NEW YORK (GenomeWeb) – IMDx said today it has received clearance from the US Food and Drug Administration to market the IMDx HSV-1/2 on the Abbott m2000 instrument.
The test detects and differentiates herpes simplex virus type 1 and type 2 DNA from male and female skin lesions from anogenital and oral sites, the Waltham, Mass.-based firm said. It added that it is the fourth test in the company's portfolio for use on the Abbott fully automated platform to receive FDA clearance in the past 10 months. Most recently, the agency cleared IMDx's C. difficile assay on the m2000 system in November.
FDA cleared the IMDx HSV-1/2 assay to aid in diagnosing HSV infection in symptomatic patients. It is not FDA-cleared for use with cerebrospinal fluid or for prenatal screening, IMDx said.
Citing statistics from the US Centers for Disease Control and Prevention, IMDx said that HSV-1 and HSV-2 are the most common causes of oral and genital lesions. An estimated one in six Americans is infected with HSV-2, while about 65 percent of Americans have HSV-1. No cure exists for HSV-associated infections, but the duration of outbreaks can be shortened and their frequency can be reduced with antiviral medications, which can also reduce transmission by sexual contact.
"Early identification of HSV is critical in controlling the spread of infection," IMDx Chairman and CEO Alice Nesselrodt said in a statement.