FOR IMMEDIATE RELEASE:
January 11, 2010

CONTACT:
Aaron Tallent
(571) 483-1371
aaron.tallent@asco.org

Society Releases Updated Policy Statement on Genetic and Genomic Testing for Cancer Susceptibility

ALEXANDRIA, Va.— To keep up with the ever-increasing advances in genetic science, today the American Society of Clinical Oncology (ASCO) issued its latest recommendations for genetic testing for cancer susceptibility. The updated statement addresses new developments over the past seven years, including the availability of genetic tests of unproven clinical benefit and direct-to-consumer (DTC) genetic testing. 

Genetic testing is used to predict the risk of disease, identify carriers (individuals who do not have the disease but have a copy of the disease gene) of disease, diagnose disease, or determine the likely course of a disease. More than 900 genetic tests are available for many different diseases, including breast, ovarian, colon, and some rare cancers. Approximately 5 percent to 10 percent of all cancers are considered to be hereditary, or due to inherited genetic susceptibility. 

“The awareness of individual genetic differences within the population has sparked a number of significant developments and an unprecedented level of raw information being made available, not only to health professionals, but also to the public in the form of direct-to-consumer tests. ASCO’s updated recommendations on genetic and genomic testing attempt to get back to the basics – patient safety and clinical utility – for the individuals considering genetic testing and the doctors who offer testing or may be asked by patients to interpret direct-to-consumer test results.” said Kenneth Offit, MD, MPH, Chief of Clinical Genetics Service at Memorial Sloan-Kettering Cancer Center, Chair of ASCO’s Ethics Committee and senior author of the statement.

The updated statement advises that when determining the role of genetic testing in cancer care, it is useful to consider whether tests are professionally mediated and have clinical utility. To date, most genetic testing for cancer susceptibility can be categorized as professionally mediated and of accepted clinical utility. However, the emergence of DTC testing and tests with unproven clinical utility are beginning to require health care providers, patients, and other consumers of genetic information to think in new ways about genetic testing in oncology and preventive care.

The statement update recommends that oncologists and other health care providers who offer genetic tests continue to be guided by ASCO’s 2003 statement, which says that testing should be offered when the following criteria are met:

• the individual being tested has a personal or family history suggestive of genetic cancer susceptibility;
• the genetic test can be adequately interpreted;
• the test results have accepted clinical utility.

However, the statement also acknowledges that emerging technologies like genomic profiling for low penetrance genetic variants (markers of very low disease risk) may be appropriate for patients who do not have a personal or family history suggestive of cancer risk. Patients may undergo genetic testing outside of the traditional patient-health care provider setting through the use of DTC tests, but may ask their health care providers for assistance in interpreting the test results and obtaining follow-up care. For any genetic test, the statement urges health care providers to recommend follow-up care that is based on established cancer risk factors such as family history, behavioral factors, environmental exposures, and scientifically-validated tests for cancer risks.

ASCO also reaffirms its position that all genetic testing should be conducted with pre- and post-test counseling and recommends that DTC testing companies provide this counseling or refer people to independent providers of these services.

For tests with unproven clinical utility, including genomic risk assessments that test for gene variations, the statement recommends that they be administered in the context of clinical trials, wherever possible. ASCO has previously noted that prospective clinical trials, large registries and retrospective reviews are the most accurate method for determining the clinically responsible use and effectiveness of individual genetic tests. In addition, ASCO supports increased funding for basic, translational, and multi-disciplinary research in clinical cancer genetics, including research to help establish an evidence base for tests that are offered on the basis of personal utility, not clinical utility.

ASCO also recommends increased oversight by the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that sets standards for the accuracy, validity and quality of genetic tests and testing laboratories. To facilitate increased oversight, ASCO supports the creation of a mandatory, publicly available registry that requires the manufacturers of genetic tests, including DTC tests, to disclose information about their tests’ analytic validity, clinical validity, and clinical utility.

Genetic testing for cancer risk is predictive testing, which means a test can help predict the likelihood that an individual will develop cancer in his or her lifetime. Not everyone with a cancer-related gene will develop cancer. For example, a woman whose genetic test indicates a 75 percent chance of developing breast cancer may remain healthy, while a woman whose genetic test indicates a 25 percent chance of developing breast cancer may eventually develop cancer.

ASCO released its first statement on genetic testing for cancer susceptibility in 1996, and last updated its recommendations in 2003. In conjunction with this latest update published today, ASCO has developed a podcast and information article for people living with cancer, which can be found on its patient website, www.cancer.net.

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This statement is being published in the January 11 issue of the Journal of Clinical Oncology (JCO), the semi-monthly peer-reviewed journal of the American Society of Clinical Oncology (ASCO), the world’s leading professional society representing physicians who treat people with cancer.

For a copy of the statement, please contact Aaron Tallent at Aaron.Tallent@asco.org.

The American Society of Clinical Oncology (ASCO) is the world’s leading professional organization representing physicians who care for people with cancer. With more than 28,000 members, ASCO is committed to improving cancer care through scientific meetings, educational programs and peer-reviewed journals. For ASCO information and resources, visit www.asco.org. Patient-oriented cancer information is available at www.Cancer.Net.