BEAVERTON, OREGON, UNITED STATES, February 3, 2022 /EINPresswire.com/ — Sedia Biosciences Corporation today announced that it has received ISO 13485:2016 Certification of its Beaverton, OR facilities for the production and distribution of two of its key Products. ISO 13485 is an internationally recognized quality standard for medical devices and Certification was provided by TÜV SÜD Product Service GmbH, of Munich Germany, an International Organization for Standardization (ISO) Certification Body.
Ronald W. Mink, Ph.D., Sedia’s President and Chief Executive Officer said “At Sedia our mission is to improve access to healthcare through the development, manufacture and sale of our innovative high-quality products. ISO 13485 Certification provides our customers with an independent, globally recognized third-party validation of our Quality Systems and assurance they will receive the highest quality products. The Certification includes our Asanté™ HIV Assays which will provide unique tools enabling anyone from individual consumers to Clinicians to Public Health Programs to rapidly identify, diagnose and characterize HIV infections at home or at the point-of-care. ISO 13485 Certification is a major accomplishment by our team and an important step in bringing our quality HIV diagnostic tests to the market.”
Recent studies indicate that more than 500 million HIV rapid diagnostics are needed globally to achieve HIV epidemic control and meet UNAIDS 95-95-95 goals by 2030. The aim is to diagnose 95% of all HIV-positive individuals, provide antiretroviral therapy medication for 95% of those diagnosed and achieve viral suppression for 95% of those treated. The first aim of diagnosing 95% of all HIV-positive individuals will require massive efforts by many NGO’s, government agencies and commercial partners to produce enough and the right type of diagnostic tests to help identify where new infections are occurring and make testing readily available in the field and at the point-of-care in order to achieve the target.
About Sedia Biosciences Corporation
Sedia Biosciences is a privately held medical device and diagnostics company, founded in 2009 and based in Beaverton, Oregon, USA. Our commitment is to become a leader in advancing global access to care through the creation of: (1) state-of-the-art rapid point-of-care diagnostic assays, (2) novel epidemiological disease surveillance assays and other Public Health tools, and (3) innovative clinical specimen collection devices to enhance remote collection of specimens for follow-up testing. Sedia brings together a dedicated team of scientists and businesspeople that share a common mission: to improve access to medical care around the world by providing innovative and affordable diagnostic, epidemiological and clinical products.
Sedia Biosciences Corp.