A new HSV diagnostic test from EraGen Biosciences Inc., a manufacturer of diagnostic products, recently received 510(k) market clearance from the FDA. The product, a PCR (Polymerase Chain Reaction) test, is called Multicode® RTx HSV 1&2 Kit.
“EraGen’s HSV 1& 2 Kit is the first FDA-cleared, molecular test for the herpes simplex virus,” states Dr. Irene Hrusovsky, president and chief executive of the company. “It has considerable advantages over the traditional testing methodologies used today for the detection and typing of the virus in symptomatic women.”
Unlike a standard herpes culture test, the new test from EraGen is approved for the detection and typing of herpes simplex virus (HSV) DNA specifically using a vaginal swab specimen. Thus, the test is approved only for symptomatic women.
PCR tests make copies of viral DNA as part of their testing process and are known to detect the herpes simplex virus even when very little virus is present. These tests can detect HSV in a sample in as little as four hours and can distinguish between HSV-1 and HSV-2.
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.
It should be noted that non-FDA approved PCR tests are routinely in use by many labs already, including the largest, Quest and LabCorp. These tests are more sensitive than culture and can type the virus as well.