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Will Myriad's Marketing to Mammogram Centers Ease or Fan Over-Testing Concerns with BRACAnalysis?


By Turna Ray 

By expanding the marketing reach of its sales force to mammography centers, Myriad Genetics is hoping to identify more women with a family history of breast and ovarian cancer who may be appropriate candidates for genetic testing on its BRACAnalysis test.

Myriad announced last week it was partnering with Mammography Reporting System to "increase the identification of patients at high risk of hereditary breast cancer." MRS, a provider of breast procedure information systems that services 2,400 mammography centers in the US, claims that approximately 8 million mammogram patients are tracked with its software each year.

Myriad's 300-member sales force currently markets the BRACAnalysis test to the Ob/Gyn community and oncologists. The company said in a statement that "mammography centers represent a new and ideal channel to identify those women at increased risk."

Under the partnership with MRS, Myriad said that it is hoping for "greater penetration into the asymptomatic market — women who do not have breast or ovarian cancer but have a family history."

According to previous statements from Myriad Chief Financial Officer Jim Evans, approximately 30 percent of Myriad’s molecular diagnostic revenues are derived from the asymptomatic or Ob/Gyn market and 70 percent of revenues come from the oncology sector [see PGx Reporter 08-26-2009]. Last year, the company said it would bolster its marketing efforts to stave off the negative impact the weak economy has had on BRACAnalysis sales.

In partnering with MRS, Myriad Genetics has garnered access to radiologists and women presenting to mammography centers. Myriad is planning to provide educational materials at mammography centers, as well as provide resources to radiologists and primary care physicians affiliated with these centers.

Specifically, Myriad and MRS' partnership will facilitate the incorporation of so-called "risk flags" for hereditary breast cancer risk within MRS' cancer tracking software. Myriad hopes that by using these built-in software tools, healthcare professionals at mammography centers may improve their ability to identify women at high risk for developing hereditary breast cancer, and as such, should be tested on BRACAnalysis to determine whether they have the BRCA 1 or BRCA2 risk genes.

Myriad cites data estimating that around 6 percent of women coming to mammography centers, or 2.4 million women per year, are at high risk for hereditary breast cancer and therefore should be tested on BRACAnalysis. According to the company's estimates, less than 10 percent of mutation carriers for the BRCA1 and BRCA2 genes have been identified in the US.

"Imaging centers represent an ideal healthcare setting where patients at risk for hereditary cancer can be identified, thereby enabling an appropriate level of monitoring and preventive care," Gregory Critchfield, president of Myriad Genetic Laboratories, said in a statement. He added that the approach "broadens and complements" Myriad's existing efforts to identify candidates for BRACAnalysis testing.

"Working in concert with the patients' primary care physician, radiologists who use MRS software can identify and recommend increased surveillance and BRCA gene testing for those patients who are at high risk," MRS CEO Mark Morris said in a statement. The "risk flags" associated with BRACAnalysis testing will be incorporated into MRS software that includes the ability to alert healthcare professionals when a patient's personal or family history indicates she may be at heightened risk for breast and ovarian cancer.

Myriad's decision to market its BRACAnalysis test to mammography centers comes a few months after the US Preventative Services Task Force reviewed clinical trial data and amended its mammogram screening recommendations to suggest that women over 40 years need to screened every two years, instead of annually. The PSTF panel issued its recommendations after reviewing data from a British study comparing the outcomes of 54,000 women who received routine mammograms from age 40 with the outcomes of 107,000 women of the same age who didn't receive them. The study found that out of 1,900 women receiving yearly mammogram screenings between ages 40 and 50, only one breast cancer related death would have been prevented in the next 20 years.

The PSTF's recommendations were highly controversial, and the American Cancer Society does not support the panel's findings and continues to recommend yearly mammogram screenings. However, studies have shown that mammography leads to overdiagnosis through the early identification of tumors that do not ultimately become cancerous. A 2006 Swedish study that followed up with women who received mammogram screenings found that 10 percent of women between ages 55 and 69 years were overdiagnosed for breast cancer based on mammograms. According to the National Cancer Institute, study estimates of overdiagnosis for breast cancer based on mammography screenings range from 5 percent to 32 percent.

Myriad has also faced some heat from payors for unnecessary testing with BRACAnalysis. Several national insurers, among them Aetna and United Healthcare, have instated prior authorization, prior notification, and mandatory genetic counseling procedures prior to covering Myriad's BRACAnalysis test to ensure that the test is being given to the right patients [see PGx Reporter 11-04-2009]. Data from insurers suggest that around 20 percent of requests for the test do not meet requirements for BRCA testing under their policy. A United Healthcare official has cited competitors' data suggesting that as much as 80 percent of requests for Myriad's BRCA test are withdrawn after pre-certification and genetic counseling procedures are conducted.

It was not immediately clear whether payors view Myriad's partnership with MRS as a move to more accurately determine which women should be tested on BRACAnalysis, or whether this move will be seen as just another aspect of Myriad's marketing plan for its flagship product.

Myriad launched a television advertising campaign in selected Northeastern states in September 2007 for its BRACAnalysis test, and has expanded the marketing campaign to the South and Midwest. After Myriad's DTC campaign launched in the Northeast, many doctors complained that their practices were not equipped to handle the resulting influx of patients who saw the ads and wanted to be tested for BRCA mutations [see PGx Reporter 09-26-2009].

In response to a request for comment on Myriad's partnership with MRS, Aetna issued the following statement: “While we don't know enough about the collaboration between Myriad and the MRS to provide comment, Aetna believes that the decision to undergo genetic testing for inherited susceptibility to breast or ovarian cancer should take place after formal genetic risk assessment by a genetics trained clinician.”

Aetna, along with several other national payors, require women receive genetic counseling prior to BRACAnalysis testing.

Requests for comment to United Healthcare were not answered. Myriad did not respond to questions ahead of press time.

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