IMDX Supports AST and ASHI STAR Working Group’s Call for Decentralized Transplant Monitoring

Insight Molecular Diagnostics (Nasdaq: IMDX) praised a Jan. 13, 2026 STAR working group position paper in the American Journal of Transplantation that calls for decentralized, high-quality dd-cfDNA testing.

Rhea-AI Summary

Insight Molecular Diagnostics (Nasdaq: IMDX) praised a Jan. 13, 2026 STAR working group position paper in the American Journal of Transplantation that calls for decentralized, high-quality dd-cfDNA testing. The company says the paper's endorsement of absolute quantification and onsite testing aligns with iMDx's GraftAssure family of assays and supports demand for its kitted diagnostics. iMDx noted GraftAssureCore is an LDT reimbursed by CMS, GraftAssureDx is an IVD kit in development, and management cited a roughly $1 billion-plus addressable market for kitted transplant rejection testing.

Positive

• Addressable market of $1 billion+ for kitted rejection testing
• GraftAssureCore LDT currently reimbursed by CMS
• Company technology quantifies dd-cfDNA, matching STAR recommendations

Negative

• GraftAssureDx IVD kit is still in development
• Commercial-scale analytic consistency depends on a third-party blood analysis system
• Future value depends on decentralized adoption and payer reimbursement

Argus Jan 13 session

+1.69% close to close Open Argus

Details

News Market Reaction – IMDX

On Jan 13, the day this news came out, IMDX closed 1.69% above the previous close.

Data tracked by StockTitan Argus for the Jan 13 session.

Key Figures

Addressable market: $1 billion-plus

Addressable market

$1 billion-plus

Kitted transplant rejection testing market size cited by company

Historical Context

5 past events · Latest: Jan 07

5 events

1. Jan 07

   Conference participation

   24h Move

   +1.5%

   Investor conference attendance and one-on-one meeting schedule.

2. Jan 06

   Leadership hire

   24h Move

   -1.1%

   Appointment of VP Medical Affairs ahead of transplant assay launch.

3. Jan 05

   Clinical progress

   24h Move

   +4.3%

   GraftAssureDx trial nearing completion and FDA submission nearing.

4. Nov 10

   Earnings and pipeline

   24h Move

   +9.0%

   Q3 2025 results and progress toward 2026 GraftAssureDx launch.

5. Nov 03

   Earnings date notice

   24h Move

   +1.8%

   Announcement of Q3 results date and conference participation.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

dd-cfDNA, laboratory-developed test (LDT), research-use-only (RUO), in vitro diagnostic (IVD), +1 more

5 terms

dd-cfDNA medical

"decentralized dd-cfDNA testing is the essential prerequisite for conducting"

Donor-derived cell-free DNA (dd-cfDNA) are tiny fragments of DNA from a transplanted organ that float in the blood of the recipient; testing measures how much of the free DNA comes from the donor. Like finding fresh crumbs that reveal whether something has been disturbed, higher levels can indicate organ injury or rejection before symptoms appear, so investors watch adoption of these noninvasive tests because they can change follow-up care, reduce costly biopsies, and drive demand for new diagnostics and monitoring services.

laboratory-developed test (LDT) regulatory

"GraftAssureCore – The company’s laboratory-developed test (LDT), currently reimbursed"

A laboratory-developed test (LDT) is a diagnostic test that a single clinical laboratory designs, builds and uses on-site rather than buying as a finished product from a manufacturer — think of it like a restaurant’s house recipe served only at that location. Investors should care because LDTs can drive a lab’s revenue and competitive edge but also carry unique regulatory, reimbursement and scalability risks that affect future growth and valuation.

research-use-only (RUO) regulatory

"GraftAssureIQ – A research-use-only (RUO) kit intended and labeled"

Research-use-only (RUO) indicates laboratory tools, reagents, or instruments intended solely for scientific investigation and not approved for diagnosing, treating, or guiding patient care. For investors, RUO status signals a narrower, early-stage market and extra regulatory hurdles—like a prototype that works in a workshop but isn’t certified for road use—so commercial sales, revenue size and timelines can be limited until products gain clinical validation and formal approvals.

in vitro diagnostic (IVD) regulatory

"GraftAssureDx – The in vitro diagnostic (IVD) kit currently in development"

In vitro diagnostic (IVD) tests are medical tests run on samples such as blood, urine or swabs outside the body to detect diseases, measure biomarkers or guide treatment decisions. Investors pay attention because IVDs generate recurring sales for test kits and instruments, are heavily influenced by regulatory approval, reimbursement and accuracy, and can quickly shift market value when a test becomes widely adopted or replaced — like a trusted household tool that professionals rely on every day.

CLIA-certified laboratory regulatory

"performed at iMDx’s CLIA-certified laboratory in Nashville"

A CLIA-certified laboratory is a medical testing lab that meets U.S. federal standards for accuracy, reliability and quality control when performing human diagnostic tests. Think of it like a safety inspection or driver's license for labs: certification shows tests are run under approved procedures and oversight. For investors, CLIA certification reduces regulatory and operational risk, affects a lab’s ability to bill insurers and sell diagnostic services, and can influence revenue and growth potential.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• American Journal of Transplantation position paper also highlights value of absolute quantification of dd-cfDNA as a diagnostic marker, a key feature of iMDx’s flagship GraftAssure^TM family of assays
  
  

NASHVILLE, Tenn., Jan. 13, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), today congratulated the STAR working group on its position paper in the American Journal of Transplantation in recognizing the need for decentralized organ health testing in the global transplant community.

Specifically, the publication states, “High-quality, standardized decentralized dd-cfDNA testing is the essential prerequisite for conducting real-world evidence-generating multicenter studies to establish the appropriate context of use for this promising assay.”

“We completely agree with the working group’s conclusion. It’s high time that we give transplant centers the tools that they need to build guidelines and manage patients themselves,” iMDx CEO Josh Riggs said. “Such a full-throated call for access to test kits is great for us as an indicator of pent-up industry demand for what we are building. We are also pleased with the positive details throughout the paper regarding absolute quantification and the potential value of having onsite testing. This conclusion directly aligns with iMDx’s strategy and is supportive of our flagship GraftAssure family of assays.”

STAR is a joint group between the American Society of Transplantation (AST) and the American Society for Histocompatibility and Immunogenetics (ASHI). AST and ASHI are the professional societies representing the clinicians and laboratories that serve the transplant community. STAR stands for Sensitization in Transplantation: Assessment of Risk. One of STAR’s working groups focuses on dd-cfDNA, and this publication is a conclusion from that group.

“We congratulate the STAR working group’s great position paper on the analytical validity of dd-cfDNA methods,” iMDx Chief Science Officer Dr. Ekkehard Schuetz said. “It is clearly articulated that the future is a decentralized high-quality assay with transparent quality control, which will facilitate broader, faster, and more cost-effective access to dd-cfDNA as the most promising rejection biomarker that it is.”

iMDx seeks to deliver the industry-leading molecular diagnostic test kit for clinical use that decentralizes access to organ health testing for kidney transplant patients. The company expects that enabling decentralized testing will deliver new value in the roughly $1 billion-plus addressable market for kitted transplant rejection testing. iMDx believes that decentralizing access to transplanted organ rejection testing will bring care closer to the patient and help hospitals to operate more sustainably, as well as create a rapidly growing, high-margin, recurring business model.

Link to paper: https://www.sciencedirect.com/science/article/pii/S1600613525029508

iMDx Transplant Products and Product Candidates in Development

iMDx’s flagship transplant testing technology quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). The company’s scientists in Germany and the U.S. have played a critical role over the past decade in developing the science that helped establish dd-cfDNA as a trusted biomarker of transplant rejection. iMDx is commercializing this technology using a market-disruptive business strategy. Under the GraftAssure™ brand, iMDx’s transplant diagnostics include the following:

• GraftAssureCore – The company’s laboratory-developed test (LDT), currently reimbursed by CMS and performed at iMDx’s CLIA-certified laboratory in Nashville.
• GraftAssureIQ – A research-use-only (RUO) kit intended and labeled for non-clinical applications.
• GraftAssureDx – The in vitro diagnostic (IVD) kit currently in development for use in clinical decision-making.
  
  

About Insight Molecular Diagnostics, Inc.

Insight Molecular Diagnostics is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. Investors may visit https://investors.imdxinc.com/ for more information.

GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Insight Molecular Diagnostics Inc.

Forward-Looking Statements

Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, demand for iMDx’s products and what the company is building, the expectation that decentralized testing will deliver new value in the roughly $1 billion-plus addressable market for kitted transplant rejection testing, the belief that democratizing access to transplanted organ rejection testing creates a rapidly growing, high-margin, recurring business model, and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Insight Molecular Diagnostics’ third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests Insight Molecular Diagnostics or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Insight Molecular Diagnostics, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Insight Molecular Diagnostics’ Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Insight Molecular Diagnostics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Investor Contact:

Doug Farrell

LifeSci Advisors LLC

dfarrell@lifesciadvisors.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did STAR and the American Journal of Transplantation recommend on Jan. 13, 2026 for dd-cfDNA testing?

They recommended high-quality, standardized decentralized dd-cfDNA testing and supported absolute quantification as a diagnostic approach.

How does the STAR paper affect Insight Molecular Diagnostics (IMDX)?

IMDX said the paper aligns with its strategy and supports demand for its GraftAssure assays and decentralized test kits.

Which IMDX product is currently reimbursed and where is it run?

GraftAssureCore is an LDT performed at IMDX’s CLIA lab in Nashville and is currently reimbursed by CMS.

Is IMDX’s GraftAssureDx kit commercially available for clinical decision-making?

No; GraftAssureDx is an IVD kit currently in development.

What market size did IMDX cite for kitted transplant rejection testing?

IMDX referenced a roughly $1 billion-plus addressable market for kitted transplant rejection testing.