Licensure & Accreditations

United States:

Canada:

Europe:

Mdxhealth’s Nijmegen Laboratory: ISO 13485:2016 Certificate of Registration

Tailored reports that connect insights
for the next step in care

Low-Risk Report

The low-risk report integrates clinical, pathological, and genomic insights into actionable information on active surveillance¹

Predicts tumor aggressiveness to help inform the decision between active surveillance and immediate treatment
Focuses on an actionable endpoint adverse pathology, with the most comprehensive definition
The Genomic Prostate Score(GPS) test is the only commercially available test to provide all these endpoints:
- Risk of high-grade (≥Grade Group 3) disease
- Risk of pT3a+ disease
- Risk of metastasis within 10 years
- Risk of PCa-specific death within 10 years

DOWNLOAD LOW-RISK SAMPLE REPORT

High-Risk Report

The high-risk report provides a defined cut point with actionable information on treatment intensity²

Helps determine the right level of treatment
Clearly stratifies patient risk into lower or higher likelihood of disease progression
Simple bell curve helps you and your patient understand the patient’s risk relative to other patients of same clinical risk group

DOWNLOAD HIGH-RISK SAMPLE REPORT

References:

Klein EA, Cooperberg MR, Magi-Galluzzi C, et al. A 17-gene assay to predict prostate cancer aggressiveness in the context of Gleason grade heterogeneity, tumor multifocality, and biopsy undersampling. Eur Urol. 2014;66(3):550-560.
Cullen J, Kuo HC, Shan J, Lu R, Aboushwareb T, Van Den Eeden SK. The 17-gene genomic prostate score test as a predictor of outcomes in men with unfavorable intermediate risk prostate cancer. Urology. 2020;143:103-111.

Insurance & Billing Policy

We are committed to making our tests accessible and affordable to your patients. Mdxhealth’s Patient First Promise Program was created to assist patients throughout the billing process. We will work directly with each patient to ensure their complete satisfaction.

Dedicated Patient Advocate Team

Our specially trained Patient Advocates are ready to answer patients’ questions about insurance coverage and personalized payment options.
Toll Free: 866-259-7001, Monday – Friday, 6:00AM – 4:30PM PT
Email: patientfirst@mdxhealth.com

Personalized Payment Options

Interest-Free Payment Plan
Financial Assistance Program

How to Order Resolve mdx

To order Resolve mdx urine transport kits or test requisition forms:
Order Supplies Online
Call: 866.259.5644
Email: client.services@mdxhealth.com
Once urine transport kits are received, complete the Resolve mdx’s test requisition form in its entirety.
Carefully follow the steps in the enclosed Instructions For Use to collect the urine specimen.
Send completed test request form along with the sealed urine transportation kit to: 7000 Preston Road, Suite 1500, Plano, TX 75024

Schedule FedEx Pick Up

View and Download Resolve mdx Test Requisition Form (TRF)
View and Download Resolve mdx Specimen Collection and Shipping Instructions
View and Download Resolve mdx Specimen Requirements and Patient Eligibility

Mr. Koen Hoffman

Chairman and Independent Director, representing Ahok BV

Koen Hoffman has served as Independent Chairman of the Board of Directors of Fagron NV since May 8, 2017. He obtained a Master in Applied Economics at the University of Ghent in 1990 and a Master in Business Administration at Vlerick Business School in Ghent in 1991. Mr. Hoffman was appointed Chief Executive Officer of Value Square in August 2016. Prior to joining Value Square, he was Chief Executive Officer of KBC Securities, member of the supervisory board of Patria Securities and member of the board of directors of Omnia Travel Belgium. He started his career at the corporate finance department of KBC Bank in 1992.

Hilde Windels

Independent Director, representing Hilde Windels BVBA

Ms. Windels 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. At Biocartis, she was CEO and interim and Deputy CEO from September 2015 until September 2017 and CFO from 2011 until September 2015. Previously, Mrs. Windels worked as an independent CFO for several private biotech companies, and from 1999 to 2008 she was CFO of Devgen. Currently, Mrs. Windels is a consultant in the life sciences industry and serves as a board member at Erytech, Celyad and GIMV. 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.

Understanding your GPS results

Deciding the most appropriate course of treatment for your prostate cancer is important. Your GPS result may help.

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 personal GPS result and risk category

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.

Current and future risk

These results can predict both your chance of:

Dying from prostate cancer and
Your cancer spreading (metastasis) in the next 10 years

Personalized assessment for individualized treatment

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

Understand your test results

Deciding between active surveillance and immediate treatment for your prostate cancer is important. Your GPS result may help.

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 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.

Current and future risk

These results can predict both your chance of:

Your cancer spreading (metastasis) and
Dying from prostate cancer in the next 10 years

Personalized assessment for individualized treatment

Additional pathology endpoints (provided for men with Gleason score 3+4)

Adverse Pathology predicts the probability your doctor would find more aggressive disease than expected from your biopsy. This helps your doctor know if you are a candidate for active surveillance or if immediate treatment is most appropriate for you.
High-Grade Disease shows the likelihood that cancer cells within your tumor are abnormal when compared to typical cells.
Non–Organ-Confined Disease indicates the likelihood that your cancer has already spread outside your prostate.

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

How to Order Select mdx

United States

To order Select mdx urine transport kits or test requisition forms:
Order Supplies Online
Call: 866.259.5644
Email: client.services@mdxhealth.com
Once urine transport kits are received, complete the Select mdx’s test requisition form in its entirety.
Carefully follow the steps in the enclosed Instructions For Use to collect the urine specimen.
Send completed test request form along with the sealed urine transportation kit to: 15279 Alton Parkway, Suite 100, Irvine, CA 92618

Schedule FedEx Pick Up
View and Download Select mdx Test Requisition Form (TRF)
View and Download Urine Collection and Preparation Instructions
View and Download Specimen Requirements and Patient Eligibility

Europe

To order Select mdx urine transportation kits contact MDxHealth at +31 (0) 88 327 2727 or email clientservices.eu@mdxhealth.com.
Once urine transportation kits are received, please fill out the Select mdx test request form in its entirety.
Carefully follow the instructions for use to collect the urine specimen.
Place the completed test request form and urine specimen inside the Select mdx urine transportation kit. Follow the instructions on the kit to contact your local DHL office and arrange the return shipment to the mdxhealth laboratory.

View and Download Test Request Form DE | EN | ES | FR | IT | NL | PL
View and Download Select mdx Instructions for Use
View and Download UrNCollect Instructions for Use

How to Order Confirm mdx

Physician Office

To Order Pre-printed Test Requisition Forms:

Order Supplies Online
Call: 866.259.5644
Email: client.services@mdxhealth.com

View and Download Confirm mdx Test Requisition Form (TRF)
View and Download Confirm mdxSpecimen Requirements and Patient Eligibility

Pathology Laboratory

To order Confirm mdx Tissue Transport Kits:

Order Supplies Online
Call: 866.259.5644
Email: client.services@mdxhealth.com

Test Cancellation Policy

Mdxhealth will honor test cancellation requests any time prior to the start of the analytical testing phase. Test cancellation requests must be submitted from the person authorized to cancel a test, following the instructions below:

Contact Client Services at 866-259-5644 for test cancellation.

A Test Cancellation Form will be sent to the authorized person for signature.

Return the completed and signed Test Cancellation Form by fax to mdxhealth 949-788-0014.

If the cancellation request is received after the specimen has entered in the analytical testing phase, the request cannot be honored and the usual test charge will be assessed.

Lieve Verplancke MD.

Independent Director, representing Qaly-Co BVBA

Lieve Verplancke MD was nominated as an Independent Non-Executive Director at the Company’s Annual General shareholders Meeting held on 26 May 2017 in Diegem, Belgium. Ms. Verplancke, a Belgian national, began her career in 1984 with The Beecham Group (now part of GlaxoSmithKline), and has since held key management positions with Merck & Co., as well as Bristol-Myers Squibb, where she served as Managing Director, leading their Belgian/GDL subsidiary, until 2012. Ms. Verplancke has also served as a Board Member for Brussels-based Europe Hospitals; the Imelda Hospital in Bonheiden; and the Euronext fund, Quest for Growth and Materialise. She is also the Founder and Managing Director of Qaly@Beersel, an elderly care center in Belgium. In addition to being a medical doctor (MD – KULeuven University), Ms. Verplancke holds a postgraduate degree in Economics and an MBA from the University of Antwerp. She has also completed courses at INSEAD, CEDEP, Columbia University and the Vlerick Business School, and is a certified Executive Coach (PCC).

Regine Slagmulder

Independent Director, representing Regine Slagmulder BV

Dr. Regine Slagmulder is a partner and 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 an independent director and chair of the audit committee on the board of the investment company Quest for Growth. (since 2011) and of Ekopak (since 2021), both listed on Euronext. Dr. Slagmulder graduated in civil electrotechnical engineering and industrial management from the University of Ghent, after which she took 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).

Mr. Jan Pensaert

Director, representing Valiance Advisors LLP

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, MyCartis, 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.

Don Hardison

Director

Mr. Hardison 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), Exact Sciences Corporation, Quest Diagnostics Inc., and Smith Kline Beecham Corporation. He currently serves as an independent director on the boards of directors of Stemina Biomarker Discovery, Inc., Seventh Sense Biosystems, BioPorto, Inc. and IQuity, Inc. He also formerly 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.

Eric Bednarski

Director

Dr. Bednarski currently serves as a Partner of MVM Partners LLP. 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.

Michael K. McGarrity

Chief Executive Officer, Director

Mr. McGarrity 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. 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). McGarrity 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. He also had executive general management responsibility for a newly created business unit focused on interventional spine pain management. Michael received a Bachelor of Arts degree from the University of Notre Dame and began his career in commercial banking.

John Bellano

Chief Commercial Officer

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.

Ron Kalfus

Chief Financial Officer

Mr. Ron 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 joins MDxHealth from Rosetta Genomics, where he helped lead efforts to reposition the company for commercial success with its oncology diagnostic products, and raised over $60 million in capital to fund these efforts. Prior to Rosetta, Mr. Kalfus served as the CFO and Treasurer of MabCure, a Belgium-based publicly-traded biotechnology startup in the field of early cancer detection using antibodies.

Miriam Reyes

Executive Vice President of Operations

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.).

Joseph Sollee

Executive Vice President of Corporate Development and General Counsel

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.

Michael K. McGarrity

Chief Executive Officer, Director

Mr. McGarrity 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. 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). McGarrity 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. He also had executive general management responsibility for a newly created business unit focused on interventional spine pain management. Michael received a Bachelor of Arts degree from the University of Notre Dame and began his career in commercial banking.

About

Prostate Cancer

For Physicians

For Patients

Infectious Disease

For Physicians

For Patients

Prostate Cancer (For Physicians)

Prostate Cancer (For Patients)

Infectious Disease (For Physicians)

Infectious Disease (For Patients)

Investors

About

Mission

Leadership

Michael K. McGarrity

Ron Kalfus

John Bellano

Miriam Reyes

Joseph Sollee

Board of Directors

Koen Hoffman

Eric Bednarski, Ph.D.

Don Hardison

Michael K. McGarrity

Jan Pensaert

Regine Slagmulder

Lieve Verplancke MD.

Hilde Windels

Licensure & Accreditations

Clinical Research Network

Our Company

Tests

Investors