Evaluating the tumor’s immune microenvironment biology to predict its response to immunotherapy.
Text: DetermaIO is a 27-gene molecular gene expression assay that assesses components of the tumor immune microenvironment (TIME) in order to determine the likelihood of response to immune checkpoint inhibitor (ICI) therapy. The test has been validated in clinical studies in over 1,000 patients, in six tumor types, across all stages of cancer, and against four approved ICIs.
The TIME consists of the tumor, immune cells (e.g. T-cells and tumor infiltrating lymphocytes), stromal cells (e.g. cancer-associated fibroblasts), and the surrounding extracellular matrix and vasculature.
Tumors in this state are often known as “Hot” tumors. They tend to exhibit high levels of immune cell infiltration and show signs of active anti-tumor immunity. Patients whose tumors are activated/inflamed are most likely to potentially benefit from ICI therapy.
One of two “Cold” states of the TME, these tumors often exhibit signs of tumor fortification via cancer-associated fibroblasts and other immune-suppressive cell types. These tumors are less likely to benefit from ICI therapy.
The other “Cold” TME state, Immune Desert tumors often lack any immune cell involvement within the tumor or its surrounding microenvironment. This state may be associated with tumors undergoing epithelial-to-mesenchymal transition (EMT) and are also less likely to benefit from ICI therapy.
DetermaIO works by measuring and algorithmically weighing the signals of an activated TME against signals of resistance from immuno-suppressive or immune desert conditions within the TME.
DetermaIO has been studied and published in multiple tumor types, with each study demonstrating a successful ability to identify patients that are likely to benefit from the addition of immunotherapy agents to their treatment regimen.
Data from the IMVIGOR 210 clinical trial showed that DetermaIO was significantly associated with response to ICI therapy and works in a complementary fashion with existing biomarkers (e.g. PD-L1, TMB) to identify additional patients those markers might miss.
KIDNEY CLINICAL SUMMARY
A Randomized Phase 2 Trial of Felzartamab in Antibody-Mediated Rejection. NEJM DOI: 10.1056/NEJMoa2400763.
KIDNEY CLINICAL SUMMARY
Donor-Derived Cell-Free DNA in Biopsy-Proven Antibody-Mediated Rejection Versus Recurrent IgA Nephropathy After Kidney Transplantation. Kidney International Reports. Vol. 8, Issue 10, P2141-2145.
KIDNEY CLINICAL SUMMARY
Absolute quantification of donor-derived cell-free DNA as a marker of rejection and graft injury in kidney transplantation: Results from a prospective observational study. Am J Transplant 19(11):3087.
KIDNEY CLINICAL SUMMARY
Time-dependent apparent increase in dd-cfDNA percentage in clinically stable patients between one and five years following kidney transplantation. Clin Chem 66(10):1290.
LIVER CLINICAL SUMMARY
Use of graft-derived cell-Free DNA as an organ integrity biomarker to reexamine effective tacrolimus trough concentrations after liver transplantation. Ther Drug Monit 36(2):136.
LIVER CLINICAL SUMMARY
Graft-derived cell-free DNA, a noninvasive early rejection and graft damage marker in liver transplantation: A prospective, observational, multicenter cohort study. PLoS Med 14(4):e1002286.
KIDNEY INFORMATION SHEET
For nephrologists, surgeons and clinical transplant professionals.
GraftAssureCore
For patients and caregivers seeking more information on GraftAssureCore, how it may help, and where it fits into post-kidney transplant care.
GraftAssureCore
For information on insurance coverage for GraftAssureCore.
KIDNEY INFORMATION SHEET
Para obtener información sobre la cobertura del seguro para VitaGraft Kidney.
LIVER INFORMATION SHEET
For hepatologists, surgeons, and clinical transplant professionals.
Blood samples must be processed within 7 days of collection.
Less than 48 hours within specified hours of operation.
Through the online portal or by filling out a paper Test Requisition Form (TRF). Please contact your Local Representative or iMDx Customer Experience (844-621-8880) for any questions.
We do not want cost to be a barrier for testing, patients can call (844-621-8880) or fax (844-584-3467) to see if they qualify for our financial assistance program.
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©2025 Insight Molecular Diagnostics Inc. All rights reserved. iMDx, GraftAssureCore, GraftAssureIQ, GraftAssureDx, DetermaIO, DetermaCNI, and OncoTIME are trademarks of Insight Molecular Diagnostics Inc. All other trademarks are the property of their respective owners. For the intended uses of all products, please refer to www.imdxinc.com.
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James Liu joined iMDx in July 2021 and was appointed Vice President of Accounting, Controller, Treasurer, and Principal Accounting Officer in March 2025. He has held several key roles at iMDx, including Senior Director, Controller & Principal Accounting Officer and Manager of SEC Reporting & Compliance. James also served as interim Principal Financial Officer from August 2023 to June 2024, overseeing financial operations and public company reporting.
Before iMDx, James served as Accounting Manager at Acacia Research Corporation, where he led the SEC reporting and compliance, accounting close, and all other financial reporting requirements of an opportunistic capital platform that identifies and acquires other. He also worked as Senior Accountant at Gatekeeper Systems, Inc. and as Senior Assurance Associate at BDO USA, LLP, gaining deep expertise in financial reporting and assurance practices across multiple industries.
James holds a BASc degree from the University of California, San Diego, and is a Certified Public Accountant.
Peter Hong oversees iMDx’s legal department. Before joining iMDx in August 2021, Peter was an associate at Stradling Yocca Carlson & Rauth, P.C., where he represented both public and private companies in capital markets, M&A, and corporate governance matters. Prior to that, he worked at the New York office of Covington & Burling LLP, where he represented underwriters in the initial public offerings and follow-on offerings of biotechnology companies. At Covington, Peter also advised overseas clients with regard to restructuring, employment matters and the formation of U.S. subsidiaries.
Peter earned his JD from Columbia Law School and his Bachelor of Science in Business Administration from Washington University in St. Louis. He is admitted to practice law in New York and California.
Ryan Andrews joined iMDx in 2019 and currently serves as Vice President of Commercial, leading the strategic commercialization of iMDx’s innovative products and solutions. Prior to this role, he held key leadership positions within the company, including Director and Senior Director of Marketing, where he played a pivotal role in shaping iMDx’s market strategy and brand presence.
With extensive experience in the diagnostics and life sciences industry, Ryan brings a deep understanding of market dynamics, business development, and commercial execution. His expertise spans product commercialization, strategic partnerships, and market expansion, ensuring iMDx’s solutions reach the healthcare providers and patients who need them most.
Before joining iMDx, Ryan was a Principal at Bethesda Group, LLC, a boutique consulting firm specializing in guiding small and mid-stage diagnostic companies and investment groups through market entry, product launches, and commercialization strategies. He has also held sales, marketing, and operational leadership roles at Thermo Fisher Scientific, Life Technologies, and Cytovance Biologics, where he gained extensive experience in the biotechnology, diagnostics, and life sciences sectors.
Ryan holds an MBA from the University of Mississippi and remains committed to advancing precision diagnostics and improving patient outcomes through innovative commercial strategies.
Sandra is an activator and results-driven leader with expertise in operational leadership, commercialization, and corporate integration. With a strong record of driving transformation across small and mid-sized organizations, Sandra brings a unique ability to align cross-functional teams, streamline operations, and deliver measurable business outcomes.
Sandra joined iMDx in December 2019, and in her current role, she leads business operations in support of product development, working closely with senior leadership to ensure alignment with the company’s long-term strategic goals. She champions scalable processes, fosters continuous improvement, and supports innovation throughout the organization.
Beyond her corporate responsibilities, Sandra serves as Vice President of the Orange County chapter of the Healthcare Businesswomen’s Association (HBA), where she partners with the board to shape the chapter’s vision, drive strategic initiatives, and engage with the Chapter Advisory Board to elevate leadership and inclusion in the healthcare industry.
Sandra is known for driving consensus among teams, focused execution of goals and turning strategy into action.
Sandra earned a Bachelor of Business Administration (B.B.A.) and HR Management Certification from California State University, Fullerton.
Andrea James is an expert in guiding financial strategy through multiple phases of growth, raising and stewarding capital, and building relationships with high quality institutional investors. Prior to joining iMDx in 2024, she served in a series of escalating roles at Axon Enterprise, Inc. (Nasdaq: AXON), including Chief Communications Officer and Head of Investor Relations, and Senior Vice President of Strategy. She played a key role in the company’s growth from a $1 billion to a $20 billion market capitalization and established Axon’s corporate strategy function, overseeing capital stewardship, mergers and acquisitions, strategic partnerships, and investments. Her leadership contributed to more than $550 million in equity capital offerings.
Before joining Axon, Andrea assisted Tesla, Inc. (Nasdaq: TSLA) with strategic investor relations, and has also served as Vice President and Senior Research Analyst at Dougherty & Co. (now Colliers Securities), specializing in researching disruptive technologies.
Andrea holds a Bachelor of Science, summa cum laude, in Computer Information Systems from American University. She also earned a Master of Science in Journalism from Northwestern University, graduating with Kappa Tau Alpha honors.
Johnson Chiang is an experienced technology leader with a strong background in molecular diagnostics, focusing on product development, systems integration, and regulatory strategy. Johnson joined iMDx in 2021, having previously served as Chief Technology Officer at Alveo Technologies, an IVD company that specializes in developing cutting-edge molecular diagnostic tests. At iMDx, he continues to leverage his expertise to drive innovation in diagnostic solutions.
Previously, Johnson led the development of the be.well COVID-19 Test at Alveo Technologies, which completed a U.S. clinical trial and earned the CE mark and UK approval. In addition to his leadership in product development, he was involved in fundraising efforts that raised $50MM over four years and played a key role in securing the XPrize Grand Award for Rapid COVID Testing. Earlier in his career, Johnson was the Head of Systems Integration & Molecular Biology at Foundation Medicine, Inc., and held senior management roles at Life Technologies and Thermo Fisher Scientific. One of his key achievements was leading the Oncomine Dx Target Test, the first NGS-based CDx test approved by the FDA. Additionally, he holds several patents and has published numerous papers in biotechnology.
Johnson holds a Ph.D. in BioMEMS (Micro Electro-Mechanical Systems) from the University of California, Irvine. He also earned a Master of Engineering from The Ohio State University.
Ekkehard (Ekke) Schütz is a renowned leading expert in molecular genetics, diagnostics, and cell-free DNA (cf-DNA) research. He joined iMDx in April 2021 through its acquisition of Chronix Biomedical Inc. and now serves as Managing Director of Chronix Biomedical GmbH (a fully owned subsidiary of iMDx) and Chief Medical Officer (CMO) for Europe.
Under his leadership, Chronix became a leader in cf-DNA diagnostics, producing numerous publications and securing a broad patent portfolio, including ten patent families with many issued patents in the U.S. and Europe, which he invented.
Fellow of the National Academy for Clinical Biochemistry (now FAACC) since 2014, Ekke has published over 190 peer-reviewed papers, contributed to 100+ congress abstracts, and received several international scientific awards. He has also been a reviewer for top scientific journals, including PNAS, Clinical Chemistry, Clinical Biochemistry, and Nucleic Acids Research.
Ekke trained in laboratory medicine at Georg-August-University Hospital in Goettingen, Germany under Prof. Dr. Michael Oellerich, a renowned expert in therapeutic drug monitoring and transplantation surveillance.
Josh Riggs is an accomplished and results-driven business leader with extensive experience in market access, molecular diagnostics, and strategic business development. He joined iMDx in August 2020, where he quickly became a key driver of the company’s growth and innovation. Initially serving as Senior Director of Business Development and General Manager of Transplant, Josh demonstrated exceptional leadership and business acumen, which ultimately led to his appointment as CEO in December 2022. As CEO, Josh has spearheaded the strategic pivot of iMDx, leading the organization to decentralize its testing approach and expand its impact on patient care.
Prior to his tenure at iMDx, Josh founded and led Intelliger Consulting, a firm specializing in healthcare marketing strategies. He also served as a principal at Bethesda Group, LLC, where he advised diagnostic companies and investors on market entry, commercialization, and expansion strategies.
Before venturing into the healthcare and diagnostics sectors, Josh gained valuable operational experience in the manufacturing industry. As part of the team at Industrial Timber, a startup manufacturer, he was responsible for managing and establishing multiple manufacturing facilities across the southeastern United States.
Josh holds an MBA from the University of Mississippi.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
