Chembio receives CE Mark approval for rapid POC detection of HIV

MEDFORD, N.Y.—Chembio Diagnostics Inc., which makes point-of-care (POC) diagnostic tests for infectious diseases, announced in March that its HIV 1/2 STAT-PAK Assay received CE Mark approval from European regulators. The Chembio HIV 1/2 STAT-PAK Assay is now cleared for commercialization within the European Union for rapid, POC detection of HIV.

According to the World Health Organization (WHO), more than 1.5 million people have been diagnosed with HIV in the European region since the start of the epidemic, including 131,000 new HIV cases in 2012. The WHO reports that in 2012, 50 percent of newly diagnosed HIV infections in the region were diagnosed late (with CD4 cell counts below 350/mm3) and 30 percent even later (with CD4 cell counts of 200/mm3 or lower), causing delayed initiation of antiretroviral therapy. Based on this data, the WHO reports that an increase in HIV testing and counseling needs to be scaled up in the battle against this disease.

“We believe the Chembio STAT-PAK HIV 1/2 and SURE CHECK HIV 1/2 Assays are important tools in the fight against HIV/AIDS. The simple test procedure, fast turnaround time, and reliable results make [the assays] uniquely suited for clinical and outreach settings, allowing immediate patient counseling and referral,” stated John Sperzel, President and CEO of Chembio.

“In the coming months, we expect to launch the Chembio HIV 1/2 STAT-PAK Assay and recently CE marked Chembio SURE CHECK HIV 1/2 Assays in Europe. In addition, we continue to work with regulators in Europe to obtain CE Marks for the Chembio DPP HIV 1/2 Oral Fluid test and the Chembio DPP HIV-Syphilis test,” added Sperzel.

Chembio Diagnostics develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $10 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the United States by Alere Inc. Chembio markets its HIV STAT-PAK line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors.

Chembio has developed a patented point-of-care test platform technology, the Dual Path Platform (DPP) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP.