GeneNews Adds Blood Test for Breast Cancer Prediction to

GeneNews Adds Blood Test for Breast Cancer Prediction to
Innovative Diagnostic Laboratory’s Offering Menu
TORONTO, CANADA (October 14, 2014): GeneNews Limited (TSX:GEN) (“GeneNews” or the
“Company”) today announced that it has in-licensed two biomarker assays - sphingotest® pro-NT
and sphingotest® pro-ENK – that aid physicians in identifying those females at highest risk for
breast cancer in the general population. Both tests were developed by sphingotec GmbH, a
Germany-based company best known for discovery and development of biomarker assays, which
has recently expanded in the U.S.
GeneNews expects to add sphingotest® pro-NT to the menu of advanced cancer assays offered
by its U.S. joint venture, Innovative Diagnostic Laboratory LLP ("IDL”) in early 2015. The
Company is also evaluating the potential expansion of IDL’s testing menu in the area of breast
cancer risk prediction through the addition of sphingotest® pro-ENK and other biomarker
candidates.
Breast cancer is the second leading cause of cancer death in U.S. women, exceeded only by
lung cancer. The American Cancer Society estimates that approximately 232,670 new cases of
invasive breast cancer will be diagnosed in women, and approximately 40,000 women will die
from the disease, in 2014. Like with most cancers, early identification of high risk patients and
intervention are the keys to improved clinical decision making. Most breast cancer cases are not
due to genetic inheritance. Accordingly, it is important to take a “multi-view” approach to properly
stratify women at the greatest risk.
Unlike other blood tests on the market that look for genetic indicators for breast cancer,
sphingotest® pro-NT is a simple blood test for the determination of proneurotensin (pro-NT).
sphingotest® pro-NT detects the release of the satiety hormone neurotensin and is applicable to
all female individuals, regardless of genetic predispositions. A study published in the peerreviewed Journal of the American Medical Association (“JAMA”) in October 2012 demonstrated
that the determination of proneurotensin levels offered a substantial advantage in prediction of
breast cancer (O. Melander et al, Plasma Pro-Neurotensin Independently Predicts
Cardiometabolic Diseases, Breast Cancer, and Death In Women, Journal of the American
Medical Association, Vol. 308, No. 14, pp. 1469- 1475).
Alan S. Maisel, MD, a Professor of Medicine at University of California San Diego and Director,
Coronary Care Unit and Heart Failure Program at the Veterans Affairs San Diego Healthcare
System, commented, “It is exciting to see that inexpensive, blood-based protein biomarkers are
now available for detecting women who are at high-risk for breast cancer, even when the family
history is completely negative."
Max S. Wicha, MD, a Distinguished Professor of Oncology and Director of the University of
Michigan Comprehensive Care Center, said, “Breast cancer risk prediction is a major
advancement for science because it’s one of the main ways we can detect and treat high risk
individuals appropriately; this could be the future of lowering the incidence of breast cancer.”
“We are excited to sign this agreement with GeneNews, especially during Breast Cancer
Awareness Month,” commented Dr. Andreas Bergmann, Founder and Managing Director of
sphingotec GmbH. “Our cooperation will allow sphingotec’s markers to be available to potentially
millions of women in the U.S. It is our common goal to lower the incidence of breast cancer by
providing breast cancer risk tests that are reliable, cost-effective and accessible for patients at
risk for breast cancer.”
GeneNews is committed to helping IDL become a leader in molecular diagnostics and
personalized medicine, serving as a strong commercialization outlet for advanced cancer tests.
Taking a multi-view approach to the diagnosis and treatment of cancer, IDL is working to
assemble, through a combination of internal pipeline development, third-party licenses and
potential acquisitions, a robust menu of novel, patent-protected cancer assays to be offered by it
throughout the United States.
“This is the third new, innovative advanced cancer assay added to our offering menu beyond
ColonSentry®,” said GeneNews’ Executive Chairman, James R. Howard-Tripp. “We believe
sphingotest® pro-NT represents a major step forward in breast cancer detection and
management, and we are looking forward to making it available to U.S. physicians nationwide
through IDL as soon as possible.”
About Proneurotensin/Neurotensin
Neurotensin is a satiety hormone, released in gastrointestinal tract. The major stimulus for
neurotensin production is fat. Breast cancer cell growth is stimulated by neurotensin. Since
neurotensin is a very unstable peptide, sphingotest® pro-NT uses the stable precursor hormone
proneurotensin as a surrogate biomarker for neurotensin. High levels of proneurotensin
correspond with a three-fold risk of developing breast cancer or a recurrence of breast cancer.
Proneurotensin is the subject of several ongoing U.S.- and European-based studies. The goal of
further investigations is the discovery of appropriate interventions (e.g. a low-fat diet) in females
at high risk.
About sphingotec GmbH
The biotechnology company sphingotec GmbH, headquartered in Hennigsdorf, Germany, was
founded in 2002. sphingotec GmbH aims to develop diagnostic methods for prediction,
prevention, intervention strategies and early treatment of diseases in the fields of cancer,
cardiovascular diseases and kidney function. Using biomarkers to indicate susceptibility for a
specific disease provides individuals with knowledge that they are at risk. The biomarkers
therefore create a starting point where intervention strategies can be employed as evidencebased recommendations on how to reduce risks are always an integral part of the complete
concept. Further information can be found on our website www.sphingotec.de.
About GeneNews
GeneNews is a company focused on developing and commercializing proprietary molecular
diagnostic tests for the early detection of diseases and personalized health management, with a
primary focus on cancer-related indications. GeneNews' first product, ColonSentry®, is the
world's first blood test to assess an individual's current risk for colorectal cancer. GeneNews’
common shares trade on the Toronto Stock Exchange under the symbol 'GEN'. More information
on GeneNews and IDL, can be found at www.GeneNews.com and www.myinnovativelab.com.
Forward-Looking Statements
This press release contains forward-looking statements, which reflect the Company's current
expectations regarding future events. The forward-looking statements involve risks and
uncertainties. Actual events could differ materially from those projected herein. Investors should
consult the Company's ongoing quarterly filings and annual reports for additional information on
risks and uncertainties relating to these forward-looking statements. The reader is cautioned not
to rely on these forward-looking statements. The Company disclaims any obligation to update
these forward-looking statements.
Company Contact:
James R. Howard-Tripp
Executive Chairman
Office: (905) 739-2030
jhoward-tripp@genenews.com
Investor & Media Contact:
Stephen Kilmer
Kilmer Lucas Inc.
Office: (212) 618-6347
Mobile: (905) 906-6908
stephen@kilmerlucas.com