Chembio Diagnostics, which develops, manufactures, markets and licences point-of-care diagnostic tests, has received CE marking for its Dual Path Platform syphilis screen and confirm assay.
Using Chembio’s patented DPP technology, the assay permits the simultaneous yet separate detection of both markers at the point of care.
The approval confirms that the product has met all relevant EU consumer safety, health or environmental requirements, and can therefore be sold within the European Economic Area.
The company has recently begun clinical trials in the US in support of an application to the FDA for 510(k) clearance, which the company anticipates submitting in 2012.
Chembio also anticipates that the test will be eligible for a Clinical Laboratory Improvement Act waiver, which, if granted, would allow use of the test in public health testing clinics and physician offices for screening of pregnant women.