MADISON, Wis.--(BUSINESS WIRE)-- EraGen Biosciences, Inc. 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.
The MultiCode®-RTx HSV 1&2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV 1&2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection. The device is not FDA cleared for the use with cerebral spinal fluid (CSF) or any lesions other than vaginal. This assay is not intended to be used for male penile specimens, for prenatal screening, or for females under the age of 18 years.
“EraGen’s HSV 1&2 Kit is the first FDA-cleared, molecular PCR test for HSV 1&2 detection and typing from vaginal lesion specimens. It has considerable advantages over the traditional testing methodologies used today,” said Irene Hrusovsky, M.D., chief executive officer and president 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 the kind 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 both HSV types 1 and 2 for vaginal lesion swabs 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 had relied on culture, serology or laboratory developed tests. We are very pleased to offer the clinical laboratory market a superior molecular 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 swab specimens in symptomatic female patients, which is critical to the diagnosis and treatment of these HSV patients, 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.
About EraGen Biosciences
EraGen Biosciences develops, manufactures and markets innovative molecular diagnostic products that are driving a new era in clinical diagnostics and research. 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. EraGen’s expanding menu of high-quality, easy-to-use products position the company for leadership in molecular diagnostics. For more information, visit the EraGen website at www.eragen.com.
Irene Hrusovsky, M.D.
President & Chief Executive
The Luminis Group, Ltd.
for EraGen Biosciences