NEW YORK (360Dx) – Chembio Diagnostics said today that it has received CE marking for its DPP HIV-Syphilis combination assay — a single-use, point-of-care test for the detection of antibodies to HIV 1 and 2 and Treponema pallidum, the causative agent of syphilis.
The assay — cleared for marketing within the member states of the European Union, and the Caribbean region except for Puerto Rico — runs on the firm's Dual Path Platform chromatographic immunoassay technology, which has significant advantages over lateral flow technologies, Chembio said.
The assay requires a 10 microliter blood sample and provides results in 15 minutes. Test samples can be a finger stick of whole blood, venous whole blood, serum, or plasma.
Chembio CEO John Sperzel said in a statement that he believes the assay "can play a role in the global initiative to reduce transmission of HIV and syphilis to unborn children, as well as to screen certain populations to address growing HIV and syphilis co-infection rates."
Co-infection rates of HIV and syphilis are on the rise, but congenital syphilis is a preventable disease that could be significantly reduced through effective prenatal screening and treatment of infected pregnant women, Chembio said.
Sperzel said that the firm plans to bring its combination assay to market in the US as quickly as possible because of the lack of these kinds of combination tests in the market here. The firm has plans to complete a US-based clinical trial and file for US Food and Drug Administration approval early this year.
Chembio has previous regulatory approvals in Mexico and Brazil, and it is working to obtain approvals in Southeast Asia countries by leveraging the recent acquisition of Malaysia-based RVR Diagnostics, Sperzel added.