Last year, the company secured CE Marking to market the assay in the European Union and other CE Mark countries
Avioq, a diagnostic medical device firm, has secured the US Food and Drug Administration (FDA) approval for its VioOne HIV Profile Supplemental Assay.
HIV Profile assay is an enzyme-linked immunosorbent assay (ELISA), used for confirmation and differentiation of individual antibodies related to different gene products of HIV-1 and HIV-2 in human serum or plasma.
The company has developed VioOne test as an additional specific test to confirm the presence of antibodies in specimens repeatedly reactive in diagnostic procedures.
In 2019, Avioq secured CE Marking to market the VioOne HIV Profile Supplemental Assay in the European Union (EU) and other CE Mark countries.
The CE Mark version of the device can also be used in epidemiological studies to distinguish recent from longstanding HIV-1 infection for incidence estimation, according to the company.
VioOne HIV Profile Supplemental Assay complements CDC’s algorithm
The new HIV testing algorithm released by CDC in 2014 includes a supplemental assay, capable of detecting and differentiating HIV-1 and HIV-2 for confirmation of repeatedly reactive HIV-1 / HIV-2 screening results.
In the US, Western Blot or IFA assay has been historically deployed for confirmation of repeatedly reactive HIV screening results.
The company claimed that its HIV Profile assay is an improved alternative with superior performance that complements the CDC algorithm.
Located in Research Triangle Park, North Carolina, Avioq is a medical device company engaged in development and marketing of high-quality immunodiagnostic products.
Avioq CEO Chamroen Chetty said: “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. We are also looking for distribution partners to expand the global availability of our CE Mark version of the assay.”