Full Press Release Details
Reports Q3 2025 Results and Progress Toward 2026 Commercial Launch
| On track to submit GraftAssureDx for FDA review by year-end | ||
| On track for commitment to have 20 transplant centers globally engaged with GraftAssure technology by end of 2025 | ||
| GraftAssure assay's head-to-head data continue to be favorable | ||
| Preparing to rapidly expand beyond kidney into heart transplant testing |
NASHVILLE, Tenn., Nov. 10, 2025 - Insight Molecular
Diagnostics Inc., or iMDx, (Nasdaq: IMDX), today published the following letter to shareholders in conjunction with its third quarter
is a palpable level of excitement and activation energy coursing through our company as we prepare to submit our application for approval
of our first molecular diagnostic test kit for clinical use, GraftAssureDxTM, to the FDA. We expect to begin selling the product
next year after we achieve regulatory marketing authorization.
are grateful to you all for your financial support. Over the past three years, it has allowed us to achieve one milestone after another.
We remain laser-focused on delivering our first kitted clinical product to the transplant market. Over time, we believe this product
will create value and improve care for transplant patients. As you probably recall, GraftAssureDx builds on the foundation of our other
transplant tests that use the same digital PCR-based technology -- our GraftAssureCoreTM lab-developed test that is
performed in our own CLIA lab in Nashville, and our GraftAssureIQTM test kit that is for research use only.
a quick recap, iMDx seeks to deliver a best-in-class molecular diagnostic test kit for clinical use that expands and improves access
to organ health testing for kidney transplant patients. We expect that enabling localized testing will deliver new value in the
roughly $1 billion-plus addressable market for kitted transplant rejection testing. We believe that regulatory clearance will
enable us to gain a foothold in the market, after which we expect to begin to dramatically scale our business quarter by quarter. We
expect this progress will enable us to surpass our near-term financial objectives, generate sustained free cash flow, and head towards $100 million
in annual high-margin revenue growing at a double-digit pace.
molecular diagnostic technology market is ripe for disruption by kitted assays. This is particularly true in the organ transplant category,
where most molecular diagnostics companies have pursued a centralized lab services model that is cost-intensive and difficult to scale. In contrast,
we are pursuing a decentralized approach that brings testing closer to patients and transplant centers. To do this, we have made a significant
investment to design a kitted form of a transplant rejection testing assay (a scientific feat of product engineering in and of itself).
We are now in the process of obtaining regulatory clearance to sell our test kits as a regulated medical device, and we believe that
the availability of our test kit will significantly improve transplant patient care.
Momentum and Upcoming Catalysts:
believe our momentum is accelerating, and we are looking forward to a series of catalysts in the coming weeks and months - including:
| our data submission to the FDA, | ||
| the official launch of our registry study and the validation of what could be industry-leading positive predictive values in transplant rejection testing, | ||
| the publication and display of additional favorable head-to-head study data, | ||
| and milestones associated with our expansion into transplant tests for hearts, among other organs. |
believe that the registry referenced above will allow us to drive clinician engagement with our assay. As a reminder, the
Centers for Medicare & Medicaid Services (CMS) issued a positive coverage decision for our test in August 2023, and since then, expanded
coverage to include our test for organ rejection surveillance in certain high-risk transplant patients. In May 2025, CMS improved
its reimbursement price for our assay to $2,753 per result.
we continue to focus on obtaining FDA marketing authorization for GraftAssureDx to be run locally at transplant centers. Our launch framework, through which we intend to drive engagement, utilization, and eventually the conversion and adoption of our kits, is presented
visually in the "Launch Framework" graphic shown below.
A Walkthrough of the Components of our FDA Submission
first communicated in March, we remain on track to submit GraftAssureDx to the FDA by the end of 2025. In line with our commitment to
be transparent about execution and accountability, as we prepare for our submission, we'd like to provide you with a thorough explanation
of the work streams orchestrated this year.
a diagnostic test to the FDA for marketing clearance is a rigorous, detail-intensive process, and we're fortunate to have very
seasoned team members who have successfully led such submissions at other companies.
FDA-compliant software development and validation for GraftAssureDx: We are finalizing development and validation of the GraftAssureDx
software in compliance with the regulatory standards for in vitro diagnostic (IVD) devices. Provided that our vendor delivers
as committed, we expect to achieve software readiness to support the FDA filing before year-end.
Clinical trial site sample collection and processing: We now have 11 sites participating in our clinical trial, with Vanderbilt
University Medical Center, Tampa General Hospital, and Cleveland Clinic already actively collecting samples. In addition to collecting clinical samples, each clinical trial site is expected to complete testing
and the associated documentation required for inclusion in our regulatory submission. We intend to continue to collect clinical trial
samples beyond year-end to support ongoing and future studies, and in preparation for potential FDA reviewer follow-up questions, which
Reproducibility work: This workstream includes repeatability and reproducibility testing necessary to demonstrate analytical performance
and consistency of results across labs, days, instruments, operators, reagent lots, and assay runs. We are pleased to report that all
underlying materials, protocols, and data review workflows are in place at our reproducibility participant sites.
GraftAssureDx kitted product development and design: Earlier this year, we finalized the kitted product design for the GraftAssureDx
assay, including all components, labeling, instructions for use, and manufacturing readiness documentation. Our kit configuration and
design are locked down. We are now finalizing the design verification and validation phase and this workstream is
Quality assurance system development: Part of any diagnostic design includes all of the work that goes into quality assurance,
including the establishment and implementation of a comprehensive quality management system that meets both FDA 21 CFR Part 820 requirements
as well as the ISO 13485 international standard for medical devices. We worked from the outset to ensure that all design controls, documentation
practices, and production processes aligned with the standards and regulations.
6. Bio-Rad's supply of instrumentation
and certain reagents: A major part of our GraftAssureDx development has been in conjunction with and is reliant upon our strategic
partner, Bio-Rad Laboratories, which provides the instrumentation and certain reagents critical to the GraftAssureDx workflow. Bio-Rad's
reliability and current project cadence support our year-end submission.
final note about timelines:
could be delays to our timeline because of the federal government shutdown that is outside of our control. Of note, our assigned reviewer
at the FDA has been working through the government shutdown even though the FDA's Center for Devices and Radiological Health paused
acceptance of new device submissions. We have previously communicated that we expected the FDA review to be completed by about mid-2026,
which allowed room for the FDA to ask us questions and for us to submit answers. We are still preparing for a mid-2026 product launch.
Importantly, the government shutdown should not affect our ability to drive engagement with customers and utilization of our assay at
our Nashville CLIA lab.
our August 11 shareholder letter, we have made diligent progress toward our long-term objectives. To highlight a few:
summary, we have a lot to look forward to as we close out the year and head into 2026. Our clinical sites are engaged, and we expect
that our registry will expand quickly. Our next development programs - including molecular
diagnostic tests for heart and lung transplants - are moving through validation in our CLIA lab in preparation for submitting
CMS coverage dossiers, which we believe should set the stage for reimbursement and broaden our reach across transplanted organ
types. We are especially excited about our prospects for expanding into heart transplant rejection testing, where our early
data strongly indicates the potential that GraftAssureDx may be the best-in-class diagnostic. Please see the adjacent chart and quote
from our Chief Science Officer for additional details regarding the use of our GraftAssure assay to detect acute rejection in heart transplant
strong momentum in both the U.S. and abroad, growing recognition of our assay's performance, and continued progress toward FDA
submission, we look forward to sharing more updates as iMDx continues to deliver on its mission.
The iMDx Management Team
2025 Financial Overview
| Relative to our strategic goal of selling diagnostic test kits for clinical use, we remain essentially "pre-revenue." | ||
| Our laboratory services are performed at the request of select clients, and we see our laboratory services revenue as a testament to our team's ability to achieve the on-time delivery of clear, scientifically sound, and accurate data sets to our clients. | ||
| We did not realize any kitted product revenue in the third quarter. As previously communicated, we do not expect material revenue on our kitted product sales until after we have achieved regulatory clearance to market GraftAssureDx. |
| We reported gross profit of $139,000 in Q3 2025, representing a 53.5% gross margin. | ||
| In Q3 2025, operating expenses of $11.2 million included $3.4 million in a non-cash change in the fair value of our contingent consideration, as well as $521,000 in non-cash stock-based compensation expenses and $563 ,000 in non-cash depreciation and amortization expenses. Excluding the impact of these non-cash charges, operating expenses increased 6% sequentially over the second quarter, as we invested more heavily in our FDA program ahead of commercial launch, while finding offsets among general and administrative expenses and realizing fewer sales and marketing expenses in the quarter. |
| Research and development expenses increased 18% sequentially to $3.9 million in the third quarter reflecting increased investment in our kitted product development - including FDA-compliant software development expenses, laboratory supplies, kit production, personnel and regulatory consulting fees. | ||
| Sales and marketing expenses declined 5% sequentially to $1.4 million in the third quarter. We continue to invest in go-to-market activities as we prepare for commercial launch, including marketing, advertising, travel and personnel. | ||
| General and administrative expenses declined 4% sequentially to $2.5 million in the third quarter, driven by cost discipline. |
and Conference Call Information
Zoom Call and Webcast on Monday, November 10, 2025, at 2:00 p.m. PT / 5:00 p.m. ET.
interested may access the live Zoom call by registering here: iMDx Q3 Earnings Registration Link
registered, a confirmation email will be sent with instructions.
replay of the Zoom call will be available on the company's website shortly after the call.
Insight Molecular Diagnostics, Inc.
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.Insight Molecular Diagnostics.com/ for more information.
GraftAssureIQ , GraftAssureDx , VitaGraft , GraftAssure , DetermaIO , and DetermaCNI are trademarks
of Insight Molecular Diagnostics Inc.
is a trademark of Bio-Rad Laboratories, Inc.
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 plans to submit
GraftAssureDx for FDA review by year-end, the anticipated rapid expansion beyond kidney into heart transplant testing, sales and cash
flow/revenue projections, commercialization strategy, ongoing clinical trial, FDA submission progress, 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