IMD’s FDA-cleared IMDx HSV-1/2 for Abbott m2000 assay is available in the U.S. This in-vitro diagnostic test, that detects and differentiates Herpes Simplex Virus type 1 (HSV-1) and type 2 (HSV-2) DNA from male and female skin lesions from anogenital or oral sites, was approved by the FDA in May.
Herpes simplex type 1 (HSV-1) and herpes simplex type 2 (HSV-2), the most common causes of oral and genital lesions, are spread through sexual and skin-to-skin contact. According to the Centers for Disease Control and Prevention (CDC) this sexually transmitted disease (STD) affects one out of every six people aged 14 to 49 years in the U.S., and more than 80% are unaware that they are infected. Qualitative detection of HSV-1 and HSV-2 is critical to control the spread of genital herpes.
The Abbott m2000 system is designed to automate all of the complex and manual steps associated with molecular diagnostic testing. The Abbott m2000 assay is intended for use as an aid in the diagnosis of HSV infection in symptomatic patients. The assay utilizes PCR to generate amplified product from the Glycoprotein-D and UL-30 genes of HSV-1 and HSV-2, respectively, present in clinical specimens. Advanced automation allows flexible sample preparation options of 24, 48, 72, or 96 samples per run and the extensive m2000 test menu for infectious disease allows platform consolidation.
Improved confidence in result reporting is ensured with more options in patient testing, differentiation between HSV-1 and HSV-2 detection for specific disease state management, and maxRatio data analysis which performs multiple validity checks on each patient result.
In the past 10 months, this is the fourth test to receive FDA clearance in IMDx’s portfolio of infectious disease tests for use on Abbott’s m2000 system. IMDx HSV-1/2 is not FDA-cleared for use with cerebrospinal fluid or for prenatal screening.