ORASURE TECHNOLOGIES (OSUR) Company Report

OraSure Technologies, Inc. submitted two separate applications to the FDA at the end of 2025 for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) and its Colli-Pee™ at-home urine collection device for sexually transmitted infections (STIs).
The CT/NG self-test, built on the Sherlock molecular diagnostics platform, is designed to provide results in approximately 30 minutes in an over-the-counter format, targeting a total addressable market estimated at over $1.5 billion.
The Colli-Pee™ device is intended for at-home urine collection for multiple STI indications, aiming to enhance access to private and convenient diagnostic testing.

Jan 5, 2026, 1:04 PM

8-K

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

OSUR

Product Launch

New Projects/Investments

OraSure Technologies (OSUR) submitted two applications to the U.S. Food and Drug Administration (FDA) at the end of 2025 for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) and its Colli-Pee™ at-home urine collection device for sexually transmitted infections (STIs).
The rapid CT/NG self-test is designed to provide results in approximately 30 minutes and targets a total addressable market estimated at over $1.5 billion.
The Colli-Pee™ device, intended for at-home urine collection for STIs, is expected to expand access to testing and reinforce OraSure's leadership in novel collection devices.

Jan 5, 2026, 1:00 PM

Press Release

OraSure Technologies Addresses Altai Capital's Director Nominations and Outlines Strategic Initiatives

OSUR

Board Change

Share Buyback

New Projects/Investments

OraSure Technologies confirmed that Altai Capital intends to nominate two candidates, including its founder Rishi Bajaj, for election to the Company's Board of Directors at its 2026 Annual Meeting of Stockholders.
The Company's Board previously evaluated Mr. Bajaj but determined not to appoint him, and has undergone significant refreshment, adding three new independent directors over the past three years, including Steven K. Boyd in October 2025 and appointing John P. Kenny as Chair in October 2025.
OraSure is executing a strategy to improve performance, focusing on advancing its innovation roadmap, consolidating operations, and improving margins, while maintaining a healthy cash position of $216 million with no debt as of September 30, 2025.
The Board initiated a new $40 million share repurchase program earlier this year, and the CEO and CFO adopted separate Rule 10b5-1 trading plans for common stock purchases.

Dec 17, 2025, 6:23 PM

Press Release

OraSure Technologies Board Nomination Announced by Altai Capital Management

OSUR

Board Change

New Projects/Investments

Demand Weakening

Altai Capital Management, a significant shareholder holding approximately 5.2% of OraSure's outstanding common stock, intends to nominate John Bertrand and Rishi Bajaj for election to the Board of Directors at the upcoming 2026 Annual Meeting of Stockholders.
The nomination is driven by OraSure's significant share price underperformance and the current Board's perceived failure in strategic and capital allocation decisions.
Altai criticizes OraSure's management for failing to turn around core product segments, making repeated ill-timed investments, and ineffectively deploying cash, which has resulted in a 25% reduction in cash and equivalents since 2023 and a 20% decline in quarterly revenue (excluding Covid-19 products) during the same period.

Dec 17, 2025, 1:00 PM

Press Release

OraSure Technologies Outlines Strategic Product Roadmap and Financial Outlook

OSUR

Product Launch

New Projects/Investments

Guidance Update

OraSure Technologies (OSUR) is celebrating its 25th year as a public company and is focused on its near-term product roadmap, particularly in molecular diagnostics following the acquisition of Sherlock. Key products include the CT/NG test for chlamydia and gonorrhea, targeting a $1.5 billion market, with FDA submission planned by the end of 2025 or early 2026 and a potential mid-2026 launch. The company also plans to submit its ColiP STI device for FDA approval around the same timeframe.
The company reported a cash balance of $216 million. While 2025 was a transition year due to government funding uncertainty, OSUR's core business is currently break-even, and they anticipate reaching overall company break-even by 2027 or 2028. They expect to achieve 50% plus gross margins in the out years, driven by increased volume leveraging existing manufacturing capacity.
OSUR's capital allocation priorities are innovation (both organic and inorganic) and share repurchases. Recent inorganic growth includes the acquisition of BioMedomics for rapid sickle cell testing, which currently generates $1 million in revenue and is expected to grow to a couple of million in a couple of years. The biggest growth engines for the next three to five years are identified as STIs, liquid biopsy, and infectious disease.

Nov 19, 2025, 4:00 PM

Transcript

OraSure Technologies Outlines 2025 Transition Year and Future Growth Strategy

OSUR

Guidance Update

Product Launch

Share Buyback

OraSure's core business has achieved break-even cash flow, supported by a $216 million cash balance as of Q3, with the company targeting overall break-even by 2027 or 2028.
2025 is a transition year due to uncertainty in government funding, impacting both international and U.S. businesses, which are in the low to mid $30 million revenue range each. The company is actively diversifying its customer base beyond public health.
Key near-term product roadmap initiatives include FDA submissions for the Sherlock CT/NG test (targeting a $1.5 billion STI market) and the ColiP STI device by late 2025 or early 2026.
Capital allocation prioritizes innovation, but OraSure also initiated a $40 million share buyback program over two years, repurchasing $5 million in both Q2 and Q3.

Nov 19, 2025, 4:00 PM

Transcript

OraSure Provides Update on Product Roadmap and Strategic Initiatives

OSUR

Product Launch

New Projects/Investments

M&A

OraSure is managing 2025 as a transition year due to uncertainties in government funding, supported by cost discipline and a strong cash position.
The company plans to submit its Sherlock CT/NG molecular device and Colli-Pee STI product for FDA approval by the end of 2025 or early 2026, with the CT/NG test targeting a $1.5 billion market and projected to be the largest product in revenue within three to five years.
OraSure recently acquired BioMedomics for rapid sickle cell testing, which is expected to contribute $1 million in revenue initially and grow to a couple of million in a few years, primarily leveraging existing international distribution channels.
Leveraging automation and insourcing capabilities developed during the COVID-19 period, OraSure is currently operating at 30% manufacturing capacity and aims for 50%+ gross margins in the out years through increased volume and operational efficiencies.
With a strong balance sheet holding $216 million in cash, the company's primary capital allocation focus is on innovation, pursued both organically and inorganically.

Nov 19, 2025, 4:00 PM

Transcript

OSUR Reports Q3 2025 Results, Issues Q4 Guidance, and Announces Acquisition

OSUR

Earnings

Guidance Update

M&A

OraSure Technologies (OSUR) reported Q3 2025 total revenue of $27.1 million and a non-GAAP operating loss of $12.7 million, ending the quarter with $216 million in cash and cash equivalents and zero debt.
The company provided Q4 2025 revenue guidance of $25 million to $28 million and expects gross margin in the low 40% range.
OSUR signed a definitive agreement to acquire Biomedomics for $4 million upfront, expanding its diagnostics portfolio with the SickleScan test, and deployed $5 million to repurchase approximately 1.5 million shares of common stock.
Key product pipeline updates include planned FDA submissions in late 2025 or early 2026 for ColiP urine collection (STI indications) and the Sherlock Molecular Diagnostics Rapid Test Platform (CT&G assay).
The company anticipates a return to growth in 2026, viewing 2025 as a transition year.

Nov 5, 2025, 10:00 PM

Transcript

OraSure Technologies Announces Q3 2025 Financial Results and Q4 2025 Guidance

OSUR

Earnings

Guidance Update

Demand Weakening

OraSure Technologies reported total net revenues of $27.1 million for Q3 2025, a 32% decrease from Q3 2024, resulting in a GAAP net loss of $(13.7) million and diluted GAAP EPS of $(0.19).
The company's GAAP gross margin improved to 43.5% in Q3 2025 compared to 42.8% in Q3 2024.
As of September 30, 2025, OraSure held $216 million in cash and cash equivalents and deployed $5 million during the quarter to repurchase approximately 1.5 million shares of its common stock.
For Q4 2025, OraSure provided guidance for total revenues between $25 million and $28 million.
Key business developments include signing an agreement to acquire BioMedomics and plans for new product launches in 2026, such as the Sherlock over-the-counter molecular self-test for Chlamydia and Gonorrhoeae.