A maker of rapid point-of-care tests, OraSure Technologies is best known for the OraQuick HIV test that runs on a simple oral swab, along with tests for COVID-19, hepatitis C, syphilis, and sickle cell, plus sample-collection kits like Oragene and Colli-Pee used in clinics and at home. The company took its current form in 2000 when Epitope and STC Technologies merged, and its name blends "oral" (for its non-invasive mouth-based testing) with "sure." A fun twist: its Oragene saliva kits helped kick off the era of mail-order DNA testing from a simple spit sample.
OraSure announces FDA clearance of Colli-Pee Dx urine collection kit for Roche STI tests.
The kit, from subsidiary DNA Genotek Inc., is cleared for use with Roche Molecular Systems tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium.
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OraSure Technologies announced FDA clearance of its Colli-Pee Dx Urine Collection Kit on June 11, 2026.
The kit is compatible with Roche's cobas 5800, 6800, and 8800 molecular diagnostic systems.
It enables at-home self-collection of first-void urine for both male and female patients.
The event was reported under Item 8.01 as a regulatory clearance announcement.
OraSure shareholders approve stock plan increase and board declassification at 2026 annual meeting
At the June 3, 2026 annual meeting, shareholders approved an amendment to the 2000 Stock Award Plan increasing authorized shares by 5,000,000.
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Shareholders approved a Certificate of Incorporation amendment to declassify the board over three years, effective from the fiscal 2027 annual meeting.
Three Class II directors were elected to terms ending in 2029: John D. Bertrand, Steven K. Boyd, and Robert W. McMahon.
Shareholders ratified Grant Thornton LLP as independent auditor for fiscal 2026 and approved an advisory vote on executive compensation.
The Certificate of Amendment was filed with the Delaware Secretary of State and became effective on June 3, 2026.
5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year · 5.07 Submission of Matters to a Vote of Security Holders · 9.01 Financial Statements and Exhibits
OraSure appoints John D. Bertrand to board and enters cooperation agreement with Altai Capital
OraSure Technologies entered a cooperation agreement with Altai Capital Management on April 16, 2026, under which Altai withdrew its director nominations and stockholder proposal.
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John D. Bertrand was appointed as an independent Class II director, effective April 16, 2026, with a term expiring at the 2026 annual meeting.
OraSure will seek shareholder approval at the 2026 annual meeting to declassify its board of directors, phasing in annual director elections.
Altai agreed to vote its shares in line with board recommendations until the agreement's termination date of March 31, 2027, subject to certain exceptions.
Bertrand will receive an initial equity award of $100,000 in time-vested restricted shares, vesting two years from grant.
1.01 Entry into a Material Definitive Agreement · 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · 7.01 Regulation FD Disclosure · 9.01 Financial Statements and Exhibits
OraSure Technologies issued a March 30, 2026 investor presentation responding to statements by Altai Capital Management, which seeks to replace two independent directors.
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The presentation disputes Altai's valuation of $4.54–$6.60 per share, noting Altai sold 127,000 shares at an average of $2.98 in March 2026.
OraSure highlights a $199M cash balance with no debt, a $40M share repurchase program initiated in 2025, and a ~40% workforce reduction since 2023.
The company cites near-term catalysts including FDA review of Sherlock CT/NG self-test and Colli-Pee device, with expected operating cash flow breakeven in 1H 2026.
OraSure says it proposed settlement options including appointing Altai's nominee, but Altai rejected them; the board has committed to declassification regardless.
The filing is under Item 7.01 Regulation FD Disclosure, as the presentation is furnished, not filed, and includes an exhibit (99.1).
7.01 Regulation FD Disclosure · 9.01 Financial Statements and Exhibits