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Mdxhealth Adds Hereditary Prostate Cancer Genetic Test to Prostate Cancer Offering

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MDxHealth introduces a hereditary prostate cancer genetic test to its prostate cancer offering, aiming to provide insights into cancer risk, disease progression, and treatment response. The test is non-invasive and uses a simple saliva sample, aligning with NCCN guidelines and covered by Medicare. CEO believes the addition will drive revenue growth in the second half of the year.
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The introduction of MDxHealth's non-invasive genetic prostate cancer test represents a significant advancement in precision diagnostics. This new test aligns with the latest NCCN guidelines, which underscores its clinical relevance. From a research perspective, the ability to assess hereditary risk factors through a non-invasive saliva sample is a leap forward in patient comfort and ease of testing, potentially increasing patient compliance and early detection rates.

Given that prostate cancer has a noted genetic component, this test could facilitate earlier and more personalized treatment strategies. The test's coverage by Medicare and many commercial insurance plans not only makes it accessible to a wider patient population but also indicates a level of clinical acceptance that can drive adoption. For stakeholders, the anticipated contribution to revenue and growth in the second half of the year is a critical point, as it suggests confidence in the test's market potential and its alignment with existing reimbursement structures.

MDxHealth's strategic expansion into hereditary prostate cancer testing could be a catalyst for the company's financial performance. By tapping into the established urology sales channel, MDxHealth leverages existing relationships and infrastructure to promote the new test, which may lead to cost-effective market penetration and quicker revenue realization.

The CEO's statement projects confidence in the test's potential to contribute to the company's growth in the latter half of the year. Investors should note the alignment with clinical guidelines and insurance coverage, which are often predictors of market acceptance and can drive volume. However, it's essential to monitor the actual adoption rate and the competitive landscape, as these factors will ultimately determine the financial impact of the new test offering.

Prostate cancer's status as a leading cause of cancer-related death among men creates a substantial market for diagnostic tests, especially those that offer precision and non-invasive methodologies. MDxHealth's new test could satisfy an unmet need within this market by providing a tool for risk stratification and therapy optimization. The test's non-invasive nature is likely to be well-received by both patients and healthcare providers.

Market growth for genetic testing in cancer is driven by technological advancements and increasing awareness of personalized medicine. MDxHealth's positioning of the test as 'clinically actionable' taps into the trend of actionable health data, which is gaining traction among clinicians. The company's ability to capitalize on this trend will depend on its marketing strategy and the effectiveness of its sales channel in educating and convincing clinicians of the test's benefits.

Mdxhealth Adds Hereditary Prostate Cancer Genetic Test to Prostate Cancer Offering

IRVINE, CA, and HERSTAL, BELGIUM – March 12, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the “Company” or “mdxhealth”), a commercial-stage precision diagnostic company, announces the introduction of a non-invasive genetic prostate cancer test through its urology sales channel.

With a simple saliva sample, the new comprehensive hereditary prostate cancer test offering provides insights into a patient’s risk of developing cancer, disease progression, and response to prostate cancer therapies. Germline testing of prostate cancer patients is recommended in the National Comprehensive Cancer Network (NCCN) guidelines and is covered by Medicare and many commercial insurance plans, for eligible patients.

Michael K. McGarrity, CEO of mdxhealth, commented: “The addition of this test to our menu reflects our commitment to delivering clinically actionable precision diagnostics to our urology customer base, providing both clinicians and patients with insights into the diagnosis and treatment of prostate cancer, particularly where genetic factors play a critical role. Given the established clinical guidelines and reimbursement, we believe this portfolio addition will contribute to revenue and growth in the second half of this year.”

Prostate cancer remains a leading cause of cancer-related death among men, with an estimated 288,300 new diagnoses and 34,700 deaths annually. Decades of research indicate that prostate cancer has a strong genetic component with implications to ancestry.

About mdxhealth

Mdxhealth is a commercial-stage precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests are based on proprietary genomic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis and prognosis of urologic cancers and other urologic diseases. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.

For more information:
info@mdxhealth.com

LifeSci Advisors (IR & PR)
US: +1 949 271 9223
ir@mdxhealth.com

This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “potential,” “expect,” “will,” “goal,” “next,” “potential,” “aim,” “explore,” “forward,” “future,” and “believes” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding expected future operating results; expectations for development of new or improved products and services and their impact on patients; our strategies, positioning, resources, capabilities and expectations for future events or performance; and the anticipated benefits of our acquisitions, including estimated synergies and other financial impacts. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, product development efforts, our strategies, positioning, resources, capabilities and expectations for future events or performance. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products; the acceptance of our products and services by healthcare providers; our ability to achieve and maintain adequate levels of coverage or reimbursement for our current and future solutions we commercialize or may seek to commercialize; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; timing, progress and results of our research and development programs; the period over which we estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements; the possibility that the anticipated benefits from our business acquisitions like our acquisition of the Oncotype DX® GPS prostate cancer business will not be realized in full or at all or may take longer to realize than expected; and the amount and nature of competition for our products and services. Other important risks and uncertainties are described in the Risk Factors sections of our most recent Annual Report on Form 20-F and in our other reports filed with the Securities and Exchange Commission. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.

NOTE: The mdxhealth logo, mdxhealth, Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate Score, GPS and Monitor mdx are trademarks or registered trademarks of MDxHealth SA. The GPS test was formerly known as and is frequently referenced in guidelines, coverage policies, reimbursement decisions, manuscripts and other literature as Oncotype DX Prostate, Oncotype DX GPS, Oncotype DX Genomic Prostate Score, and Oncotype Dx Prostate Cancer Assay, among others. The Oncotype DX trademark, and all other trademarks and service marks, are the property of their respective owners.

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FAQ

What new test did MDxHealth add to its prostate cancer offering?

MDxHealth added a hereditary prostate cancer genetic test to its prostate cancer offering.

How does the new genetic test provide insights into prostate cancer?

The test offers insights into a patient's risk of developing cancer, disease progression, and response to prostate cancer therapies.

Is the genetic prostate cancer test invasive?

No, the test is non-invasive and uses a simple saliva sample.

Are prostate cancer patients recommended to undergo germline testing?

Yes, germline testing of prostate cancer patients is recommended in the NCCN guidelines.

Is the genetic test covered by insurance plans?

The genetic test is covered by Medicare and many commercial insurance plans for eligible patients.

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