OraSure Technologies (NASDAQ: OSUR) wins FDA clearance for Colli-Pee Dx at-home urine collection kit

Filing Impact

(High)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

OraSure Technologies, Inc. reported that the U.S. Food and Drug Administration granted clearance for its Colli-Pee™•Dx Urine Collection Kit, developed by subsidiary DNA Genotek Inc., for use with several Roche Molecular Systems tests for common sexually transmitted infections.

The kit is cleared for use with Roche tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium on Roche’s cobas® 5800, 6800, and 8800 molecular diagnostic systems. The FDA-cleared kit supports at-home self-collection of first-void urine, enabling more convenient sample collection for both male and female patients.

Positive

FDA clearance of Colli-Pee™•Dx kit for use with multiple Roche molecular tests on cobas® 5800, 6800, and 8800 systems, enabling at-home first-void urine self-collection for both male and female patients.

Negative

None.

Insights

FDA clearance expands OraSure’s at-home diagnostics reach with Roche platforms.

OraSure Technologies obtained U.S. FDA clearance for its Colli-Pee™•Dx Urine Collection Kit to be used with multiple Roche molecular tests for sexually transmitted infections on cobas® 5800, 6800, and 8800 systems. This ties an OraSure collection device directly into widely used lab instruments.

The clearance covers at-home self-collection of first-void urine for both male and female patients, which can lower testing barriers and support remote care models. Because the kit is specific to Roche assays and platforms, adoption will depend on how clinical laboratories and healthcare providers integrate this workflow.

Future company disclosures may clarify commercial rollout, uptake across cobas® 5800/6800/8800 installed bases, and whether additional assays or platforms are added. These details will shape how meaningful the FDA-cleared indication becomes within OraSure’s diagnostics portfolio.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Key Terms

FDA clearance, molecular diagnostic systems, first-void urine, at-home self-collection

4 terms

FDA clearance regulatory

"announced U.S. Food and Drug Administration (“FDA”) clearance of the Company’s Colli-Pee™•Dx Urine Collection Kit"

FDA clearance is the U.S. Food and Drug Administration’s official permission to market certain medical devices or diagnostic tests after reviewing evidence that they are as safe and effective as similar products already on the market. For investors, it’s like a product passing a required safety inspection — it reduces regulatory uncertainty, speeds commercial rollout, and can directly affect sales prospects, valuation, and partnership opportunities.

molecular diagnostic systems technical

"and run on Roche’s cobas® 5800, 6800, and 8800 molecular diagnostic systems"

Laboratory instruments and test kits that find and measure tiny biological markers — such as DNA, RNA or proteins — in patient samples to diagnose disease, detect infections, or guide treatment. Think of them as a detective kit that reads molecular “fingerprints” to give fast, precise answers; investors care because their accuracy, speed, cost and regulatory clearance determine how widely they are adopted, shaping sales growth, profit margins and competitive position in healthcare markets.

first-void urine medical

"supports at-home self-collection of first-void urine, enabling convenient at-home sample collection"

The initial portion of urine expelled when a person first urinates, which tends to contain higher concentrations of cells, proteins, or pathogens than later urine. Investors should care because many diagnostic tests and clinical studies rely on first-void samples for more reliable detection and regulatory validation; that affects market demand, test performance claims, and the pathway to approval in the diagnostics and healthcare sectors.

at-home self-collection medical

"The FDA-cleared collection kit supports at-home self-collection of first-void urine"

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Understanding 8-K Material Events →

06/11/2026 - 09:02 AM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): June 11, 2026

OraSure Technologies, Inc.

(Exact Name of Registrant as Specified in Charter)


Delaware	001-16537	36-4370966
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)


220 East First Street Bethlehem, Pennsylvania			18015-1360
(Address of Principal Executive Offices)			(Zip Code)

Registrant’s telephone number, including area code: 610-882-1820

N/A

(Former name or former address, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, $0.000001 par value per share

OSUR

The Nasdaq Stock Market LLC

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by a check mark whether the Registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company o

If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 8.01 Other Events.

On June 11, 2026, OraSure Technologies, Inc. (the “Company”) announced U.S. Food and Drug Administration (“FDA”) clearance of the Company’s Colli-Pee™•Dx Urine Collection Kit from its subsidiary DNA Genotek Inc., for use with Roche Molecular Systems, Inc. (“Roche”) tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium and run on Roche’s cobas® 5800, 6800, and 8800 molecular diagnostic systems. The FDA-cleared collection kit supports at-home self-collection of first-void urine, enabling convenient at-home sample collection for both male and female patients.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


	ORASURE TECHNOLOGIES, INC.

Date: June 11, 2026	By:	/s/ Carrie Eglinton Manner
		Carrie Eglinton Manner
		President and Chief Executive Officer

Source: View Original Filing on SEC EDGAR

FAQ

What did OraSure Technologies (OSUR) announce in this 8-K filing?

OraSure Technologies announced U.S. FDA clearance of its Colli-Pee™•Dx Urine Collection Kit. The kit, from subsidiary DNA Genotek, is cleared for use with selected Roche molecular tests for sexually transmitted infections on Roche cobas® diagnostic systems.

Which infections can OraSure’s Colli-Pee™•Dx kit support testing for with Roche systems?

The Colli-Pee™•Dx kit is cleared for use with Roche tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. These are common sexually transmitted infections, making the clearance relevant for broad sexual health screening programs.

How does the Colli-Pee™•Dx Urine Collection Kit benefit patients of OraSure Technologies (OSUR)?

The kit supports at-home self-collection of first-void urine, providing more convenient sample collection for patients. It allows both male and female patients to collect specimens at home that can then be processed using Roche’s cobas® molecular diagnostic systems.

Which Roche diagnostic platforms are compatible with OraSure’s Colli-Pee™•Dx kit?

The Colli-Pee™•Dx kit is cleared for use with Roche’s cobas® 5800, 6800, and 8800 molecular diagnostic systems. These platforms run the Roche tests for the specified sexually transmitted infections using urine collected with the OraSure device.

What role does DNA Genotek Inc. play in OraSure Technologies’ FDA clearance?

DNA Genotek Inc., a subsidiary of OraSure Technologies, developed the Colli-Pee™•Dx Urine Collection Kit. The FDA clearance covers this subsidiary’s kit for use with specific Roche molecular tests, strengthening OraSure’s position in sample collection technologies.

Filing Exhibits & Attachments

3 documents