Oklahoma Breast Care Center One of the First in Nation to Offer
Genetic-Based Breast Cancer Risk Test
OncoVue Test is Released Under FDA Investigational Study
OKLAHOMA CITY—Oklahoma Breast Care Center is among the first centers in the nation to be selected to participate in a study being conducted by InterGenetics under a Food and Drug Administration (FDA) approved investigational device exemption study. OncoVue is the first genetic-based, breast cancer risk test applicable for women with or without a strong family history of breast cancer that incorporates both personal history measures and individualized genetic-based single nucleotide polymorphisms (SNP).
“OncoVue is the nation’s first genetic-based breast cancer risk test to undergo the FDA approval process and it is very important to us to be a part of a process that could bring this Oklahoma-researched technology to all women,” said Dr. Larry Killebrew, Medical Director of Oklahoma Breast Care Center. “Our patients expect us to be on the forefront of the best practices and prevention strategies, certainly OncoVue has the potential to enhance our ability to move to greater prevention options for our patients.”
Nearly 1 in 8 women develop breast cancer in their lifetime, but current genetic tests only detect hereditary gene mutations present in approximately 5% of women who get breast cancer, and hereditary mutations may only account for as much as 10% of the cases. Consequently, 90% of women who get breast cancer have no indication they are predisposed to the disease. The OncoVue test can provide a trained medical professional with a genetic based tool for improving clinical estimates of individualized breast cancer risk. Knowing the genetically predisposed level of risk can enable individuals, along with a trained medical professional, to develop an appropriate plan for managing risk.
The OncoVue test is simple. A woman completes a short medical history questionnaire, then swishes a harmless mouthwash and deposits the fluid into a tube. In the InterGenetics’ laboratory, the woman’s cheek cells collected from the mouthwash are analyzed using the OncoVue CombiSNP™ technology that looks at combinations of genes, rather than any one specific gene. Research has shown such combinations have a significant relationship to women diagnosed with ‘sporadic’ breast cancer the type of breast cancer affecting 90-95% of all women who get breast cancer. The research also reveals a strong dependence on age for genetic contribution to breast cancer risk.
“OncoVue has already undergone years of research and the genetic information for this test came from testing over 7,500 women with and without breast cancer from 5 geographic regions of the country,” said Dr. Craig Shimasaki, InterGenetics CEO/president. “The completion of this FDA investigational period will mark a new level of confidence in genetic breast cancer risk testing for the patients, physicians and breast care centers who are the first to use this technology.”
Participants in the study will be asked to pay $397 for the test to cover a portion of the research, development and processing of the specimen. The patient will receive the OncoVue report which identifies her risk assessment in three stages of her life; Pre-menopause, Peri-menopause, and Post-menopause. The OncoVue IDE study is open to all women between the ages of 30 and 69 who have never been diagnosed with invasive breast cancer.
“The OncoVue investigational study will also assess the patient’s emotional state related to their risk perception both before and after testing and the impact of the physician’s medical recommendations based on the results of the testing,” continued Dr. Shimasaki. “The study will also provide valuable insight into the widespread acceptance for the applicability of the Breast Cancer Risk Test as a tool for risk assessment in a clinical setting.”
Comprehensive Breast Care Centers and individual physician’s practices participating in the study are Investigational Review Board (IRB) approved and operating under the protocols as recommended by the IRB to meet the requirements of the FDA Investigational Device Exemption study. The test has been released in centers in Indianapolis, Tucson, Chicago, Boise, and Oklahoma City. A total of 50 study sites will soon be operational under the Investigational Device Exemption Study by early 2007.
About InterGenetics
InterGenetics, is a genetics-based cancer-risk testing company emerging as an innovator in the frontier of genetic medicine to improve women’s health through genetics. The company's lead product, the OncoVue® Breast Cancer Risk Test, uses proprietary gene combinations and DNA assessment technology developed by InterGenetics' scientists to quickly and accurately identify women who are at high risk of developing breast cancer, potentially many years in advance of their diagnosis. InterGenetics has a promising research pipeline of predictive tests for other cancers such as ovarian, colon, prostate, and pancreatic cancer. The Company's core research has future application in also predicting risk for heart disease, diabetes and in enhancing the effectiveness of drug therapies and preventative medicine in these fields. www.intergenetics.com