Intergenetics develops breast cancer test via mouthwash

InterGenetics Inc. developed the OncoVue Breast Cancer Risk Test which uses a mouthwash to collect a DNA specimen. The test is expected to be released and available in October.

Sherry Bellack, director of market relations for InterGenetics, said OncoVue will only be available through comprehensive breast centers, and initially, only 50 centers will be able to offer the test.

Missouri does not yet have a center designated to offer OncoVue, Bellack said, but eligible centers will be those that would be able to counsel and work with women who are found to have moderate to high risk.

“We have a lot of safeguards in place to make sure we are being responsible … with our approach to the market,” she said.

Designed as a once-in-a-lifetime test, OncoVue, which costs $647, uses a mouthwash rinse-and-spit method.

When the test is officially on the market, test results will be available to the provider within 72 hours of the specimen arriving at the InterGenetics laboratory for analysis. The DNA sample, collected from a woman’s cheek, is analyzed for cancer risk.

Dr. Craig Shimaski, president and CEO of InterGenetics, said OncoVue enables the laboratory to look at 1.3 million combinations of genes, in combination with a patient’s personal history.

“(OncoVue) is used for predicting the lifetime risk of developing breast cancer, potentially many years before diagnosis,” he said.

Other genetic tests – BRCA-1 and BRCA-2 – look for risk by studying mutation in a single gene, Shimaski said.

About 5 percent to 10 percent of breast cancer is believed to be caused by genes found in the BRCA-1 and BRCA-2 tests, but Shimaski said that means that for the majority of breast cancer patients, it is not evident through mutation of a particular gene.

“The rest of the genes and gene mutations are carried in all women. That’s why this test is applicable to all women,” he said.

OncoVue research

During the past 11 years, InterGenetics spent $15 million to $20 million studying 12,000 women from across the country.

Dean Alberty, executive director of Research Tissue Recovery Network, said he has collected samples from many women in the Ozarks for OncoVue.

“Over 400 women in southwest Missouri have participated in the blinded study,” Alberty said. “We’ve been out to places like Aurora and Mt. Vernon collecting samples and educating women from different organizations on breast cancer research.”

The nature of the OncoVue test makes collecting faster and easier, Alberty said. “It’s a simple rinse and spit, but it could save hundreds of thousands of lives. And we can bring the results back to the area,” Alberty said, adding that RTRN plans to move its headquarters from Lee’s Summit to Springfield within the year. The company will keep its office in Lee’s Summit.

Treading carefully

Dr. John W. Buckner, a surgeon with Ferrell-Duncan Clinic, is very interested in genetic testing and cancer research, but he approaches genetic tests with caution.

“Even in the strongest components of genetic testing we have to admit it’s a very multi-factual issue with most people. And probably even the most conservative would say probably 70 (percent) to 90 percent of people can’t be predicted based on genetic testing,” said Buckner, whose practice is dominated by breast cancer patients.

Tests such as OncoVue spark interest, but Buckner said that regardless of what tests are available, women should not use them as the sole basis of making health care decisions. “It’s really easy to do a mouth swab or blood test and get the reassurance that you so want,” Buckner said. “That (test) could be sort of a false security. Then, if you drop your guard on your routine exam and your mammogram and seeing your doctor and all the other things that are so very important … then you can hurt more people than help.”

Shimaski said that one challenge to finding 50 centers to administer OncoVue – to date, 20 centers have committed once it’s released in the fall – is that InterGenetics must find acceptance and approval in the medical community.

For doctors familiar with the industry, the decision to use something new is not easy. “BRAC 1 and BRAC 2 are very well developed tests and have been proven to be very valid in a certain population,” Buckner said. “The InterGenetics testing is a little tougher for me to sort out. It seems to me that most of the information that I am seeing from them is still pretty preliminary. And I’m not sure how I would use that in my practice.”

These same decisions carry over to organizations such as the Breast Cancer Foundation of the Ozarks, where Buckner serves as a board member.

“We’re being very cautious. I mean, we’d like to be on the cutting edge, but you know that’s kind of a double-edged sword. If you get too far out there, sometimes you look back and say, ‘Gee, we thought that was the right thing,’ but then you realize that maybe it was not as accurate as you thought,” Buckner said. “At BCFO, we want to be reasonable with the information.”

Ellen Hammock, executive director for the Breast Cancer Foundation of the Ozarks, has allowed OncoVue to come and share information at the foundation, in an attempt to connect researchers with doctors.

“We obviously have a good connection with everybody – that’s about as far as we took it,” Hammock said. “If there’s anything they can do to find out more about breast cancer, then more power to them.”

BCFO statistics show that approximately 3 million women in the United States are living with breast cancer; 2 million have been diagnosed; and an estimated 1 million do not yet know they have the disease.

Buckner said one of his biggest concerns is how the OncoVue test will be used in doctor’s offices.

“What worries me is having people out there with the little kits in their offices where women do the mouth rinse and spit and then get this thing in the mail and suddenly have this information and, again, what do you do with it?” Buckner said. “I think (InterGenetics) is a very reputable group and they are going to be very cautious with how they promote (the test), but it’s hard to know how it’s going to be used by any one practitioner.”

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