MDxHealth's MGMT Test Included in NCCN Guidelines and Awarded Tier 1
Reimbursement Code by AMA
MGMT Test Successfully Identifies Glioblastoma Patients Most Likely to Respond
to Treatment in Clinical Validation Study
IRVINE, Calif. and HERSTAL, Belgium, Oct. 16, 2013 (GLOBE NEWSWIRE) --
MDxHealth SA (NYSE Euronext:MDXH), a leading molecular diagnostic company that
develops and commercializes epigenetic tests to improve the diagnosis and
treatment of cancer patients, today announced that the company's MGMT
(O6-methylguanine-DNA methyl transferase) test, PredictMDx(TM) for
Glioblastoma, used to identify patients most likely to respond to targeted
therapy, has been included in the 2013 National Comprehensive Cancer Network
(NCCN) Guidelines. The NCCN is an alliance of 23 world-leading cancer centers.
The new guidelines are published online at www.nccn.org.
The American Medical Association (AMA) has also awarded the PredictMDx for
Glioblastoma test with Tier 1 reimbursement code. The AMA Current Procedural
Terminology (CPT®) Editorial Panel awarded a Tier 1 Code, 81287, to MGMT
methylation analysis following an application from MDxHealth. Tier 1 codes are
assigned to report gene-specific and genomic procedures and are considered
category 1 codes.
"We are extremely pleased with the clinical support for our MGMT test.
Acceptance into the NCCN treatment guidelines establishes the test within the
"standard of care" for the improved management of glioblastoma patients, and
the award of the Tier 1 CPT code by the AMA provides a clear basis for
comprehensive reimbursement," stated Dr. Jan Groen, CEO of MDxHealth. "In
addition, the clinical validation study for MGMT, branded PredictMDx for
Glioblastoma, and the accompanying peer-reviewed publication of the data,
further demonstrate the clinical importance and validity of the MGMT test for
treatment decision making."
In the international prognostic Phase III (RTOG 0525) validation study,
published in the Journal of Clinical Oncology (10.1200/JCO.2013.49.6968*), the
PredictMDx for Glioblastoma test successfully identified newly diagnosed
glioblastoma patients who are more likely to live longer and have a longer
progression free time period following treatment with temozolomide.
"The publication of these results confirms the value of measuring the
methylation status of the MGMT gene in a prospective manner," explained Prof.
Dr. Monika Hegi, PhD, Head Laboratory of Brain Tumor Biology and Genetics,
Neurosurgery, University Hospital Lausanne, Switzerland. "The MDxHealth MGMT
test was successfully carried out prior to patient randomization which allowed
for proper patient stratification. Newly diagnosed grade IV glioblastoma
patients who have a methylated MGMT gene experience a survival and disease
progression benefit from the current standard-of-care treatment. This study
emphasizes the need to test glioblastoma patients for MGMT promoter
methylation as a stratification factor in future clinical studies."
About PredictMDx for Glioblastoma
MDxHealth's PredictMDx for Glioblastoma (MGMT) test provides actionable
information to oncologists seeking to provide personalized treatment of
patients with brain cancer. The test assesses the methylation status of the
MGMT gene, which is crucial to promoting DNA repair. If the MGMT gene is
methylated, cancer patients have shown improved response to alkylating drug
therapy. Studies on thousands of patients have shown that PredictMDx for
Glioblastoma can help identify patients that are likely to respond to the most
commonly used class of brain cancer drugs (alkylating agents).
MDxHealth 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, ConfirmMDx^TM for
Prostate Cancer, has been shown to help distinguish patients who have a
true-negative biopsy from those who may have undetected cancer, thereby aiding
in the reduction of unnecessary repeat biopsies. 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 prostate, brain
and lung cancers. The company is based in Irvine, California with a European
headquarters in Herstal, Belgium. For more information visit MDxHealth's
website at www.mdxhealth.com.
For more information:
Dr. Jan Groen, CEO Mike Sinclair (Media) Matt Clawson
MDxHealth Halsin Partners Allen & Caron, Inc
US: +1 949 812 6979 UK: +44 20 7318 2955 US: +1 949 474 4300
BE: +32 4 364 20 70 Cell:+44 7968 022075
firstname.lastname@example.org email@example.com firstname.lastname@example.org
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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
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control, and may turn out to be materially different. MDxHealth expressly
disclaims any obligation to update any such forward-looking statements in this
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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
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NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx and PredictMDx are trademarks
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