IMDx Receives FDA Clearance for IMDx HSV-1/2 for Abbott m2000 Assay
Waltham, MA, May 16, 2014 – IMDx announced today that it has received FDA clearance for the IMDx HSV-1/2 for Abbott m2000 assay, a 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. This is the fourth test in IMDx’s portfolio of infectious disease tests for use on Abbott’s fully-automated m2000 system to receive FDA clearance in the past 10 months.
HSV-1 and HSV-2 are the most common causes of oral and genital lesions and are spread through sexual and skin-to-skin contact. An estimated 1 in 6 Americans is infected with HSV-2 (16.7%), with more than 80% being unaware that they are infected1. Likewise, infection rates with HSV-1 are high, with an estimated 65% of Americans living with the virus2. While there is no cure for HSV-associated infections, antiviral medications are available that can shorten the duration of outbreaks, decrease their frequency, and reduce the threat of transmission to sexual partners.
“Early identification of HSV is critical in controlling the spread of infection,” says Dr. Alice Nesselrodt, Chairman & CEO of IMDx. “We are proud to now offer the IMDx HSV-1/2 for Abbott m2000 assay to customers in the United States.” The IMDx HSV-1/2 for Abbott m2000 test is intended for use as an aid in the diagnosis of HSV infection in symptomatic patients and is not FDA-cleared for use with cerebrospinal fluid or for prenatal screening.
About IMDx
Based in Waltham, MA, IMDx (www.IntelligentMDx.com) designs, develops and manufactures platform agnostic, regulatory-cleared molecular diagnostic tests that enable partners to more rapidly and efficiently expand test menus. Beyond growing its portfolio of assays for infectious disease, IMDx is pursuing new targets in companion diagnostics, oncology and human genetics, as well as next generation instrument systems. IMDx facilities are ISO 13485:2003 certified and all products are developed and manufactured within a regulatory compliant (FDA QSR, CE-IVDD and cGMP) environment.
1. Centers for Disease Control and Prevention, 2013- 2014
2. Wald, A., and Corey, L., (2007) Persistence in the population: epidemiology, transmission in Human Herpesviruses: Biology, Therapy, and Immunoprophylaxis (Chapter 36)., Cambridge University Press
Renda Hawwa, Ph.D.
Regulatory and Clinical Affairs Specialist
IntelligentMDx
285 Bear Hill Road
Waltham, MA 02451
Phone: (617) 871-6405
Fax: (617) 871-6399
Email rhawwa@IntelligentMDx.com
Visit us at www.intelligentMDx.com
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