FDA Approval For MedMiras Reveal G2 Rapid HIV-1 Antibody Test
MedMira have announced today that it has received U.S. Food and Drug Administration approval of its new Reveal G2 Rapid HIV-1 Antibody Test (Reveal G2) for use in detecting HIV-1 antibodies in human serum or plasma.
This second generation rapid HIV test is significantly different from the previous version (FDA-approved in April 2003). One of its key features, an on-board control line, will assist laboratory professionals to obtain rapid and high quality-controlled results while virtually eliminating the requirement for external control testing with each batch of specimens. Performance of this new product in clinical studies has demonstrated 100% correlation between the two generations of the Reveal product.
The new Reveal G2 will soon be available in the USA, replacing the current version of the product. With over 180,000 testing locations, including laboratories and hospitals, conducting an estimated 65 million HIV tests each year in the United States, MedMira anticipates continued sales growth and broader application of rapid flow-through testing.
The new on-board control line featured in RevealTM G2 allows laboratory technicians to quickly and easily determine the validity of the test result, allowing for easier use, best time efficiency in busy labs and faster access to patient care.
Source : MedMira Inc., View Company Information
Posted on June 25, 2004