Approximately 20 percent of people with breast cancer have tumor types with increased levels of the HER2 protein. Accurately interpreting test results for this tumor marker or protein is vital to determining the right treatment. People with tumors that are HER2 positive benefit from trastuzumab therapy. People with HER2 negative tumors, however, are less likely to benefit from the drug. Poorly interpreted tests can expose people to the side effects of a drug they may not need or miss an opportunity to treat breast cancer with effective medications.
A medical professional society review of HER2 test accuracy found that as many as 20 percent of tests may be falsely positive; as many as 10 percent may be falsely negative.
"Accurate laboratory testing in breast cancer care is absolutely critical. This is the information from which subsequent treatment decisions follow," said Joanne Armstrong, MD, a senior medical director at Aetna and head of its genetics and women's health programs. "Lab quality for HER2 testing is of particular concern which is why Aetna has stepped forward to guide members and their physicians toward qualified labs that meet externally validated criteria."
Despite the growing availability of genetic tests, and new guidelines for quality testing, there is no publicly available source of information for consumers or health care professionals about which labs meet quality standards. Aetna is making clinicians aware of the quality issues in testing and encouraging them to use high-volume labs that meet guidelines from the American Society for Clinical Oncology/College of American Pathologists (ASCO/CAP). The company has sent letters to medical and surgical oncologists across the country with information about ASCO/CAP guidelines and the importance of using labs that meet those criteria.
Aetna's contracted labs, Genzyme Genetics, a division of Genzyme Corporation, and Quest Diagnostics, meet the guidelines. Both labs have been conducting HER2 testing since 1998.
Genzyme also is collaborating with Aetna to incent compliance with the ASCO/CAP guidelines and advance the quality of genetic laboratory tests. Genzyme has taken the proactive step of building quality standards into its contract with Aetna that tie reimbursement to specific targets of quality, testing volume, and turnaround time.
To further promote confidence in genetic tests for breast cancer, Aetna has a flexible reimbursement policy. Aetna will provide coverage for a repeat HER2 test performed at Quest Diagnostics or Genzyme Genetics if the accuracy of the original test result is uncertain and repeat testing will influence treatment decisions.
Aetna also is working with researchers to understand how doctors use genetic lab tests to inform their treatment recommendations for women with breast cancer. The Aetna Foundation is funding research at the University of California, San Francisco and Brigham and Women's Hospital to evaluate whether women with breast cancer are offered genetic tests that help physicians individualize patient treatment based on the results. The results of this research are expected to guide the future development of educational interventions and decision support tools for patients and clinicians.
The initiatives above build on Aetna's industry leadership in genetic medicine. Telephone and Web-based genetic counseling for inherited cancers is available through Informed Medical Decisions. This national genetic counseling company is staffed with board-certified genetic counselors. Aetna also has developed policies to promote the evidence-based use of genetic services and recently announced its support of the passage of the Genetic Information Nondiscrimination Act.
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