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 Vio One™ 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 Vio One™ HIV Profile™ Supplemental Assay, visit www.avioq.com .
About Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
AMS18.10.2019 19:18:03 CEST | Press release
ams to Launch New Takeover Offer for OSRAM at EUR 41.00 Per Share With Minimum Acceptance Threshold of 55%
CA-RESECURITY18.10.2019 17:40:10 CEST | Press release
Resecurity Appoints Selene Giupponi Managing Director of Resecurity Europe
CO-SECURE-2418.10.2019 16:22:10 CEST | Press release
Secure-24 Completes Acquisition of Symmetry Corporation
CA-RESMED18.10.2019 15:02:04 CEST | Press release
New Research Reveals Updated Patient Preferences on Digital Health Technology
JANSSEN18.10.2019 14:45:03 CEST | Press release
CHMP Grants Positive Opinion for Expanded Use of Janssen’s Darzalex®▼(daratumumab) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible
VERTEX-PHARMACEUTICALS18.10.2019 14:39:12 CEST | Press release
Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Eligible Infants with Cystic Fibrosis as Early as 6 Months of Age
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom