A recently launched advertising campaign for a genetic test to assess breast cancer risk has cancer experts debating the merits and pitfalls of promoting the expensive tests to the general public.
The test, called BRACAnalysis, is marketed by the company Myriad Genetic Laboratories Inc. and costs more than $3,000. It is designed to detect mutations in two different genes, called BRCA1 and BRCA2, which bestow a three- to sevenfold increased risk of breast cancer, according to the National Cancer Institute.
Myriad contends that these tests may help women find these mutations early, helping them determine whether or not they possess a high risk of developing breast cancer.
Television commercials, airing in New York, Boston, Hartford, Conn., and Providence, R.I., feature young and middle-aged women talking about how the test helped them detect their cancer risk. The campaign also includes radio and magazine spots.
"The BRACAnalysis Awareness Campaign is designed to raise public awareness so that women with mutations with BRCA1 or BRCA2 can avail themselves to technologies that are potentially lifesaving," says Dr. Gregory Critchfield, the company's president.
Some doctors in the field agree that increasing public knowledge of the test is a step in the right direction.
"Anything that gets patients more aware of their family history and of the options available is a good thing," says Dr. Kevin Hughes, co-director of the Breast and Ovarian Cancer Genetics and Risk Assessment Program at Massachusetts General Hospital. "I see this campaign as one more approach to educating both primary doctors and patients."
Dr. Marisa Weiss, a breast radiation oncologist at Lankenau Hospital in Philadelphia and founder of the Web site breastcancer.org, agrees.
"There is no question genetic testing is being underutilized today," she says. "There are plenty of women out there who have not talked to their doctor about their family history. People need a nudge to begin a conversation with their doctor."
However, other cancer and genetic specialists are worried.
"I'm really concerned about the message because it will excite fear and anxiety," says Shelly Cummings, senior genetic counselor in the Cancer Risk Clinic at the University of Chicago. "Although it will start conversation with a genetic counselor, I'm afraid of the psychological effect this TV campaign will have."
Dr. Stephanie Hines of Mayo's Multidisciplinary Breast Clinic and Breast Cancer Program in Jacksonville, Fla., agrees. "I'm afraid the commercials will cause a lot of demand for the test. People who actually have a very low likelihood of having a mutation will be requesting the test."
Like commercials for prescription medications, these commercials for genetic testing urge women to discuss their family history with a doctor or to call a toll-free number to find out if they are good candidates for the test.
Hughes says that despite the broad approach of the campaign, the fact that only a doctor can order the test ensures that it will not be used inappropriately.
"I anticipate a large number of patients coming in, but only a small number getting tested if genetic tests are done in the right way: First increase awareness, then test only the most appropriate patients," he says.
Only a very small percentage of people are candidates for the genetic test. Before recommending genetic testing, doctors and counselors extensively research a patient's family history.
"Genetic testing is recommended for people with a strong family history of breast cancer; either people who have been diagnosed early, in their 30s or 40s, or who have lots of cases of breast or ovarian cancer in their family," says Cummings. "Only about 5 to 7 percent of people will have the mutation."
However, Myriad Genetics argues that extensive genetic testing is needed to find all those at increased cancer risk. "Fewer than 3 percent of patients who carry these mutations have been identified to date," says Critchfield. "The vast majority of individuals have yet to be identified."
And Weiss says the campaign seems to be primarily aimed at those women who may have the highest risk -- those with a family history of cancer.
"Although breast cancer is pretty common, only 15 percent of women have a family history," she says. "Most people will be listening to the commercial and think, 'I don't have a family history. This doesn't apply to me.'"
Gene Test No Simple Proposition
However, identifying those who have a family history of breast cancer is only the first step. "Genetic testing is not a simple blood test," Hines says. "It requires substantial pretest and post-test counseling."
And some doctors and genetic counselors may not be up to the task of interpreting the results of the test and explaining them to their patients, Cummings says.
"Sometimes doctors don't know how to interpret the results which might mean patients have procedures that they might not need," she says. "Testing is not cut and dry."
Further complicating the issue is the fact that a BRCA mutation does not necessarily mean that an individual will develop breast cancer.
"Finding a mutation means that there is an elevated risk of developing breast cancer, but it doesn't mean that you will have cancer," says Hines. "And just because you don't have a mutation doesn't mean that you will not get cancer."
But finding a mutation could cause women to take sometimes drastic steps to limit their risk, from potentially expensive annual MRI screenings to preventive mastectomy -- surgically removing the breast before cancer can develop.
But proponents of the test say any knowledge gained through the test is useful, as long as a well-informed doctor is present to guide a patient through her best options.
And in the future, Hughes says, such screening tests may gain wider acceptance, even for other diseases and conditions.
"In the future, there will be genetic tests for other diseases such as heart disease and diabetes," Hughes says. "This will allow us to prevent diseases in high-risk patients or to detect them earlier at a more treatable stage."
ABC News Medical Unit researcher Dr. Susan Kansangra contributed to this report.