Full Press Release Details
NEWS RELEASE - INSIDE INFORMATION
April 19, 2023, 4:00PM EDT / 22:00 CET
Foundational LCD Covers Select mdx for Prostate
IRVINE, CA, and HERSTAL, BELGIUM - April
19, 2023 - MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial-stage precision diagnostics
company, received notice that its Select mdx for Prostate Cancer test has successfully completed a rigorous technical assessment process
with the Molecular Diagnostics Services (MolDX) Program developed by Palmetto GBA. Select mdx will be reimbursed throughout the U.S. for
Medicare patients who meet coverage conditions under the foundational Local Coverage Determination (LCD) for Molecular Biomarkers
to Risk-Stratify Patients at Increased Risk for Prostate Cancer.
Michael K. McGarrity, CEO of mdxhealth, commented:
"We are pleased to report this very positive and important development for mdxhealth. The quality of our clinical data for the Select
mdx test, strong adoption from our urology customer base and inclusion in the NCCN Guidelines all reflect this positive reimbursement
decision that now provides coverage for Medicare patients. We look forward to expanding the availability of our test to current and new
customers and to patients entering the diagnostic pathway of prostate cancer. We believe our pre-biopsy Select mdx test, coupled with
our post-biopsy Confirm mdx and Genomic Prostate Score (formerly Oncotype DX GPS) tests, provides the most comprehensive and clinically
actionable pathway for urologists and patients."
Select mdx for Prostate Cancer is a proprietary urine-based
mRNA test that offers a non-invasive method to assess a patient's risk for clinically significant prostate cancer. Select mdx helps
identify men at increased risk for undetected aggressive, potentially lethal, prostate cancer who may benefit most from a prostate biopsy
and earlier detection. The test delivers a negative predictive value of 95% for clinically significant disease, helping to reduce the
need for MRI procedures and invasive prostate biopsies, thereby reducing healthcare costs. The test has been included in the Early Detection
for Prostate Cancer National Comprehensive Cancer Network (NCCN) clinical guidelines.
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. The Company's U.S. headquarters and laboratory operations are in Irvine, California,
with additional laboratory operations in Plano, Texas. European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen,
and linkedin.com/company/mdxhealth.
For more information:
| mdxhealth 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 the acquisition of Oncotype DX GPS prostate cancer business
from Exact Sciences including statements regarding the anticipated benefits of the acquisition; statements regarding expected future operating
results; statements regarding product development efforts; and statements regarding our strategies, positioning, resources, capabilities
and expectations for future events or performance. 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: uncertainties associated with the coronavirus (COVID-19) pandemic, including its possible effects on our
operations, and the demand for our products; our ability to successfully and profitably market our products; the acceptance of our products
and services by healthcare providers; 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; 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.