Avioq kondigt CE Mark en de Europese lancering van VioOne hiv-profiel Supplemental Assay aan
RESEARCH TRIANGLE PARK, N.C.-(BUSINESS WIRE)-Avioq, Inc. heeft de CE Marking (Conformité Européenne) gekregen en is begonnen met het op de markt brengen van hun VioOne™ HIV Profile™ Supplemental Assay in de Europese Unie en andere CE Mark landen.
Het product is ook ter goedkeuring aan de FDA voorgelegd. “We zijn blij dat we de CE Mark HIV Profile™ test kunnen leveren aan landen buiten de VS”, aldus Chamroen Chetty, CEO van Avioq. Dr. Chetty vervolgt: “We zijn ook op zoek naar distributiepartners om de wereldwijde beschikbaarheid uit te breiden”.
Het HIV Profile™ is een enzyme-linked immunosorbent assay (ELISA) voor de bevestiging en differentiatie van individuele antilichamen gericht op verschillende genproducten van HIV-1 (Group M & Group O) en HIV-2 in menselijk serum of plasma die herhaaldelijk reactief waren in diagnostische screeningsprocedures.
Avioq Announces CE Mark and European Launch of VioOne HIV Profile Supplemental Assay
RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)– 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.
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. 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.
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