Can you elaborate on the demand trends observed in the advanced genetic testing labs within the Sample Management Solutions segment?

Management noted a consistent recovery among advanced genetic testing labs, contributing to sequential growth in SMS. They also observed an uptick in microbiome collection, which had been soft in previous years, indicating broader improvement across key customer segments. “So we're seeing the sort of continued not only green shoots in other labs that are growing, but we're seeing a fairly consistent recovery amongst kind of the advanced genetic labs more broadly.”

OSUR

OraSure (OSUR) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 5, 2026

Source: earnings call transcript

Executive summary

OraSure Q2 FY26 — Strong Revenue, Margin Expansion, and Pipeline Progress Despite InteliQuick Delay

OraSure delivered a strong Q2 FY26, surpassing revenue guidance and expanding gross margins, driven by sequential growth in both Diagnostic Products and Sample Management Solutions. While the InteliQuick CT/NG test faces a regulatory delay, the company remains confident in its pipeline, including recent FDA clearances for Colli-Pee Dx and OraQuick Ebola 2.0, and is focused on achieving operating cash flow breakeven by early 2027 through disciplined execution and strategic launches.

Highlights

Total revenue of $30.6 million exceeded guidance and grew 9.7% sequentially.
GAAP gross margin expanded 120 basis points sequentially to 43.5%.
Non-GAAP gross margin increased to 44.2% from 43.4% sequentially.
FDA clearance received for Colli-Pee Dx urine collection kit for 8 STI indications.
FDA Emergency Use Authorization granted for OraQuick Ebola 2.0 rapid antigen test.

Concerns

InteliQuick CT/NG test FDA clearance and U.S. launch delayed beyond 2026 due to withdrawal of submission for resubmission.
Operating cash flow was negative $9.9 million in Q2.
Year-over-year increase in G&A expenses due to nonrecurring legal and professional service costs related to proxy and stockholder activism.

Guidance & targets

Category	Target	Timeline	Confidence
Q3 Revenue	$29.5 million to $32.5 million high materiality	Q3 FY26	High
Q3 Gross Margin	similar to Q2 medium materiality	Q3 FY26	High
Cash Flow from Operations	breakeven high materiality	entering 2027 · FY27	High
Revenue Growth	growth high materiality	FY26	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
Diagnostic Products Revenue was higher in the U.S. than international. Growth driven by stronger public health demand, customer purchasing tied to fiscal year cycles, higher syphilis revenue, and the addition of BioMedomics' Sickle SCAN.	$19.4 million	—	14.7%	—
Sample Management Solutions (SMS) Growth across segments, including commercial advanced diagnostic testing laboratories, microbiome collection, and early signs of recovery in academic and research channels. Anticipated contribution from Colli-Pee Dx.	$9.9 million	—	9%	—

Product announcements

Product	Type	Timeline	Details
Colli-Pee Dx urine collection kit	launch	mid-June
OraQuick Ebola 2.0 rapid antigen test	launch	recently received authorization

Deals & partnerships

BioMedomics Integration of Sickle SCAN into international commercial channels

Progress following the acquisition of BioMedomics with Sickle SCAN, pursuing opportunities with national health programs in geographies with unmet sickle cell testing needs.

BARDA Development of OraQuick Ebola 2.0 rapid antigen test

OraQuick Ebola 2.0 rapid antigen test was developed in partnership with BARDA, building on the previous version.

Roche Colli-Pee Dx urine collection kit for use with Roche's Cobas molecular diagnostic platform

FDA clearance of OTI's Colli-Pee Dx collection device with NucleoPrecision technology for use with Roche's STI test on its Cobas platform, increasing access to STI testing.

Risks & headwinds

InteliQuick CT/NG regulatory delay beyond 2026

FDA clearance and U.S. launch delayed beyond 2026

Mitigation:Working with FDA on resubmission, incorporating feedback; confidence in product performance remains high; financial impact offset by reduced milestone payments.

Increased G&A expenses Q2 FY26

Year-over-year increase in Q2 FY26

Mitigation:Primarily due to nonrecurring legal and professional service costs related to proxy and stockholder activism; expected to decline to more normalized levels beginning in Q3.

Federal funding pressure for HIV testing programs ongoing

Continued pressure

Mitigation:HIV testing remains an important public health priority; strong demand for OraQuick HIV Self-Test; diversifying channels (consumer, B2B2C, telehealth).

What to watch in Q3 FY26

InteliQuick CT/NG Resubmission Timing

next quarter

Current Submission withdrawn, plan for resubmission being built

Target Update on specific timing for resubmission and potential approval

Why it matters

The InteliQuick CT/NG test is a key pipeline asset, and its regulatory path and market entry timing are critical for future growth and investment thesis.

We will provide additional updates on our progress in future quarters as we move quickly to complete the work we think is necessary for regulatory clearance and full market launch.

Find out whether OSUR delivers this. Inve re-checks your case every morning.

Q&A highlights

Given the InteliQuick CT/NG test submission withdrawal, what is the revised timing for resubmission and approval, and how will this affect the cost structure, particularly regarding post-approval studies and the contingent payment?

Management confirmed plans to resubmit the InteliQuick CT/NG test after incorporating FDA feedback, but could not provide specific timing yet. They clarified that any incremental costs for resubmission will be offset by a reduction in the $20 million contingent consideration liability, ensuring no incremental impact on cash flow from operations.

“As far as the cost, this will not incrementally add to our overall cash flow from operations usage. There's an offset here related to the milestone payments that will be reduced.”

asked by Steven Etoch · answered by Kenneth McGrath

2 min read 6 chapters

Detailed narrative

Q2 Performance Highlights and Strategic Transformation

OraSure reported Q2 FY26 total revenue of $30.6 million, exceeding guidance, and saw sequential GAAP gross margin expansion to 43.5%. The company is undergoing a multi-year transformation, shifting from restructuring to focused growth, with 2026 identified as a transition year. Key milestones include FDA clearance of Colli-Pee Dx and EUA for OraQuick Ebola 2.0, positioning the business for sustainable growth and long-term shareholder value.

InteliQuick CT/NG Regulatory Update and Impact

The FDA clearance and U.S. launch of the InteliQuick CT/NG test are delayed beyond 2026. OraSure elected to withdraw its submission to incorporate FDA feedback and plans to resubmit. Despite the delay, management expressed high confidence in the test's performance and market potential, emphasizing that this does not alter the company's 2026 revenue growth or 2027 operating cash flow breakeven targets.

The cost impact of the delay is expected to be offset by reduced milestone payments.

International Diagnostics Evolution

The International Diagnostics business is strategically evolving to stabilize, diversify, and localize. This includes continued service to HIV testing customers, expansion of the portfolio, and deepening partnerships. Recent progress highlights include the OraQuick Ebola 2.0 Rapid Test authorization, near-shoring and in-country value-added assembly programs for OraQuick HIV Self-Test, and the successful integration and growth of Sickle SCAN, which is growing twice as fast in 2026 as in 2025.

U.S. Diagnostics Performance and Market Trends

U.S. Diagnostics experienced stronger public health demand in Q2, influenced by customer purchasing patterns tied to fiscal year cycles. Demand for the OraQuick HIV Self-Test remained strong, benefiting from the syndemic testing approach across HIV, HCV, and syphilis. Consumer and B2B2C channels, including telehealth, continue to grow, reinforcing demand for convenient, private access to diagnostic testing and supporting future OTC and decentralized STI testing opportunities.

Sample Management Solutions (SMS) Growth and Innovation

SMS revenue increased sequentially in Q2, driven by improvements across commercial advanced diagnostic testing laboratories, precision healthcare applications like microbiome collection, and early recovery in academic/research channels. The FDA clearance of Colli-Pee Dx, which incorporates NucleoPrecision chemistry for STI testing with Roche's Cobas platform, represents a significant innovation milestone and is off to a strong start with customer interest.

Financial Overview and Capital Allocation

OraSure ended Q2 with $161 million in cash and no debt. The company repurchased $2 million of common stock (647,000 shares) in Q2, bringing the total to $22 million (7.7 million shares) since program inception, utilizing 55% of the $40 million authorization.

Share repurchases were paused to prioritize balance sheet flexibility for launch-related investments. Operating cash flow was negative $9.9 million, consistent with expectations, with a target to reach breakeven by early 2027.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.