MDxHealth (R): MDxHealth Announces Favorable Draft Medicare Coverage for the SelectMDx Test
26 Août 2019 - 07:00AM
IRVINE, CA – August 26, 2019 –
MDxHealth SA (Euronext: MDXH.BR), a commercial-stage
innovative molecular diagnostics company, today announced that
Palmetto GBA, a Medicare Administrative Contractor (MAC) that
assesses molecular diagnostic technologies under its MolDx program,
has issued a draft local coverage determination (LCD) for the
SelectMDx® for Prostate Cancer test. The draft LCD recommends
coverage of the test for qualified Medicare patients throughout the
United States.
“We are pleased that Medicare has taken this
important step toward providing coverage for SelectMDx — a test
that can help improve the disposition of men at risk for aggressive
prostate cancer,” stated Michael McGarrity, CEO of MDxHealth. “It
is a vital step toward ensuring all Medicare patients will have
access to the highest quality and accurate prostate cancer risk
assessment.” The company will provide further comment in its
Mid-Year 2019 Results scheduled for August 29, 2019.
The proposed LCD policy can be accessed on the
CMS website.
About SelectMDx® for Prostate Cancer
Of the nearly 2 million prostate biopsies
performed each year, less than a third identify cancer. Most of
these men could have avoided a painful and invasive prostate biopsy
procedure, with its associated complications and costs. SelectMDx
for Prostate Cancer is a proprietary urine-based, molecular
diagnostic test that offers a non-invasive liquid biopsy method to
assess a patient’s risk for prostate cancer. SelectMDx helps
identify men at increased risk of harboring aggressive, potentially
lethal, prostate cancer who may benefit most from a prostate biopsy
and earlier detection. The test delivers a negative predictive
value (NPV) of 95% for clinically significant disease, helping to
reduce the need for invasive prostate biopsies, thereby reducing
healthcare costs. The test has been included in the 2018 European
Association of Urology (EAU) clinical guidelines.
About MDxHealth
MDxHealth is a multinational healthcare company
that provides actionable molecular diagnostic information to
personalize the diagnosis and treatment of cancer. The Company's
tests are based on proprietary genetic, epigenetic (methylation)
and other molecular technologies and assist physicians with the
diagnosis of urologic cancers, prognosis of recurrence risk, and
prediction of response to a specific therapy. The Company’s
European headquarters are in Herstal, Belgium, with laboratory
operations in Nijmegen, The Netherlands, and US headquarters and
laboratory operations based in Irvine, California. 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:
Consilium Strategic Communications (IR & PR)Amber Fennell,
Chris Welsh, Marieke Vermeersch, Nicholas BrownUK: +44 20 3709
5701
mdxhealth@consilium-comms.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.
NOTE: The MDxHealth logo,
MDxHealth, ConfirmMDx, SelectMDx, and UrNCollect are trademarks or
registered trademarks of MDxHealth SA. All other trademarks and
service marks are the property of their respective
owners.
- SelectMDx Medicare LCD Announcement
MDxHealth (EU:MDXH)
Graphique Historique de l'Action
De Fév 2024 à Mar 2024
MDxHealth (EU:MDXH)
Graphique Historique de l'Action
De Mar 2023 à Mar 2024