EraGen Biosciences Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance for EraGen's MultiCode®-RTx HSV 1&2 Kit.
“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”
"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," said Irene Hrusovsky, M.D., president and chief executive of EraGen. "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."
EraGen's FDA-cleared HSV 1&2 Kit utilizes patented MultiCode®-RTx technology based on the company's novel synthetic DNA base pair: isoC:isoG. This unique probe free chemistry provides customers significant ease-of-use and workflow advantages.
"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," said Maria Foster, EraGen's vice president of commercial operations. "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."
Herpes simplex viruses cause oral and genital herpes infections. In immunocompromised individuals and infants, they can cause central nervous system disorders, blindness, liver disease, brain infections and other illnesses. EraGen's HSV 1&2 Kit will 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. Roughly one in six Americans between the ages of 14 and 49 are infected with HSV-2, according to the U.S. Centers for Disease Control and Prevention. It is one of the most common sexually-transmitted diseases in the United States.