Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 16,408.54 -16.31 -0.10%
S&P 500 1,864.85 2.54 0.14%
NASDAQ 4,095.52 9.29 0.23%
Ticker Volume Price Price Delta
STOXX 50 3,155.81 16.55 0.53%
FTSE 100 6,625.25 41.08 0.62%
DAX 9,409.71 91.89 0.99%
Ticker Volume Price Price Delta
NIKKEI 14,516.27 98.74 0.68%
TOPIX 1,173.37 6.78 0.58%
HANG SENG 22,760.24 64.23 0.28%

MDxHealth's ConfirmMDx(R) Meets All Primary Endpoints in Blinded U.S. Clinical Validation Study



MDxHealth's ConfirmMDx(R) Meets All Primary Endpoints in Blinded U.S. Clinical
Validation Study

IRVINE, Calif. and HERSTAL, Belgium, Oct. 7, 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 its ConfirmMDx for Prostate
Cancer test met all of the primary endpoints in the recently completed
multicenter, blinded DOCUMENT (Detection of Cancer Using Methylated Events in
Negative Tissue) clinical validation trial. Preliminary analysis of data
verifies the test's high negative predictive value (NPV) for ruling out the
presence of prostate cancer and is a significant, independent predictor of
risk for men being considered for repeat biopsy.

"This validation study confirms the high negative predictive value of the
ConfirmMDx test in a U.S. population," says Wim van Criekinge, Ph.D.,
Professor at The University of Ghent and Chief Scientific Officer for
MDxHealth. "The clinical utility of this test lies in its ability to reduce
unnecessary repeat biopsies, improving patient care and optimizing limited
healthcare resources."

ConfirmMDx for Prostate Cancer is a non-invasive test performed on the
residual prostate tissues from the previous negative biopsy, providing
critical epigenetic insights beyond histopathology alone, to enable more
informed patient management decisions. The multicenter DOCUMENT study was
conducted at five major U.S. urologic centers. The study involved analyzing
tissue from initial negative biopsies and comparing assay results to cancer
detection in subsequent biopsies within 24 months. ConfirmMDx for Prostate
Cancer was used to analyze the epigenetic profile of prostate biopsy cores
from 350 men screened by PSA. Results from the DOCUMENT study will be
published after full analysis of the data is completed.

"We are extremely pleased with these results, demonstrating that ConfirmMDx
for Prostate Cancer validates as a significant, independent predictor for the
presence of prostate cancer in a repeat biopsy," said Dr. Jan Groen, CEO of
MDxHealth. "These findings are consistent with the results from our earlier
European clinical validation study that demonstrated a NPV of 90% (95% CI,
86-94%)".

About ConfirmMDx for Prostate Cancer

Over 975,000 American men are diagnosed with a negative prostate biopsy each
year; however approximately 25-35% of those men receive false-negative
results. Under the current standard of care, prostate biopsy procedures
consisting of 10-12 needle biopsy cores only sample approximately 1% of a
man's prostate. This approach leaves men at risk of occult cancer, leading to
a high rate of repeat biopsies, often on cancer-free men.  There is an unmet
medical need for a clinically effective diagnostic test to address this
dilemma.  ConfirmMDx for Prostate Cancer is able to detect an epigenetic field
effect or 'halo' associated with the cancerization process at the DNA level.
This "halo" around a cancer lesion can be present despite cells having a
normal appearance under the microscope. Thus ConfirmMDx for Prostate Cancer
aids urologists in identifying truly negative men who may forego an
unnecessary repeat biopsy procedure.

About MDxHealth

MDxHealth is a leading molecular diagnostic company that develops and
commercializes epigenetic tests to support cancer treatment. The company's
tests are based on proprietary gene methylation (epigenetics) technology and
assist physicians with the diagnosis of cancer, prognosis of recurrence risk,
and prediction of response to a specific therapy. For more information visit
mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.

For more information:

Dr. Jan Groen, CEO   Mike Sinclair          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    
info@mdxhealth.com   msinclair@halsin.com   matt@allencaron.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 and PredictMDx are trademarks
or registered trademarks of MDxHealth SA. All other trademarks and service
marks are the property of their respective owners.

To access the PDF version, please click here:
http://hugin.info/137314/R/1733659/580522.pdf
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement