Insight Molecular Diagnostics Inc.

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

Insight Molecular Diagnostics appointed Donnie Purto as SVP of Sales to lead commercialization of GraftAssureDx, which is currently under FDA medical device review. Purto brings 20+ years of diagnostics sales leadership, including a decade at Natera spanning transplant and oncology launches. CEO Josh Riggs framed the hire as launch preparation to disrupt transplanted organ health testing in 2027, with key kidney transplant centers like Cleveland Clinic and Mayo Clinic already engaged from the FDA submission.

•18d ago

Insight Molecular Diagnostics to Host Virtual KOL Event on August 17, 2026: Moving Toward In-House Heart Transplanted Organ Rejection Testing

Insight Molecular Diagnostics announced it will host a virtual Key Opinion Leader event on August 17 to discuss its GraftAssure platform and the shift toward in-house testing for transplanted organ rejection. The event features Dr. Max Jacob Liebo alongside company executives, focusing on the GraftAssureDx kit which is currently under FDA review for kidney transplant rejection monitoring. Management aims to transition testing from centralized send-out models to local hospital labs to improve result turnaround times and patient care.

•2mo ago

IMDX Reports Second Quarter 2026 Results and Timely Progress on FDA Review of GraftAssureDx

Partner Insight Molecular Diagnostics (IMDX) reported progress on the FDA review of its GraftAssureDx test, which utilizes Bio-Rad's digital PCR instrument. Bio-Rad SVP Jonathan Seaton commented on the collaboration, emphasizing the suitability of Droplet Digital PCR for transplant monitoring and confidence in the commercialization path. IMDX noted favorable Medicare reimbursement coverage expanding testing frequency, though the partner remains pre-revenue with a Q2 net loss of $11.3 million.

•2mo ago

iMDx GraftAssure Assay Guides Use of Potentially Kidney-Graft-Saving Drug in New Lancet Group Publication

A new study in The Lancet Regional Health – Europe validated iMDx’s GraftAssure assay for guiding treatment decisions in kidney transplant patients using the drug felzartamab, demonstrating that dd-cfDNA monitoring can help manage high-risk patients and potentially spare drug usage. Separately, iMDx received confirmation from MolDX regarding Medicare reimbursement coverage for kidney transplant rejection treatment response monitoring, directly supporting the use case highlighted in the clinical study. These developments signal a market expansion opportunity for the GraftAssure portfolio beyond ruling out biopsies, though the clinical kit GraftAssureDx remains under FDA review.

•3mo ago

Favorable Medicare Coverage Decision Supports Commercial Adoption of iMDx GraftAssure Assay Portfolio

Insight Molecular Diagnostics announced that a new Medicare policy (LCD) issued by MolDX expands coverage for donor-derived cell-free DNA testing, supporting the commercial adoption of its GraftAssure assay portfolio. The final policy establishes a recurring testing baseline and increases allowed surveillance frequencies, such as moving kidney transplant testing in the first year from four to six tests, which aligns with the company's publicly stated $2 billion total addressable market. The company notes a Medicare reimbursement rate of $2,753 per result for its GraftAssureCore lab-developed test, while its GraftAssureDx kit remains under FDA review for marketing authorization.

•3mo ago

IMDx Chief Science Officer Ekkehard Schuetz Publishes 200th Research Paper

Insight Molecular Diagnostics Chief Science Officer Dr. Ekkehard Schuetz has published his 200th scientific article, achieving an H-index of 58 which places him in the top 2.5% of researchers globally. Dr. Schuetz is the co-inventor of the dd-cfDNA technology underlying the company's GraftAssure family of assays. His recent publications in journals like Clinical Chemistry and American Journal of Transplantation validate the analytical sensitivity of the GraftAssure technology over NGS-based approaches. The company recently submitted a de novo FDA application for its GraftAssureDx kit to market in the U.S. CEO Josh Riggs highlighted that Dr. Schuetz's continued leadership validates the company's scientific foundation as it seeks to decentralize transplant rejection testing.

•4mo ago

Favorable Head-to-Head Data on iMDx’s GraftAssure with Competing NGS Assay Published in Clinical Chemistry

Insight Molecular Diagnostics announced the publication of favorable head-to-head data in Clinical Chemistry comparing its GraftAssure test to a competing NGS assay. The study demonstrated 99.2% agreement at the clinical threshold of 0.5%, while GraftAssure showed superior analytical sensitivity with a lower limit of quantification of 0.04%. Management highlighted that the results support the assay's clinical interchangeability and ongoing efforts to secure FDA marketing authorization for the transplant monitoring test.

•4mo ago

IMDX GraftAssure Assay Sets New Standard in Screening Kidney Transplant Patients Per American Journal of Transplantation

Insight Molecular Diagnostics published data in the American Journal of Transplantation showing its GraftAssure CM-score is statistically superior to standard dd-cfDNA metrics for detecting kidney transplant rejection. The new combination model achieved a positive predictive value (PPV) greater than 80% in for-cause testing, compared to a weighted average of 54% for existing single-metric tests, while maintaining a high negative predictive value of 91%. The company is using this data to support its ongoing FDA marketing authorization application for GraftAssureDx and has initiated the GALACTIC registry to validate clinical decision-making impacts.

•4mo ago

iMDx to Highlight In-House Transplant Testing Opportunity and Host Key Opinion Leaders at American Transplant Congress

iMDx will highlight its GraftAssure technology at the American Transplant Congress in Boston, showcasing favorable third-party head-to-head data comparing its assay to leading commercial tests. The company will announce winners of a research grant sponsored jointly with the American Society of Transplant Surgeons to evaluate the economics of in-house versus centralized transplant rejection testing. iMDx continues to seek FDA marketing authorization for GraftAssureDx, an in-house test kit designed to shift dd-cfDNA testing from centralized labs to local hospital laboratories, targeting a $2 billion annual market opportunity.

•4mo ago