olivLaw · US equity research
OraSure Technologies, Inc. OSUR
Surgical & Medical Instruments & Apparatus · SIC 3841 · Vertical: Surgical & Medical Instruments & Apparatus (SIC 3841)
OraSure Technologies develops and sells rapid point-of-care diagnostic tests and sample management solutions, serving clinics, laboratories and consumers through self-testing. The company is recovering from a period of falling revenue, with net revenues of $115.0 million in 2025 and $30.6 million in the second quarter of 2026, while its losses turned into a GAAP quarterly profit.
At the close of 04 Nov 2026, OraSure Technologies, Inc. (OSUR) stock was 3.72 USD (+5.38% on the day), with market capitalisation 256.6 m USD, beta 1.12, 52-week range 2.11–4.50 USD. Latest reported quarter (Q2 2026): revenue of 30.6 m USD (−1.9% YoY), net income of 6.2 m USD, diluted EPS 0.09 USD.
Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.
Price history
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Technical reading
- RSI (14)
- 46.6
- neutral
- Bollinger (20, 2)
- 3.45 – 4.25
- in the lower half of the band · %B 0.34 · band width 20.8%
- SMA 50 / 200
- 3.74 / 3.53
- mixed trend
- MACD (12, 26, 9)
- -0.01 / 0.03
- MACD below signal
Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).
Performance
| Company | S&P 500 | vs S&P 500 | Vertical median | |
|---|---|---|---|---|
| 1 month | −9.5% | −1.1% | −8.4 pp | — |
| 3 months | −10.4% | −0.5% | −9.9 pp | — |
| 6 months | +24.0% | +4.4% | +19.6 pp | — |
| Year to date | +53.7% | +12.3% | +41.4 pp | — |
| 1 year | +44.7% | +13.5% | +31.2 pp | −29.7% |
| 3 years | −33.9% | +76.4% | −110.3 pp | −20.7% |
| 5 years | −61.5% | +63.7% | −125.2 pp | — |
Price returns, dividends excluded.
Quarterly results
Latest quarter: Q2 2026 · 30 Jun 2026
Quarterly margins
Quarterly statements · USD
| Fiscal year | Q3 '24 | Q4 '24 | Q1 '25 | Q2 '25 | Q3 '25 | Q4 '25 | Q1 '26 | Q2 '26 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 39.9 m | 37.4 m | 29.9 m | 31.2 m | 27.1 m | 26.8 m | 27.9 m | 30.6 m |
| Cost of revenue | 22.8 m | 23.9 m | 17.6 m | 18.1 m | 15.3 m | 15.8 m | 16.1 m | 17.3 m |
| Gross profit | 17.1 m | 13.6 m | 12.3 m | 13.2 m | 11.8 m | 11.0 m | 11.8 m | 13.3 m |
| Research & development | 5.6 m | 6.1 m | 9.6 m | 11.4 m | 10.1 m | 11.4 m | 13.7 m | 9.4 m |
| Operating income | -6.0 m | -12.4 m | -17.8 m | -18.0 m | -16.1 m | -20.1 m | -23.3 m | 5.4 m |
| Depreciation & amortisation | 3.0 m | 2.5 m | 2.8 m | 2.5 m | 2.5 m | 2.4 m | 2.3 m | 2.4 m |
| Pre-tax income | -3.2 m | -9.5 m | -16.0 m | -16.9 m | -13.3 m | -18.4 m | -21.7 m | 6.8 m |
| Income tax | 678.0 k | 758.0 k | -456.0 k | 2.0 m | 47.0 k | 210.0 k | -432.0 k | 55.0 k |
| Net income | -4.5 m | -10.8 m | -16.0 m | -19.7 m | -13.7 m | -19.3 m | -22.4 m | 6.2 m |
| Diluted EPS | -0.06 | -0.14 ≈ | -0.21 | -0.26 | -0.19 | -0.27 ≈ | -0.32 | 0.09 |
| Operating cash flow | 12.7 m ≈ | 109.0 k | -19.7 m | -10.2 m ≈ | -10.1 m ≈ | -9.0 m | -13.9 m | -9.9 m ≈ |
| Capex | 145.0 k ≈ | 456.0 k | 420.0 k | 1.9 m ≈ | 919.0 k ≈ | 922.0 k | 913.0 k | 2.4 m ≈ |
| Share repurchases | 0 ≈ | 0 | 0 | 5.0 m ≈ | 5.0 m ≈ | 5.0 m | 5.0 m | 2.0 m ≈ |
≈ derived quarter (cumulative difference / share-days average)
E/P over time
E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.
Fiscal years
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 181.7 m | 154.6 m | 171.7 m | 233.7 m | 387.5 m | 405.5 m | 185.8 m | 115.0 m |
| Revenue YoY | +8.8% | −14.9% | +11.1% | +36.1% | +65.8% | +4.6% | −54.2% | −38.1% |
| Net income | 20.4 m | 16.7 m | -14.9 m | -23.0 m | -17.1 m | 53.7 m | -19.5 m | -68.7 m |
| Net income YoY | −34.1% | −18.3% | −189.6% | unavailable | unavailable | unavailable | −136.3% | unavailable |
| Diluted EPS | 0.33 | 0.27 | 0.22 | -0.32 | -0.24 | 0.72 | -0.26 | -0.94 |
| Diluted EPS YoY | −35.3% | −18.2% | −18.5% | −245.5% | unavailable | unavailable | −136.1% | unavailable |
| net % | 11.2% | 10.8% | -8.7% | -9.8% | -4.4% | 13.2% | -10.5% | -59.8% |
| Free cash flow | 32.7 m | 490.0 k | -20.9 m | -57.3 m | -54.0 m | 135.8 m | 23.6 m | -53.2 m |
Reported results vs expectations
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Balance sheet & financial health
Fiscal year 2025 · 31 Dec 2025
- Cash
- 199.3 m USD
- Financial debt
- unavailable USD
- Net debt
- unavailable USD
- Equity
- 340.8 m USD
- Total assets
- 403.2 m USD
- Debt / equity
- unavailable
- Current ratio
- 6.58x
- ROE
- -18.3%
- ROA
- -15.6%
- FCF margin
- -46.3%
Financial statements (source on every figure)
Revenue and net income (USD)
Margins
Income statement · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Revenue | 171.7 m | 233.7 m | 387.5 m | 405.5 m | 185.8 m | 115.0 m | SEC (XBRL)· 09 Mar 2026verified |
| Cost of revenue | 69.9 m | 116.1 m | 239.0 m | 233.8 m | 106.4 m | 66.8 m | SEC (XBRL)· 09 Mar 2026verified |
| Gross profit | 101.9 m | 117.6 m | 148.4 m | 171.7 m | 79.4 m | 48.2 m | SEC (XBRL)· 09 Mar 2026verified |
| Research & development | 31.0 m | 34.2 m | 36.2 m | 33.7 m | 26.0 m | 42.5 m | SEC (XBRL)· 09 Mar 2026verified |
| Operating income | -5.2 m | -10.2 m | -22.2 m | 32.7 m | -28.3 m | -72.0 m | SEC (XBRL)· 09 Mar 2026verified |
| Depreciation & amortisation | 9.4 m | 11.7 m | 15.3 m | 20.9 m | 10.9 m | 10.2 m | SEC (XBRL)· 09 Mar 2026verified |
| EBITDA | 4.2 m ≈ | 1.5 m ≈ | -6.8 m ≈ | 53.6 m ≈ | -17.4 m ≈ | -61.8 m ≈ | SEC (XBRL)· 09 Mar 2026derived |
| Pre-tax income | -3.5 m | -9.3 m | -15.7 m | 56.3 m | -16.0 m | -64.6 m | SEC (XBRL)· 09 Mar 2026verified |
| Income tax | 11.4 m | 13.7 m | 1.5 m | 2.6 m | 1.8 m | 1.8 m | SEC (XBRL)· 09 Mar 2026verified |
| Net income | -14.9 m | -23.0 m | -17.1 m | 53.7 m | -19.5 m | -68.7 m | SEC (XBRL)· 09 Mar 2026verified |
| Diluted EPS | 0.22 | -0.32 | -0.24 | 0.72 | -0.26 | -0.94 | SEC (XBRL)· 09 Mar 2026verified |
| Weighted average diluted shares | 67.5 m | 72.0 m | 72.5 m | 74.4 m | 74.4 m | 73.5 m | SEC (XBRL)· 09 Mar 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Operating income + Depreciation & amortisation.
Balance sheet · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Cash | 160.8 m | 116.8 m | 84.0 m | 290.4 m | 267.8 m | 199.3 m | SEC (XBRL)· 09 Mar 2026verified |
| Receivables | 38.8 m | 45.3 m | 70.8 m | 40.2 m | 23.8 m | 22.2 m | SEC (XBRL)· 09 Mar 2026verified |
| Inventories | 31.9 m | 53.1 m | 95.7 m | 47.6 m | 34.2 m | 31.1 m | SEC (XBRL)· 09 Mar 2026verified |
| Current assets | 288.9 m | 299.3 m | 325.2 m | 386.5 m | 333.2 m | 261.9 m | SEC (XBRL)· 09 Mar 2026verified |
| Property, plant & equipment, net | 51.9 m | 73.4 m | 59.4 m | 45.4 m | 45.1 m | 39.2 m | SEC (XBRL)· 09 Mar 2026verified |
| Goodwill | 40.4 m | 40.3 m | 35.1 m | 35.7 m | 40.3 m | 43.4 m | SEC (XBRL)· 09 Mar 2026verified |
| Intangibles (excl. goodwill) | 17.9 m | 14.3 m | 11.7 m | 1.2 m | 17.4 m | 19.0 m | SEC (XBRL)· 09 Mar 2026verified |
| Total assets | 454.5 m | 461.0 m | 444.2 m | 482.8 m | 479.7 m | 403.2 m | SEC (XBRL)· 09 Mar 2026verified |
| Accounts payable | 17.4 m | 28.0 m | 38.0 m | 13.2 m | 8.2 m | 6.5 m | SEC (XBRL)· 09 Mar 2026verified |
| Current liabilities | 46.5 m | 68.1 m | 69.1 m | 39.5 m | 33.5 m | 39.8 m | SEC (XBRL)· 09 Mar 2026verified |
| Total liabilities | 55.9 m | 80.5 m | 79.8 m | 52.2 m | 69.3 m | 62.3 m | SEC (XBRL)· 09 Mar 2026verified |
| Equity | 398.6 m † | 380.5 m † | 364.4 m † | 430.7 m † | 410.3 m † | 340.8 m † | SEC (XBRL)· 09 Mar 2026verified |
† equity attributable to the parent's shareholders: in these years the issuer no longer reports the total including non-controlling interests.
Cash flow · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Operating cash flow | 5.8 m | -35.4 m | -47.2 m | 141.6 m | 27.4 m | -49.0 m | SEC (XBRL)· 09 Mar 2026verified |
| Capex | 26.7 m | 21.9 m | 6.8 m | 5.8 m | 3.8 m | 4.2 m | SEC (XBRL)· 09 Mar 2026verified |
| Free cash flow | -20.9 m ≈ | -57.3 m ≈ | -54.0 m ≈ | 135.8 m ≈ | 23.6 m ≈ | -53.2 m ≈ | SEC (XBRL)· 09 Mar 2026derived |
| Investing cash flow | -14.0 m | -5.5 m | 21.1 m | 66.2 m | -39.0 m | -6.8 m | SEC (XBRL)· 09 Mar 2026verified |
| Financing cash flow | 92.5 m | -2.8 m | -3.8 m | -3.0 m | -4.2 m | -16.9 m | SEC (XBRL)· 09 Mar 2026verified |
| Share repurchases | 2.1 m | 2.1 m | 2.3 m | 0 | 0 | 15.0 m | SEC (XBRL)· 09 Mar 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Operating cash flow − Capex.
Computed indicators
Growth
Profitability
Returns
Balance sheet
Liquidity
Cash
Efficiency
Market and valuation
1 indicators that do not apply to the sector.
Valuation
olivLaw classification
- indicators available: 5 of at least 6
- score weight coverage: 33.3% of at least 60%
- valuation methods computed: 0 of at least 1
A scoring methodology on indicators and valuation, not investment advice.
Closing price
04 Nov 2026Source: olivLaw, closing series
Market cap: 256.6 m USD
Key indicators
Coverage and freshness
Score by group
33% · Insufficient data
Estimated value range
unavailable — no valuation method could be computed
Valuation assumptions are editorial choices, not measured; beta is not measured.
Valuation methods
- DCF (discounted cash flow)unavailable · the reported interest expense is far older than the latest period (the filer changed its XBRL tag): a stale figure is not used
- Peers: EV/EBITDAunavailable · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
- Peers: P/Eunavailable · the base of the ratio is not positive
- Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption
no valuation method could be computed
Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.
Assumptions (illustrative, editorial)
- Risk-free rate
- 4.3%
- Equity risk premium
- 5.0%
- Beta (default)
- 1.00
- Cost of equity
- 9.3%
- Terminal growth
- 2.5%
Factor scorecard
Insufficient data
Minimum-evidence gate: indicators available: 5 of at least 6; score weight coverage: 33.3% of at least 60%; valuation methods computed: 0 of at least 1
| Factor | Value | Score | Weight used |
|---|---|---|---|
| ROIC · Quality | unavailable | unavailable | — |
| Net margin · Quality | -43.7% | 35 (vs peers) | 19% |
| FCF conversion · Quality | unavailable | unavailable | — |
| Revenue CAGR 3Y · Growth | -33.3% | 0 (on a fixed band) | 25% |
| EPS CAGR 3Y · Growth | unavailable | unavailable | — |
| Net debt / EBITDA · Balance sheet | unavailable | unavailable | — |
| Interest coverage · Balance sheet | unavailable | unavailable | — |
| Current ratio · Balance sheet | 8.9x | 100 (on a fixed band) | 13% |
| P/E (TTM) · Valuation | unavailable | unavailable | — |
| EV/EBITDA · Valuation | unavailable | unavailable | — |
| FCF yield · Valuation | -18.7% | 0 (on a fixed band) | 25% |
| Shareholder yield (distributions) · Returns | 6.6% | 95 (on a fixed band) | 19% |
| Payout ratio (FCF) · Returns | unavailable | unavailable | — |
Factors without a value were dropped; the remaining weights were renormalised.
Score groups
- Balance sheet· partial100/100 · 1/3 factors with a value
- Growth· partial0/100 · 1/2 factors with a value
- Quality· partial35/100 · 1/3 factors with a value
- Returns· partial95/100 · 1/2 factors with a value
- Valuation· partial0/100 · 1/3 factors with a value
A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.
Memo
ORASURE TECHNOLOGIES, INC (OSUR). Latest full fiscal year: 2025; data up to 2026-06-30.
Figures computed from the financial statements: revenue 115.0 m USD in 2025; YoY growth -38.1%; net margin -43.7%; ROE -14.1%.
Valuation cannot be computed from the available data.
Insufficient data for a verdict (indicators available: 5 of at least 6; score weight coverage: 33.3% of at least 60%; valuation methods computed: 0 of at least 1).
Text generated deterministically from the figures shown; no language model. Not investment advice.
What supports the thesis
- Current ratio: 8.9x
- Shareholder yield (distributions): 6.6%
What contradicts it
- Revenue CAGR 3Y: -33.3%
- FCF yield: -18.7%
Not assessed (insufficient data or a ratio without meaning): ROIC, FCF conversion, EPS CAGR 3Y, Net debt / EBITDA, Interest coverage, P/E (TTM), EV/EBITDA, Payout ratio (FCF).
Versus the vertical median
Surgical & Medical Instruments & Apparatus (SIC 3841) · same industry (4-digit SIC) · compared with 39 companies
Multiples and returns vs the median
Price rebased to 100 (monthly, 5 years)
Companies in the vertical
| Market cap | P/E | ROE | Net margin | Revenue YoY | 1A / 3A | |
|---|---|---|---|---|---|---|
| SYKStryker Corp | 129.3 bn | 36.2 | 16.0% | 13.8% | +11.2% | −8% / +15% |
| MMM3m Company | 100.2 bn | 28.9 | 80.8% | 14.0% | +1.5% | +13% / +134% |
| BSXBoston Scientific Corporation | 66.4 bn | 19.4 | 14.3% | 16.6% | +19.9% | −55% / −18% |
| BDXBecton, Dickinson And Company | 57.0 bn | 63.2 | 3.8% | 4.0% | +8.2% | +37% / +13% |
| RMDResMed Inc. | 33.8 bn | 21.9 | 26.4% | 27.8% | +9.9% | −6% / +52% |
| DXCMDexcom, Inc. | 33.0 bn | 34.8 | 37.7% | 19.4% | +15.6% | +39% / −23% |
| WSTWest Pharmaceutical Services, Inc. | 28.5 bn | 45.9 | 21.2% | 18.8% | +6.3% | +47% / +17% |
| SOLVSolventum Corporation | 15.2 bn | 10.9 | 34.0% | 17.3% | +0.9% | +5% / unavailable |
| GMEDGlobus Medical, Inc. | 11.7 bn | 22.3 | 11.8% | 17.0% | +16.7% | −4% / +94% |
| TFXTeleflex Incorporated | 6.4 bn | — | -28.9% | -45.8% | +17.2% | +31% / −34% |
| ICUIIcu Medical Inc | 4.3 bn | 144.2 | 1.4% | 1.4% | −6.3% | +16% / +97% |
| ATECAlphatec Holdings, Inc. | 1.3 bn | — | -1,888.0% | -10.3% | +25.0% | −63% / −30% |
| SIBNSi-Bone, Inc. | 1.1 bn | — | -7.7% | -6.2% | +20.2% | +28% / +32% |
| KIDSOrthoPediatrics Corp | 875.0 m | — | -9.8% | -12.8% | +15.4% | +81% / +9% |
| SGHTSight Sciences, Inc. | 538.0 m | — | -50.1% | -32.1% | −3.1% | +16% / +184% |
| CERSCerus Corp | 487.7 m | — | -10.7% | -2.9% | +16.1% | +37% / +50% |
| SIShoulder Innovations, Inc. | 437.4 m | — | -151.9% | -58.3% | +49.6% | +36% / unavailable |
| OFIXOrthofix Medical Inc. | 395.9 m | — | -13.9% | -7.4% | +2.9% | −40% / −12% |
| CLPTClearPoint Neuro, Inc. | 325.7 m | — | -167.5% | -79.4% | +17.8% | −30% / +76% |
| TMCITreace Medical Concepts, Inc. | 292.7 m | — | -72.0% | -29.0% | +1.6% | +51% / −49% |
| CTSOCytosorbents Corporation | 286.6 m | — | -336.2% | -48.9% | +4.1% | −72% / −81% |
| OSUROrasure Technologies, Inc | 256.6 m | — | -14.1% | -43.7% | −38.1% | +45% / −34% |
| GUTSFractyl Health, Inc. | 154.8 m | — | — | — | −100.0% | −95% / unavailable |
| KRMDKoru Medical Systems, Inc. | 151.0 m | — | -10.5% | -4.0% | +22.2% | −45% / +45% |
| LUNGPulmonx Corporation | 123.2 m | — | -90.3% | -47.9% | +8.0% | +75% / −74% |
1- and 3-year price returns: for OSUR from daily closes (the same as the performance table), for the other companies from month-end closes.
olivLaw engine forecast
The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.
The engine has no published run for this company yet.
Valuation scenarios (editable assumptions)
Illustrative scenarios
Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.
Estimated price (USD)
| Estimated price | Bear | Base | Bull |
|---|---|---|---|
| 1 years | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable |
| 3 years | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable |
| 5 years | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable |
AI analysis
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
In brief
OraSure Technologies develops and sells rapid point-of-care diagnostic tests and sample management solutions, serving clinics, laboratories and consumers through self-testing. The company is recovering from a period of falling revenue, with net revenues of $115.0 million in 2025 and $30.6 million in the second quarter of 2026, while its losses turned into a GAAP quarterly profit.
SWOT
Strengths
- Broad rapid test portfolio with FDA authorizations and WHO recognition for several products.
- Solid balance sheet with significant liquidity, giving capacity to fund innovation and share repurchases.
- Established position in genomic and microbiome sample collection with academic and commercial customers.
Weaknesses
- Reliance on government funding makes revenue hard to forecast and sensitive to budget changes.
- Net losses in 2025 show that sustainable profitability has not yet been reached.
- Customer concentration, including the loss of a large customer to bankruptcy, affects revenue stability.
Opportunities
- Home self-testing and urine collection for sexually transmitted infections could open new markets.
- Integration of SickleSCAN could extend the portfolio into regions with sickle cell disease.
- Temporary demand for Ebola tests could rise if the outbreak spreads.
Threats
- FDA delays or refusals could postpone the launch of new products.
- Competitors with greater resources could take market share through aggressive pricing.
- Reduced funding for public health programs could continue to weigh on demand.
Risks
- Dependence on public fundinghigh
Revenue depends on government budgets and public health programs, which can be reduced or delayed. This makes future quarters difficult to anticipate.
- Regulatory timetablehigh
FDA approvals for new products, such as the temporarily withdrawn CT/NG test, can be delayed, and planned launches could be postponed.
- Customer concentrationmedium
The loss of a large customer, as happened with a sample management client's bankruptcy, can significantly affect revenue.
- Intellectual property litigationmedium
The company discloses litigation, including the NowDx matter, which could raise legal costs and limit sales of some products.
- International exposurelow
Sales in many countries carry regulatory, cultural and currency risks, and cash held by the Canadian subsidiary raises questions of accessibility.
Investment thesis
What would need to be true (bull case)
- A return to growth, with a quarter above guidance and a GAAP profit, could signal stabilization if the trend holds.
- Recent authorizations for Colli-Pee Dx and the Ebola 2.0 test could open new revenue sources.
- The solid balance sheet and share repurchase program provide flexibility for strategic investment or acquisitions.
What would break the thesis
- Net losses in 2025 and falling revenue show that profitability is not yet sustainable.
- Reliance on public budgets and funding programs keeps revenue volatile.
- The 2026 quarterly profit was driven in part by an accounting reduction of a liability, not only by operating activity.
What to watch
- Achievement of third-quarter revenue guidanceQ3 2026
- FDA decision on the new CT/NG test submission2027
- Trend in revenue from government-funded HIV programsnext 10-K
- Pace of share repurchases under the $40 million authorizationQ4 2026
Products, market & competition
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
The business
OraSure (OTI) focuses on developing, manufacturing and distributing simple, easy-to-use rapid tests, such as OraQuick for HIV, HCV and syphilis, along with specimen collection devices for genomics, microbiome and urine. The company sells to clinical laboratories, hospitals and government agencies, and directly to consumers through OTC and self-test formats. In November 2025 it acquired BioMedomics, adding the SickleSCAN test for sickle cell disease, currently sold outside the U.S. The stated strategy is to decentralize diagnostics and bring testing closer to the patient.
The reporting structure is unified: diagnostic products and sample management products sit within a single business unit, making the portfolio operationally integrated. The company exited its risk assessment testing line and its substance abuse testing line, narrowing its scope. In June 2026 it received FDA clearance for the Colli-Pee Dx kit, and in July 2026 an Emergency Use Authorization for the OraQuick Ebola 2.0 test.
The CT/NG test submission was withdrawn from the FDA in July 2026 to incorporate agency feedback, and the company plans a future submission. This shows that launches of new products depend on the regulatory timetable, not only on technical development.
Segments
Diagnostics
The diagnostics segment includes HIV, HCV, syphilis, SickleSCAN and SureQuick tests, sold in the U.S. and internationally. In fiscal 2025 revenues were $66.5 million, down from the prior year, due to lower funding for HIV programs in Africa and Asia. In the second quarter of 2026 segment revenues rose slightly, helped by syphilis sales and the inclusion of SickleSCAN.
Sample management
The sample management segment covers collection of DNA, RNA, microbiome and urine samples, with products such as Oragene, OMNIgene and Colli-Pee. In fiscal 2025 revenues were $38.4 million, down under the impact of a large customer's bankruptcy. In the second quarter of 2026 revenues were nearly flat, suggesting stabilization but not a clear recovery.
Market context
The market for rapid diagnostics and sample collection is shaped by government funding, public health programs and the adoption of point-of-care testing in place of centralized laboratories. For OraSure, a significant part of demand depends on U.S. public procurement and international HIV programs, which can fluctuate considerably from year to year. Demand for genomic collection is also cyclical, tied to the consumer genetic testing market.
The COVID-19 market has contracted sharply, with revenue from this line nearly zero in fiscal 2025 and the first half of 2026. On the other hand, the Ebola epidemic declared a global public health emergency by the WHO could create demand for rapid Ebola tests if authorities expand purchases.
Trends
- Volatile government fundingheadwind
Cuts to HIV program funding and U.S. budget changes weighed on diagnostic revenue in 2025. If funding stabilizes, demand could recover, but the timing remains uncertain.
- Home self-testingtailwind
Self-tests for HIV, HCV and now sexually transmitted infections offer a growth channel that could extend the market beyond laboratories. The Colli-Pee Dx clearance for use on Roche tests is a step in this direction.
- FDA regulationheadwind
The approval timetable for new products such as CT/NG has lengthened, and the withdrawal of the submission shows how complex the process is. Delays could postpone expected revenue from products in development.
- Ebola outbreakmixed
The emergency authorization of the OraQuick Ebola 2.0 test could open temporary demand linked to the outbreak in the Democratic Republic of the Congo. The financial impact, however, depends on government purchases and is hard to forecast.
Competitive position
The company faces competition from other rapid test providers, particularly for HIV testing outside the U.S. and for SARS-CoV-2 antigen tests. In sample management, Oragene competes with blood collection kits and buccal swabs, and some customers could develop their own devices. Larger competitors have greater financial and technical resources, which could lead to market share losses.
OraSure's advantage lies in its rapid test portfolio with FDA authorizations and WHO recognition for several products. However, price and innovation competition could limit margins, especially in consumer and sample collection segments.
- Genomic sample collection providers
Compete with Oragene products through similar saliva collection devices.
- SARS-CoV-2 antigen test makers
Compete with the InteliSwab test in rapid COVID-19 testing.
- Point-of-care HIV test providers
Compete with OraQuick, particularly outside the United States.
- Centralized molecular diagnostic laboratories
Represent the traditional alternative that rapid tests must displace.
Links, dependencies and risks
Who the company is tied to, from its own SEC filings (customers, suppliers, production, partners, competitors, countries, regulation), from the 5 %+ holders' statements (13D/13G) and from what other companies say about it. Click a node for its evidence; on a listed company the graph moves to it.
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News & filings
In the press
- OraSure (OSUR) Returns To Profit, But Growth Remains ElusiveYahoo Finance — News · 06 Sept 2026 · EN
SEC filings
- Quarterly report07 Aug 2026
- Current report05 Aug 2026Results of operations · Financial statements and exhibits
- Current report11 Jun 2026Other events
- Current report03 Jun 2026Departure or appointment of officers · Amendments to articles or bylaws · Shareholder vote · Financial statements and exhibits
- Quarterly report08 May 2026
- Current report06 May 2026Results of operations · Regulation FD disclosure · Financial statements and exhibits
- Proxy statement30 Apr 2026
- Current report17 Apr 2026Material agreement · Departure or appointment of officers · Regulation FD disclosure · Financial statements and exhibits
- Current report30 Mar 2026Regulation FD disclosure · Financial statements and exhibits
- Annual report09 Mar 2026
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / OraSure Technologies, Inc. · 09 Mar 2026
- [2] Form 10-Q, quarter ended 2026-06-30 · SEC / OraSure Technologies, Inc. · 07 Aug 2026
- [3] Form 8-K, results release (exhibit 99.1) · SEC / OraSure Technologies, Inc. · 05 Aug 2026
Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.