Avioq, Inc. issued the following announcement on October 22.
Avioq, Inc. announces it has received approval from the U.S. Food and Drug Administration (FDA) for their VioOne™ HIV Profile™ Supplemental Assay.
The HIV Profile™ assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 (Group M & Group O) and HIV-2 in human serum or plasma. It is intended as an additional, more specific test to confirm the presence of antibodies in specimens repeatedly reactive in diagnostic procedures. The CE Mark version can also be used in epidemiological studies to distinguish recent from longstanding HIV-1 infection for incidence estimation.
“We are pleased to provide this state of the art HIV Profile™ assay to laboratories in the U.S. The performance has been established in years of clinical trials and we are pleased with the results,” said Dr. Chamroen Chetty, CEO of Avioq. “We are also looking for distribution partners to expand the global availability of our CE Mark version of the assay.”
About Confirmatory Testing
In 2014 the CDC released a new algorithm for HIV testing. The second step of the algorithm includes a supplemental assay that can detect and differentiate HIV-1 and HIV-2 for confirmation of repeatedly reactive HIV-1 / HIV-2 screening results. Historically this has been done using Western Blot, or more recently a HIV 1/2 immunochromatographic assay. The HIV Profile™ assay is an improved alternative with exceptional performance that aligns with the CDC algorithm.
About Avioq
Avioq, Inc., located in Research Triangle Park, North Carolina, is a medical device company established to develop and market high-quality immunodiagnostic products. For more information about VioOne™ HIV Profile™ Supplemental Assay, visit http://www.avioq.com.
Original source can be found here.
