2010 Registration Document: English | Francais
Securities Transactions Note -April 7, 2011: English | Francais
Summary Note – April 7, 2011: English
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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
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.
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, management, and strategic transactions. Mr. Kalfus joined 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. Mr. Kalfus received his Master’s degree in Accounting from Fairleigh Dickinson University and his Bachelor’s degree in Finance from the University of Georgia. Mr. Kalfus is a Certified Public Accountant, licensed in the State of New Jersey.
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.
· Dall’Era MA, Maddala T, Polychronopoulos L, Gallagher JR, Febbo PG, and Denes BS. Utility of the Oncotype DX® Prostate Cancer Assay in Clinical Practice for Treatment Selection in Men Newly Diagnosed with Prostate Cancer: A Retrospective Chart Review Analysis. Urology Practice. 2015;2(6):343-348.
· Eure G, Germany R, Given R, Lu R, Shnidel AW, Rothney M, et al. Use of a 17-Gene Prognostic Assay in Contemporary Urologic Practice: Results of an Interim Analysis in an Observational Cohort. Urology. 2017;107:67-75.
· Lynch JA, Rothney MP, Salup RR, Ercole CE, Mathur SC, Duchene DA, et al. Improving Risk Stratification Among Veterans Diagnosed With Prostate Cancer: Impact of the 17-Gene Genomic Prostate Score Assay. Am J Manag Care. 2017;24(1 Suppl):S4-S10.
· Murphy AB, Abern MR, Liu L, Wang H, Hollowell CMP, Sharifi R, Vidal P, et al. Impact of a Genomic Test on Treatment Decision in a Predominantly African American Population With Favorable-Risk Prostate Cancer: A Randomized Trial. J Clin Oncol. 2021;39(15):1660-1670.
· Brooks MA, Thomas L, Magi-Galluzzi C, Li J, Crager MR, Lu R et al. Validating the association of adverse pathology with distant metastasis and prostate cancer mortality 20-years after radical prostatectomy. Urol Oncol. 2022;40(3):104.e1-104.e7.
· Covas Moschovas M, Chew C, Bhat S, Sandri M, Rogers T, Dell’Oglio P, et al. Association Between Oncotype DX Genomic Prostate Score and Adverse Tumor Pathology After Radical Prostatectomy. Eur Urol Focus. 2022;8(2):418-424.
· Cullen J, Rosner IL, Brand TC, Zhang N, Tsiatis AC, Moncur J, et al. A biopsy-based 17-gene genomic prostate score predicts recurrence after radical prostatectomy and adverse surgical pathology in a racially diverse population of men with clinically low- and intermediate-risk prostate cancer. Eur Urol. 2015;69(1):123-131.
· Cullen J, Kuo HC, Shan J, Aboushwareb T, and 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.
· Cullen J, Lynch JA, Klein EA, Van Den Eeden SK, Carroll PR, Mohler JL, et al. Multicenter Comparison of 17-Gene Genomic Prostate Score as a Predictor of Outcomes in African American and Caucasian American Men with Clinically Localized Prostate Cancer. J Urol. 2021;205(4):1047-1054.
· Eggener S, Karsh LI, Richardson T, Shindel AW, Lu R, Rosenberg A et al. A 17-gene panel for prediction of adverse prostate cancer pathologic features: prospective clinical validation and utility. Urology. 2019;126:76-82.
· Helfand BT, Paterakos M, Wang CH, Talaty P, Abran J, Bennett J et al. The 17-gene Genomic Prostate Score assay as a predictor of biochemical recurrence in men with intermediate and high-risk prostate cancer. PLoS One. 2022;17(9):e0273782.
· Janes JL, Boyer MJ, Bennett JP, Thomas VM, De Hoedt AM, Edwards DK, et al. Prognostic for outcomes after primary external beam radiation therapy in men with clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2023;115(1):120-131.
· Klein EA, Cooperberg MR, Magi-Galluzzi C, Simko JP, Falzarano SM, Maddala T 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.
· Kornberg Z, Cowan JE, Westphalen AC, Cooperberg MR, Chan JM, Zhao S, et al. Genomic prostate score, PI-RADS version 2 and progression in men with prostate cancer on active surveillance. J Urol. 2019;201:300-307.
· Leapman MS, Westphalen AC, Ameli N, Lawrence HJ, Febbo PG, Cooperberg M, et al. Association between a 17-gene genomic prostate score and multi-parametric prostate MRI in men with low and intermediate-risk prostate cancer. PLoS One. 2017;12(10):e0185535.
· Lin D, Zheng Y, McKenney JK, Brown MD, Lu R, Crager M, et al. 17-gene genomic prostate score test results in the Canary Prostate Active Surveillance Study (PASS) cohort. J Clin Oncol. 2020;38(14):1549-1557.
· Magi-Galluzzi C, Isharwal S, Falzarano SM, Tsiatis A, Dee A, Maddala T et al. The 17-gene genomic prostate score assay predicts outcomes after radical prostatectomy independent of PTEN status. Urology. 2018;121:132-138.
· Murphy AB, Carbunaru S, Nettey OS, Gornbein C, Dixon MA, Macias V, et al. A 17-Gene Panel Genomic Prostate Score Has Similar Predictive Accuracy for Adverse Pathology at Radical Prostatectomy in African American and European American Men. Urology. 2020; 142:166-173.
· Salmasi A, Said J, Shindel AW, Khoshnoodi P, Felker ER, Sisk Jr AE et al. A 17-gene Genomic Prostate Score assay provides independent information on adverse pathology in the setting of combined multiparametric magnetic resonance fusion-targeted and systematic prostate biopsy. J Urol. 2018;200(3):564-572.
· Van Den Eeden SK, Lu R, Zhang N, Queensberry Jr CP, Shan J, Han JS, et al. A biopsy-based 17-gene genomic prostate score as a predictor of metastases and prostate cancer death in surgically treated men with clinically localized disease. Eur Urol. 2017;73(1):129-138.
· Brand TC, Zhang N, Crager MR, Maddala T, Dee A, Sesterhenn IA, et al. Patient-specific meta-analysis of 2 clinical validation studies to predict pathologic outcomes in prostate cancer using the 17-gene Genomic Prostate Score. Urology. 2016;89:69-75.
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.
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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.
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.
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 bell curve illustrates where your GPS result falls in relation to the GPS results of other men in the same risk category.
DOWNLOAD SAMPLE REPORT OVERVIEW FOR CLINICALLY LOW-RISK PROSTATE CANCER
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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 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).
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. 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.
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.
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.
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.
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. 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.