OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review [Yahoo! Finance]
OraSure Technologies, Inc. (OSUR)
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Source: Yahoo! Finance
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). “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.” 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 d
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News
- OraSure Files for FDA Review of Molecular Self-Test & Colli-Pee Device [Yahoo! Finance]Yahoo! Finance
- OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA ReviewGlobeNewswire
- OraSure Technologies Issues Statement Regarding Altai Capital's Intent to Nominate Director Candidates [Yahoo! Finance]Yahoo! Finance
- OraSure Technologies Issues Statement Regarding Altai Capital’s Intent to Nominate Director CandidatesGlobeNewswire
- Altai Capital Management Announces Intention to Nominate Two Highly-Qualified Candidates for Election to OraSure Board of Directors [Yahoo! Finance]Yahoo! Finance
OSUR
Earnings
- 11/5/25 - Beat
OSUR
Analyst Actions
- 11/12/25 - Stephens & Co.
OSUR
Sec Filings
- 1/5/26 - Form 8-K
- 12/19/25 - Form 4
- 12/17/25 - Form DEFA14A
- OSUR's page on the SEC website