Chembio Diagnostics has received CE mark approval for its DPP Syphilis Screen & Confirm Assay.
DPP Syphilis Screen & Confirm assay utilizes the company’s patented Dual Path Platform technology which simultaneously yet separately detects both markers at the point of care, thus eliminating the need and resulting cost of two separate laboratory tests.
The company also anticipates that this test will be eligible for a Clinical Laboratory Improvement Act (CLIA) waiver and said which if granted would allow use of the test in point-of-care settings such as public health testing clinics and physician offices for screening of pregnant women.
Chembio Diagnostics CEO Lawrence Siebert said now that they intend to focus their efforts in the EU market in order to ramp up sales of DPP Syphilis Screen & Confirm Assay to meet that need, while they also move forward on their US FDA regulatory pathway.