GraftAssure™ Assay Significantly Enhances Transplant Monitoring Accuracy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 11 2026
0mins
Source: Newsfilter
- CM-Score Superiority: iMDx's GraftAssure CM-Score demonstrated a positive predictive value exceeding 80% in a clinical validation involving 81 rejections and 282 non-rejections, significantly outperforming single-metric dd-cfDNA, indicating its reliability and effectiveness in kidney transplant monitoring.
- Clinical Validation Progress: The company has initiated the GALACTIC registry study to further confirm the clinical decision-making impact of the CM-Score and evaluate long-term patient outcomes in guiding biopsy decisions and immunosuppression management, facilitating clinical adoption.
- Market Transformation Potential: iMDx aims to drive local testing in transplant center laboratories by providing faster and more affordable testing tools, which is expected to transform the current paradigm of transplanted organ health monitoring and enhance patient care quality.
- FDA Authorization Application: iMDx is seeking FDA marketing authorization to sell the GraftAssure testing tools to transplant centers in the U.S., further solidifying its market position in transplant monitoring.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy IMDX?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on IMDX
Wall Street analysts forecast IMDX stock price to rise
3 Analyst Rating
2 Buy
1 Hold
0 Sell
Moderate Buy
Current: 5.690
Low
8.00
Averages
8.50
High
9.00
Current: 5.690
Low
8.00
Averages
8.50
High
9.00
About IMDX
Insight Molecular Diagnostics Inc., formerly Oncocyte Corporation, is a molecular diagnostics technology company. The Company's technology quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). It is in the process of rebranding its VitaGraft assay (also known as VitaGraft Kidney), which is a lab developed test, under the name GraftAssureCore. The Company's transplant products include GraftAssureCore, GraftAssureDx, GraftAssureIQ. Its oncology products include DetermaCNI, DetermaIO, and OncoTIME. GraftAssureCore is a clinical blood-based solid organ transplantation monitoring test. GraftAssureIQ is a research use only (RUO) blood-based solid organ transplantation monitoring test. DetermaIO is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies. DetermaCNI is a blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients. OncoTIME enables research on the tumor immune microenvironment.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
iMDx and ASTS Fund Kidney Transplant Research Grant
- Grant Announcement: Insight Molecular Diagnostics and the American Society of Transplant Surgeons (ASTS) announced a $100,000 research grant awarded to Dr. Kenneth Andreoni and Dr. Kenneth Chavin to compare the costs of in-house versus send-out donor-derived cell-free DNA testing in kidney transplantation.
- Economic Model Development: The research aims to develop a rigorous economic model that will assist transplant centers in evaluating the true costs and benefits of in-house testing versus centralized laboratory testing, thereby providing data to support future laboratory infrastructure decisions.
- Clinical Impact Assessment: The study will compare the clinical impact and operational efficiency of in-house diagnostic testing against send-out centralized laboratory testing, which is expected to generate critical information for the commercialization planning of GraftAssureDx™, currently under FDA review.
- Expert Team Background: The grant recipients possess extensive experience in transplant surgery and health systems management, enabling them to provide meaningful insights that will advance the understanding of the economics of in-house diagnostics in the transplant field.
See More
iMDx and ASTS Collaborate on Economic Research for Kidney Transplant Testing
- Grant Announcement: Insight Molecular Diagnostics and the American Society of Transplant Surgeons have announced a $100,000 research grant aimed at comparing the health economics of in-house versus send-out dd-cfDNA testing in kidney transplantation, facilitating informed decisions regarding laboratory infrastructure and assay selection for transplant centers.
- Clear Research Objectives: The study will evaluate the costs, clinical impacts, and operational implications of in-house testing versus centralized laboratory testing, with the resulting data expected to support future commercialization planning for GraftAssureDx™, which is currently under FDA review.
- Expert Team Background: Grant recipients Dr. Andreoni and Dr. Chavin bring extensive clinical and administrative expertise in kidney transplantation and health systems management, respectively, and their collaboration is poised to generate meaningful insights that will aid in assessing the true costs and benefits of in-house diagnostics.
- Urgent Industry Need: As more transplant centers explore in-house dd-cfDNA testing, obtaining rigorous health economic data will be critical for helping these programs evaluate their options and plan accordingly, ultimately improving patient care and enhancing testing efficiency.
See More
GraftAssure™ Assay Significantly Enhances Transplant Monitoring Accuracy
- CM-Score Superiority: iMDx's GraftAssure CM-Score demonstrated a positive predictive value exceeding 80% in a clinical validation involving 81 rejections and 282 non-rejections, significantly outperforming single-metric dd-cfDNA, indicating its reliability and effectiveness in kidney transplant monitoring.
- Clinical Validation Progress: The company has initiated the GALACTIC registry study to further confirm the clinical decision-making impact of the CM-Score and evaluate long-term patient outcomes in guiding biopsy decisions and immunosuppression management, facilitating clinical adoption.
- Market Transformation Potential: iMDx aims to drive local testing in transplant center laboratories by providing faster and more affordable testing tools, which is expected to transform the current paradigm of transplanted organ health monitoring and enhance patient care quality.
- FDA Authorization Application: iMDx is seeking FDA marketing authorization to sell the GraftAssure testing tools to transplant centers in the U.S., further solidifying its market position in transplant monitoring.
See More
Insight Molecular Diagnostics Q1 2026 Earnings Call Insights
- Positive FDA Engagement: Insight Molecular Diagnostics has experienced high engagement with the FDA since submitting GraftAssureDx, with expectations for continued progress, indicating potential market demand as the company anticipates its first U.S. orders later this year.
- Market Research Insights: The company conducted a survey of over 200 potential U.S. buyers to guide its pricing strategy for GraftAssure, aiming for software-like margins, which underscores its focus on market positioning and profitability commitments.
- Registry Expansion: Interest from 34 U.S. transplant centers to join the registry marks a significant increase from 28 centers six weeks ago, moving towards a goal of 50 centers, while Medicare's reimbursement rate of $2,753 per result for GraftAssureCore enhances commercialization prospects.
- Cash Flow Projections: The company projects a cash burn exceeding $9 million in Q2, marking the year's peak, with plans to reduce cash burn to approximately $6 million per quarter in the second half, reflecting a focus on cost control and market adaptability.
See More
Insight Molecular Diagnostics Set to Announce Q1 Earnings Results
- Earnings Announcement Date: Insight Molecular Diagnostics Inc. (IMDX) is set to release its Q1 2023 earnings report on May 13th after market close, with a consensus EPS estimate of -$0.26, indicating ongoing challenges in profitability.
- Revenue Decline Forecast: Analysts project IMDX's revenue to be $230,000, reflecting a staggering 89.2% year-over-year decline, highlighting significant pressures in market competition and product promotion that could impact investor confidence.
- Historical Performance Review: Over the past year, IMDX has only beaten EPS estimates 25% of the time and revenue estimates 50% of the time, indicating instability in financial performance that may lead to cautious investor sentiment regarding future results.
- Market Opportunity Outlook: Despite current financial struggles, IMDX outlines a $2 billion annual market opportunity in the GraftAssureDx sector, demonstrating confidence in rapid commercialization efforts that could drive future growth.
See More
Insight Molecular Diagnostics Q4 2025 Earnings Call Highlights
- FDA Submission Milestone: Insight Molecular Diagnostics has submitted GraftAssureDx to the FDA, marking a significant advancement in the dd-cfDNA testing space, which is expected to accelerate product commercialization and enhance market competitiveness.
- Clinical Engagement Growth: Since the fall, 28 transplant centers have initiated the registry process, bringing the company closer to its goal of 50 centers, indicating strong market demand and effective clinical outreach strategies.
- Capital Raise and Spending Management: CFO Andrea James reported the completion of a $26 million capital raise, with maintenance spending projected at $5.5 million per quarter and growth spending at $2 million, ensuring financial stability while expanding market access.
- Market Outlook and Challenges: The company anticipates low lab services revenue in 2026, necessitating successful commercialization for self-sustainability; despite strong demand for heart transplant testing, clinician adoption remains a significant hurdle.
See More
iMDx and ASTS Fund Kidney Transplant Research Grant
- Grant Announcement: Insight Molecular Diagnostics and the American Society of Transplant Surgeons (ASTS) announced a $100,000 research grant awarded to Dr. Kenneth Andreoni and Dr. Kenneth Chavin to compare the costs of in-house versus send-out donor-derived cell-free DNA testing in kidney transplantation.
- Economic Model Development: The research aims to develop a rigorous economic model that will assist transplant centers in evaluating the true costs and benefits of in-house testing versus centralized laboratory testing, thereby providing data to support future laboratory infrastructure decisions.
- Clinical Impact Assessment: The study will compare the clinical impact and operational efficiency of in-house diagnostic testing against send-out centralized laboratory testing, which is expected to generate critical information for the commercialization planning of GraftAssureDx™, currently under FDA review.
- Expert Team Background: The grant recipients possess extensive experience in transplant surgery and health systems management, enabling them to provide meaningful insights that will advance the understanding of the economics of in-house diagnostics in the transplant field.
See More
iMDx and ASTS Collaborate on Economic Research for Kidney Transplant Testing
- Grant Announcement: Insight Molecular Diagnostics and the American Society of Transplant Surgeons have announced a $100,000 research grant aimed at comparing the health economics of in-house versus send-out dd-cfDNA testing in kidney transplantation, facilitating informed decisions regarding laboratory infrastructure and assay selection for transplant centers.
- Clear Research Objectives: The study will evaluate the costs, clinical impacts, and operational implications of in-house testing versus centralized laboratory testing, with the resulting data expected to support future commercialization planning for GraftAssureDx™, which is currently under FDA review.
- Expert Team Background: Grant recipients Dr. Andreoni and Dr. Chavin bring extensive clinical and administrative expertise in kidney transplantation and health systems management, respectively, and their collaboration is poised to generate meaningful insights that will aid in assessing the true costs and benefits of in-house diagnostics.
- Urgent Industry Need: As more transplant centers explore in-house dd-cfDNA testing, obtaining rigorous health economic data will be critical for helping these programs evaluate their options and plan accordingly, ultimately improving patient care and enhancing testing efficiency.
See More
GraftAssure™ Assay Significantly Enhances Transplant Monitoring Accuracy
- CM-Score Superiority: iMDx's GraftAssure CM-Score demonstrated a positive predictive value exceeding 80% in a clinical validation involving 81 rejections and 282 non-rejections, significantly outperforming single-metric dd-cfDNA, indicating its reliability and effectiveness in kidney transplant monitoring.
- Clinical Validation Progress: The company has initiated the GALACTIC registry study to further confirm the clinical decision-making impact of the CM-Score and evaluate long-term patient outcomes in guiding biopsy decisions and immunosuppression management, facilitating clinical adoption.
- Market Transformation Potential: iMDx aims to drive local testing in transplant center laboratories by providing faster and more affordable testing tools, which is expected to transform the current paradigm of transplanted organ health monitoring and enhance patient care quality.
- FDA Authorization Application: iMDx is seeking FDA marketing authorization to sell the GraftAssure testing tools to transplant centers in the U.S., further solidifying its market position in transplant monitoring.
See More
Insight Molecular Diagnostics Q1 2026 Earnings Call Insights
- Positive FDA Engagement: Insight Molecular Diagnostics has experienced high engagement with the FDA since submitting GraftAssureDx, with expectations for continued progress, indicating potential market demand as the company anticipates its first U.S. orders later this year.
- Market Research Insights: The company conducted a survey of over 200 potential U.S. buyers to guide its pricing strategy for GraftAssure, aiming for software-like margins, which underscores its focus on market positioning and profitability commitments.
- Registry Expansion: Interest from 34 U.S. transplant centers to join the registry marks a significant increase from 28 centers six weeks ago, moving towards a goal of 50 centers, while Medicare's reimbursement rate of $2,753 per result for GraftAssureCore enhances commercialization prospects.
- Cash Flow Projections: The company projects a cash burn exceeding $9 million in Q2, marking the year's peak, with plans to reduce cash burn to approximately $6 million per quarter in the second half, reflecting a focus on cost control and market adaptability.
See More
Insight Molecular Diagnostics Set to Announce Q1 Earnings Results
- Earnings Announcement Date: Insight Molecular Diagnostics Inc. (IMDX) is set to release its Q1 2023 earnings report on May 13th after market close, with a consensus EPS estimate of -$0.26, indicating ongoing challenges in profitability.
- Revenue Decline Forecast: Analysts project IMDX's revenue to be $230,000, reflecting a staggering 89.2% year-over-year decline, highlighting significant pressures in market competition and product promotion that could impact investor confidence.
- Historical Performance Review: Over the past year, IMDX has only beaten EPS estimates 25% of the time and revenue estimates 50% of the time, indicating instability in financial performance that may lead to cautious investor sentiment regarding future results.
- Market Opportunity Outlook: Despite current financial struggles, IMDX outlines a $2 billion annual market opportunity in the GraftAssureDx sector, demonstrating confidence in rapid commercialization efforts that could drive future growth.
See More
Insight Molecular Diagnostics Q4 2025 Earnings Call Highlights
- FDA Submission Milestone: Insight Molecular Diagnostics has submitted GraftAssureDx to the FDA, marking a significant advancement in the dd-cfDNA testing space, which is expected to accelerate product commercialization and enhance market competitiveness.
- Clinical Engagement Growth: Since the fall, 28 transplant centers have initiated the registry process, bringing the company closer to its goal of 50 centers, indicating strong market demand and effective clinical outreach strategies.
- Capital Raise and Spending Management: CFO Andrea James reported the completion of a $26 million capital raise, with maintenance spending projected at $5.5 million per quarter and growth spending at $2 million, ensuring financial stability while expanding market access.
- Market Outlook and Challenges: The company anticipates low lab services revenue in 2026, necessitating successful commercialization for self-sustainability; despite strong demand for heart transplant testing, clinician adoption remains a significant hurdle.
See More
