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IMDx Receives FDA Clearance for IMDx HSV-1/2 for Abbott m2000 Assay

IMDx announced has received FDA clearance for the IMDx HSV-1/2 for Abbottm2000 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 infected. Likewise, infection rates with HSV-1 are high, with an estimated 65% of Americans living with the virus. 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.

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