(GENE) Clinically Validated Brevagenplus(R) Accurately Identifies Sporadic Breast Cancer Risk

CHARLOTTE, N.C., May 28, 2015  — Phenogen Sciences, Inc., the U.S. subsidiary of Australia-based Genetic Technologies Limited (NASDAQ: GENE), today notes with interest the special report on May 27, 2015 in The New England Journal of Medicine entitled, “Gene-Panel Sequencing and the Prediction of Breast Cancer Risk” authored by DF Easton, et al. The company’s lead product, BREVAGenplus, is a clinically validated, genetically-based predictive risk test for sporadic, or non-hereditary, breast cancer.

Richard Allman, Ph.D., Scientific Director, Genetic Technologies Ltd. states, “While the BREVAGenplus test does not evaluate gene-panel sequencing or hereditary cancer testing, we welcome the findings of the authors which re-inforce the message that adequate validation is required for cancer risk assessment tests.”

According to The New England Journal of Medicine article, there is a reasonably clear distinction between single nucleotide polymorphisms (SNPs) that confer a small increased susceptibility to breast cancer and variants that confer a moderate-to-high susceptibility as identified through sequencing.1 BREVAGenplus evaluates a panel of SNPs known to be associated with sporadic breast cancer combined with clinical risk factors to provide a more accurate risk assessment.

How BREVAGenplus Works

The BREVAGenplus predictive risk test is performed in a physician’s office using a simple, non-invasive “cheek swab.” The test combines information from the patient’s genetic markers (SNPs) known to be associated with sporadic breast cancer, with their Clinical Risk Score which includes factors such as the patient’s current age, age at menarche, age at live first birth, race/ethnicity, etc, to calculate their risk of developing sporadic breast cancer. This Clinical Risk Score is determined by the National Cancer Institute Breast Cancer Risk Assessment Tool (BCRAT); also known as the “Gail model” (http://www.cancer.gov/bcrisktool/).

Following analysis in a CLIA-certified laboratory, the test provides five-year and lifetime predictive risk assessments to more accurately determine the patient’s risk of developing breast cancer during those timeframes.

Clinically Validated, Proven Superior

The first generation test, BREVAGen™, was proven superior in determining breast cancer risk compared to Clinical Risk Score alone (ie, “Gail model score.”).2 In the U.S. Women’s Health Initiative (WHI) Clinical Trial, 3,300 women underwent breast cancer assessment utilizing the BREVAGen test. Studies showed BREVAGen reclassified 64 percent of above average (ie, “intermediate”) risk (as determined by the Gail model) subjects as either high or low risk for development of breast cancer. Furthermore, the BREVAGen test reclassified the breast cancer risk for 33 percent of the total 3,300 trial subjects.2

BREVAGenplus expands on this initial work by leveraging recent advancements in SNP research and development. BREVAGenplus incorporates a ten-fold increase in the number of genetic markers over the first generation test. In addition, the applicability of BREVAGenplus has been expanded to include African-American and Hispanic women, whereas the BREVAGen test was only applicable to Caucasian women.

There is no single mutation for sporadic breast cancer, nor is there a repository of information about genetic contribution to a complex disease such as breast cancer. At present, the measurable genetic markers associated with complex diseases are identified using genome-wide association (GWA) studies. GWA studies have been used to identify novel breast cancer susceptibility loci. Several dozens of SNPs were identified for BREVAGenplus testing based on an initial review of over 500,000 SNPs in multiple GWA studies involving over 50,000 women.3,4

About BREVAGenplus

An enhancement of Phenogen Sciences, Inc. first generation product, BREVAGen, BREVAGenplus evaluates an increased number of genetic markers (SNPs); and testing is now available for African-American and Hispanic American women.

BREVAGenplus is a clinically-validated, personalized predictive risk assessment test that more accurately evaluates a woman’s personal risk of developing sporadic, or non-hereditary, breast cancer. By evaluating a woman’s clinical information (Gail score) and genetic markers (SNP profile), BREVAGenplus assists physicians in developing personalized risk management plans and taking appropriate steps towards managing each woman’s risk of developing sporadic breast cancer with greater precision than ever before.

Phenogen Sciences, Inc. markets BREVAGenplus to healthcare providers in women’s health, primarily obstetricians/gynecologists (OBGYNs), breast cancer risk assessment specialists (such as breast surgeons) and comprehensive breast health care and imaging centers. For more information, visit http://www.brevagenplus.com.

About Phenogen Sciences, Inc.

Phenogen Sciences, Inc., 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’ product, BREVAGenplus is a scientifically validated test that combines a woman’s clinical history with a panel of genetic markers to more accurately categorizing her personal risk of developing breast cancer. For more information, visit http://www.phenogensciences.com.

About Genetic Technologies Limited

Genetic Technologies (NASDAQ: GENE) is a molecular diagnostics company that offers predictive testing and assessment tools to help physicians proactively manage women’s health. The Company’s lead product, BREVAGenplus®, is a clinically validated risk assessment test for non-hereditary breast cancer and is first in its class. BREVAGenplus improves upon the predictive power of the first generation, BREVAGen™ test and is designed to facilitate better informed decisions about breast cancer screening and preventive treatment plans. BREVAGenplus expands the application of BREVAGen from Caucasian women to include African-Americans and Hispanics, and is directed towards women aged 35 years or above, who have not had breast cancer and have one or more risk factors for developing breast cancer.

The Company has successfully launched the first generation BREVAGen test across the U.S. via its U.S. subsidiary Phenogen Sciences, Inc. and the addition of BREVAGenplus, launched in October 2014, significantly expands the applicable market. The Company markets BREVAGenplus to healthcare professionals in comprehensive breast health care and imaging centers, as well as to obstetricians/gynecologists (OBGYNs) and breast cancer risk assessment specialists (such as breast surgeons).

For more information, please visit http://www.brevagenplus.com.

1. Easton DF, et al. Gene-Panel Sequencing and the Prediction of Breast-Cancer Risk. NEJM, May 2015 DOI: 10.1056/NEJMsr1501341.
2. Mealiffe ME, Stokowski RP, Rhees BK et al. Clinical validity assessment of a breast cancer risk model combining genetic and clinical information. Journal of the National Cancer Institute. 2010. 21: 1618-1627.
3. Easton DF. Pooley KA, Dunning AM, et al. (2007).  Genome-wide association study identifies novel breast cancer susceptibility loci.  Nature 447: 1087-1093.
4. Michailidou K, Hall P, Gonzalez-Neira A, et al. Large-scale genotyping identifies 41 new loci associated with breast cancer risk. Nature Genetics. 2013. 45: 353-361.

CONTACT: Bruce Likly
         Kovak-Likly Communications
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         blikly@klcpr.com