iMDx Welcomes New Diagnostics Sales Leader to Prepare for Planned GraftAssureDx Launch

Commercial launch of GraftAssureDx remains pending FDA authorization.

Rhea-AI Summary

Insight Molecular Diagnostics (IMDX) appointed Donnie Purto as Senior Vice President of Sales to lead commercialization efforts ahead of its planned GraftAssureDx launch.

GraftAssureDx remains under FDA review for use in clinical decision-making, and commercial launch is pending regulatory authorization. Purto brings more than 20 years of experience across diagnostics, life sciences and healthcare, including a decade at Natera. His responsibilities there included new product launches and managing hundreds of millions of dollars in revenue. The company said the appointment supports its goal of advancing transplanted organ health testing in 2027.

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Positive

• Moderate pointGraftAssureDx commercial launch preparations are underway, with Purto appointed to lead commercialization efforts.

Negative

• Minor pointGraftAssureDx launch is pending FDA authorization, with the diagnostic kit still under review.

Key Terms

dd-cfDNA, laboratory-developed test (ldt), research-use-only (ruo), in vitro diagnostic (ivd), +1 more

5 terms

dd-cfDNA medical

"donor-derived cell-free DNA (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.

laboratory-developed test (ldt) medical

"The company’s laboratory-developed test (LDT)"

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

"A research-use-only (RUO) kit"

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) medical

"The in vitro diagnostic (IVD) kit"

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 regulatory

"performed at iMDx’s CLIA-certified laboratory"

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.

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NASHVILLE, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), today announced the appointment of Donnie Purto as Senior Vice President of Sales to lead the company’s commercialization efforts as it prepares to bring GraftAssureDx to market. GraftAssureDx is currently under FDA medical device review and is awaiting regulatory authorization.

Mr. Purto is an accomplished sales leader with more than 20 years of experience building and leading high-performing sales organizations across diagnostics, life sciences and healthcare. During a decade at Natera, Inc., he had success in leadership roles spanning sales, training, oncology, transplant and women’s health. Responsibilities included new product launches as well as managing hundreds of millions of dollars in revenue in highly competitive markets.

“We are excited to have Donnie take the reins of our commercial organization as we prepare to advance our goal of disrupting transplanted organ health testing in 2027,” said iMDx CEO Josh Riggs. “His ability to drive sales of products, which are based on innovative science, into positions of market leadership is exactly what we need in this next phase as we ready for a product launch. He has already established a track record in the transplant community, and we look forward to benefiting from his expertise.”

Newly appointed SVP Sales Donnie Purto said, “I'm excited to join iMDx at such a pivotal moment for the company. Our commercial team has already built strong relationships with many of the highest volume kidney transplant centers in the country, including Cleveland Clinic, Tampa General Hospital, Mayo Clinic, Vanderbilt University and others, which were involved in the FDA submission for GraftAssureDx. That foundation gives us a head start as we prepare for a commercial launch pending FDA authorization.”

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 Franklin, Tennessee.
• GraftAssureIQ – A research-use-only (RUO) kit intended and labeled for non-clinical applications.
• GraftAssureDx – The in vitro diagnostic (IVD) kit currently under FDA review 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, the company’s efforts to commercialize its GraftAssure technology, expected FDA marketing authorization and commercial launch of GraftAssureDx, Mr. Purto’s expected contributions to the company, transplant and other product candidates in development, 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.  

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:
Alexandra Grossman
LifeSci Advisors LLC
imdx@lifesciadvisors.com

FAQ

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Who is Insight Molecular Diagnostics appointing to lead GraftAssureDx commercialization?

Donnie Purto has been appointed Senior Vice President of Sales to lead commercialization efforts. He brings more than 20 years of experience across diagnostics, life sciences and healthcare, including a decade at Natera in roles spanning sales, training, oncology, transplant and women’s health.

Is IMDX's GraftAssureDx authorized for commercial launch?

GraftAssureDx is awaiting FDA authorization and remains under medical device review for use in clinical decision-making. Its planned commercial launch is pending that authorization.