Each year, more than 200,000 women in the United States are diagnosed with breast cancer. Nearly 90 percent of these women have no strong family history of the disease and had no idea they were at high risk. But now a genetic test developed in Oklahoma by InterGenetics can give women insight into their odds.
The OncoVue test is non-invasive and evaluates a combination of genes as well as personal history and lifestyle factors to determine a patient’s level of risk. The test is offered as part of an FDA-approved investigational study.
Edmond resident Dr. Craig Shimasaki, president of InterGenetics, said there are many benefits to a patient knowing her individual risk, including earlier detection and preventive measures.
"If detected early, the vast majority of patients have improved outcomes and longer survival rates," Shimasaki said.
The OncoVue test requires a patient to swish a small amount of mouthwash in her mouth and spit it into a tube. This collects cheek cells that are analyzed at the InterGenetics lab in Oklahoma City.
"Almost every cell type in the body carries the DNA you were born with," Shimasaki said. By analyzing the samples and identifying combinations of genes, we can identify the patient’s propensity for being diagnosed with a particular disease in the future, he said.
Locally, the test is available at Breast Imaging of Oklahoma, and Okalahoma Breast Care Center, two of only seven centers currently offering OncoVue in the United States.
InterGenetics has developed a genotyping database using 8,000 women from across the country. For each of these women, 117 different genes were evaluated to identify the differences in those that had been diagnosed with breast cancer and those who had not. Shimasaki said using a large sample to build the statistical model provides better projections for the general population, thus increasing the accuracy of OncoVue. Each test specimen is compared to the genetic markers in the database, along with personal history to determine a risk factor. From there, the patient can work with her doctor to develop a plan of action. For patients with a higher risk, that might mean more frequent or advanced mammograms or preventive medications. For others, the risk assessment can bring added peace of mind.
"Those with a family history (of breast cancer) tend to overestimate their risk," Shimasaki said. He emphasized that low risk does not mean no risk, and it is important for all women to perform monthly self breast examinations and have regular mammograms.
Shimasaki said he likes to think of it as "Back to the Future" in reverse. Instead of going back in time to change something, patients can take a peek at their genetic future encoded in their DNA to determine their risk and then do something to change the outcome of the future.
Melissa Craft, RN, MS, offers genetic counseling to women considering the test at Breast Imaging of Oklahoma. She said some women aren’t interested in knowing their risk, but others are “information seekers,” and for those women, especially those who suspect their risk is high, the OncoVue test is beneficial.
The test is offered to patients at a cost of $397. Women who would like to schedule an appointment or talk to Craft about genetic testing can call the Breast Imaging Center at 844-2601 or the Oklahoma Breast Care Center at 755-2273.
The OncoVue test relies on the latest understanding of the human genome to identify the specific genetic markers that are strong indicators for breast cancer risk. Shimasaki likes the idea of translating science and technology discoveries into things that can help people live longer.
The InterGenetics team has been working many years to develop a reliable prediction of a woman's risk of breast cancer. The work began at the Samuel Noble Foundation and later moved to the Oklahoma Medical Research Foundation. In 1999, InterGenetics spun off as a private company to continue development of the OncoVue test.
Developing a diagnostic tool like OncoVue usually costs between $25 million and $50 million, but InterGenetics was able to bring the test to its current status at a cost of $12.5 million.
“There are a lot of forces helping to create an environment for Oklahoma to be a biotech hub,” Shimasaki said. But a key element is missing. “The problem still is a lack of seed capital and development-stage funds for companies … . It is a significant part of Oklahoma’s plan that needs to be addressed very soon.” Shimasaki said he thinks funding should come from both public and private sources – like incentives to make investing in local technology companies more attractive.
“If you can’t get capital, you either won’t exist or you will go to another state that will fund you,” he said. “Fortunately, most of our funding up to this point has come from local investors that have helped us keep the company here.”
For more information on InterGenetics, visit www.intergenetics.com.