MDxHealth SA, a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer diagnosis and treatment, today announced the publication of results from a health economic study in the Journal of American Health & Drug Benefits. The budget impact analysis demonstrated achievable cost savings of MDxHealth's ConfirmMDx™ for Prostate Cancer test, which is used by urologists to identify men who may avoid unnecessary repeat prostate biopsies, thereby reducing overall healthcare spending.
The analysis projected the benefits, costs, and cost savings of the ConfirmMDx for Prostate Cancer test based on empirical evidence of its clinical effectiveness compared to a standard of care reference scenario not using the assay. The goal was to quantify the impact on costs by avoiding medically unnecessary repeat prostate biopsy procedures for a managed care plan of one million members that reimburses for the ConfirmMDx for Prostate Cancer test. A budget impact model was built to test the hypothesis that the ConfirmMDx for Prostate Cancer test can produce cost savings to payers as well as benefits to urologists and patients by providing actionable guidance to treat with more appropriate and less costly care.
The analysis demonstrated that a commercial health plan would realize cost savings within the first year of establishing coverage for the ConfirmMDx for Prostate Cancer test. The upfront cost will be recovered based on the savings associated with avoided biopsy procedures and associated complications. Given these assumptions and the costs associated with the current standard of care, the inclusion of the test into the management of men screened for prostate cancer resulted in a net cost savings of $588.00 per patient or budget impact of in a managed care plan of one million members.
"Even with conservative assumptions, our budget impact analysis demonstrates that the ConfirmMDx for Prostate Cancer test can provide economic returns that may generate net cost savings to health plans by reducing unnecessary prostate biopsies, thus improving clinical management and patient outcomes," said lead author Wade Aubry, M.D., Senior Medical Director for Quorum Consulting and Associate Clinical Professor of Medicine at the University of California, San Francisco. "ConfirmMDx demonstrates the exciting potential of personalized medicine. In today's cost-conscious healthcare environment, well-validated molecular tests hold the promise to address not only unmet clinical needs, but also provide health economic benefits."
About Prostate Cancer
Prostate cancer is the most frequent cancer in men worldwide, with one out of six men being diagnosed with prostate cancer in a lifetime. In the United States approximately 19 million men are screened with the PSA test on an annual basis, leading to more than 1.3 million biopsy procedures and about 240,890 newly diagnosed cases.
About ConfirmMDx for Prostate Cancer
Over 650,000 American men receive a negative prostate biopsy result each year; though approximately 25% of these men may still harbor occult prostate cancer. This well-documented risk of undetected cancer, often with clinically significant Gleason scores, leads to a high rate of repeat biopsies with over 40% of men receiving at least one repeat biopsy, and many receiving a 3rd and 4th biopsy. Today's gold standard diagnostic approach is the prostate biopsy procedure, collecting 10-12 needle core biopsy samples, however, this sampling represents less than 1% of the volume of a man's prostate gland. ConfirmMDx for Prostate Cancer is an epigenetic assay to help urologists distinguish patients who have a true-negative biopsy from those at risk for occult cancer. The test is able to detect an epigenetic field effect or "halo" associated with the cancerization process at the DNA level in cells adjacent to cancer foci. This molecular "halo" around a cancer lesion can be present despite having a normal appearance under the microscope. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and, helps rule in high risk patients who may require repeat biopsies and potential treatment.
MDxHealth (mdxhealth.com) is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. The company's first commercial product, the ConfirmMDx for Prostate Cancer test, has been shown to help distinguish patients who have a true-negative biopsy from those who may have occult cancer. MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. The company has a proprietary platform and a strong epigenetic product pipeline focused on the development of products for brain and lung cancers. The company is based in Irvine, California with a European headquarters in Liege, Belgium.
Mike Sinclair, Halsin Partners
T: +44 20 7318 2955 / C: +44 7968 022075 - E: msinclair[.]halsin.com
Seth Lewis, The Trout Group
T: +1 646 378 2952 - E: slewis[.]troutgroup.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. 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. 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.
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