Chembio’s HIV Assays Gains CE Mark Approval
Chembio Diagnostics’ Dual Path Platform HIV 1/2 assay has won CE Mark approval, with an EU launch planned for the fourth quarter of this year, the Medford, N.Y., devicemaker announced Wednesday.
The assay works by detecting HIV antibodies in oral fluid or blood, relying on DPP technology which allows for a high degree of sensitivity and specificity, the company claims.
Data demonstrates that early HIV diagnosis enables those affected to enjoy almost the same life expectancy as those who are negative for the disease, says John Sperzel, president and CEO. In the EU alone, about 2.3 million are HIV positive, with at least one in three afflicted unaware of the condition.
In the U.S., the assay ranks as one of two FDA-cleared, CLIA-waived oral fluid HIV1/2 tests commercially available. — Jason Scott