Develop blue ocean, care for life and health

Avioq, Inc., a subsidiary of Orient Ocean, Receives FDA Premarket Approval (PMA) for the Next-Generation VioOne™ HIV Detection Reagent

Date: 2021-09-15 19:57



Hits: 145

Recently, the new-generation VioOne™ HIV detection reagent independently developed by Avioq, Inc., a subsidiary of Shandong Oriental Ocean Technology Co., Ltd. ("Oriental Ocean"), received premarket approval (PMA) from the U.S. Food and Drug Administration ("FDA"). ). Previously, the detection reagent has obtained EU CE certification.

It is understood that the new-generation VioOne™ HIV detection reagent approved by the FDA this time can confirm and distinguish the antibodies of different gene products of HIV-1 and HIV-2 in human serum or plasma. Confirming the presence of antibodies in repeat-reactive samples during diagnostic procedures has unique and superior performance in compliance with the CDC testing guidelines strategy. The new-generation VioOne™ HIV test, previously CE marked in the European Union, enables complementary testing to confirm HIV antibodies, differentiate antibodies to different gene products of HIV-1 and HIV-2, and differentiate between emerging and long-standing HIV-1 in a single test Infection and use in epidemiological research, with exclusive global advantages.

"We are delighted to be able to offer laboratories in the United States the new generation of VioOne™ HIV testing reagents whose excellent performance is based on years of clinical trials, and we are pleased with the results." Dr. Chamroen Chetty, CEO, Avioq, Inc. Said that the company will start the production and sales of a new generation of VioOne™ HIV detection reagents in the United States, and will actively expand the sales of the above products that have obtained EU CE certification in the global market.


About confirmatory testing

According to the new version of HIV testing guidelines issued by the U.S. Centers for Disease Control and Prevention ("CDC") in 2014, the second step in the testing strategy includes supplemental testing, which confirms repeat responses by detecting and distinguishing between HIV-1 and HIV-2. Screening results of sexual HIV-1/HIV-2 samples. The CDC in the United States used Western blotting for detection in the past, and in recent years, it has been carried out with HIV-1/2 immunochromatographic test. Avioq, Inc.'s FDA-approved next-generation VioOne™ HIV Profile™ Supplemental Assay is an improved assay with unique and excellent performance in line with the CDC testing guidelines strategy.


About Avioq, Inc.

Avioq, Inc. is a wholly-owned subsidiary of Shandong Oriental Ocean Technology Co., Ltd., located in Research Triangle Park, North Carolina, USA. Its main business includes antigen-antibody-based (immunization) Diagnostic/diagnostic technology and reagent development, the R&D  team has participated in the development of the world's first FDA-approved HIV diagnostic reagents and the world's first HIV antigen detection reagents, and participated in the development and production of the world's first batch of hepatitis B virus diagnostic reagents.

Avioq, Inc.Previously, it has FDA-certified HTLV-I/II (leukemia) detection reagents and HIV-1 (AIDS) detection reagents, of which HTLV detection reagents have obtained FDA biological product license (BLA). ) approval, and the HIV detection reagent (Avioq HIV-1 Microelisa System) has obtained FDA pre-market approval (PMA) approval for Class III medical devices. At the same time, Avioq, Inc. has obtained more than 80 EU approvals, and its R&D level of immunodiagnostic reagents is in a leading position in the world.