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Insight Molecular Diagnostics Inc, a pioneering diagnostics technology company with mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes, announced that in February the company completed several major milestones to support the GraftAssureDx test kit clinical trial for its planned in vitro diagnostic (IVD) De Novo submission to the US Food and Drug Administration (FDA) and also received its ISO 13485 certification.
Beginning in 2026, iMDx seeks to deliver the industry-leading molecular diagnostic test kit for clinical use that expands and improves access to organ health testing for kidney transplant patients. The company expects that enabling localized testing will deliver new value in the roughly $2 billion-plus addressable market for regulated transplant rejection testing.
Milestones completed in February include the conclusion of the three-site reproducibility study for GraftAssureDx, performed at Tampa General Hospital, Mayo Clinic and Baylor Scott & White Health, the collection of what the company believes is sufficient clinical samples to execute its submission, and the receipt of ISO 13485 certification, described in more detail below.
The company is rapidly finishing the remainder of its internal analytical performance studies. Of the approximately 12,000 instrument and assay cycles needed to support the FDA submission package, about 340 remain.
The IVD submission can be broken down into two categories – (1) the clinical validation studies that happen at the clinical trial sites, and (2) the internal analytical performance studies, performed at the company’s Nashville laboratory.
On the clinical validation, iMDx has received what it believes should be sufficient clinical samples to execute the US FDA submission. Our clinical trial site partners are continuing to collect and test those patient samples, as well as perform patient biopsies to confirm that the assay performed as it should. We are pleased with the level of engagement at these major transplant hospitals and are working closely with our site partners to move as efficiently as possible, recognizing that certain clinical activities remain outside of our direct control.
A reproducibility study at three clinical trial sites, Tampa General Hospital, Mayo Clinic, and Baylor Scott & White Health, is also part of our analytical validation. This reproducibility study was finished at the clinical trial sites on February 23, representing the conclusion of a major milestone.
“Our clinical trial sites have now collected the needed number of samples to finalize the clinical trial part for our US FDA submission, based on the projected 25% to 30% organ rejection rate, and those results are being gathered at the sites,” said iMDx chief science officer Dr. Ekkehard Schuetz. “This combined with the reproducibility study conclusion represents two major milestones, and we are thrilled about the collaboration with our clinical partners to help us achieve our goal of finalizing our de-novo submission.”
Regarding internal analytical performance studies, as noted above, we are working diligently to complete the large-scale precision and repeatability study using our final IVD software combined with the finalized Bio-Rad equipment and reagents.
“We feel confident about every IVD work stream that is within our control, and we are very close to executing our submission to the FDA,” said iMDx chief technology officer Johnson Chiang. “We are proud of our team’s ability to manage complexity and coordinate with multiple stakeholders, including our kit manufacturer, software vendor, the clinical trial sites, and Bio-Rad, which has also been working tirelessly to support a timely submission.”
Preparing for global manufacturing, it is also worth noting that achieving ISO 13485 means that our independent European auditor, TÜV SÜD, has certified that iMDx runs its operations under a disciplined, regulator-aligned quality management system. We believe that this certification showcases reduced risk of surprises in the FDA review, as well as reduced quality risk regarding future manufacturing and commercialization.
The ISO13485 certification at the end of February also immediately paves the way for an IVD submission in the UK, which then will be followed by an IVD-R submission for the EU during 2026, which is also already in preparation.
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 US 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 Nashville. GraftAssureIQ - A research-use-only (RUO) kit intended and labelled for non-clinical applications. GraftAssureDx - The in vitro diagnostic (IVD) kit currently in development for use in clinical decision-making.
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