Insight Molecular Diagnostics Inc (iMDx) has reached several key milestones as it prepares a De Novo in vitro diagnostic (IVD) submission to the U.S. Food and Drug Administration for its transplant monitoring test, GraftAssureDx.
The company confirmed that in February 2026 it completed major clinical trial progress steps and secured ISO 13485 certification, strengthening its regulatory and manufacturing readiness.
These developments move iMDx closer to launching a clinical molecular diagnostic test kit designed to monitor organ health in kidney transplant patients.
Transplant recipients require continuous monitoring to detect early signs of organ rejection.
iMDx’s flagship diagnostic technology measures donor-derived cell-free DNA (dd-cfDNA), a molecular biomarker that increases when a transplanted organ begins to fail.
By tracking this biomarker, clinicians can potentially:
The company believes the technology could unlock significant value in the $2+ billion global transplant rejection testing market.
In February, iMDx completed several critical steps required for its FDA submission.
A three-site reproducibility study for GraftAssureDx was successfully completed.
Clinical trial sites included:
The study concluded on February 23, marking an important analytical validation milestone.
According to iMDx, clinical trial sites have collected sufficient patient samples to support its planned FDA submission.
The trial assumes a 25–30% transplant rejection rate, enabling researchers to evaluate the assay’s ability to detect rejection events.
Clinical sites continue to:
The company is also finalizing its internal analytical performance studies at its Nashville laboratory.
These studies evaluate precision, repeatability, and overall system performance.
Completion of this testing will finalize the technical package required for the FDA submission.
The regulatory submission for GraftAssureDx consists of two major components:
1. Clinical validation studies
2. Internal analytical performance studies
According to Ekkehard Schuetz, Chief Science Officer at Insight Molecular Diagnostics Inc, the company has now reached a major inflection point.
The clinical trial sites have collected the number of samples needed to finalize the clinical trial portion of the submission.
Another key milestone was iMDx receiving ISO 13485 certification, the internationally recognized quality management standard for medical device manufacturing.
The certification was issued by TÜV SÜD, an independent European auditor.
This certification confirms that iMDx operates under a regulator-aligned quality management system, supporting:
The company believes this milestone will also help reduce potential surprises during FDA review.
With ISO 13485 certification secured, iMDx is preparing additional regulatory submissions beyond the United States.
Planned next steps include:
These moves position the company to commercialize its transplant diagnostic platform across multiple markets.
iMDx is developing a portfolio of transplant diagnostics under the GraftAssure brand.
The product lineup includes:
GraftAssureCore
GraftAssureIQ
GraftAssureDx
The science behind donor-derived cell-free DNA (dd-cfDNA) has been developed over more than a decade.
Researchers from the United States and Germany working with iMDx have played a key role in establishing dd-cfDNA as a reliable biomarker for transplant rejection.
By transforming this technology into a scalable diagnostic kit, the company hopes to expand access to transplant monitoring beyond centralized labs.
If successful, localized testing could make transplant care faster, more accessible, and less invasive for patients worldwide.