Post by icemandios on Nov 3, 2022 13:22:57 GMT
OraSure Technologies Receives General Clearance for its ORAcollect®•Dx Device for Over-the Counter (OTC) Use from the U.S. Food and Drug Administration (FDA)
FDA Clearance Received Through Partnership with Grifols to Support Screening for Risk of Alpha 1 - Antripsyn Deficiency (Alpha-1) in U.S. Adult Population
BETHLEHEM, Pa., Nov. 03, 2022 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that the Company received U.S. FDA clearance for its ORAcollect®•Dx saliva collection device for OTC (i.e. direct-to-consumer) use. The device had been previously cleared for prescription use by the FDA. ORAcollect®•Dx joins the Oragene®•Dx product line which previously received FDA general clearance for prescription and OTC use. This new designation now allows ORAcollect®•Dx devices to be used by OraSure’s commercial partners and legally marketed with their therapeutics or devices in conjunction with their product’s intended use. Both the ORAcollect®•Dx, and Oragene®•Dx devices are designed to be used by an adult at home, without direction from a healthcare professional.
OraSure received this designation through its partnership with Grifols to support screening for alpha1-antitrypsin deficiency (alpha-1) in individuals who may be at risk for alpha-1. Alpha-1 raises patients’ risks for lung disorders and it is estimated that about 3% of COPD patients have alpha-1. Beginning in Q2 2023, Grifols will offer free AlphaID™ At Home Genetic Health Risk Service, supporting alpha-1 screening, that utilize the ORAcollect®•Dx device to help identify individuals at risk. According to the Centers for Disease Control, COPD affects over 15 million people in the United States.
“This clearance represents a major milestone for OraSure as we work in conjunction with our commercial partners to increase access to healthcare,” said Kathleen Weber, President of Molecular Solutions for OraSure Technologies. “With the movement toward precision medicine, we increasingly see the need for genetic testing supporting FDA approved therapeutics as drugs become more specialized for targeted patient populations. This expanded designation now allows us to better support our customers and expands the potential for future indications with the ORAcollect®•Dx device.”
“We look forward to working with an experienced partner such as OraSure to expand access to alpha-1 testing and awareness,” said Antonio Martínez, President, Grifols Diagnostic.
About DNA Genotek
DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., focuses on providing high-quality biological sample collection products and end-to-end services for human genomics and microbiome applications. The Company's Oragene®•Dx and ORAcollect®•Dx product lines are the first and only FDA 510(k) cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types. DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries. For more information about DNA Genotek, visit www.dnagenotek.com .
About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com .
[About Grifols]
FDA Clearance Received Through Partnership with Grifols to Support Screening for Risk of Alpha 1 - Antripsyn Deficiency (Alpha-1) in U.S. Adult Population
BETHLEHEM, Pa., Nov. 03, 2022 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that the Company received U.S. FDA clearance for its ORAcollect®•Dx saliva collection device for OTC (i.e. direct-to-consumer) use. The device had been previously cleared for prescription use by the FDA. ORAcollect®•Dx joins the Oragene®•Dx product line which previously received FDA general clearance for prescription and OTC use. This new designation now allows ORAcollect®•Dx devices to be used by OraSure’s commercial partners and legally marketed with their therapeutics or devices in conjunction with their product’s intended use. Both the ORAcollect®•Dx, and Oragene®•Dx devices are designed to be used by an adult at home, without direction from a healthcare professional.
OraSure received this designation through its partnership with Grifols to support screening for alpha1-antitrypsin deficiency (alpha-1) in individuals who may be at risk for alpha-1. Alpha-1 raises patients’ risks for lung disorders and it is estimated that about 3% of COPD patients have alpha-1. Beginning in Q2 2023, Grifols will offer free AlphaID™ At Home Genetic Health Risk Service, supporting alpha-1 screening, that utilize the ORAcollect®•Dx device to help identify individuals at risk. According to the Centers for Disease Control, COPD affects over 15 million people in the United States.
“This clearance represents a major milestone for OraSure as we work in conjunction with our commercial partners to increase access to healthcare,” said Kathleen Weber, President of Molecular Solutions for OraSure Technologies. “With the movement toward precision medicine, we increasingly see the need for genetic testing supporting FDA approved therapeutics as drugs become more specialized for targeted patient populations. This expanded designation now allows us to better support our customers and expands the potential for future indications with the ORAcollect®•Dx device.”
“We look forward to working with an experienced partner such as OraSure to expand access to alpha-1 testing and awareness,” said Antonio Martínez, President, Grifols Diagnostic.
About DNA Genotek
DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., focuses on providing high-quality biological sample collection products and end-to-end services for human genomics and microbiome applications. The Company's Oragene®•Dx and ORAcollect®•Dx product lines are the first and only FDA 510(k) cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types. DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries. For more information about DNA Genotek, visit www.dnagenotek.com .
About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com .
[About Grifols]