Insight Molecular Diagnostics (IMDX)
NASDAQ:IMDX
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Insight Molecular Diagnostics
(NASDAQ:IMDX)
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Rating:45Neutral
Price Target:
$3.00
▼(-5.36% Downside)
Action:ReiteratedDate:04/01/26
The score is held down primarily by weak financial performance (large recurring losses, heavy cash burn, and negative equity) and bearish technicals (price below key moving averages with negative MACD). These are partially offset by a relatively positive earnings-call backdrop featuring regulatory progress, early commercial traction signals, and recent financing to support the launch plan.
Positive Factors
Regulatory milestone (FDA submission)
An FDA submission for GraftAssureDx is a structural de-risking event: authorization would enable a broader commercialization model (kitted IVD), shorten payer discussions, and create first-mover regulatory advantage that supports scalable, repeatable revenue and durable clinical adoption across transplant centers.
Negative Factors
Heavy cash burn and negative equity
Persistent multi-year negative operating and free cash flows and a shift to negative equity materially weaken financial flexibility. This structural funding gap increases reliance on external capital, heightens dilution risk, constrains investment choices, and can limit the firm's ability to scale commercialization over the medium term.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory milestone (FDA submission)
An FDA submission for GraftAssureDx is a structural de-risking event: authorization would enable a broader commercialization model (kitted IVD), shorten payer discussions, and create first-mover regulatory advantage that supports scalable, repeatable revenue and durable clinical adoption across transplant centers.
Read all positive factors
Insight Molecular Diagnostics (IMDX) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$96.50M
Dividend YieldN/A
Average Volume (3M)42.75K
Price to Earnings (P/E)―
Beta (1Y)0.52
Revenue Growth520.87%
EPS Growth36.11%
CountryUS
Employees46
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.72
Shares Outstanding32,167,976
10 Day Avg. Volume47,668
30 Day Avg. Volume42,754
Financial Highlights & Ratios
PEG Ratio0.07
Price to Book (P/B)-7.26
Price to Sales (P/S)56.37
P/FCF Ratio-9.01
Enterprise Value/Market Cap0.92
Enterprise Value/Revenue21.90
Enterprise Value/Gross Profit467.43
Enterprise Value/Ebitda-3.13
Forecast
1Y Price Target
$10.50Price Target Upside231.23% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering3
EPS Forecast (FY)-0.92
Revenue Forecast (FY)$3.30M
Insight Molecular Diagnostics Business Overview & Revenue Model
Company Description
OncoCyte Corporation, a molecular diagnostics company, researches, develops, and commercializes proprietary laboratory-developed tests for the detection of cancer in the United States and internationally. The company offers DetermaRx, a molecular ...
Insight Molecular Diagnostics Earnings Call Summary
Earnings Call Date:Mar 26, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 18, 2026
Earnings Call Sentiment Positive
The call highlights major strategic and operational progress: submission of GraftAssureDx to the FDA, robust early clinical engagement (registry and head-to-head data), successful $26M financing with strategic investor support, a clear U.S. reimbursement pathway (Medicare rate and MolDx Z-code submission), and a defined plan to expand into heart transplants via a 510(k) pathway. Near-term risks include low expected lab revenue in Q1, front-loaded cash burn and higher quarterly spending, an intangible write-down on oncology assets, and reimbursement/operational complexity in EU/UK and MAC territories. Overall, the positives—regulatory milestone, strong external validation, funding, and an explicit commercialization plan—outweigh the near-term financial and market-access risks, supporting an optimistic outlook while acknowledging execution risk.Positive Updates
FDA Submission — GraftAssureDx
Submitted GraftAssureDx to the FDA for review; company believes it is the first dd-cfDNA assay submitted for FDA authorization. This is a major regulatory milestone and shifts the company's focus toward product launch and commercialization.
Negative Updates
Low Near-Term Lab Revenue
Company expects low levels of lab services revenue for the year and almost no revenue in Q1, indicating limited near-term top-line contribution from lab operations prior to authorization and commercialization.
Read all updates
Q4-2025 Updates
Positive
Negative
FDA Submission — GraftAssureDx
Submitted GraftAssureDx to the FDA for review; company believes it is the first dd-cfDNA assay submitted for FDA authorization. This is a major regulatory milestone and shifts the company's focus toward product launch and commercialization.
Read all positive updates
Company Guidance
The company’s guidance focused on progressing regulatory and commercial milestones and the investments to support a launch later this year: GraftAssure has been submitted to the FDA (first dd‑cfDNA assay submitted), the GALACTIC registry has 28 centers started (goal 50) and management says 37 U.S. centers are engaged, with a registry target of ~5,000 patients (~100 patients/center) and roughly 10 tests per patient (≈50,000 tests); early head‑to‑head data include a >140‑sample study and the planned heart program contemplates a ~150‑patient study across 4–5 centers and a 510(k) path (≈90‑day review), while Medicare reimbursement is $27.53/test. Financial and operating metrics: $26M financing completed (Bio‑Rad now at just under 10% ownership and a 90‑day right of first negotiation post‑authorization), maintenance spend ≈$5.5M/quarter and growth spend ≈$2M/quarter (management says maintenance spending is covered at ≈$35M revenue/year), expected average revenue of ~$1M/center annually, TAM >$2B/year, and cash‑flow sequencing with low lab service revenue (almost none in Q1), an average run‑rate moving from ~$6M/quarter historically to ~$7.5M currently (over $8M in H1 then ~ $6M in back half).Insight Molecular Diagnostics Financial Statement Overview
Summary
Income Statement
18
Very Negative
Balance Sheet
24
Negative
Cash Flow
20
Very Negative
| Breakdown | Dec 2025 | Dec 2024 | Mar 2024 | Mar 2023 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 4.05M | 1.88M | 1.50M | 958.00K | 2.20M |
| Gross Profit | 190.00K | 740.00K | 413.00K | -18.00K | 1.42M |
| EBITDA | -28.38M | -59.02M | -23.12M | -13.31M | -48.46M |
| Net Income | -50.22M | -60.66M | -27.78M | -72.90M | -64.10M |
Balance Sheet | |||||
| Total Assets | 25.76M | 35.08M | 74.89M | 100.09M | 159.56M |
| Cash, Cash Equivalents and Short-Term Investments | 11.58M | 8.64M | 9.43M | 20.43M | 33.85M |
| Total Debt | 3.50M | 3.66M | 2.87M | 3.54M | 5.68M |
| Total Liabilities | 57.22M | 47.35M | 54.42M | 60.50M | 94.35M |
| Stockholders Equity | -31.46M | -12.27M | 20.47M | 39.59M | 65.22M |
Cash Flow | |||||
| Free Cash Flow | -25.37M | -21.23M | -23.61M | -49.91M | -38.19M |
| Operating Cash Flow | -22.18M | -20.71M | -23.32M | -45.57M | -35.94M |
| Investing Cash Flow | -3.19M | -512.00K | -932.00K | -4.34M | -13.96M |
| Financing Cash Flow | 28.07M | 20.43M | 12.19M | 35.81M | 78.36M |
Insight Molecular Diagnostics Technical Analysis
Negative
3.17
Price Trends
4.91
Negative
5.56
Negative
4.66
Negative
Market Momentum
-0.49
Negative
45.32
Neutral
54.92
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For IMDX, the sentiment is Negative. The current price of 3.17 is below the 20-day moving average (MA) of 3.62, below the 50-day MA of 4.91, and below the 200-day MA of 4.66, indicating a bearish trend. The MACD of -0.49 indicates Negative momentum. The RSI at 45.32 is Neutral, neither overbought nor oversold. The STOCH value of 54.92 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for IMDX.
Insight Molecular Diagnostics Risk Analysis
Insight Molecular Diagnostics disclosed 58 risk factors in its most recent earnings report. Insight Molecular Diagnostics reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 1 New Risks
1.
We currently market certain IVDs that have not been cleared by the FDA in reliance on the regulatory exemption for IVDs intended for RUO, but if the FDA determines that our RUO tests do not meet the applicable requirements for exemption or have intended uses that are inconsistent with RUO tests, we may be required to suspend commercialization of such products until we can obtain the requisite FDA clearance and/or subject to FDA warning or untitled letters, seizure, injunction, fines, or other enforcement action. Q3, 2024
Insight Molecular Diagnostics Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
52 Neutral | $220.54M | -1.80 | -120.20% | ― | -9.70% | 23.23% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
51 Neutral | $47.06M | 0.54 | -225.83% | ― | -14.92% | 72.81% | |
47 Neutral | $342.99M | -0.70 | ― | ― | -63.96% | -28.50% | |
46 Neutral | $45.73M | -2.19 | -65.56% | ― | ― | -9.42% | |
45 Neutral | $96.50M | -4.55 | 684.60% | ― | 520.87% | 36.11% |
* Healthcare Sector Average
IMDX
Insight Molecular Diagnostics
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Insight Molecular Diagnostics Corporate Events
Business Operations and Strategy
Insight Molecular Diagnostics Signs Quest Specimen Collection Agreement
Positive
Feb 26, 2026
On February 20, 2026, Insight Molecular Diagnostics Inc. signed a Specimen Collection Agreement with Quest Diagnostics under which Quest will provide specimen collection services for patients undergoing the company’s GraftAssureCore blood te...
Business Operations and StrategyPrivate Placements and Financing
Insight Molecular Diagnostics Raises Capital to Advance Transplant R&D
Positive
Feb 12, 2026
Insight Molecular Diagnostics Inc. entered into securities purchase agreements on February 10, 2026, with institutional investors for a registered direct offering of 3,482,498 common shares and pre-funded warrants for up to 1,043,478 additional sh...
Business Operations and StrategyRegulatory Filings and Compliance
Insight Molecular Diagnostics Provides Updated Investor Presentation Materials
Neutral
Feb 11, 2026
Insight Molecular Diagnostics Inc. disclosed that it has prepared a slide presentation for potential use in meetings with investors and analysts. The company indicated that the materials may be presented from time to time but did not characterize ...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.