STOCK TITAN

iMDx and the American Society of Transplant Surgeons Announce Recipients of the ASTS-iMDx Health Economics Research Grant

(Neutral)
(Very Positive)
Tags

Insight Molecular Diagnostics (Nasdaq: IMDX) and the American Society of Transplant Surgeons awarded a $100,000 ASTS‑iMDx Health Economics Research Grant to Drs. Kenneth Andreoni and Kenneth Chavin. The study will compare in-house versus send-out dd-cfDNA testing in kidney transplantation and inform commercialization planning for GraftAssureDx, currently under FDA de novo review.

Loading...
Loading translation...

Positive

  • $100,000 ASTS‑iMDx grant funds dd-cfDNA health economics research
  • Study designed to inform future commercialization planning for GraftAssureDx
  • GraftAssureCore LDT reimbursed by CMS and run in CLIA lab
  • GraftAssureDx diagnostic kit submitted to FDA under Class II de novo pathway

Negative

  • Key GraftAssureDx product remains under FDA review, not yet cleared
  • Certain products are under clinical investigation and limited to investigational use
  • Forward-looking statements highlight regulatory, funding, and commercialization risks

News Market Reaction – IMDX

-0.74%
3 alerts
-0.74% Session close to close
+9.4% Peak Tracked
-4.8% Trough Tracked
$173.40M Market Cap
0.1x Rel. Volume

In the Jun 22 session, IMDX declined 0.74%, reflecting a mild negative market reaction. Argus tracked a peak move of +9.4% during that session. Argus tracked a trough of -4.8% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement underscores iMDx’s push to quantify dd-cfDNA economics via a $100,000 ASTS grant a...
Analysis

This announcement underscores iMDx’s push to quantify dd-cfDNA economics via a $100,000 ASTS grant and support GraftAssureDx under FDA review, though execution risks around regulatory outcomes and in-house test adoption remain key to monitor.

Key Figures

Health economics grant: $100,000
1 metrics
Health economics grant $100,000 ASTS-iMDx research grant funding dd-cfDNA testing economics study

Historical Context

5 past events · Latest: Jun 16 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jun 16 Clinical assay data Positive +0.0% Peer-reviewed head-to-head data showed strong agreement with leading NGS dd-cfDNA assay.
Jun 11 Clinical performance Positive +0.3% Journal reported superior diagnostic performance of GraftAssure CM-Score for kidney monitoring.
Jun 09 Conference preview Positive -1.5% Planned American Transplant Congress presence and highlighting of GraftAssure platform and grant.
May 13 Q1 2026 earnings Positive +25.9% Reported Q1 results, financing, and progress toward GraftAssure commercialization and trials.
May 06 Earnings date set Neutral -1.4% Announced timing and webcast details for upcoming Q1 2026 earnings release.

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

Pattern Detected

IMDX has reacted strongly to major financing/earnings updates, while product and conference news have produced modest or mixed price moves.

Key Terms

dd-cfDNA, laboratory-developed test, research-use-only, in vitro diagnostic, +2 more
6 terms
dd-cfDNA medical
"in-house versus send-out of donor-derived cell-free DNA (dd-cfDNA) testing"
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 regulatory
"GraftAssureCore – The company’s laboratory-developed test (LDT), currently reimbursed"
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.
research-use-only regulatory
"GraftAssureIQ – A research-use-only (RUO) kit intended and labeled for non-clinical"
Products labeled “research-use-only” are tools, tests, or reagents sold for laboratory experiments and scientific study, not approved for diagnosing, treating, or making clinical decisions about patients. For investors, the label matters because it limits where and how a product can be sold, keeps regulatory burdens lower but also narrows market size and revenue potential until the product is validated and approved for clinical or commercial use — like a prototype that can’t yet be sold in stores.
in vitro diagnostic regulatory
"GraftAssureDx™, a kitted in vitro diagnostic for clinical decision-making, to the FDA"
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.
class II de novo pathway regulatory
"for regulatory review under the Class II de novo pathway"
A U.S. Food and Drug Administration review pathway that allows a novel medical device that poses moderate risk—but has no previously cleared equivalent—to gain permission to be marketed by demonstrating reasonable assurance of safety and effectiveness. For investors, a successful Class II de novo is like winning approval to create a new product category: it reduces regulatory uncertainty, shortens time to market, and can expand commercial potential, whereas failure adds delay, cost, and risk to sales prospects.
clia-certified regulatory
"performed at iMDx’s CLIA-certified laboratory in Franklin, Tenn."
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

-Grant Supports Health Economic Research Comparing In-House versus Send-Out dd-cfDNA Testing in Kidney Transplantation-

NASHVILLE, Tenn., June 22, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), and the American Society of Transplant Surgeons (ASTS) today announced the selection of Kenneth Andreoni, MD, Surgical Director of Kidney Transplantation at Thomas Jefferson University, and Kenneth Chavin, MD, MBA, PhD, FACS, of Temple Health, as the recipients of the ASTS-iMDx Research Grant for Understanding the Health Economics of In-House versus Send-Out of donor-derived cell-free DNA (dd-cfDNA) testing. The pursuit of this research is timely as the transplant community increasingly considers adopting in-house dd-cfDNA testing, and rigorous economic and outcomes data is essential to guide transplant programs in making informed decisions about their laboratory infrastructure and assay selection.

The $100,000 grant will be administered through ASTS and funded by iMDx. This health econometric research will compare the costs, clinical impact, and operational implications of in-house diagnostic testing versus send-out centralized laboratory testing. The results of this independent econometric study will generate important information to support future commercialization planning for GraftAssureDx™, which is currently under FDA review.

About the ASTS-iMDx Health Economics Research Grant Recipients

Dr. Andreoni serves as Surgical Director of Kidney Transplantation at Thomas Jefferson University and brings deep clinical and administrative expertise to the evaluation of transplant program operations and diagnostic testing strategies. Dr. Chavin holds appointments at Temple Health and has a unique interdisciplinary perspective informed by his combined training in medicine, business, and science. Together, the grant recipients offer complementary experience in transplant surgery, health systems management, and clinical research that positions this project to generate meaningful and actionable insights for the transplant field.

"We are very pleased to announce Drs. Andreoni and Chavin as the recipients of this grant," said iMDx CEO Josh Riggs. "Both physicians have outstanding experience and credibility in the field of transplantation, and we are confident that their research will advance the community's understanding of the real-world economics of in-house diagnostics. We are also grateful for the opportunity to partner with the American Society of Transplant Surgeons on this important program. As more transplant centers explore in-house dd-cfDNA testing, having rigorous health economic data will be critical to helping programs evaluate their options and plan accordingly."

"The question of whether to perform dd-cfDNA testing in-house or through a centralized laboratory is one that many transplant programs are actively grappling with," said Dr. Kenneth Chavin of Temple Health. "This grant gives us the opportunity to develop a rigorous economic model that will help transplant centers think through the true costs and benefits of each approach. We look forward to producing research that can serve as a practical resource for the community."

"In-house testing has the potential to meaningfully improve turnaround times and, ultimately, patient care," said Dr. Kenneth Andreoni, Surgical Director of Kidney Transplantation at Thomas Jefferson University. "But making the case for that investment requires data. We are excited to conduct this research in partnership with ASTS and iMDx and to contribute evidence that transplant programs can use as they evaluate their diagnostic testing strategies."

ASTS and iMDx established the grant to support research that compares the total cost of care, return on investment, clinical outcomes, and operational efficiency associated with in-house versus send-out transplant testing. Proposed studies are encouraged to utilize advanced econometric modeling such as Markov models, decision-tree analysis, or instrumental variable approaches.

iMDx Transplant Products and Product Candidates in Development

iMDx's flagship GraftAssure technology quantifies dd-cfDNA, a molecular biomarker of kidney transplant rejection that has been validated in peer-reviewed studies across leading academic transplant centers around the world. 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. 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 Franklin, Tenn.
  • GraftAssureIQ – A research-use-only (RUO) kit intended and labeled for non-clinical applications.
  • GraftAssureDx – iMDx has submitted GraftAssureDx, a kitted in vitro diagnostic for clinical decision-making, to the FDA for regulatory review under the Class II de novo pathway.

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™, GraftAssure™, and iMDx™ 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 expected outcomes and findings of the ASTS-iMDx grant research, the company's plans to deliver GraftAssureDx as an industry-leading molecular diagnostic kit for clinical use, the FDA's review of iMDx's submission of GraftAssureDx, 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. 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.

FDA 

CAUTION: This press release concerns certain products that are under clinical investigation, and which have not yet been cleared or authorized for marketing by the U.S. Food and Drug Administration. These products are currently limited by federal law to investigational use, and no representation is made as to the safety or effectiveness of these products for the purposes for which they are being investigated. 

Investor Contact
Douglas Farrell
LifeSci Advisors LLC 
imdx@lifesciadvisors.com 


FAQ

What is the ASTS‑iMDx Health Economics Research Grant announced on June 22, 2026 for IMDX?

The ASTS‑iMDx Health Economics Research Grant is a $100,000 award supporting dd-cfDNA testing research. According to iMDx, it funds an econometric study comparing in-house versus send-out donor-derived cell-free DNA testing for kidney transplantation, focusing on costs, outcomes, and operational impact.

Who received the 2026 ASTS‑iMDx dd-cfDNA health economics grant and what will they study?

Drs. Kenneth Andreoni and Kenneth Chavin were selected as grant recipients. According to iMDx, they will develop an economic model comparing the total cost of care, clinical outcomes, and operational efficiency of in-house versus centralized dd-cfDNA testing for kidney transplant programs.

How could the ASTS‑iMDx health economics study affect GraftAssureDx and IMDX investors?

The study is intended to generate evidence supporting future commercialization planning for GraftAssureDx. According to iMDx, independent health economic data on in-house versus send-out dd-cfDNA testing may help transplant centers evaluate adoption, potentially influencing demand for the company’s GraftAssureDx diagnostic kit if cleared.

What transplant diagnostic products does iMDx (Nasdaq: IMDX) offer under the GraftAssure brand?

iMDx offers GraftAssureCore, GraftAssureIQ, and the GraftAssureDx candidate. According to iMDx, GraftAssureCore is a CMS-reimbursed LDT, GraftAssureIQ is a research-use-only kit, and GraftAssureDx is a kitted in vitro diagnostic submitted for FDA de novo review.

What is GraftAssureDx and what is its current FDA regulatory status for IMDX?

GraftAssureDx is a kitted in vitro diagnostic for transplant clinical decision-making. According to iMDx, it has been submitted to the U.S. Food and Drug Administration under the Class II de novo pathway and remains under regulatory review, with certain related products limited to investigational use.

How does GraftAssure technology from IMDX use dd-cfDNA in kidney transplantation?

GraftAssure technology measures donor-derived cell-free DNA as a biomarker of kidney transplant rejection. According to iMDx, dd-cfDNA has been validated in peer-reviewed studies at leading academic centers and underpins the company’s GraftAssureCore LDT, GraftAssureIQ RUO kit, and GraftAssureDx diagnostic candidate.