SEKISUI Diagnostics, a global medical diagnostics manufacturer, has formalized an exclusive distribution agreement with Aptitude Medical Systems (Aptitude™), an innovative developer of decentralized molecular diagnostics, to sell the Aptitude Metrix™ COVID-19 Test in the U.S.
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| [03-January-2024] |
| BURLINGTON, Mass., Jan. 3, 2024 /PRNewswire/ -- SEKISUI Diagnostics, a global medical diagnostics manufacturer, has formalized an exclusive distribution agreement with Aptitude Medical Systems (Aptitude™), an innovative developer of decentralized molecular diagnostics, to sell the Aptitude Metrix™ COVID-19 Test in the U.S. The Metrix test is currently the only EUA approved, molecular test which can be used with both swab and saliva samples and can performed by healthcare professionals or at home by consumers. The Metrix™ COVID-19 Test is a single-use molecular in vitro diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2 using anterior nasal swab and saliva samples.
“The unique features of this test are what make this addition to our portfolio so exciting. It pairs a molecular test with a small, low-cost reader which provides highly accurate results in an affordable and simple to use format which can fit in the palm of your hand. This aligns with efforts to expand into the molecular testing market and the company’s long term strategic vision,” said Lee Lipski, Sr. VP, Strategy & Business Management of SEKISUI Diagnostics. “Aptitude built Metrix from the ground up so anyone can harness the power of lab-quality molecular testing – without the lab,” said Dr. Scott Ferguson, CEO and co-founder of Aptitude. “Metrix is the result of over a decade of R&D to disrupt access and cost barriers for molecular testing without compromising performance. We’re already delivering on this promise to consumers, and we’re excited to partner with SEKISUI Diagnostics to amplify our reach to healthcare professionals, enabling molecular testing anywhere and everywhere.” SEKISUI Diagnostics is a well-known provider of many rapid diagnostic solutions to the professional and home testing markets through a portfolio of tests under the OSOM® and Acucy® brands. They also supply tests through the HHS/ASPR program (COVIDTests.gov) which delivers tests for free to households across the country. The agreement includes access to a second assay in Aptitude’s pipeline which is currently in clinical trials. “Our investment and partnership with Aptitude will drive manufacturing, scale-up and portfolio expansion which supports our mission to provide intelligent solutions to the healthcare market and more specifically, to bring molecular testing into the home,” said Bob Schruender, President & CEO of SEKISUI Diagnostics. About SEKISUI Diagnostics: With over 40 years of experience, SEKISUI Diagnostics’ mission is to provide intelligent solutions to enhance life with science and improve the health of all people. We supply innovative medical diagnostics globally to physicians, hospitals, laboratories and alternate testing locations. Our product lines include clinical chemistry reagents, point-of-care tests, pre-analytic systems as well as enzymes and specialty biochemicals. About Aptitude: Aptitude is an innovative deep-tech healthcare company changing how infectious diseases are being detected and treated. Aptitude’s mission is to democratize diagnostics by bringing the lab to the end-user via the easy-to-use Metrix platform, delivering actionable lab-quality molecular results in 15 to 30 minutes. The Metrix tests can be run anywhere and anytime, including physician offices, pharmacies, and in home settings. Aptitude has an extensive development pipeline to deliver on this mission for a wide range of health and wellness conditions. This test has not been FDA cleared or approved. It is authorized by FDA under an EUA for non-prescription home use. It has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C S360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. OSOM® and Acucy® are registered trademarks for SEKISUI Diagnostics, LLC. Metrix™ is a trademark of Aptitude Medical Systems.
SOURCE SEKISUI DIAGNOSTICS, LLC |
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