$GENE Now Offering BREVAGenplus(R)

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ROCKVILLE GYNECOLOGY NOW OFFERING BREVAGenplus(R), A STATE-OF-THE-ART TEST FOR ASSESSING BREAST CANCER RISK

Personalized, Genetically-Based Test Enables Physicians to Tailor Breast Cancer Screening and Reduction Services Based on Individual Risk
 Carolynn Young, MD, Board-Certified Obstetrician and Gynecologist, announces that Rockville Gynecology is now offering BREVAGenplus(R), a state-of-the-art risk assessment test that helps physicians determine a patient’s risk of developing sporadic, or non-hereditary, breast cancer.

“There are so many women who want more information about their breast cancer risk since about 85 percent of breast cancer cases occur in women with little-to-no family history of the disease,” Dr. Young explained. “Our practice emphasizes ‘power in prevention’ and BREVAGenplus offers patients individualized screening, enabling our team to provide personalized screening and risk reduction plans according to each woman’s risk. This is exactly what we should be doing to optimize patient health and potentially save lives.”

BREVAGenplus is a clinically-validated, personalized predictive risk assessment test that more accurately identifies a woman’s unique risk of developing sporadic, or non-hereditary, breast cancer. By evaluating a woman’s clinical information (such as age at first child and age at menarche), as well as genetic markers, BREVAGenplus helps physicians develop personalized breast cancer risk reduction and screening plans, and to take appropriate steps towards managing each woman’s risk of developing sporadic breast cancer with greater precision than ever before.

Dr. Young uses BREVAGenplus with a variety of patients who have risk factors for breast cancer but do not necessarily meet criteria for screening with the BRCA gene test. Such patients have included, among others, women over the age of 35 with some family history of breast cancer and patients with dense breast tissue, whose breasts are difficult to palpitate and image, making cancer detection more difficult.

In Dr. Young’s experience, patients benefit from a BREVAGenplus screening test regardless of whether their results show them to be at higher or lower risk for developing breast cancer. Dr. Young may counsel a patient with a relatively low risk score to adjust her breast cancer screening schedule. For patients with a high risk score, the practice offers enhanced breast cancer screening and thus improved early detection, as well as other strategies for preventing breast cancer and reducing its incidence. She explained, “BREVAGenplus is a powerful tool that gives me important information about each individual’s breast cancer risk within five years and across their lifetime, thus allowing me to give more accurate, individualized screening and treatment recommendations.”

BREVAGenplus is performed by Phenogen Sciences, a subsidiary of Genetic Technologies Limited (GENE). For more information about BREVAGenplus at Rockville Gynecology, please contact the practice at (301) 330-7007.

How BREVAGenplus Works

The BREVAGenplus predictive risk assessment test is performed in a physician’s office using a simple, non-invasive “cheek 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 developing sporadic breast cancer is calculated by combining their relative risk score from genetic markers called SNPs (single nucleotide polymorphisms) with factors that comprise the patient’s clinical and reproductive history, including current age, age at menarche, age at first live birth, and race/ethnicity. 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/).

The BREVAGenplus 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(TM), was proven superior in determining breast cancer risk compared to Clinical Risk Score alone (ie, Gail model score). 1

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.

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. 2,3

About Rockville Gynecology

The Rockville Gynecology team is led by Dr. Carolynn Young, a board-certified Obstetrician and Gynecologist who was selected as one of Washington D.C.’s Top Doctors by Washingtonian Magazine. She received her medical degree from Vanderbilt University’s School of Medicine and served as Chief of Gynecology at Suburban Hospital from 2009 to 2012. Dr. Astrid Gonzalez, a graduate of Loma Linda University School of Medicine, is also a member of the Rockville Gynecology team. During her residency at Los Angeles County University of Southern California Medical Center, Dr. Gonzalez received various awards for patient care, patient advocacy and dedication to clinical quality. The Rockville Gynecology team is completed by Tosha Luchtefield, MS, FNP-BC, a board-certified Nurse Practitioner who graduated first in her class from Georgetown University’s Family Nurse Practitioner Program.

Rockville Gynecology provides individualized care for all gynecologic needs, including but not limited to: routine well-woman exams, hereditary cancer risk assessment, abnormal pap smears, infertility treatment, abnormal bleeding, fibroid treatment, contraception, and minimally invasive surgery.

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 categorize her personal risk of developing breast cancer. For more information, visit http://www.phenogensciences.com.

About Genetic Technologies Limited

Genetic Technologies 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(R), 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(TM) 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.

REFERENCES

1. 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.

2. Easton DF, Pooley KA, Dunning AM et al. Genome-wide association study identifies novel breast cancer susceptibility loci. Nature. 2007. 447:1087-1093.

3. 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
203-762-8833
blikly@klcpr.com

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