OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review

Rhea-AI Summary

OraSure (NASDAQ: OSUR) announced it submitted two separate applications to the U.S. Food and Drug Administration at the end of 2025 for clearance of a rapid molecular CT/NG self-test and the Colli-Pee™ at-home urine collection device for sexually transmitted infections. The CT/NG self-test, built on the Sherlock molecular platform, is designed to deliver results in approximately 30 minutes in an OTC disposable format using a self-collected swab and a handheld reader that requires no electrical connection. OraSure estimates the CT/NG total addressable market at $1.5 billion+. The Colli-Pee™ submission covers multiple STI indications and is pursued with a leading diagnostics platform partner.

Positive

• CT/NG self-test delivers results in ~30 minutes
• Test designed for over-the-counter disposable, portable use
• Company cites a CT/NG TAM > $1.5 billion
• Colli-Pee™ submission covers multiple STI indications

Negative

• FDA submissions were filed end of 2025; clearances are pending
• Current Colli-Pee™ availability limited to Research-use Only

Key Figures

CT/NG test time approximately 30 minutes Result time for rapid molecular self-test

CT/NG TAM more than $1.5 billion Estimated total addressable market for CT/NG testing

Market Reality Check

$2.63 Last Close

Volume Volume 739,626 vs 20-day average 684,119 (relative volume 1.08) ahead of the news. normal

Technical Shares at $2.38, trading below the 200-day MA of $2.91 and 43.6% under the 52-week high.

Peers on Argus

Peers show mixed performance: gains in STSS (+9.27%), flat STXS (0%), and declines in INFU (-6.88%), NYXH (-4.26%), and UTMD (-0.59%), suggesting company-specific factors for OSUR.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 17	Activist engagement	Neutral	+1.6%	Altai Capital signaled board nominations; company responded emphasizing cash and buyback.
Dec 17	Activist announcement	Neutral	+1.6%	Altai detailed plans to nominate two director candidates to OraSure’s board.
Nov 17	Conference participation	Neutral	-2.6%	Announcement of participation in the Stephens investment conference and webcast details.
Nov 05	Earnings release	Negative	+0.0%	Q3 2025 revenue decline and operating loss with neutral immediate price reaction.
Oct 29	Earnings date notice	Neutral	-2.8%	Notice of upcoming Q3 2025 earnings release and conference call logistics.

Pattern Detected

Recent OSUR news has produced modest or flat price reactions, even around earnings and activist developments.

Recent Company History

Over the last few months, OraSure reported weaker Q3 2025 results with $27.1M revenue and an operating loss of $16.1M, alongside guidance of $25M–$28M for Q4. Activist interest emerged with Altai Capital’s 5.13% stake and intent to nominate directors, while the company highlighted $216M cash, no debt, and a $40M repurchase program. Conference participation and governance updates framed an ongoing strategic transition, to which this FDA submission news now adds a product-development milestone.

Market Pulse Summary

This announcement details FDA submissions for a rapid molecular CT/NG self-test and the Colli-Pee™ at-home urine collection device, targeting a CT/NG market estimated at more than $1.5 billion. It builds on prior disclosures of higher R&D spending for the Sherlock-based CT/NG program and ongoing strategic changes. Investors may watch for FDA clearance decisions, commercialization plans, and how these products affect revenue trends and margins over coming quarters.

Key Terms

chlamydia trachomatis medical

"rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG)"

Chlamydia trachomatis is a common bacterial infection that spreads mainly through sexual contact and can infect the genital tract and eyes; it often causes mild or no symptoms but can lead to long-term reproductive damage if untreated. For investors, it matters because rates of infection and advances in testing, treatments, or vaccines influence healthcare spending, diagnostic and pharmaceutical markets, regulatory reviews, and public health policies—similar to how a persistent household problem can drive demand for repair services.

neisseria gonorrhoeae medical

"rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG)"

A bacterium that causes gonorrhea, a common sexually transmitted infection that can produce painful symptoms or go unnoticed while leading to serious reproductive and systemic complications if untreated. Rising resistance to standard antibiotics makes it a focus for companies developing new tests, treatments, or vaccines, so changes in infection rates, drug efficacy, or regulatory approvals can have direct financial and market implications for healthcare and biotech investors.

molecular diagnostics medical

"built on the Sherlock molecular diagnostics platform and is designed to provide"

Molecular diagnostics are laboratory tests that look for specific molecules — such as genes, pieces of DNA or RNA, or proteins — to detect disease, predict risk, or guide treatment choices. For investors, these tests matter because they can change how illnesses are diagnosed and treated, create recurring revenue through specialized tests and companion products, and face clear regulatory and reimbursement pathways that drive commercial value; think of them as reading a biological barcode to inform medical decisions.

over-the-counter regulatory

"in a disposable, over-the-counter format. The test uses a self-collected swab"

Over-the-counter describes securities or trades that occur directly between buyers and sellers rather than on a formal stock exchange. Think of it like buying at a flea market instead of a big supermarket: prices, rules and transparency can vary, which can mean lower liquidity, wider price swings and less regulatory oversight—factors investors watch because they affect ease of trading and risk level.

AI-generated analysis. Not financial advice.

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).

“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 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.

OTI also submitted the Colli-Pee™ device, which is designed for at-home urine collection and is aligned with patient preferences for private and convenient diagnostic testing. The submission covers multiple STI indications and is being pursued in collaboration with a leading diagnostics platform provider. Receipt of clearance for the Colli-Pee™ device for these indications would be in addition to the existing Research-use Only (RUO) product and is expected to expand access to testing and further strengthen OTI’s leadership position in novel collection devices and chemistries.

About OraSure Technologies, Inc. 
OraSure Technologies, Inc. (“OraSure” and “OTI”) transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. OTI improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. Together with its wholly-owned subsidiaries, DNA Genotek Inc., Sherlock Biosciences, Inc., and BioMedomics, Inc., OTI is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OTI’s portfolio of products is sold globally to clinical laboratories, hospitals, physicians’ offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers.  For more information, please visit www.orasure.com.

Forward Looking Statements
This press release contains certain “forward-looking statements,” including with respect to products, product candidate development, regulatory submissions and authorizations and other matters. Forward-looking statements are based on current expectations of future events and are not guarantees of future performance or results. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from expectations and projections. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: uncertainty of commercial success; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; uncertainty and timing of regulatory clearances or approvals; ability to comply with applicable regulatory requirements; uncertainty relating to patent protection and potential patent infringement claims; impact of competitors, competing products and technology changes and patents obtained by competitors; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; impact of negative economic conditions; changes in behavior and spending patterns of purchasers; and changes to applicable laws and regulations. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2024, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure undertakes no duty to update these statements.

Investor Contact: Jason Plagman VP, Investor Relations investorinfo@orasure.com

Media Contact: Amy Koch Director, Corporate Communications media@orasure.com

FAQ

What did OraSure (OSUR) submit to the FDA on January 5, 2026?

OraSure submitted applications for a rapid molecular CT/NG self-test and the Colli-Pee™ at-home urine collection device.

How fast does OraSure’s CT/NG self-test (OSUR) provide results?

The CT/NG self-test is designed to provide results in approximately 30 minutes.

Is OraSure’s CT/NG test intended for at-home use and OTC sale (OSUR)?

Yes. The CT/NG test is designed as a disposable, over-the-counter self-test using a self-collected swab and handheld reader.

What market size does OraSure (OSUR) estimate for CT/NG testing?

OraSure estimates the total addressable market for CT/NG testing at more than $1.5 billion.

What does the Colli-Pee™ submission from OraSure (OSUR) cover?

The submission covers multiple STI indications for the at-home urine collection device and is pursued with a diagnostics platform partner.

Are the OraSure (OSUR) CT/NG test and Colli-Pee™ device FDA-cleared now?

No. OraSure has filed submissions; FDA clearance for both products is currently pending.