MDxHealth Stock

MDxHealth SA (MDxHealth), a commercial-stage precision diagnostics company, provides non-invasive, clinically actionable and cost-effective urologic solutions to improve patient care.

The company's novel genomic testing solutions combine advanced clinical modeling with genomic data to provide each patient with a personalized risk profile, which provides more accurate and actionable information than traditional clinical risk factors used by clinicians. The company's Select mdx and Confirm mdx tests address men at risk for undetected prostate cancer, providing physicians with a clear clinical pathway to accurately identify clinically significant prostate cancer while reducing the use of invasive procedures that are prone to complications. The company's GPS test addresses men newly diagnosed with localized prostate cancer, providing physicians with a clear clinical pathway to make the most informed treatment decision for their individual disease. The company's team's collective decades of experience in precision diagnostics and its portfolio of novel biomarkers for diagnostic, prognostic and predictive molecular assays supports its active pipeline of new testing solutions for urologic diseases.

The company's Select mdx and Confirm mdx testing solutions directly address this unmet clinical need. Since the commercial launch of Confirm mdx in 2012 and Select mdx in 2016, the company has performed over 200,000 tests ordered by more than 1,000 urologists in the United States. Select mdx for Prostate Cancer (a urine test for men being considered for their first prostate biopsy) and Confirm mdx for prostate cancer (an epigenetic test for men post-prostate biopsy), are designed to improve the earlier detection of clinically significant prostate cancer in at-risk men and (ii) reduce the unnecessary costs and patient anxiety associated with the diagnosis and treatment of the disease. Both tests have been included in the National Comprehensive Cancer Network (NCCN) Guidelines for the Early Prostate Cancer Detection. NCCN is a non-profit alliance of the 31 leading cancer centers in the United States. Both tests have also successfully completed formal technical assessment review for Medicare reimbursement and have received a positive final local coverage determination (LCD).

While its existing prostate cancer tests, Select mdx and Confirm mdx, improve the decision for biopsy in at-risk patients, the company's recently acquired GPS test moves it further into the cancer management pathway, providing solutions for patients newly diagnosed with localized prostate cancer to make the most informed treatment decision for their individual disease. The company's acquisition of the GPS prostate cancer business in August 2022 from Genomic Health, Inc., a subsidiary of Exact Sciences, has accelerated its plans to build on its leadership in the urologic diagnostic space.

GPS is able to provide a more precise and accurate assessment of disease progression, which helps more men avoid the lifelong complications associated with aggressive treatments. In 2015, the company's GPS test received a positive Medicare LCD under the MolDX Program, which provides coverage and reimbursement for Medicare beneficiaries throughout the United States.

While MDxHealth is domiciled and listed as a public company in Belgium, the company's primary commercial focus is the United States, where over 95% of its tests are performed and revenues are generated. The company's leadership change in 2019 and coincident organizational and operational discipline implemented throughout the MDxHealth group of companies has further focused its commitment to U.S.-sourced growth, with its entire executive management team and over 90% of staff based in or reporting to its U.S. headquarters and laboratories.

The company has established a systematic approach to commercializing its precision diagnostic solutions in its target markets in the United States, focusing on active engagement, education and market development directed toward health care professionals and their patients. The company's commercial team focuses on prioritizing large and high-volume community urology centers, and on building long-standing relationships with key physicians and practice groups who have strong connections to the population of men who may be eligible for its solutions.

Product Portfolio

The company's core commercial tests address a substantial unmet clinical need in the prostate cancer diagnostic and treatment pathway. The company's Select mdx test - which is a noninvasive urine test with 95% Negative Predictive Value (NPV) for clinically significant prostate cancer - can be used to help physicians determine whether a costly, painful and complication-prone needle-core biopsy is advisable when a patient presents with an elevated PSA level or an abnormal digital rectal exam (DRE). For those men who proceed to a biopsy procedure, the company's Confirm mdx test, which measures biomarker signals in the biopsied tissue, provides additional information to physicians and increases the accuracy of the biopsy, with a 96% Negative Predictive Value (NPV) for clinically significant disease.

Upon an initial diagnosis of localized prostate cancer, the company's GPS test - which measures the expression of a panel of genes in prostate cancer tissue to predict the aggressiveness of the disease - can help distinguish between aggressive and indolent prostate cancer, which informs treatment decisions and helps to identify patients who may avoid unnecessary interventions.

To further supplement its prostate cancer menu, with Resolve mdx the company has developed a novel, advanced urinary tract infection (UTI) test that delivers patient-specific antimicrobial treatment options within 24-48 hours (standard urine cultures can take up to 5 to 7 days). Developed especially for patients with recurrent, persistent, and complicated UTIs, Resolve mdx combines precise pathogen identification and resistance gene detection with a proprietary susceptibility methodology that identifies personalized oral antibiotic options for fast resolution and improved patient outcomes.

Strategy

The key elements of the company's strategy are to educate physicians and patients through a variety of channels, including by supporting clinical studies for the publication of peer reviewed journals and abstracts at key scientific conferences, forging relationships with the leading medical and scientific opinion leaders in urology, developing strategic partnerships with leading pathology laboratories with large urology client bases and via public relations and advertising campaigns; expand test menu; and expand reimbursement for its tests.

Pipeline

The company intends to build on its leadership in the urologic diagnostic space by expanding its menu of tests beyond Select mdx, Confirm mdx, GPS and Resolve mdx. The company is developing an additional product for the prostate cancer diagnostic and treatment pathway. AS is a management approach for prostate cancer that involves closely monitoring the cancer's progression through regular tests and imaging, without immediately initiating active treatment such as surgery or radiation therapy.

Men on active surveillance (AS) are monitored using prostate-specific antigen (PSA), MRI and periodic biopsies to determine if their prostate cancer has progressed and whether definitive treatment is necessary. The company is actively analyzing urine and blood biomarker panels with the goal of developing a non-invasive test for monitoring these patients that it calls Monitor mdx. A testing solution that allows a physician to forego or delay their patient's surveillance biopsy would represent a significant business opportunity with little or no direct competition. In the AS setting, Monitor mdx would provide methods to identify and monitor patients who could remain on AS as a treatment option.

Sales and Marketing

The company's sales approach focuses on the clinical and economic benefits of its tests as supported by peer-reviewed literature covering the clinical validation and utility of these tests. The company's sales and marketing team include molecular diagnostic specialists, reimbursement account managers, clinical liaisons and client service personnel. Sales personnel are primarily field based, client service and marketing personnel are primarily based in its California headquarters.

The company's sales team is trained to address the clinical, economic and reimbursement questions associated with selling its tests. The company's sales force focuses on educating its primary and secondary clientele, which consists of urologists and their clinical staff, including nurses, laboratory and pathology personnel, finance administrators and billing personnel, and secondarily the pathology and laboratory staff who fulfil test requests on behalf of their clinician clients. The company's urology sales force consists of direct sales representatives, strategic account managers and regional sales managers.

The company's sales efforts are directed towards increasing adoption and utilization of its tests in clinical practice. The strategy entails working with community-based, large group practices and academic urologists to educate them on the clinical and economic benefits provided by its tests; nurturing and strengthening relationships with key thought leaders in urology; supporting ongoing collaborations with leading universities and research institutions that have generated clinical validation data supporting its tests; and encouraging ongoing exploration and studies of expanded indications for its tests.

Successful penetration of the urology market and clinical adoption of the company's tests has been achieved with a multi-faceted approach to build brand recognition and raise awareness of the tests. The company's efforts and programs include sharing information with leaders in the medical community on a national and regional scale, supporting clinical studies for the publication of peer reviewed journals and abstracts at key scientific conferences, development of tools for its customers to interact with patients and consumers (doctor-to-consumer education), providing support to patient advocacy groups like Prostate Conditions Education Council, developing strategic partnerships with leading pathology laboratories with large urology client bases, participation in industry trade shows and the implementation of public relations, media and advertising campaigns.

Materials Needed for Laboratory Services

In connection with its role as a CLIA-certified provider of laboratory services, the company assists healthcare providers with certain logistics related to the collection and return of samples for testing.

The processing of testing solutions requires items and services, the majority of which are sourced from multiple suppliers. Certain of the consumable supplies and reagents used in the company's testing process are procured from a limited number of suppliers, some of which are single source.

Intellectual Property

As of December 31, 2022, the company owned or had exclusive rights to more than 17 patent families related to its molecular technology and cancer-specific biomarkers. Specifically, there are 116 granted or pending patent applications in this group comprised of 16 issued or allowed U.S. patents, 7 pending U.S. provisional or non-provisional applications, 19 pending international patent applications filed under the PCT and 74 granted or allowed patents in jurisdictions outside the United States, including Japan, Canada, Israel and certain European countries. The company's issued U.S. patents expire at various times between 2024 and 2038. Of these issued patents, 1 covers intellectual property used in its Confirm mdx test, which expires in 2024, 7 cover intellectual property used in its Select mdx test, the last of which expires in 2036, and 52 cover intellectual property used in its GPS test, the last of which expires in 2038.

Collaboration and License Agreements

The company has entered into agreements with universities, medical centers and external researchers for research and development work and for the validation of its technology and products. MDxHealth has collaborated on research and clinical development with a number of the world's leading academic and government cancer research institutes.

In particular, the company is party to an Amended and Restated Exclusive License Agreement with The Johns Hopkins University through which it holds an exclusive license to intellectual property that is used in its Confirm mdx test.

In regard to its developed tests, the company has entered into a range of marketing and sales arrangements with commercial entities. These important relationships provide the company with additional resources and infrastructure to expand the geographic reach and awareness of its solutions. The company's marketing partners include Ferrer Internacional, SouthGenetics, LifeLabs, Helix Laboratories, Laboratory Corporation of America (LabCorp), Inform Diagnostics (InformDx) and Poplar Healthcare.

Government Regulations

Certain of the company's activities are subject to regulatory oversight by CMS pursuant to CLIA, as well as agencies in various states, including New York. The company is subject to many other federal, state and foreign laws, including anti-fraud and abuse, anti-kickback and patient privacy. The company is subject to numerous federal and state fraud and abuse laws, including the federal False Claims Act. The company's commercialization activities subject it to regulations of the Department of Transportation, the U.S. Postal Service, and the Centers for Disease Control and Prevention that apply to the surface and air transportation of clinical laboratory specimens. The company's U.S. laboratory facilities in Irvine, California and Plano, Texas are certified under CLIA. As a clinical laboratory that engages in HIPAA-covered standard transactions, the company is a Covered Entity subject to regulation under HIPAA. The company is required to comply with international personal data protection laws and regulations, including the European Union's General Data Protection Regulation (GDPR). As a CLIA-certified laboratory, the company offers its Select mdx and Confirm mdx testing services as LDTs.

Research and Development

The company's research and development costs for the year ended December 31, 2022, amounted to $7.6 million.

Trademarks and Service Marks

The company owns various trademark registrations and applications, and unregistered trademarks and service marks. MDxHealth, Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate Score, GPS, Monitor mdx, the MDxHealth logo and other trademarks or service marks of MDxHealth SA.

History

The company was founded in 2003. It was incorporated in Belgium in 2003. The company was formerly known as OncoMethylome Sciences SA and changed its name to MDxHealth SA in 2010.