Avioq Announces CE Mark and European Launch of VioOne HIV Profile Supplemental Assay
Avioq, Inc. has received CE Marking (Conformité Européenne) and has begun marketing their VioOne™ HIV Profile™ Supplemental Assay in the European Union and other CE Mark countries.
The product has also been submitted for FDA approval. “We are pleased to provide the CE Mark HIV Profile™ assay to countries outside the U.S.,” said Chamroen Chetty, CEO of Avioq. Dr. Chetty continues, “We are also looking for distribution partners to expand the global availability.”
The HIV Profile™ 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 that were repeatedly reactive in diagnostic screening procedures. Results can also be used to distinguish recent from longstanding HIV-1 infection for HIV-1 incidence estimation.
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 in the USA, this has been done using an FDA approved Western Blot or IFA assay. The HIV Profile™ assay is an improved, faster and easier alternative with performance that aligns with the algorithm.
Avioq, Inc., located in Research Triangle Park, North Carolina, is a medical device company established to develop and market high-quality immunodiagnostic products. Avioq is committed to working closely with its customers to meet their needs and provide the highest quality service. For more information about the VioOne™ HIV Profile™ Supplemental Assay, visit www.avioq.com.
Mike Cronin, 919-314-5535
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