Business
OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review
BETHLEHEM, Pa., Jan. 05, 2026 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR) (“OraSure” and “OTI”), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced that it submitted two separate applications at the end of 2025 to the U.S. Food and Drug Administration (FDA) for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) as well as its Colli-Pee™ at-home urine collection device for sexua
About this update from Orasure Technologies, Inc.
[{"type":"image","alt":"OraSure Technologies, Inc.","displaySize":"","headline":null,"caption":"OraSure Technologies, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":95,"url":"https://media.zenfs.com/en/globenewswire.com/ee6ee9213fb9d24f63cdaa40b86ea197"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/uVsIhqxzmWwFwYtjpoEGOA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEzMztjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/ee6ee9213fb9d24f63cdaa40b86ea197","width":300,"height":95}},"lazy":false},{"type":"text","content":"BETHLEHEM, Pa., Jan. 05, 2026 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR) (“OraSure” and “OTI”), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced that it submitted two separate applications at the end of 2025 to the U.S. Food and Drug Administration (FDA) for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) as well as its Colli-Pee™ at-home urine collection device for sexually transmitted infections (STIs).","length":539,"tagName":"p"},{"type":"text","content":"“These submission milestones reflect meaningful progress on our innovation roadmap and bring us closer to realizing our vision of decentralizing diagnostics and connecting people to care that is more accessible, convenient, private, and personalized,” said Carrie Eglinton Manner, President and CEO of OTI. “As we look ahead to 2026, we are continuing to execute on our strategy with purpose and momentum to create value for all our stakeholders.”","length":447,"tagName":"p"},{"type":"text","content":"OTI’s rapid self-test for CT/NG is built on the Sherlock molecular diagnostics platform and is designed to provide results in approximately 30 minutes in a disposable, over-the-counter format. The test uses a self-collected swab, and results can be read directly on the hand-held testing device without the need for an electrical connection, enhancing flexibility and convenience. OTI estimates that testing for CT/NG represents a total addressable market of more than $1.5 billion. Today, the vast majority of CT/NG tests in the U.S. are processed in centralized laboratories, creating an opportunity for meaningful market expansion through the introduction of an affordable rapid self-test.","length":692,"tagName":"p"},{"type":...