results, and is simple to use. Previously "testing vaginal lesion specimens...relied on culture, serology or laboratory developed tests. We are very pleased to offer the clinical laboratory market a superior HSV testing alternative," she stated.

According to the manufacturer, the test is not FDA cleared for the use with cerebral spinal fluid or any lesions other than vaginal and is not intended to be used for male penile specimens, for prenatal screening, or for girls younger than age 18 years.