olivLaw · US equity research
Insight Molecular Diagnostics Inc. IMDX
In Vitro & In Vivo Diagnostic Substances · SIC 2835 · Vertical: In Vitro & In Vivo Diagnostic Substances (SIC 2835)
Insight Molecular Diagnostics (iMDx) develops molecular tests for monitoring transplanted organ rejection that hospitals and laboratories could run locally instead of sending samples to central labs. The company is still almost pre-revenue on kit sales while the FDA reviews GraftAssureDx, and its fiscal 2025 revenue was only 4.1 million USD.
At the close of 04 Nov 2026, Insight Molecular Diagnostics Inc. (IMDX) stock was 2.65 USD (−3.28% on the day), with market capitalisation 86.7 m USD, beta 1.07, 52-week range 2.55–8.48 USD. Latest reported quarter (Q2 2026): revenue of 239.0 k USD (−53.9% YoY), net income of -11.3 m USD, diluted EPS -0.31 USD.
Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.
Price history
Loading chart…
Technical reading
- RSI (14)
- 35.0
- weak (30–45)
- Bollinger (20, 2)
- 2.64 – 3.36
- in the lower half of the band · %B 0.02 · band width 24.2%
- SMA 50 / 200
- 3.53 / 4.68
- downtrend (price < SMA50 < SMA200)
- MACD (12, 26, 9)
- -0.20 / -0.20
- MACD above 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 | −27.8% | −1.1% | −26.7 pp | — |
| 3 months | −47.0% | −0.5% | −46.5 pp | — |
| 6 months | −47.3% | +4.4% | −51.7 pp | — |
| Year to date | −64.7% | +12.3% | −77.0 pp | — |
| 1 year | −56.8% | +13.5% | −70.3 pp | −21.1% |
| 3 years | +4.3% | +76.4% | −72.1 pp | −63.5% |
| 5 years | −96.1% | +63.7% | −159.7 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 | 115.0 k | 1.5 m | 2.1 m | 518.0 k | 260.0 k | 1.1 m | 32.0 k | 239.0 k |
| Cost of revenue | 43.0 k | 869.0 k | 813.0 k | 180.0 k | 121.0 k | 643.0 k | 17.0 k | 82.0 k |
| Gross profit | 50.0 k | 595.0 k | 1.3 m | 338.0 k | 139.0 k | 496.0 k | 15.0 k | 157.0 k |
| Research & development | 2.8 m | 2.3 m | 2.9 m | 3.3 m | 3.9 m | 5.8 m | 5.0 m | 4.5 m |
| Operating income | -13.5 m | -33.6 m | -6.8 m | -9.8 m | -11.0 m | -23.4 m | -4.4 m | -11.4 m |
| Depreciation & amortisation | 340.0 k | 563.0 k | 491.0 k | 559.0 k | 584.0 k | 563.0 k | 631.0 k | 665.0 k |
| Pre-tax income | -13.5 m | -33.5 m | — | — | — | — | — | — |
| Income tax | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Net income | -13.5 m | -33.5 m | -6.7 m | -9.7 m | -10.9 m | -23.0 m | -4.3 m | -11.3 m |
| Diluted EPS | -0.98 | -1.93 ≈ | -0.26 | -0.30 | -0.34 | -0.72 ≈ | -0.12 | -0.31 |
| Operating cash flow | -5.5 m ≈ | -5.4 m | -5.8 m | -6.2 m ≈ | -4.6 m ≈ | -5.5 m | -7.6 m | -9.3 m ≈ |
| Capex | 87.0 k ≈ | 214.0 k | 307.0 k | 349.0 k ≈ | 1.1 m ≈ | 1.5 m | 613.0 k | 779.0 k ≈ |
≈ 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 | unavailable | unavailable | 1.2 m | 2.2 m | 958.0 k | 1.5 m | 1.9 m | 4.1 m |
| Revenue YoY | unavailable | unavailable | unavailable | — | −56.4% | +56.9% | +25.1% | +115.6% |
| Net income | -15.8 m | -22.4 m | -29.9 m | -64.1 m | -72.9 m | -27.8 m | -60.7 m | -50.2 m |
| Net income YoY | unavailable | unavailable | unavailable | — | unavailable | unavailable | unavailable | unavailable |
| Diluted EPS | unavailable | unavailable | unavailable | -0.72 | -13.25 | -3.75 | -4.66 | -1.65 |
| Diluted EPS YoY | unavailable | unavailable | unavailable | — | unavailable | unavailable | unavailable | unavailable |
| net % | unavailable | unavailable | -2,461.5% | -2,916.2% | -7,609.8% | -1,848.4% | -3,225.0% | -1,238.5% |
| Free cash flow | -11.7 m | -20.6 m | -27.2 m | -38.2 m | -49.9 m | -23.6 m | -21.2 m | -25.4 m |
The series breaks before 2021: earlier years come from the original reports of the issuer of that time, later years from a subsequent filing that restated the perimeter (a separation, discontinued operations). The year-on-year change across the break is not shown.
Reported results vs expectations
Loading…
Balance sheet & financial health
Fiscal year 2025 · 31 Dec 2025
- Cash
- 11.6 m USD
- Financial debt
- unavailable USD
- Net debt
- unavailable USD
- Equity
- -31.5 m USD
- Total assets
- 25.8 m USD
- Debt / equity
- unavailable
- Current ratio
- 1.27x
- ROE
- unavailable
- ROA
- -165.1%
- FCF margin
- -625.6%
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 | 1.2 m | 2.2 m | 958.0 k | 1.5 m | 1.9 m | 4.1 m | SEC (XBRL)· 26 Mar 2026verified |
| Cost of revenue | 1.9 m | 697.0 k | 880.0 k | 1.0 m | 1.1 m | 1.8 m | SEC (XBRL)· 26 Mar 2026verified |
| Gross profit | -639.0 k | 1.4 m | -18.0 k | 413.0 k | 740.0 k | 2.3 m | SEC (XBRL)· 26 Mar 2026verified |
| Research & development | 9.8 m | 5.0 m | 7.3 m | 9.3 m | 9.8 m | 15.9 m | SEC (XBRL)· 26 Mar 2026verified |
| Operating income | -29.7 m | -53.7 m | -18.0 m | -25.1 m | -61.0 m | -51.1 m | SEC (XBRL)· 26 Mar 2026verified |
| Depreciation & amortisation | 313.0 k | 800.0 k | 1.5 m | 1.7 m | 1.6 m | 2.2 m | SEC (XBRL)· 26 Mar 2026verified |
| EBITDA | -29.4 m ≈ | -52.9 m ≈ | -16.5 m ≈ | -23.5 m ≈ | -59.5 m ≈ | -48.9 m ≈ | SEC (XBRL)· 26 Mar 2026derived |
| Pre-tax income | -31.2 m | -52.9 m | -18.6 m | -24.9 m | -60.7 m | — | SEC (XBRL)· 24 Mar 2025verified |
| Income tax | -1.3 m | -9.3 m | — | 0 | 0 | 0 | SEC (XBRL)· 26 Mar 2026verified |
| Net income | -29.9 m | -64.1 m | -72.9 m | -27.8 m | -60.7 m | -50.2 m | SEC (XBRL)· 26 Mar 2026verified |
| Diluted EPS | — | -0.72 | -13.25 | -3.75 | -4.66 | -1.65 | SEC (XBRL)· 26 Mar 2026verified |
| Weighted average diluted shares | — | — | 5.5 m | 7.7 m | 13.1 m | 30.5 m | SEC (XBRL)· 26 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 | 7.1 m | 32.9 m | 20.0 m | 9.4 m | 8.6 m | 11.6 m | SEC (XBRL)· 26 Mar 2026verified |
| Receivables | 203.0 k | 1.4 m | 2.0 m | 484.0 k | 1.6 m | 1.1 m | SEC (XBRL)· 26 Mar 2026verified |
| Inventories | — | — | — | — | 410.0 k | 446.0 k | SEC (XBRL)· 26 Mar 2026verified |
| Current assets | 9.2 m | 39.1 m | 25.5 m | 10.7 m | 11.8 m | 15.3 m | SEC (XBRL)· 26 Mar 2026verified |
| Property, plant & equipment, net | 4.4 m | 7.1 m | 8.7 m | 4.7 m | 6.3 m | 6.4 m | SEC (XBRL)· 10 Aug 2026verified |
| Goodwill | 9.2 m | 18.7 m | — | — | — | — | SEC (XBRL)· 11 Mar 2022verified |
| Intangibles (excl. goodwill) | 15.0 m | 61.7 m | 61.6 m | 56.6 m | 14.6 m | 0 | SEC (XBRL)· 26 Mar 2026verified |
| Total assets | 55.4 m | 159.6 m | 100.1 m | 74.9 m | 35.1 m | 25.8 m | SEC (XBRL)· 26 Mar 2026verified |
| Accounts payable | 432.0 k | 1.8 m | 1.3 m | 953.0 k | 1.6 m | 2.5 m | SEC (XBRL)· 26 Mar 2026verified |
| Current liabilities | 9.0 m | 14.1 m | 12.1 m | 7.2 m | 7.3 m | 12.1 m | SEC (XBRL)· 26 Mar 2026verified |
| Total liabilities | 21.9 m | 94.3 m | 60.5 m | 49.3 m | 47.4 m | 57.2 m | SEC (XBRL)· 26 Mar 2026verified |
| Equity | 33.5 m † | 65.2 m † | 34.3 m † | 20.5 m † | -12.3 m † | -31.5 m † | SEC (XBRL)· 26 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 | -26.0 m | -35.9 m | -45.6 m | -23.3 m | -20.7 m | -22.2 m | SEC (XBRL)· 26 Mar 2026verified |
| Capex | 1.2 m | 2.2 m | 4.3 m | 281.0 k | 516.0 k | 3.2 m | SEC (XBRL)· 26 Mar 2026verified |
| Free cash flow | -27.2 m ≈ | -38.2 m ≈ | -49.9 m ≈ | -23.6 m ≈ | -21.2 m ≈ | -25.4 m ≈ | SEC (XBRL)· 26 Mar 2026derived |
| Investing cash flow | -11.7 m | -14.0 m | -4.3 m | -932.0 k | -512.0 k | -3.2 m | SEC (XBRL)· 26 Mar 2026verified |
| Financing cash flow | 22.8 m | 78.4 m | 35.8 m | 12.2 m | 20.4 m | 28.1 m | SEC (XBRL)· 26 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: 4 of at least 6
- score weight coverage: 27.1% 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: 86.7 m USD
Key indicators
Coverage and freshness
Score by group
27% · 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: 4 of at least 6; score weight coverage: 27.1% of at least 60%; valuation methods computed: 0 of at least 1
| Factor | Value | Score | Weight used |
|---|---|---|---|
| ROIC · Quality | unavailable | unavailable | — |
| Net margin · Quality | -2,955.6% | 20 (vs peers) | 23% |
| FCF conversion · Quality | unavailable | unavailable | — |
| Revenue CAGR 3Y · Growth | 61.8% | 100 (on a fixed band) | 31% |
| EPS CAGR 3Y · Growth | unavailable | unavailable | — |
| Net debt / EBITDA · Balance sheet | unavailable | unavailable | — |
| Interest coverage · Balance sheet | unavailable | unavailable | — |
| Current ratio · Balance sheet | 2.0x | 100 (on a fixed band) | 15% |
| P/E (TTM) · Valuation | unavailable | unavailable | — |
| EV/EBITDA · Valuation | unavailable | unavailable | — |
| FCF yield · Valuation | -35.7% | 0 (on a fixed band) | 31% |
| Shareholder yield (distributions) · Returns | unavailable | unavailable | — |
| 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· partial100/100 · 1/2 factors with a value
- Quality· partial20/100 · 1/3 factors with a value
- Returns· partialunavailable · 0/2 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
Insight Molecular Diagnostics Inc. (IMDX). Latest full fiscal year: 2025; data up to 2026-06-30.
Figures computed from the financial statements: revenue 4.1 m USD in 2025; YoY growth 115.6%; net margin -2,955.6%.
Valuation cannot be computed from the available data.
Insufficient data for a verdict (indicators available: 4 of at least 6; score weight coverage: 27.1% 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
- Revenue CAGR 3Y: 61.8%
- Current ratio: 2.0x
What contradicts it
- Net margin: -2,955.6%
- FCF yield: -35.7%
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, Shareholder yield (distributions), Payout ratio (FCF).
Versus the vertical median
In Vitro & In Vivo Diagnostic Substances (SIC 2835) · same industry (4-digit SIC) · compared with 17 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 | |
|---|---|---|---|---|---|---|
| IDXXIdexx Laboratories Inc | 55.0 bn | 47.1 | 68.9% | 25.4% | +10.4% | −7% / +50% |
| LNTHLantheus Holdings, Inc. | 6.6 bn | 24.5 | 22.2% | 17.7% | +0.5% | +72% / +41% |
| NEOGNeogen Corporation | 2.7 bn | — | -2.7% | -6.3% | −2.7% | +108% / −27% |
| TRIBTrinity Biotech PLC | 2.4 bn | — | — | -51.6% | +8.3% | −80% / −91% |
| CLDXCelldex Therapeutics, Inc. | 2.4 bn | — | -43.9% | -190,220.9% | −78.0% | +11% / −1% |
| NTLAIntellia Therapeutics, Inc. | 1.7 bn | — | -6,424.8% | -672.2% | +16.9% | +37% / −58% |
| QDELQuidelortho Corp | 984.6 m | — | -19.3% | -14.2% | −1.9% | −48% / −79% |
| ACHVAchieve Life Sciences, Inc. | 718.3 m | — | -845.0% | — | unavailable | +43% / +21% |
| MYGNMyriad Genetics, Inc. | 575.8 m | — | -32.5% | -14.0% | −1.6% | −21% / −68% |
| TKNOAlpha Teknova, Inc. | 395.7 m | — | -24.2% | -38.4% | +7.4% | +57% / +261% |
| ICCCImmuCell Corporation | 94.2 m | 138.2 | 2.6% | 2.6% | +4.3% | +114% / +128% |
| IMDXInsight Molecular Diagnostics Inc. | 86.7 m | — | — | -2,955.6% | +115.6% | −57% / +4% |
| BMRABiomerica, Inc. | 8.0 m | — | -113.8% | -115.5% | −16.2% | −27% / −77% |
| CDIOCardio Diagnostics Holdings, Inc. | 4.9 m | — | -75.4% | -44,771.8% | −57.5% | −43% / −97% |
| QCLSQ/C Technologies, Inc. | 3.2 m | — | -155.0% | — | −5.3% | −89% / −100% |
| VNRXVolitionRx Limited | 2.8 m | — | — | -1,043.1% | +40.0% | −97% / −99% |
| VRAXVirax Biolabs Group Ltd | 695.1 k | — | -109.6% | -95,739.2% | −96.0% | −88% / −98% |
| NNNNAnbio Biotechnology | — | 25.0 | 27.0% | 74.1% | +5.6% | −84% / unavailable |
1- and 3-year price returns: for IMDX 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
Insight Molecular Diagnostics (iMDx) develops molecular tests for monitoring transplanted organ rejection that hospitals and laboratories could run locally instead of sending samples to central labs. The company is still almost pre-revenue on kit sales while the FDA reviews GraftAssureDx, and its fiscal 2025 revenue was only 1 4.1 million USD 1.
SWOT
Strengths
- The company offers a kit that can be run locally, with a stated advantage in sample economics and turnaround time, supported by published comparative data 13.
- The partnership with Bio-Rad provides a digital PCR platform and industrial support for kit development 13.
- The company holds a patent portfolio and research teams in Germany and the US that contributed to the science behind dd-cfDNA 1.
Weaknesses
- Revenue is very small and comes mainly from laboratory services, while kit sales are not yet material 13.
- The company has recurring net losses, a large accumulated deficit and depends on share issuances for funding 1.
- The company is out-of-network with major commercial payers, which limits reimbursement for its tests 1.
Opportunities
- FDA authorization of GraftAssureDx could open kit sales for clinical use in the US, with reported interest from large reference laboratories 23.
- The new Medicare surveillance LCD and coverage for treatment-response monitoring could increase test volumes if hospitals adopt them 3.
- Planned expansion into heart transplant testing, with a key opinion leader event scheduled, could add a new market 3.
Threats
- FDA delays or refusal could postpone or block kit revenue, with direct impact on financing 2.
- Competitors with far greater resources and established customer bases could reduce the company's market share 1.
- Changes in reimbursement policy or Medicare delays could affect revenue and clinician adoption 1.
Risks
- FDA authorizationhigh
Clinical kit sales depend on FDA authorization of GraftAssureDx. If authorization were delayed or not obtained, expected kit revenue could be postponed 12.
- Financing and dilutionhigh
The company has recorded repeated losses and has funded operations through share issuances. If future financing were unfavorable, significant dilution could follow 1.
- Reimbursementmedium
The lack of contracts with private payers and dependence on Medicare policies could limit revenue if those policies changed 1.
- Competitionmedium
Larger competitors could launch cheaper or faster tests, which would reduce the appeal of iMDx products 1.
- Product liabilitylow
Test defects or errors could lead to recalls, litigation and reputational damage, and insurance may be hard to obtain at a reasonable cost 1.
Investment thesis
What would need to be true (bull case)
- If the FDA authorizes GraftAssureDx and large laboratories adopt the test, the company could transform transplant monitoring with locally run kits 23.
- The expanded Medicare surveillance policy could increase test volumes, and published comparative evidence could support adoption 3.
- The Bio-Rad partnership and patent portfolio could provide a lasting technical advantage if confirmed in practice 13.
What would break the thesis
- The company is almost pre-revenue on kits, and FDA authorization could be delayed, extending periods of losses 12.
- Reliance on share issuances could lead to repeated dilution if revenue does not grow enough 1.
- Competitors with established customer bases and greater resources could limit the company's market share 1.
What to watch
- FDA decision on GraftAssureDx2026
- Private payer reimbursement and network contracts2027
- Kit revenue after any FDA authorizationQ1 2027
- Trend in net losses and need for new share issuancesnext 10-K
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
iMDx is a molecular diagnostics company seeking to expand access to new molecular testing, first in transplanted organ rejection monitoring. Its flagship GraftAssure technology quantifies dd-cfDNA, a rejection biomarker, and comes in three forms: GraftAssureCore, a CMS-reimbursed LDT run at its CLIA laboratory in Franklin, Tennessee, GraftAssureIQ, a research-use-only kit, and GraftAssureDx, an IVD kit under FDA review 12. Its oncology tests DetermaIO and DetermaCNI are not planned for commercialization in the next 12 months 1.
The business model is built on test kits that let hospital laboratories run tests locally, as an alternative to send-out testing. The company has said that until FDA authorization it remains essentially pre-revenue on kits, and its current revenue comes mainly from laboratory services 123.
The company was incorporated in California in September 2009 and moved its headquarters to Nashville, Tennessee in June 2025, when it changed its name from Oncocyte Corporation. It relies on its partnership with Bio-Rad, whose digital PCR platform runs its assays, and on its own patent portfolio, including a patent awarded in July 2025 for detecting colorectal cancer from circulating cell-free DNA 1.
Segments
Market context
The company estimates the addressable market for kitted transplant rejection testing at roughly 2 billion USD 1. Medicare reimbursement shapes market access, and CMS raised the reimbursement price for GraftAssureCore to 2,753 USD per result in May 2025 1.
The market also depends on private payer reimbursement, which usually takes twelve to twenty-four months to obtain. The company is out-of-network with all commercial payers, so it could face reimbursement difficulties until it negotiates contracts 1.
Trends
- Medicare surveillance policytailwind
A favorable LCD issued by MolDX in July 2026 expands reimbursement for surveillance testing, which could increase test volumes if hospitals adopt more frequent testing 3.
- FDA authorization of GraftAssureDxmixed
The company says the FDA review has progressed and that a few well-defined items remain. Authorization would allow kit sales for clinical use in the US, but delays could extend the period without kit revenue 23.
- Head-to-head clinical evidencetailwind
Recent publications, including a head-to-head study against an NGS-based competitor, support GraftAssure performance, but much of the evidence comes from the company and research groups linked to it 3.
- Reliance on equity financingheadwind
The company has funded operations through share issuances and announced a 26.0 million USD offering in February 2026. If future financing became more expensive, dilution for shareholders could follow 1.
Competitive position
Competing transplant rejection methods include manual biopsy and liquid dd-cfDNA tests from CareDx, Natera, Transplant Genomics, Omixon and Devyser. CareDx, Natera and Transplant Genomics already have established customer bases, while iMDx argues that digital PCR offers attractive sample economics and faster turnaround 1.
Competitors generally have far greater financial, technical and sales resources than iMDx, which describes itself as an early-stage company. Competition could intensify if large reference laboratories develop their own dd-cfDNA tests 13.
- CareDx, Inc.CDNA
Competitor with a liquid dd-cfDNA test and an established customer base in transplant monitoring 1.
- Natera, Inc.NTRA
Competitor with a liquid dd-cfDNA test and an established customer base, described by the company as having greater resources 1.
- Transplant Genomics
Competitor with a liquid dd-cfDNA test and an established customer base; no confirmed US ticker in the sources 1.
- Omixon Inc. and Devyser
Competitors offering liquid dd-cfDNA tests in transplant monitoring, without an established customer base mentioned in the sources 1.
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.
Loading the links…
News & filings
In the press
No news in our archive over the last 180 days.
SEC filings
- Current report21 Sept 2026Material agreement · Financial statements and exhibits
- Quarterly report10 Aug 2026
- Current report10 Aug 2026Results of operations · Regulation FD disclosure · Other events · Financial statements and exhibits
- Current report17 Jun 2026Departure or appointment of officers · Shareholder vote · Financial statements and exhibits
- Quarterly report13 May 2026
- Current report13 May 2026Results of operations · Financial statements and exhibits
- Current report (amendment)13 May 2026Other events
- Proxy statement30 Apr 2026
- Current report30 Apr 2026Other events · Financial statements and exhibits
- Annual report26 Mar 2026
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Insight Molecular Diagnostics Inc. · 26 Mar 2026
- [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Insight Molecular Diagnostics Inc. · 10 Aug 2026
- [3] Form 8-K, results release (exhibit 99.1) · SEC / Insight Molecular Diagnostics Inc. · 10 Aug 2026
Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.