AVIOQ, INC.
RESEARCH TRIANGLE PARK, NC

About Avioq Avioq, Inc., founded in 2005 and incorporated in North Carolina, has headquarters in Research Triangle Park, NC. The Management Team is comprised of 9 individuals (6 PhDs) with over 250 years of experience in the diagnostics industry. The company’s current products include an FDA approved HIV-1 assay (a Class III device), an FDA licensed HTLV-I/II assay for screening serum and plasma from blood donor, and cadaveric samples, which also has CE marking and Health Canada approval. In addition, three other products with CE marking including a homogeneous biochemiluminescence based Flu A/B diagnosis test, a rapid influenza virus drug resistance test and an Oral fluid collection device. The company has two other HIV products in final development; a 4 Gen HIV-1/2/Ag test and an HIV Profile assay for the detection and estimation of antibody levels directed to different gene products of HIV-1 and HIV-2. The company also offers contract research, development and manufacturing for diagnostic test kits and critical biomaterials to third parties. Our manufacturing facility is FDA (BLA) licensed and ISO 13485 certified. The facility includes a Bio Safety Level 2 facility for large scale viral lysate production, a suite for production of recombinant antigens produced either in mammalian cells or bacterial cells, a multi-room suite for production of kit components, an area for kit assembly, a QC laboratory, several walk-in refrigeration rooms, and warehouse areas for receiving, quarantining and storage of raw materials. Bio-manufacturing and analytical capabilities include production of antigens produced either in mammalian or bacterial cells, monoclonal antibodies produced in hybridomas, and viral lysates/virus produced from large-scale cell cultures. A variety of tools are used to purify the antigens, monoclonal antibodies or viruses, including gel filtration chromatography, affinity chromatography, tangential flow filtration, and sucrose gradient ultracentrifugation. Our R&D scientific team has designed and developed numerous medical diagnostic products during the past 25 years. As a result, our R&D team, along with our teams in manufacturing, quality assurance and regulatory, have ample experience in all phases of IVD product development, starting from raw material development and finishing with an FDA approved and/or CE marked IVD. Avioq’s Design Control and Quality Systems are fully developed. Our facility has been inspected numerous times by FDA and ISO, as well as by external partners. We are compliant with FDA 21 CFR Part 820 and ISO 13485 requirements for document and purchasing controls, complaint handling, CAPA, non-conformances, design/production/process controls, quality audits, risk management and training. About Avioq Avioq, Inc., founded in 2005 and incorporated in North Carolina, has headquarters in Research Triangle Park, NC. The Management Team is comprised of 9 individuals (6 PhDs) with over 250 years of experience in the diagnostics industry. The company’s current products include an FDA approved HIV-1 assay (a Class III device), an FDA licensed HTLV-I/II assay for screening serum and plasma from blood donor, and cadaveric samples, which also has CE marking and Health Canada approval. In addition, three other products with CE marking including a homogeneous biochemiluminescence based Flu A/B diagnosis test, a rapid influenza virus drug resistance test and an Oral fluid collection device. The company has two other HIV products in final development; a 4 Gen HIV-1/2/Ag test and an HIV Profile assay for the detection and estimation of antibody levels directed to different gene products of HIV-1 and HIV-2. The company also offers contract research, development and manufacturing for diagnostic test kits and critical biomaterials to third parties. Our manufacturing facility is FDA (BLA) licensed and ISO 13485 certified. The facility includes a Bio Safety Level 2 facility for large scale viral lysate production, a suite for production of recombinant antigens produced either in mammalian cells or bacterial cells, a multi-room suite for production of kit components, an area for kit assembly, a QC laboratory, several walk-in refrigeration rooms, and warehouse areas for receiving, quarantining and storage of raw materials. Bio-manufacturing and analytical capabilities include production of antigens produced either in mammalian or bacterial cells, monoclonal antibodies produced in hybridomas, and viral lysates/virus produced from large-scale cell cultures. A variety of tools are used to purify the antigens, monoclonal antibodies or viruses, including gel filtration chromatography, affinity chromatography, tangential flow filtration, and sucrose gradient ultracentrifugation. Our R&D scientific team has designed and developed numerous medical diagnostic products during the past 25 years. As a result, our R&D team, along with our teams in manufacturing, quality assurance and regulatory, have ample experience in all phases of IVD product development, starting from raw material development and finishing with an FDA approved and/or CE marked IVD. Avioq’s Design Control and Quality Systems are fully developed. Our facility has been inspected numerous times by FDA and ISO, as well as by external partners. We are compliant with FDA 21 CFR Part 820 and ISO 13485 requirements for document and purchasing controls, complaint handling, CAPA, non-conformances, design/production/process controls, quality audits, risk management and training. is an expanding in-vitro diagnostic medical device company Specializing in the development, production and distribution of quality products, as well as providing flexible Apply our IVD product development experience and proven quality system to shorten your timeline. We have experience in all phases of IVD product development, starting from raw material development and finishing with an FDA approved and/or CE marked IVD. How can we help bring your IVD assay development project to market?