EraGen Biosciences has received FDA 510(k) market clearance for its MultiCode-RTx HSV 1&2 Kit, which utilises patented MultiCode-RTx technology based on the company’s synthetic DNA base pair: isoC:isoG.
EraGen’s HSV 1&2 Kit is expected to distinguish between HSV-1 and HSV-2 in vaginal lesion specimens from symptomatic female patients. This is critical to the diagnosis and treatment of patients with HSV, as HSV-2 infections have a higher recurrence rate than HSV-1.
EraGen said that the device is not FDA cleared for the use with cerebral spinal fluid (CSF) or any lesions other than vaginal. The assay is not intended to be used for male penile specimens, for prenatal screening, or for females under the age of 18 years.
According to the US Centers for Disease Control and Prevention, roughly one in six Americans between the ages of 14 and 49 are infected with HSV-2, It is one of the most common sexually-transmitted diseases in the US.
Irene Hrusovsky, president and chief executive of EraGen, said: “EraGen’s HSV 1&2 Kit is the first FDA-cleared, molecular test for the herpes simplex virus. It has considerable advantages over the traditional testing methodologies used today for the detection and typing of the virus in symptomatic women.
“This clearance is an important accomplishment for EraGen. It represents the commitment of everyone in the company to meeting the rigorous regulatory requirements necessary to achieve clearance of innovative, high-quality in vitro diagnostic tests.”
Maria Foster, vice president of commercial operations of EraGen, said: “With the clearance of EraGen’s HSV 1&2 Kit, clinical laboratories can now provide PCR-based, qualitative detection of HSV types 1 or 2 as indicated in the package insert in approximately four hours utilizing a common nucleic acid extraction system and real-time PCR instrument.
“The HSV 1&2 Kit delivers excellent sensitivity and specificity, rapid time to result, streamlined workflow and simple implementation for both large and small laboratories. Until the FDA’s clearance of EraGen’s MultiCode-RTx HSV test, laboratories testing vaginal lesion specimens have relied on culture, serology or laboratory developed tests. We are very pleased to offer the clinical laboratory market a superior HSV testing alternative.”
EraGen Biosciences develops, manufactures and markets molecular diagnostic products. The company’s in-market and pipeline products, based on its novel, patented MultiCode platform chemistry, are the next generation of DNA- and RNA-based testing for the early detection of infectious diseases and genetic conditions.