Phenogen Sciences Announces Immediate Availability of BREVAGen™ Breast Cancer Risk Assessment Test in 49 of 50 States

CHARLOTTE, N.C., Oct. 3, 2012 /PRNewswire/ -- Phenogen Sciences, Inc. [www.phenogensciences.com] today announced the immediate availability of BREVAGen, a predictive risk test for the millions of women at above average risk of developing estrogen-receptor positive breast cancer. This first-in-class, scientifically-validated risk assessment test examines a woman’s clinical risk factors, such as her lifetime exposure to estrogen, combined with scientifically validated genetic markers to determine each patient’s personalized five-year and lifetime risk of developing breast cancer.¹

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“By knowing a woman’s personal risk of developing breast cancer, doctors can work with their patients to develop personalized ‘breast health plans’,” said Owen Winsett, M.D. of the Breast Center of Austin. “Breast health plans identify lifestyle changes that a patient can use to reduce their risk of developing breast cancer and provide them with motivation to follow a personalized surveillance / monitoring plan including an appropriate frequency of designated screenings such as mammograms, MRIs and ultrasounds. Detecting breast cancer early has a 95% survival rate; when detected at later stages survival is only 41%. By utilizing the BREVAGen breast cancer risk assessment test, 80% of women with little or no family history of breast cancer are able to identify their breast cancer risk and take appropriate action thus increasing their chances for survival.”

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] guidelines for prevention and early detection of breast cancer.^{2, 3}

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 our 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 SNP’s (single nucleotide polymorphisms), with factors that comprise the patient’s clinical and reproductive history including current age, age at menarche, age at live first birth and race/ethnicity.

The BREVAGen test provides five-year and lifetime predictive risk assessments to more accurately evaluate the patient’s risk of developing sporadic breast cancer, regardless of family history.

Clinically Validated

BREVAGen was proven superior in determining breast cancer risk compared to Gail score alone.¹ BREVAGen is the first genetic risk prediction test to have been validated in a large scale, peer reviewed, case controlled study. Utilizing data from 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 reclassified 64% of Gail score above average risk subjects as either high or average risk for development of breast cancer. Furthermore, the BREVAGen test reclassified the breast cancer risk for 33% of the total 3,300 trial subjects.¹

About Breast Cancer

• Approximately one in eight women will get breast cancer equating to approximately 207,000 American women.⁴
• Up to 80% of women who get breast cancer do not have a strong family history of the disease.²
• 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-receptor 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
• Approximately 40,000 deaths related to breast cancer in women, annually⁴

About BREVAGen

The first product in Phenogen Sciences’ 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 of developing breast cancer. For women whose clinical profile indicates prolonged estrogen exposure, BREVAGen helps to provide a more accurate risk assessment for estrogen-receptor 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. For more information, visit http://www.brevagen.com.

• 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
• BREVAGen reclassified 64% of subjects with an above average Gail risk score as either high or average risk for development of breast cancer¹
• Aligns with existing industry guidelines for the prevention of estrogen-receptor positive breast cancer^2,3

About Phenogen Sciences, Inc.

Phenogen Sciences, the U.S. subsidiary of Australia-based Genetic Technologies Limited, is a pioneer in personalized healthcare. Phenogen Sciences offers novel predictive testing and assessment tools that help physicians proactively manage women’s health risks. Phenogen Sciences’ lead product, BREVAGen is a scientifically 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 of 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.

SOURCE Phenogen Sciences, Inc.