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GeneNews Launches Blood-Based, Biomarker Test for Breast Cancer Risk Assessment
Date:3/29/2017

TORONTO, March 29, 2017 /PRNewswire/ - GeneNews Limited (TSX:GEN) ("GeneNews" or the "Company") announced today the launch of BreastSentry™, a new risk stratification test for breast cancer, via its Virginia-based clinical reference lab, Innovative Diagnostics Laboratory ("IDL"). BreastSentry incorporates a blood-based biomarker test with a sophisticated algorithm to determine a woman's five-year and lifetime risk for developing breast cancer.  

BreastSentry measures the fasting plasma levels of two biomarkers in the blood, proneurotensin ("pro-NT") and proenkephalin ("pro-ENK"), which are highly predictive of a woman's risk for developing breast cancer. Various longitudinal clinical studies have shown that elevated levels of pro-NT and decreased levels of pro-ENK are strong, independent risk factors for the development of breast cancer.1-17 In addition, BreastSentry measures seven key risk factors, based on the Gail Model, for developing breast cancer to provide an additional level of personal data into the risk stratification algorithm to create an enriched, personalized score. The Gail Model is a statistical breast cancer risk assessment algorithm designed by scientists at the U.S. National Cancer Institute and the National Surgical Adjuvant Breast and Bowel Project to estimate a woman's risk of developing invasive breast cancer.

BreastSentry is intended for use in average risk women who have no family history of breast cancer. However, it is especially suited for the approximate 50% of women who have dense breasts and, therefore, require further risk stratification where mammography leaves off. Elevated risk scores can help physicians determine if further screening with 3D Tomography, Screening Breast Ultrasound and/or MRI are necessary. Women with elevated risk scores are also encouraged to adopt lifestyle changes in diet and exercise to reduce risk moving forward.

"We are excited to make this test available to women throughout the U.S. who are concerned with their risk for developing breast cancer, especially those 50% of U.S. women with dense breast tissue, who cannot rely on mammography alone to determine if they currently have the disease," said James Howard-Tripp, Chairman and CEO of GeneNews.

Approximately two-thirds of pre-menopausal and one-quarter of post-menopausal women have dense breast tissue, which makes it challenging to detect breast cancer by mammography alone.6 High breast density, as seen on a mammogram, is linked to an increased risk of breast cancer. Women with heterogeneously (40%) and extremely dense breast (10%) tissue are four-to-five times more likely to develop breast cancer than women with low breast density.18,19

The American Cancer Society suggests women with dense breasts talk to their health care providers about whether they should consider adding MRI and/or Ultrasound to their annual mammography screening.20  To help physicians determine what comes next following either an elevated or normal BreastSentry test score, GeneNews and IDL have also developed a BreastSentry Patient Advocacy Protocol.

"This is a significant breakthrough for women with dense breasts," commented Dr. Belinda Barclay-White, founder and medical director of Arizona Breastnet, a full service diagnostic breast center. "Any additional information that can be added to a patient profile to determine ongoing risk for developing breast cancer is very much needed to help physicians, radiologists and patients determine what the next course of action should be." 

About GeneNews

GeneNews is committed to becoming a leader in advanced diagnostics and personalized medicine, serving as a strong commercialization outlet for early detection of cancer and other chronic diseases. Our mission is to identify, assess and make commercially available a comprehensive menu of diagnostics that provide physicians and patients with personalized clinical intelligence and actionable information to improve health out-comes through the early diagnosis of disease.  Our Richmond, Virginia-based Innovative Diagnostic Laboratory clinical reference lab specializes in traditional and advanced clinical evidence-based blood testing that helps find, understand, and address cancer risk in patient populations. Currently, IDL offers risk assessment blood tests for four major cancer types - colon, lung, prostate and breast. GeneNews' common shares trade on the Toronto Stock Exchange under the symbol 'GEN'. More information on GeneNews can be found at www.GeneNews.com.

Forward-Looking Statements

This press release contains forward-looking statements identified by words such as "expects", "will" and similar expressions, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties that could cause the Company's actual events to 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, except as required by law. 

References

1.        Melander O. et al., Plasma Proneurotensin and Incidence of Diabetes, Cardiovascular Disease, Breast Cancer, and Mortality, JAMA (Journal of the American Medical Association). October 10, 2012, Issue 308, 14, P. 1469-75.
2.        Melander O, et al., Validation of plasma proneurotensin as a novel biomarker for the prediction of incident breast cancer, Cancer Epidemiol Biomarkers Prev. August, 2014; 238 : P. 1672-6.
3.        Ernst, A, et al., Proneurotensin 1-117, a stable neurotensin precursor fragment identified in human circulation. Peptides. July, 2006, Issue 27, 7, P. 1787-93.
4.        Dupouy S, et al., The Neurotensin Receptor-1 Pathway Contributes to Human Ductal Breast Cancer Progression. PLoS ONE. 2009;41: e4223
5.        Souazé F, et al., Expression of Neurotensin and NT1 Receptor in Human Breast Cancer: A Potential Role in Tumor Progression. Cancer Res. June 15, 2006;6612: 6243-9.
6.        Carraway, R. et al., Involvement of neurotensin in cancer growth: Evidence, mechanisms and development of diagnostic tools. Peptides. October, 2006;2710: 2445-60.
7.        Devader, C. et al, The Anti-Apoptotic Role of Neurotensin. Cells. March, 2013; 21:
8.        Go, V. et al, Role of nutrients in the gastrointestinal release of immunoreactive neurotensin, Peptides. 1981;2 Suppl 2: 267-9.
9.        Dupouy S, et al, The potential use of the neurotensin high affinity receptor 1 as a biomarker for cancer progression and as a component of personalized medicine in selective cancers. Biochimie. 2011 Sep;939:1369-78. doi: 10.1016/j.biochi.2011.04.024. Epub 2011 May 17.
10.     Somai S. et al, Neurotensin counteracts apoptosis in breast cancer cells, Biochemical and Biophysical Research Communications, Volume 295, Issue 2, 12 July 2002, Pages 482â€"488
11.     Melander, O, et al, Plasma Pro-Enkephalin, a stable peptide of the precursor to the endogenous opioid Enkephalin, predicts breast cancer risk, Oncol Res Treat 2014;37(suppl 1): 4
12.     Melander, O. Plasma Pro-Enkephalin adds value to Proneurotensin for the risk prediction of incident breast cancer. Oncol Res Treat 2014;37(suppl 1): 6
13.     Ernst A, Proenkephalin A 119-159, a stable proenkephalin A precursor fragment identified in human circulation.Peptides. July, 2006;27: 1835-40.
14.     Faith, R. et al, Inhibition of Pulmonary Metastases and Enhancement of Natural Killer Cell Activity by Methionine-Enkephalin, Brain Behav Immun. June, 1988;2: 114-22.
15.     Schäfer, M. et al, Opioid therapy and tumor progression. Advances in Palliative Medicine 2009, 8, 53–56
16.     Mernenko OA, et al, Met-enkephalin induces cytolytic processes of apoptotic type in K562 human erythroid leukemia cells. FEBS Lett. April 1, 1996;3833: 230-2.
17.     Maneckjee R, et al, Opioids induce while nicotine suppresses apoptosis in human lung cancer cells Cell Growth Differ. October, 1994;510: 1033-40.
18.     Boyd NF, Guo H, Martin LJ, et al. Mammographic density and the risk and detection of breast cancer. N Engl J Med. 3563:227-36, 2007.
19.     Tamimi RM, Byrne C, Colditz GA, Hankinson SE. Endogenous hormone levels, mammographic density, and subsequent risk of breast cancer in postmenopausal women. J Natl Cancer Inst. 9915:1178-87, 2007.
20.     Saslow D, Boetes C, Burke W, et al. for the American Cancer Society Breast Cancer Advisory Group. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 572:75-89, 2007.


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