OraSure Technologies (NASDAQ:OSUR) reported second-quarter revenue of $30.6 million, exceeding its guidance range and rising 9.7% sequentially, as stronger public-health diagnostics demand and growth in sample-management products supported results.
President and Chief Executive Officer Carrie Eglinton Manner said the quarter marked continued progress in the company’s transformation, citing sequential gross-margin improvement, new regulatory milestones and efforts to position the business for growth in the second half of 2026 and beyond.
Diagnostics and Sample Management Growth
Diagnostic-products revenue totaled $19.4 million, increasing 14.7% from the prior quarter. Chief Financial Officer Ken McGrath said U.S. diagnostics revenue exceeded international revenue during the period. The sequential gain reflected stronger public-health demand, including customer purchasing associated with fiscal-year cycles, higher syphilis-test revenue and contributions from BioMedomics’ Sickle SCAN product.
The company said demand for its OraQuick HIV Self-Test was strong in U.S. public-health programs despite ongoing federal funding pressure. OraSure also cited growth in consumer and business-to-business-to-consumer channels, including telehealth and digital-access outlets.
Internationally, OraSure said it is seeking to diversify and localize its diagnostics business. The company continues to support long-standing HIV testing customers while pursuing nearshoring and in-country value-added assembly programs for OraQuick HIV Self-Test products. Eglinton Manner said the company expects to provide additional details on localization initiatives later this year.
Sickle SCAN revenue is growing at twice the rate in 2026 as it did in 2025, according to Eglinton Manner, as OraSure integrates the product into its international commercial channels and pursues national health-program opportunities.
Sample Management Solutions revenue was $9.9 million, up 9% sequentially, with growth across segments. OraSure said it saw improving demand among commercial and advanced diagnostic-testing laboratories, microbiome-collection applications and early signs of recovery in academic and research markets.
During the question-and-answer session, Eglinton Manner said the company is seeing a “fairly consistent recovery” among advanced genetic-testing laboratories, while noting that the segment has remained muted since the COVID period.
Regulatory Milestones and IntelliQuick Delay
In June, OraSure received FDA clearance for its Colli-Pee Dx urine collection kit, which enables at-home self-collection of volumetric first-void urine samples for sexually transmitted infection testing. The clearance covers use of the collection device and its NucleoPrecision technology with Roche cobas tests for chlamydia, gonorrhea, trichomoniasis and M. genitalium in male and female self-collected urine samples.
The company said the Colli-Pee Dx launch has started positively, with customers expressing interest in its potential to make STI testing more convenient and private.
OraSure also received FDA Emergency Use Authorization for its second-generation OraQuick Ebola 2.0 Rapid Antigen Test. The test detects all four Ebola virus species known to cause human disease, including the Bundibugyo species associated with the current outbreak in Central Africa, according to the company.
However, the company said it no longer expects FDA clearance and a U.S. launch for its IntelliQuick CT/NG test on the Sherlock platform during 2026. OraSure withdrew its FDA submission after constructive discussions with the agency and plans to incorporate FDA feedback before resubmitting.
Eglinton Manner said the company remains confident in the rapid molecular self-test’s performance and clinical value but did not provide a timetable for resubmission or potential clearance. “This is a recent discussion, and in terms of timing, we plan to come back to share more on that,” she said.
McGrath said costs associated with the resubmission effort are not expected to increase the company’s overall operating cash-flow usage. He said incremental spending would be more than offset by a reduction in expected milestone payments, confirming an analyst’s reference to a $20 million contingent payment.
Margins, Cash Position and Outlook
GAAP gross margin increased 120 basis points sequentially to 43.5% from 42.3% in the first quarter. Non-GAAP gross margin rose to 44.2% from 43.4%. McGrath attributed the gains to lower scrap and operational efficiencies, partly offset by revenue mix.
Second-quarter GAAP operating income was $5.4 million, while non-GAAP operating loss was $14.7 million. OraSure recorded a reduction in its contingent-consideration liability after updating its CT/NG submission plan. The company ended the quarter with no debt and $161 million in cash and cash equivalents.
Operating cash flow was negative $9.9 million in the quarter. Management reiterated its expectation to reach break-even cash flow from operations as it enters 2027, supported by anticipated revenue growth, new product launches, cost savings and operating efficiencies.
OraSure repurchased 647,000 shares for $2 million during the second quarter. Since beginning its repurchase program last year, the company has spent $22 million to buy back 7.7 million shares, representing nearly 10% of outstanding shares. The company paused further repurchases during the quarter to preserve flexibility for launch-related investments, including Colli-Pee and Ebola 2.0.
For the third quarter, OraSure projected revenue of $29.5 million to $32.5 million and said gross margin is expected to be similar to the second quarter.
About OraSure Technologies (NASDAQ:OSUR)
OraSure Technologies, Inc is a Bethlehem, Pennsylvania–based diagnostic and medical device company specializing in the development, manufacture and commercialization of point-of-care and self-testing products. Founded in 1988, OraSure has built a portfolio of oral fluid and other non-invasive specimen collection technologies that support the detection of infectious diseases, drugs of abuse, and health and wellness biomarkers.
The company’s flagship product, the OraQuick® rapid HIV test, was the first Food and Drug Administration–approved over-the-counter oral fluid test for the detection of HIV-1/2 antibodies.
