Second Study Affirms Superiority of iMDx GraftAssure Assay’s Proprietary dd-cfDNA Combination Model Score

Rhea-AI Summary

Insight Molecular Diagnostics (Nasdaq: IMDX) highlighted a peer-reviewed study of 249 biopsy-matched kidney transplant patients showing its GraftAssure Combination Model (CM) score outperformed percentage-only and absolute dd-cfDNA measures in correlating with four histopathology-derived rejection indices.

The company cites a prior World Transplant Congress readout showing a rise in positive predictive value to over 80% at 25% prevalence, and plans to commercialize an IVD kit in 2026 to address a roughly $2 billion transplant testing market.

Positive

• Study analyzed 249 biopsy-matched patients
• GraftAssure CM-score outperformed percentage and absolute dd-cfDNA
• Positive predictive value >80% at 25% prevalence
• Plans to commercialize an IVD kit in 2026
• Addresses a roughly $2 billion transplant testing market

Negative

• GraftAssureDx remains in development (no commercial IVD yet)
• Clinical testing currently limited to GraftAssureCore LDT in Nashville
• Supporting analyses were investigator-led using company-provided measurements

Argus Mar 13 session

+0.41% close to close Open Argus

Details

News Market Reaction – IMDX

In the Mar 13 session, IMDX gained 0.41%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement strengthens the clinical foundation for iMDx’s GraftAssure platform, with a 249‑pa...

Analysis

This announcement strengthens the clinical foundation for iMDx’s GraftAssure platform, with a 249‑patient biopsy-matched study and a Combination Model showing positive predictive value above 80% at 25% rejection prevalence. It reinforces prior milestones toward an FDA De Novo submission and targets a $2 billion-plus transplant testing market. Investors may watch for regulatory filings, adoption trends for GraftAssureCore, and any further capital raises that could affect the company’s trajectory.

Key Figures

Biopsy-matched patients: 249 patients Positive predictive value: Above 80% Rejection prevalence: 25% +5 more

Biopsy-matched patients

249 patients

Multi-center kidney transplant study for GraftAssure assay

Positive predictive value

Above 80%

GraftAssure CM-score at 25% rejection prevalence

Rejection prevalence

25%

For-cause settings in World Transplant Congress 2025 data

Transplant testing TAM

$2 billion-plus

Addressable market for regulated transplant rejection testing

Rejection indices

4 indices

AMR/MVI, TCMR/TI, Activity, Chronicity indices in study analysis

Price move

-6.86%

IMDX 24h move before/around publication of study news

52-week range

$2.33–$8.51

IMDX 52-week low and high before this news

Market cap

$150,591,326

Equity value prior to this announcement

Historical Context

5 past events · Latest: Mar 03

5 events

1. Mar 03

   Clinical milestones

   24h Move

   +10.3%

   Completion of key GraftAssureDx studies and ISO 13485 certification for FDA submission.

2. Feb 11

   Equity offering

   24h Move

   -22.7%

   Registered direct equity raise of $26.0M at $5.75 causing dilution concerns.

3. Jan 13

   Industry endorsement

   24h Move

   +1.7%

   STAR working group paper supporting decentralized dd‑cfDNA testing aligned with GraftAssure.

4. Jan 07

   Conference participation

   24h Move

   +0.0%

   Announcements of JPM Week and BTIG Snowbird investor meetings and outreach.

5. Jan 06

   Management hire

   24h Move

   -1.1%

   Appointment of VP Medical Affairs to support upcoming commercial transplant assay launch.

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

Key Terms

dd-cfDNA, cell-free DNA, microvascular inflammation, antibody-mediated rejection, +4 more

8 terms

dd-cfDNA medical

"Proprietary “Combination Model” score outperformed percentage-only measures of dd-cfDNA"

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.

cell-free DNA medical

"Donor-Derived Cell-Free DNA as a Non-Invasive Readout of Activity"

Fragments of DNA that float freely in the bloodstream after being released by dying or damaged cells, like puzzle pieces carried downstream that hint at what’s happening upstream. Investors care because measuring these fragments enables non‑invasive tests — for example to detect cancer, monitor treatment response, check pregnancy health, or spot organ rejection — so advances, approvals, or reimbursement changes can quickly affect companies that develop the tests and related technologies.

microvascular inflammation medical

"strongest associations observed in microvascular inflammation (MVI) and antibody-mediated rejection"

Microvascular inflammation is damage and swelling in the body’s smallest blood vessels that supply tissues and organs, like tiny pipes becoming leaky or clogged. It matters to investors because this condition can signal serious disease, drive demand for specific drugs or diagnostics, influence clinical trial results and regulatory decisions, and create costs or liabilities for healthcare companies—so news about it can move valuations and market expectations.

antibody-mediated rejection medical

"microvascular inflammation (MVI) and antibody-mediated rejection (AMR)"

A form of organ transplant failure where a patient’s own antibodies target and damage the donated organ, causing inflammation, reduced function, or loss of the graft. Investors care because it drives demand for diagnostic tests, specialized drugs and procedures, influences clinical trial outcomes and regulatory decisions, and can materially affect healthcare costs and the commercial prospects of companies developing treatments—like a security system that misidentifies and attacks a new team member.

T-Cell Mediated Rejection medical

"T-Cell Mediated Rejection / Tubulointerstitial Inflammation (TCMR/TI index)"

T-cell mediated rejection is when a recipient’s immune cells called T cells recognize and attack a transplanted organ or tissue, causing inflammation and damage. It matters to investors because its frequency and severity drive demand for drugs, diagnostics and procedures that prevent or treat rejection, influence clinical trial outcomes and commercial prospects, and affect regulatory approvals and long-term transplant costs—like guards mistakenly ejecting a welcomed guest and triggering a costly response.

in vitro diagnostic medical

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

In vitro diagnostics are tests, instruments and kits used to analyze samples taken from the body—such as blood, urine or swabs—outside the body (in a lab or cartridge) to detect disease, infections, genetic traits or other biological signs. Investors care because these products generate sales, recurring revenue from consumable test kits, and value that hinges on test accuracy, regulatory approvals and reimbursement policies; like a home pregnancy test but for many medical conditions.

laboratory-developed test medical

"GraftAssureCore - The company's laboratory-developed test (LDT), currently reimbursed by CMS"

A laboratory-developed test is a diagnostic test that a single clinical laboratory designs, builds and uses in its own facility rather than buying from an outside manufacturer; think of it as a custom recipe made and run in-house for diagnosing disease. Investors care because these tests can be quicker to bring to market and create a revenue stream for labs, but they also carry regulatory and quality-risk differences that can affect demand, reimbursement and legal exposure.

CLIA-certified regulatory

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

CLIA-certified means a laboratory has passed U.S. federal standards for performing tests on human samples, showing its results are accurate, reliable and timely. For investors this matters because certification is often required to sell clinical test services, bill insurers, win hospital or physician partnerships and avoid regulatory penalties — much like a restaurant passing a health inspection or a car getting a safety sticker before it can be sold.

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

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• New data supports GraftAssure commercialization efforts
• Multi-center study featured 249 biopsy-matched patients
• Proprietary “Combination Model” score outperformed percentage-only measures of dd-cfDNA
• Reinforces data presented at World Transplant Congress in 2025

NASHVILLE, Tenn., March 13, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc. (Nasdaq: IMDX) (“iMDx”) today highlighted the publication of a new peer-reviewed study demonstrating the potential superiority of the company’s flagship GraftAssure^TM assay technology.

The study, published in Transplant International, and titled “Donor-Derived Cell-Free DNA as a Non-Invasive Readout of Activity Across the Rejection Continuum,” was conducted by investigators from Heidelberg University Hospital and Charité – Universitätsmedizin Berlin and included iMDx scientist authors.

This new study, combined with data presented at World Transplant Congress in 2025, point to growing clinical differentiation and marketability of the GraftAssure technology and support iMDx’s strategic vision. Beginning in 2026, iMDx seeks to deliver the industry-leading molecular diagnostic test kit for clinical use that expands and improves access to organ health testing for kidney transplant patients. The company expects that enabling localized testing will deliver new value in the roughly $2 billion-plus addressable market for regulated transplant rejection testing.

The new peer-reviewed publication reports on 249 patients, who had undergone clinically indicated kidney transplant biopsies, from two independent cohorts, comparing dd-cfDNA measurements in blood plasma with newly developed histopathology-derived rejection indices ⁽¹⁾ that quantify transplant rejection activity across a continuous biological spectrum.

The investigators found that dd-cfDNA levels increased with histological evidence of graft inflammation, with the strongest associations observed in microvascular inflammation (MVI) and antibody-mediated rejection (AMR), which are the most clinically significant forms of transplant rejection.

IMDx's newly developed GraftAssure Combination Model (CM)-score mathematically combines the relative (percentage, or %) and absolute (copies per milliliter, or cp/mL) measurements of DNA fragments from the transplanted organ. In this study, the tight correlation between the novel GraftAssure CM-score and rejection indices suggests that the assay is reliably measuring complex biological signals in kidney transplantation.

Notably, GraftAssure’s CM-score outperformed both fractional and absolute measures on their own, in correlation analyses with the four indices of transplanted organ health, which are Antibody-mediated Rejection / Microvascular Inflammation (AMR/MVI index), T-Cell Mediated Rejection / Tubulointerstitial Inflammation (TCMR/TI index), Activity index, and Chronicity index. The rejection (AMR/MVI and TCMR/TI) indices were of particular interest to investigators because they are known to have a strong association with graft survival⁽¹⁾.

As mentioned above, study authors also presented data at the World Transplant Congress in 2025 that showed an improvement in positive predictive value from around 50% seen in the literature to an unprecedented value of above 80% using the GraftAssure CM-score (at 25% prevalence, which is often seen in for-cause settings) enabling the rule-in option for transplanted organ rejection for the first time. That study is currently under review for publication.

“Kidney transplant rejection is increasingly understood as a biological continuum rather than a simple yes-or-no diagnosis,” said iMDx Chief Science Officer Prof. Dr. Ekkehard Schuetz, who co-authored the study. “Our results show that dd-cfDNA measured in the blood closely mirrors the inflammatory activity observed in transplant biopsies. One unexpected finding was that in TCMR, the total cell-free DNA increases with severity, which resulted in a loss of correlation for dd-cfDNA when reported as percentage. Whereas the Combination Model score showed the strongest correlation with TCMR. This supports the concept that integrated blood-based monitoring can provide clinicians with a real-time view of graft immune activity and help guide earlier intervention as rejection begins to develop.”

The study was investigator-initiated and investigator-led. Insight Molecular Diagnostics provided dd-cfDNA measurements used in the analysis.

References

(1)	Vaulet T et al. Continuous indices to assess the phenotypic spectrum of kidney transplant rejection. Nat Commun. 2025;16(1):10417

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^TM 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^TM,GraftAssureIQ^TM, GraftAssureDx^TM, VitaGraft^TM, GraftAssure^TM, DetermaIO^TM, and DetermaCNITM 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, the company’s expected FDA submission, anticipated delivery in 2026 of the industry-leading molecular diagnostic test kit for clinical use that expands and improves access to organ health testing for kidney transplant patients, anticipated added value of the company’s GraftAssureDx kit to the roughly $2 billion-plus addressable market for regulated transplant rejection testing, 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:

Alexandra Grossman
LifeSci Advisors LLC
alex@lifesciadvisors.com

FAQ

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

What did IMDX announce about the new GraftAssure study on March 13, 2026?

The company highlighted a peer-reviewed study linking dd-cfDNA to transplant rejection activity in 249 patients. According to the company, the GraftAssure CM-score correlated more strongly with four histopathology indices than percentage-only or absolute measures, suggesting improved biological readout.

How did the GraftAssure CM-score perform compared with percentage-only dd-cfDNA for IMDX (IMDX)?

The CM-score outperformed percentage-only and absolute dd-cfDNA in correlation analyses with rejection indices. According to the company, combining relative and absolute measures improved correlation across AMR/MVI, TCMR/TI, activity, and chronicity indices.

What clinical impact does IMDX claim for the GraftAssure CM-score in kidney transplant care?

IMDX says the CM-score offers a more reliable blood-based reflection of graft inflammatory activity. According to the company, this could enable earlier intervention by providing clinicians a real-time, integrated view of rejection biology.

What evidence did IMDX provide about positive predictive value improvements for GraftAssure?

The company cites prior World Transplant Congress data indicating PPV rose from ~50% to >80% at 25% prevalence. According to the company, this improvement supports a potential rule-in application for transplant rejection in for-cause settings.

When does IMDX plan to commercialize the GraftAssure IVD kit and market scope?

IMDX expects to deliver an IVD kit beginning in 2026 to enable localized testing. According to the company, the target is the roughly $2 billion-plus addressable market for regulated transplant rejection testing.