Chembio Diagnostics, Inc., a leader in point-of-care ("POC") diagnostic tests for infectious diseases, announced today that its HIV 1/2 STAT-PAK(R) Assay received CE Mark approval from European regulators. The Chembio HIV 1/2 STAT-PAK(R) 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% of newly diagnosed HIV infections in the European Region were diagnosed late (with CD4 cell counts below 350/mm) and 30% even later (with CD4 cell counts of 200/mm 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(R) HIV 1/2 and SURE CHECK(R) HIV 1/2 Assays are important tools in the fight against HIV/AIDS. The simple test procedure, fast turnaround time, and reliable results make Chembio STAT-PAK(R) HIV 1/2 and SURE-CHECK(R) HIV 1/2 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(R) Assay and recently CE marked Chembio SURE CHECK(R) HIV 1/2 Assays in Europe. In addition, we continue to work with regulators in Europe to obtain CE Marks for the Chembio DPP(R) HIV 1/2 Oral Fluid test and the Chembio DPP(R) HIV-Syphilis test," added Sperzel.
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% of newly diagnosed HIV infections in the European Region were diagnosed late (with CD4 cell counts below 350/mm) and 30% even later (with CD4 cell counts of 200/mm 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(R) HIV 1/2 and SURE CHECK(R) HIV 1/2 Assays are important tools in the fight against HIV/AIDS. The simple test procedure, fast turnaround time, and reliable results make Chembio STAT-PAK(R) HIV 1/2 and SURE-CHECK(R) HIV 1/2 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(R) Assay and recently CE marked Chembio SURE CHECK(R) HIV 1/2 Assays in Europe. In addition, we continue to work with regulators in Europe to obtain CE Marks for the Chembio DPP(R) HIV 1/2 Oral Fluid test and the Chembio DPP(R) HIV-Syphilis test," added Sperzel.