AVIOQ, INC.
RESEARCH TRIANGLE PARK, NC

Avioq, Inc., established in 2005 and incorporated in North Carolina, is headquartered in Research Triangle Park, NC. The management team consists of nine individuals, including six PhDs, with over 250 years combined experience in the diagnostics industry. Avioq specializes in the development, production, and distribution of innovative in-vitro diagnostic (IVD) medical devices. Its current product lineup includes an FDA-approved HIV-1 assay (a Class III device), an FDA-licensed HTLV-I/II assay for screening serum, plasma from blood donors, and cadaveric samples, which also holds CE marking and Health Canada approval. Additionally, the company offers three other products with CE marking: a homogeneous biochemiluminescence-based Flu A/B diagnosis test, a rapid influenza virus drug resistance test, and an oral fluid collection device. In development are two additional HIV products: a 4-Gen HIV-1/2/Ag test and an HIV Profile assay for antibody level estimation across different gene products of HIV-1 and HIV-2. Avioq also provides contract research, development, and manufacturing services for diagnostic test kits and critical biomaterials to third-party clients. The company's manufacturing facility is FDA (BLA) licensed and ISO 13485 certified, equipped with a Bio Safety Level 2 setup for viral lysate production, recombinant antigen production suites in mammalian or bacterial cells, and various areas dedicated to kit component production, assembly, testing, and storage. Avioq's bio-manufacturing capabilities extend to the production of antigens, monoclonal antibodies from hybridomas, and viral preparations using a diverse range of purification technologies. With over 25 years of experience in IVD product development, Avioq emphasizes rigorous design controls and quality systems fully compliant with FDA 21 CFR Part 820 and ISO 13485 standards. The company has been inspected numerous times by the FDA, ISO, and external partners to ensure adherence to stringent regulatory requirements in document control, purchasing, complaint handling, corrective action and preventive actions (CAPA), non-conformances, design controls, quality audits, risk management, and training. Led by a team comprising Zhi-Yuan Che as Chairman and Chamroen Chetty as CEO and DVPT, Avioq continues to leverage its vast expertise in IVD product development. The company strategically positions itself to expedite partners' IVD assay project timelines from concept to market with an FDA-approved or CE marked solution. Located at PO BOX 12808, Research Triangle Park, NC, 27709, US, and reachable via phone numbers (919) 314-5535 and (919) 314-5536, Avioq remains a leader in advancing diagnostic technology. Official documents, including the Florida incorporation records under filing number F17000002258 as of May 17, 2017, indicate Avioq's commitment to maintaining transparency and compliance within its operational framework. The last annual report filed on March 7, 2024, underscores ongoing strategic developments for 2024.