Chembio Diagnostics, Inc.which develops, manufactures, markets and licenses point-of-care diagnostic tests, reported it recently filed the first module of its Pre-Marketing Approval (PMA) application to the United States Food & Drug Administration for its DPP HIV 1/2 Screening Assay.
Chembio's DPP HIV 1/2 Screening Assay is a “yes/no” qualitative rapid test for the detection of antibodies to HIV 1 & 2 in oral fluid, finger-stick whole blood, venous whole blood, serum or plasma samples. The test is intended to be used as an aid in the diagnosis of HIV/AIDS in point-of-care settings such as public health and other clinics, hospital emergency rooms, and physicians' offices.
The DPP HIV 1/2 Screening Assay delivers visual results within approximately 15 minutes, is simple to use, has a shelf life of 24 months, and does not require refrigeration. The product incorporates Chembio's patented Dual Path Platform technology as well as a proprietary sample collection system that enables certain unique product features.
In March Chembio received approval from the FDA to submit this PMA application as a Modular PMA. In a Modular PMA the PMA is viewed as a compilation of sections such as preclinical, clinical, and manufacturing that together become a complete application. The process begins with a PMA Shell which lays out the plan for submission of the modules.
Lawrence Siebert, Chembio's CEO, commented, “We are pleased that we have initiated the FDA's Modular PMA process, including the approval of our filing plan last month and our recent submission of this first module. We anticipate filing our remaining two modules in the third and fourth quarters of 2011, respectively.”
The PMA Shell is an outline of modules and identifies information necessary to support the filing and approval of a product subject to the PMA requirements (such as an HIV test) through a combined IDE and PMA process. The FDA reviews each module separately as it is received, allowing manufacturers to receive timely feedback during the review process. A traditional PMA takes 180 days for the FDA to complete its initial review. A modular PMA takes the FDA 90 days to complete its review of each module. Thus the modular approach will allow the FDA to make a decision in half the time once all information to support the basis of approval is on file.
The first PMA module that Chembio recently submitted is the manufacturing information for the product. The non-clinical data and clinical data will constitute the second and third PMA modules, respectively. Chembio anticipates filing these remaining modules during the next six months, although there can be no assurance of this. As previously reported, during the last year, this product was approved in Brazil and evaluated in comparative studies in Mozambique and Nigeria with excellent results. The product is now in the process of being deployed in Brazil's national testing programme.