The only exosome-based test that provides unique, actionable intelligence to help you decide if biopsy is necessary; independent of PSA and other standard of care (SOC) features.
The only exosome-based test that provides unique, actionable intelligence to help you decide if biopsy is necessary; independent of PSA and other standard of care (SOC) features.
What is the Exo mdx test?
Exo mdx is a simple, non-DRE, urine-based, liquid biopsy test indicated for men 50 years of age and older with a prostate-specific antigen (PSA) 2-10ng/mL, or PSA in the “gray zone”, considering prostate biopsy. Exo mdx returns a risk score that determines a patient’s risk of clinically significant prostate cancer (≥GG2 (GS 3+4)) on prostate biopsy. A score above the validated cut-point of 15.6 is associated with an increased likelihood of ≥GG2 (GS 3+4) on a biopsy and a score below the cut-point of 15.6 is associated with a decreased likelihood of ≥GG2 (GS 3+4). This test can help reassure a patient to avoid a prostate biopsy or improve patient compliance with physician recommendation.
What’s unique about the Exo mdx test is that it is an exosome-based genomic test that offers an additional data point that is not obtained through the general work up. It offers unique intelligence that is not influenced by DRE, family history, PSA, or other standard of care features.
Key Features of the Exo mdx Test
Negative Predictive Value for Exo mdx
Sensitivity for Exo mdx
Improved Patient Compliance to Physician Recommendation
More HGPCa Identified vs. SOC Alone
Clinical Validity
The clinical validity of Exo mdx is supported by multiple peer-reviewed publications and presentations, representing approximately 5000 patients from 40 academic and community urology clinics in the US.
The Exo mdx test has been clinically validated to risk stratify clinically significant prostate cancer from low grade prostate cancer and benign disease. A patient-specific individual risk score is calculated based on a proprietary algorithm that combines the weighted expression of a three-gene signature associated with clinically significant prostate cancer (PCA3, SPDEF, ERG) directly from urinary exosomal RNA.
Negative
Positive
Ordering & Coverage: Medicare and Private Insurance Options
Ordering is simple with options for both in-office and at-home collection. Insurance coverage and telehealth compatibility make it accessible for diverse patient needs.
Numerous Studies Verify Exo mdx’s Clinical Utility and Validity
Publications & Abstracts
For Physicians
For Patients
Ms. Leroux has more than 20 years of leadership experience in healthcare diagnostics with deep expertise in revenue cycle management, managed care, and payer relations. She currently serves as Executive Vice President of Revenue Cycle Management at mdxhealth, where she leads strategy and execution to optimize financial performance and expand patient access to precision diagnostics.
Prior to mdxhealth, Ms. Leroux was Vice President of Revenue Cycle Management & Managed Care at Invitae, where she oversaw a team of nearly 200 professionals and drove monthly cash collections from $6 million to over $45 million, while implementing automation, offshoring, and process optimization initiatives that significantly strengthened operational efficiency. She previously served as Vice President of Billing & Reimbursement at CombiMatrix, where she aligned payer strategy and billing operations with corporate growth goals. Earlier in her career, she held leadership roles at US LABS/Esoterix, where she directed client services across multiple laboratories and spearheaded programs that improved revenue capture and client engagement.
In addition to her corporate leadership, Ms. Leroux served as President and Board Member of the California Clinical Laboratory Association for over a decade, playing a key role in shaping policy and advocating for the laboratory community at state and federal levels. Ms. Leroux received her Bachelor of Arts degree in Communications, with a concentration in Public Relations, from California State University, Fullerton.
Mr. Holder most recently served as CEO of Sensable Health, a Stead Impact Venture portfolio company leveraging AI with a focus on personalized health and biologics to improve metabolic health. Previously, Mr. Holder served as CFO of AVITA Medical Inc. (Nasdaq:RCEL, ASX: AVH), a regenerative medicine company, as CFO of ImmuneCyte Inc., a privately-held biopharmaceutical company, as CEO and Portfolio Manager of Carolina Longevity Institute, LLC, a biotech and medtech private investment company, as CEO and CFO of Organ Transport Systems Inc, a privately-held medical device company, as VP of Sales, Operations and Finance and CFO for Premier Sourcing Partners Inc., a wholly-owned subsidiary of Premier Inc., a privately-held medical and information technology product and services company, as CFO of Clarkston-Potomac Group, a privately-held ERP implementation and integration services company, and as CFO of Beacon Eye Institute Inc.. Mr. Holder currently serves as a board director and audit committee chair of Cytek Biosciences Inc. (Nasdaq:CKTB), a flow cytometry and cell analysis solutions company, as well as a board director of Keyron Limited., a London, England based medical device company. Mr. Holder has previously served as a board director of Carolina Longevity Institute, LLC, Limitless LLC, Organ Transport Systems, Inc., and Cyphre Inc., and Beacon Eye Institute Inc. Mr. Holder holds a B.S. in Business Administration from The Kenan-Flagler Business School at the University of North Carolina at Chapel Hill, and an M.B.A. with a major in Corporate Strategy and Finance from The Wharton School at the University of Pennsylvania. Mr. Holder previously obtained his certified public accountant license (currently inactive).
The GPS test measures prostate cancer gene levels to assess how aggressively your cancer will grow or spread. Since certain genes influence this more than others, knowing which ones are active in your tumor helps determine your personal GPS result.
Your score is based on a scale of 0-100. Your genomic risk will indicate how your tumor behaves and can help you and your doctor determine the most appropriate course of treatment.
These results can predict both your chance of:
The GPS test provides a personalized assessment of how aggressive your prostate cancer is, helping you and your doctor discuss next steps with confidence.
DOWNLOAD SAMPLE REPORT OVERVIEW FOR CLINICALLY HIGH-RISK PROSTATE CANCER
The GPS test measures prostate cancer gene levels to assess how aggressively your cancer will grow or spread. Since certain genes influence this more than others, knowing which ones are active in your tumor helps determine your personal GPS result.
The bell curve illustrates where your GPS result falls in relation to the GPS results of other men in the same risk category.
These results can predict both your chance of:
The GPS test provides a personalized assessment of how aggressive your prostate cancer is, helping you and your doctor discuss next steps with confidence.
DOWNLOAD SAMPLE REPORT OVERVIEW FOR CLINICALLY LOW-RISK PROSTATE CANCER
The low-risk report integrates clinical, pathological, and genomic insights into actionable information on active surveillance1
The high-risk report provides a defined cut point with actionable information on treatment intensity2
References:
Hilde Windels, Independent Non-Executive Director of our Company, has over 20 years of experience in the biotechnology sector with a track record of building and structuring organizations, fundraising, M&A, public capital markets and corporate strategies. Currently, Mrs. Windels serves as a board member at PHAXIAM Therapeutics, GIMV NV, MCROPHYT SA, and Celyad. Previously, she served as CEO of immunodiagnostic company Antelope Dx BV, and as CEO ad interim and Deputy CEO of Biocartis from September 2015 until September 2017 and as CFO of Biocartis from 2011 until September 2015. Mrs. Windels has also worked as independent CFO for several private biotech companies and from 1999 to 2008 she was CFO of Devgen. In the past, she also served on the boards of Devgen, Biocartis, Ablynx, VIB and FlandersBio. Mrs. Windels holds a Masters in Economics (commercial engineer) from the University of Leuven, Belgium.
Dr. Siegel has more than 45 years of experience as a practicing urologist and over 35 years of executive leadership experience. Dr. Siegel previously served as Chairman of the Board and Chief Executive Officer of United Urology Group, which was acquired by Audax in 2016. United Urology Group was formed under Dr. Siegel’s leadership and is one of the nation’s leading urology networks. Previously, Dr. Siegel served as the President and Chief Executive Officer of Chesapeake Urology Associates, which he founded in 1999. Dr. Siegel is a founding member of the Large Urology Group Practice Association (LUGPA), which was formed in 2008. He was a board member of the Urology Care Foundation (UCF) from 2016 until 2023 and The Urology Times. As a recognized leader in the field of medicine, Dr. Siegel has been honored with official citations for outstanding commitment and leadership from both the Governor and the General Assembly of Maryland. Dr. Siegel earned his medical degree from the University of Maryland School of Medicine and completed his specialty training in urology at Temple University Hospital in Philadelphia. He has been certified by the American Board of Urology and as Fellow of the American College of Surgeons.
Dr. Slagmulder is a full professor in management accounting & control at Vlerick Business School. Previously, she worked as a strategy practice consultant at McKinsey & Company. She also previously worked as a professor of management accounting at INSEAD and at the University of Tilburg. She serves as a non-executive director and member of the audit committee on the board of the investment company Quest for Growth (since 2011) and as an independent director and chair of the audit committee and member of the remuneration & nomination committee of Ekopak (since 2021), both listed on Euronext. Dr. Slagmulder graduated in civil electrotechnical engineering and industrial management from the University of Gent, after which she received a management doctorate at Vlerick Business School. As part of her research activities, she was a research fellow attached to INSEAD, Boston University (USA) and the P. Drucker Graduate Management Center at Claremont University (USA). She is an INSEAD certified director (IDP-C).
Jan Pensaert is the Founding Managing Partner of Valiance. He brings over 20 years of experience in growth investing. He leads the Investment Committee for the Valiance Funds and is responsible for all aspects of the Funds’ investment processes. Jan currently serves on the Board of several Valiance entities funds and portfolio companies including MDxHealth, JenaValve, NeoSync, and 4Tech. Prior to founding Valiance, Jan was CEO of La Fayette, where during his tenure the La Fayette Funds increased in AUM from $750 million to $5.5 billion. Before that, he was responsible for the Permal Group’s European-based investment management and research activities, and prior to that, he worked at Lazard in Corporate Finance M&A. Jan holds a BA in Business Economics from Gent University in Belgium, and a Masters in Banking & Finance from the University of Aix-Marseille, France.
Mr. Hardison currently is the sole proprietor of DMH Consulting, a management consulting firm that he founded and previously operated from April 2016 to January 2017. He was most recently the President and Chief Executive Officer, and served on the board of directors, of Biotheranostics, Inc., a molecular diagnostic company focused on oncology, from February 2017 until it was acquired by Hologic, Inc. in February 2021. From April 2010 to March 2016, Mr. Hardison was the President and Chief Executive Officer of Good Start Genetics, a molecular genetic testing and information company. For more than 20 years prior to that, Mr. Hardison held various executive and senior management positions at companies including Laboratory Corporation of America (LabCorp) a clinical laboratory company, Exact Sciences Corporation, a molecular diagnostics company, OnTarget, Inc., a sales and marketing consulting company, Quest Diagnostics Inc., a clinical laboratory company, SmithKline Beecham Corporation, a pharmaceutical company, and others. He served on the board of directors of Exact Sciences Corporation (Nasdaq: EXAS) from May 2000, through its initial public offering in February 2001, until August 2007. Mr. Hardison received his Bachelor of Arts degree, in political science, from the University of North Carolina, Chapel Hill.
Dr. Bednarski currently serves as a Partner of MVM Partners, a healthcare growth equity firm. Before joining MVM in 2008, he was a Partner at Advent Healthcare Ventures and a Principal at Advent International Corporation. Prior to Advent, he was a Director in the Corporate Finance Group of Silicon Valley Bank. Dr. Bednarski has a B.S. degree in Neural Science from Brown University and a Ph.D. in Biological Sciences from the University of California, Irvine.
Mr. Hoffman, Chair of our Board of Directors, obtained a Master in Applied Economics and an MBA at Vlerick Business School. Between 1992 and July 2016, he worked at KBC Group, where he started his career in the corporate finance department and later became the CEO of KBC Securities in October 2012. Since August 2016, he is the CEO of Value Square asset management. Mr. Hoffman serves also as board member at Fagron NV (Chair) and Greenyard (Chair).
Mr. McGarrity, Chief Executive Officer and Executive Director of our Company, has more than 25 years of experience in the healthcare industry with a unique combination of device, diagnostics and biotechnology experience. Michael was most recently the CEO of Sterilis Medical from November 2017 to February 2019. Prior to Sterilis Michael was the CEO of Nanosphere (Nasdaq: NSPH), a nanotechnology-based molecular diagnostics company, where he engineered an operational and strategic turnaround that resulted in its successful sale to Luminex (Nasdaq: LMNX) in 2016. Prior to Nanosphere, McGarrity spent 13 years at Stryker Corporation (NYSE: SYK). Mr. McGarrity holds a BA from the University of Notre Dame.
Mr. Sollee has more than 20 years of experience in the healthcare industry, including senior management roles in both private and publicly listed pharmaceuticals, health information technology and molecular diagnostics companies. He has served as chief legal counsel to MDxHealth since its inception in 2003. Prior to MDxHealth, he led the Life Sciences Practice Group at the law firm of Kennedy Covington (now K&LGates) and held senior legal and management positions at TherapyEdge and Triangle Pharmaceuticals. In addition, he has practiced as a corporate attorney in the Washington D.C. legal firm Swidler & Berlin and as an investment banker at Smith Barney in New York. Mr. Sollee received a Juris Doctorate in Law and a Masters degree in International Law from Duke University, a BA degree from Harvard University, and has been awarded New York, Washington D.C. and North Carolina legal bar certifications.
Miriam Reyes has 25 years of experience in life science and laboratory operations, and R&D. She has served as Operations Leader at MDxHealth since its US inception in 2011. Prior to MDxHealth, Mrs. Reyes was Director of Laboratory Operations at Agendia where she established/built and led the CLIA lab for the Agendia’s FDA cleared MammaPrint breast cancer test. In addition to Agendia, she established laboratory operations at Combimatrix (Invitae) Molecular Diagnostics and developed commercial assays at both IBIS Biosciences and US Labs (LabCorp.).
Mr. Bellano has more than 25 years of experience in the Healthcare Industry. Mr. Bellano started his career in Pharmaceuticals and transitioned to molecular diagnostics where he has spent the past 20 years of his career. Most recently the Chief Commercial Officer of Sterilis Solutions Prior to Sterilis Solutions he served as the commercial leader for Pharmacogenomic companies Assurex Health and AltheaDx. While at Assurex Health (Myriad Genetics) revenue grew from $700k to a run rate of $100 Million during his 5 year span with the organization.
Mr. Kalfus has over 20 years of leadership experience in both public and private companies within diagnostics/biotech and other sectors, and brings extensive knowledge in financial operations and management. Mr. Kalfus joined MDxHealth from Rosetta Genomics, where he helped lead efforts to reposition the company for commercial success with its oncology diagnostic products. Prior to Rosetta, Mr. Kalfus served as the CFO and Treasurer of MabCure, a Belgium-based publicly traded biotechnology start-up in the field of early cancer detection using antibodies. Mr. Kalfus holds a MS in Accounting from Fairleigh Dickinson University and a BBA in Finance from the University of Georgia and is a CPA licensed in New Jersey.
Mr. McGarrity has more than 25 years of experience in the healthcare industry with a unique combination of device, diagnostics and biotechnology experience. Mr. McGarrity was most recently the CEO of Sterilis Medical. Prior to Sterilis Mr. McGarrity was the CEO of Nanosphere (NASDAQ: NSPH), a nanotechnology-based molecular diagnostics company, where he engineered an operational and strategic turnaround that resulted in its successful sale to Luminex (NASDAQ: LMNX) in 2016. Prior to Nanosphere, Mr. McGarrity spent 13 years at Stryker Corporation (NYSE: SYK) where he served in leadership roles in sales and marketing and led Stryker into new growth markets such as post-operative pain management, surgical fluid waste management and interventional pain management. Mr. McGarrity also had executive general management responsibility for a newly created business unit focused on interventional spine pain management. Mr. McGarrity received a Bachelor of Arts degree from the University of Notre Dame and began his career in commercial banking.