Dr. Owen Winsett of the Breast Center of Austin is one of the first physicians in the nation to make the BREVAGen™ predictive risk test available to his patients. Clinically validated BREVAGen is the latest advance in assessing a woman’s unique risk of developing non-familial or sporadic breast cancer.

“Seventy to eighty percent of women who get breast cancer do not have familial risk indicators. Now, for the first time, BREVAGen allows me to make informed decisions for those patients with non-familial or sporadic risk of breast cancer based on their personal history and genetics, not simply a statistical risk score,” said Owen Winsett, M.D. “BREVAGen test results make it easier for my patients and me to decide on an appropriate level of monitoring and, if necessary, a more intensive surveillance plan of action including MRI or chemoprevention.”

BREVAGen is a clinically validated predictive risk test that more accurately identifies a woman’s unique risk of developing sporadic, estrogen-positive breast cancer. BREVAGen combines a woman’s clinical history of prolonged estrogen exposure (Gail score) with identified genetic markers to determine five-year and lifetime risk assessments of developing breast cancer. 1 BREVAGen is supplied by Phenogen Sciences, a subsidiary of Genetic Technologies Limited (NASDAQ: GENE). For more information about BREVAGen, contact Alma Avila at (512) 451-5788 or TheDoctor@OwenWinsettMD.com.

How BREVAGen Works

The BREVAGen predictive risk test is administered in a physician’s office using a simple, non-invasive “oral-swab”. Following analysis in a CLIA-certified laboratory, physicians receive a comprehensive genetic risk prediction report to review with the patient. The patient’s risk of breast cancer is calculated by combining their relative risk score from seven genetic markers, called SNPs (single nucleotide polymorphisms), with their Gail score (factors that comprise the patient’s clinical make-up including current age, age at menarche, age at live first birth, race/ethnicity, etc).

The BREVAGen test provides five-year and lifetime predictive risk assessments to more accurately evaluate the patient’s risk for developing hormone-dependent breast cancer, regardless of family history or previous indeterminate test results.

Clinically Validated

BREVAGen was proven superior in determining breast cancer risk compared to Gail score alone.1 In the U.S. Women’s Health Initiative (WHI) Clinical Trial, 3,300 women underwent breast cancer assessment utilizing the BREVAGen test. Of those 3,300 women, 1,664 were diagnosed with breast cancer and 1,636 were in the breast cancer-free control group. BREVAGen test results support current American Cancer Society (ACS) [www.cancer.org], American Society of Clinical Oncology (ASCO) [www.asco.org] and The National Comprehensive Care Network (NCCN) [www.nccn.org] treatment guidelines.2, 3

About Breast Center of Austin and Dr. Owen Winsett

The Breast Center of Austin was established by Dr. Owen Winsett in 1992 with the goal of creating a comprehensive state-of-the-art center for the care of breast disease. Having been active in medical research and a past recipient of the American Cancer Society Junior Fellowship Award, Dr. Winsett and the team at Breast Center of Austin help women focus on getting healthy as well as staying healthy. Dr. Winsett has been a regional board member of the American Cancer Society and medical director of Reach to Recovery. He has participated in national breast disease studies and he has been selected by his colleagues consistently, since 2001, as one of The Best Doctors in America.

About Phenogen Sciences

Phenogen Sciences, the U.S. subsidiary of Australia-based Genetic Technologies Limited, is a pioneer in personalized healthcare. Phenogen offers novel predictive testing and assessment tools that help physicians proactively manage women’s health risks. Phenogen’s lead product, BREVAGen™ is a clinically validated test that combines a woman’s clinical history of estrogen exposure with her genetic predisposition to its effects; more accurately categorizing her personal risk for developing breast cancer. For more information, visit http://www.phenogensciences.com.

About Genetic Technologies Limited

Genetic Technologies is an established diagnostics company with more than 20 years of experience in commercializing genetic testing, non-coding DNA and product patenting. The company has operations in Australia and the U.S. and is dual-listed on the ASX (GTG.AX) and NASDAQ (GENE). Genetic Technologies is focused on the commercialization of its patent portfolio through an active out-licensing program and the global expansion of its oncology and cancer management diagnostics assets. For more information, please visit http://www.gtglabs.com,

Notes To Editors

About Breast Cancer

  • Approximately one in eight women will get breast cancer4
  • 70% to 80% of those who get breast cancer do not have familial risk indicators2
  • Risk of invasive vs. non-invasive breast cancer is approximately four times greater in women age 40-645
  • Approximately 75% of all breast cancer is estrogen-positive and, if detected early, can be effectively treated with five-year survival rates of over 95%

Breast Cancer Demographics

According to the American Cancer Society, breast cancer is the most common cancer among women in the United States, other than skin cancer. It is the second leading cause of death in women, after lung cancer.4 According to the 2010 breast cancer demographics there are:

  • Approximately 207,000 new cases diagnosed each year4
  • Of the 207,000 new cases, about 54,000 are non-invasive forms of breast cancer that have been diagnosed early4
  • Approximately 40,000 deaths related to breast cancer in women, annually4

About BREVAGen™

The first product in Phenogen Science’s portfolio, BREVAGen™ is a predictive risk test for sporadic, hormone-dependent breast cancer. The BREVAGen test combines a woman’s clinical history of estrogen exposure with the presence of identified genetic markers to determine her five-year and lifetime risk for developing breast cancer. For women whose clinical profile indicates prolonged estrogen exposure, BREVAGen helps to provide a more accurate risk assessment for estrogen-positive breast cancer. The test results assist physicians in developing a personalized care path toward managing each woman’s risk of developing breast cancer with greater precision than ever before.

  • Non-invasive, easy-to-use predictive risk assessment test
  • The first genetic risk prediction test to have been validated in a large-scale, peer-reviewed, case-controlled study1
  • Recent studies demonstrate that 64% of women who have above average risk of prolonged estrogen exposure were either reclassified above the guidelines for high risk management or below the general population risk when compared to clinical risk factors alone1
  • Supports existing industry guidelines for the prevention of estrogen-positive breast cancer2,3

1 Mealiffe M, Stokowski RP, Rhees, BK, et al. J Nat Cancer Inst. 2010;102(21):1618-1627.

2 Saslow D, Boetes C, Burke W, et al. CA Cancer J Clin. 2007;57(2):75-89.

3 Visvanathan K, Chlebowski RT, Hurley P, et al. J Clin Oncol. 2009;27(19):3235-3258.

4 Breast Cancer Overview. American Cancer Society. Accessed 3/14/12 at http://www.cancer.org/Cancer/BreastCancer/OverviewGuide/breast-cancer-overview?docSelected=breast-cancer-overview-key-statistics

5 DeSantis C, Siegel R, Bandi P, Jemal A. CA: A Cancer Journal For Clinicians. 2011;61: 409-418

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