Chembio Diagnostics has completed patient enrolment in a pivotal clinical trial of its dual path platform (DPP) human immunodeficiency virus (HIV) 1/2 assay, used for the detection of antibodies for HIV-1 and 2 in oral fluid, finger-stick whole blood, venous whole blood, serum or plasma samples.
The 3,000-patient study is designed to include various patient groups, as required by the US Food and Drug Administration (FDA) to support the sensitivity and specificity of the product across various demographics. The trial is in support of a pre-marketing approval (PMA) application to the FDA for DPP HIV 1/2 assay.
The test is intended to be used in the preliminary diagnosis of patients with HIV in point-of-care settings, such as public health and other clinics, hospital emergency rooms and physician offices.
The HIV 1/2 test is intended to be used in the preliminary diagnosis of patients with HIV in public health and other clinics, hospital emergency rooms and physician offices, delivering visual results within 15 minutes.
The assay is based on the company’s patented DPP technology, which enables samples to directly bind with target analytes before detection reagents are introduced to visualise the test results, improving accuracy compared to current lateral flow HIV test technologies.
Lawrence Siebert, Chembio chief executive officer, said now that enrolment in the pivotal trial is complete, reference lab testing will be completed and the clinical sites will be closed by early May. Then the company will finalise and submit the third and final module of the PMA application to the FDA.
"This final module is principally comprised of this study’s data. We believe that the product will meet the required performance on all sample matrices," Siebert added.
Chembio Diagnostics develops, manufactures, licenses and markets proprietary rapid diagnostic tests.