MISSISSAUGA, Ontario, Dec. 02, 2019 (GLOBE NEWSWIRE) — Microbix Biosystems Inc. (TSX: MBX, Microbix®), a life sciences innovator making critical ingredients that enable the production of clinical diagnostics and creating medical devices that help ensure test accuracy, announces it has been invited to present the performance of its in-vitro diagnostics (IVD) quality products “IVD Controls” at EUROGIN 2019, the annual congress of the European Research Organization on Genital Infection & Neoplasia.
At EUROGIN, Microbix will be exhibiting alongside leading IVD and pharmaceutical companies working on prevention and detection of Human Papilloma Virus (HPV) infection. The majority of sexually-active adults are infected with one or more types of HPV and the high-risk variants of the virus are a well-known and common cause of multiple human cancers. Tests to establish whether individuals are infected with a high-risk type of HPV provide important health information and require validated, regulated, and third-party IVD Controls to help ensure their accuracy. Microbix has created IVD Control products that support tests for high-risk HPV types 16, 18, & 45, and cleared them for sale in both the European Union (via CE mark) and the United States under its REDx™ Controls brand name.Microbix will also review the performance of those novel, proprietary, and branded IVD Controls to support quality control of nucleic acid amplification tests (NAATs) for high-risk types of HPV. Its presentation is entitled “Novel Cross-Platform High-Risk (HR) HPV NAAT Positive Controls for Use in L1 and E6/E7 Targeted Nucleic Acid (DNA and RNA) Detection Methods” and establishes that Microbix’s REDx Controls for HPV tests contain all required diagnostic targets, support all test steps, and are compatible across the leading NAAT testing instrument platforms. A well-designed IVD Control should work with any test equipment, just like a patient sample. Microbix believes its REDx Control results support the quality objectives of clinical labs testing for high-risk HPV infections, will assist with the provision of effective healthcare globally, and represent meaningful new revenue opportunities.This scientific “poster” was authored by Microbix’s development team, provides new performance results in a complete and succinct fashion, and is being presented by its Director of Quality Assessment Products (QAPs™), Pavel Zhelev, supported by its SVP of Sales & Business Development, Phillip Casselli. The full poster will be made available on the company website (www.microbix.com) and by EUROGIN following its presentation and includes Microbix’s thankful acknowledgement of its collaborators.Microbix’s REDx Controls, are highly representative of patient samples, provide safe and reliable means of monitoring the laboratory workflow and performance accuracy of complex medical tests and, where relevant, work across both immunologic and NAAT test methods. Microbix’s QAPs are provided to (i) laboratory accreditation organizations to support their proficiency testing programs, (ii) test makers to support product development, instrument validation and technician training, and (iii) clinical laboratories, as regulated medical devices to support their quality management systems.About Microbix Biosystems
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