iMDx Welcomes New VP Marketing to Prepare for Commercial Transplant Assay Launch

Rhea-AI Summary

Insight Molecular Diagnostics (Nasdaq: IMDX) named Steven Tahmooressi as Vice President of Marketing to lead global commercialization for its GraftAssure family as the company prepares a kitted clinical launch in 2026.

The company said it plans to submit GraftAssureDx for FDA authorization in 2025; its existing GraftAssureCore LDT is currently reimbursed by Medicare and performed at a CLIA lab in Nashville, and GraftAssureIQ is available RUO. iMDx cites an estimated $1 billion addressable market for kitted transplant rejection testing.

Positive

• Planned FDA submission for GraftAssureDx in 2025
• GraftAssureCore LDT currently reimbursed by Medicare
• Experienced VP hire with 25 years in transplant and oncology commercialization

Negative

• GraftAssureDx not yet authorized, commercialization depends on FDA outcome
• Clinical kitted launch targeted for 2026 but timing remains contingent on regulatory milestones

Insights

Commercialization Strategist

New marketing hire supports upcoming kitted transplant assay launch; commercial execution and regulatory timing remain key.

iMDx is scaling commercial capabilities ahead of the planned FDA authorization submission in 2025 and a clinical kitted launch targeted for 2026, positioning the company to distribute its GraftAssureDx IVD to hospitals and expand access beyond its CLIA lab offering, GraftAssureCore.

Success depends on clear regulatory progress and the company’s ability to convert clinical authorization into routine hospital adoption; marketing execution must align with reimbursement pathways for a device aiming at an estimated $1 billion addressable kitted market.

Watch the timing and outcome of the FDA authorization in 2025, evidence of payer coverage or reimbursement updates for the kitted product, and early commercial adoption signals after launch in 2026. These milestones will clarify whether the hire materially shifts commercial traction.

• Steven Tahmooressi to lead global marketing efforts for GraftAssure family of assays and future products
• Brings 25 years of experience driving new product adoption across geographies in transplantation, oncology and immunology

NASHVILLE, Tenn., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), today announced that it has welcomed Steven Tahmooressi to its executive leadership team as the company prepares to launch its first clinical kitted assay in 2026.

As Vice President of Marketing, Mr. Tahmooressi will be responsible for leading transplant and oncology assay marketing, bringing more than 25 years of healthcare industry experience, including a strong history in supporting the transplantation community, ranging from U.S. sales and marketing leadership to regional and global commercialization.

Mr. Tahmooressi joins iMDx most recently from Astellas Pharma where he was the Global Brand Lead of Established Products Marketing covering its transplant, urology and oncology brands. He also worked in various career progressing commercial roles during his respective tenures at Abbott Laboratories and Bristol-Myers Squibb.

“After three years of laser-focused investing in our kitted product for transplant rejection testing, we are now approaching the critical product launch phase of GraftAssureDx,” iMDx CEO Josh Riggs said. “As we prepare for FDA authorization of GraftAssureDx next year, we are thrilled to welcome Steven to the team to lead our marketing efforts on this mission-critical product. He brings a proven track record of new product marketing to drive commercial adoption in the U.S., Europe, Japan, Middle East, and the Asia Pacific regions.”

Mr. Riggs added, “With a relentless focus on the customer, Steven has led multiple successful U.S. and international product launches in high-touch fields of medicine including transplantation and immunology. Since starting with iMDx in late September, he has hit the ground running, including meeting with customers and supporting our successful presence at the annual meeting of the American Society of Histocompatibility & Immunogenetics in Orlando this month.”

The mission at iMDx is to democratize access to molecular diagnostic testing – and the company’s first targeted strategic market is transplantation rejection testing, through its GraftAssure family of assays. These assays represent iMDx’s initial flagship technology. The assay family includes GraftAssureCore, the company’s laboratory-developed test (LDT), currently reimbursed by Medicare and performed at its CLIA-certified laboratory in Nashville. GraftAssureIQ became available for purchase in summer 2024 for research use only, while GraftAssureDx is in development as a clinical molecular diagnostic test kit, which can be distributed to hospitals to expand and improve testing access for kidney transplant patients.

The company expects that the clinical kitted version of its assay will deliver new value in the estimated $1 billion addressable market for kitted transplant rejection testing. GraftAssure tests measure an established biomarker of transplant rejection, known as donor-derived cell-free DNA, or dd-cfDNA.

“I am passionate about ensuring that patients and health care providers have access to the tools they need, and it's clear to me that iMDx is developing a product that will deliver value to the transplantation market,” iMDx Marketing VP Tahmooressi added. “Since starting with the company in September, I have met with transplant physicians and HLA lab leads who have lauded the potential that iMDx transplant products can bring to their patients, and I am confident that we are developing a solution to fit those needs.”

iMDx Transplant Products and Product Candidates in Development
The company’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 crucial role over the past decade in developing the science that helped establish dd-cfDNA as a trusted biomarker of transplant rejection, and iMDx is now commercializing that technology using a market disruptive approach. Its transplant diagnostics under the GraftAssure brand include the following:

• GraftAssureCore – The company’s laboratory-developed test (LDT), currently reimbursed by CMS and performed at its CLIA-certified laboratory in Nashville. The company is rebranding its VitaGraft assay (previously known as VitaGraft Kidney), which is a lab developed test, under the name GraftAssureCore. For purposes of this press release, references to “GraftAssureCore” shall be deemed to include the test previously marketed as VitaGraft.
• 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, which the company intends to submit for FDA authorization in 2025.
  

About Insight Molecular Diagnostics Inc.
Insight Molecular Diagnostics Inc., or iMDx, formerly Oncocyte Corp. (OCX), is a pioneering precision diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. iMDx utilizes a well-established proprietary approach to quantify dd-cfDNA, which is a widely used molecular biomarker of transplant rejection.

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

Insight Molecular Diagnostics (Nasdaq: IMDX) moved its headquarters from Irvine, Calif., to Nashville, Tenn., in June 2025. The company’s new NASDAQ symbol became effective June 18. Investors may visit https://investors.imdxinc.com/ for more information.

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, iMDx’s development and commercialization efforts and the potential value of the GraftAssure family of assays to kidney transplant patients, 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 iMDx’s 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 iMDx 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 iMDx, particularly those mentioned in the “Risk Factors” and other cautionary statements found in iMDx’s 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. iMDx 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 

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c8a1b114-4240-4eda-83a3-c2c6a3879b36

FAQ

What role will Steven Tahmooressi play at Insight Molecular Diagnostics (IMDX)?

He joins as VP Marketing to lead global marketing for the GraftAssure transplant and oncology assays.

When does IMDX plan to submit GraftAssureDx to the FDA (IMDX)?

The company intends to submit GraftAssureDx for FDA authorization in 2025.

When is the clinical kitted GraftAssureDx launch expected for IMDX shareholders?

IMDX is preparing for a clinical kitted launch in 2026, subject to FDA authorization and commercialization readiness.

Is any GraftAssure test currently reimbursed or available to clinicians (IMDX)?

GraftAssureCore (LDT) is currently reimbursed by Medicare and performed at the company’s CLIA lab; GraftAssureIQ is available RUO.

How large is the target market for IMDX’s kitted transplant test?

IMDX estimates an approximately $1 billion addressable market for kitted transplant rejection testing.

What commercial experience does IMDX’s new marketing VP bring to the IMDX launch?

He has 25 years of healthcare experience including global brand and product launch roles in transplantation, oncology, and immunology.