Better regulations are needed for quality assurance in commercial genetic and genomic testing for cancer susceptibility.
Better regulations are needed for quality assurance in commercial genetic and genomic testing for cancer susceptibility, and oncologists who order these tests for patients should seek training in cancer risk assessment and inherited cancer risks, according to the American Society of Clinical Oncology's (ASCO) newly updated policy statement on genetic and genomic testing. The policy statement was published online in the Journal of Clinical Oncology on Aug. 31, 2015.1
The policy statement reviews how emerging DNA-sequencing technologies are “transforming the assessment and identification of inherited cancer susceptibility,” and makes several key recommendations for the development and use of these tools.
“As cancer diagnosis and treatment is becoming more genetically-driven, new opportunities and questions are emerging about screening for hereditary cancers,” said ASCO President Julie Vose, MD, MBA, FASCO, in an ASCO press release. “ASCO is releasing this updated policy statement at this critical juncture to ensure that all interested parties thoughtfully consider these concerns as the future of genetic and genomic testing for cancer susceptibility unfolds.”2
New genetic and genomic sequencing technologies like next generation sequencing (NGS) are introducing “great complexity” to clinical oncology, the policy update notes. NGS allows rapid cataloguing of gene variants much more quickly – and inexpensively – than traditional genetic sequencing methods.
But clinicians and patients are not always familiar with these technologies or their limitations, or the genes included on multigene cancer susceptibility panels. Little is yet known about some genes that are included on commercially available multigene panels – and that could lead to overtreatment and unnecessarily aggressive cancer prevention efforts, such as surgery to remove breasts or ovaries, according to the authors.
“As this promising field moves forward, we must ensure that providers are well-versed in the diagnostic and treatment options available, that patients have access to genetic testing that identifies hereditary risk, and that these tests have appropriate regulatory oversight,” said Mark E. Robson, MD, Chair of ASCO’s Ethics Committee and lead author of the updated policy statement.2
The US Food and Drug Administration is currently considering whether or not to more closely regulate these tests, which are currently regulated under the Clinical Laboratory Improvement Amendments. Existing regulations do not require that the tests’ validity or clinical utility be demonstrated before they are made commercially available.
In addition to calling for regulation, the authors also recommended research should be conducted to develop “best practices” guidelines for telling patients about incidental or secondary germ-line mutation findings. More also needs to be learned about how best to educate patients about these tests and their limitations before testing, the authors believe. They also recommended that testing laboratories “should develop mechanisms to report only somatic results for patients who decline to receive germ-line findings.”
“Providers with particular expertise in cancer risk assessment should be involved in ordering and interpreting multigene panels that include genes of uncertain clinical utility and genes not suggested by the patient’s personal and/or family history,” the authors recommended. “Further, ASCO encourages research to delineate the optimal use of panel-based testing, development of evidence-based practice guidelines as data emerges, and education of providers on the challenges of using these tests.”
ASCO’s policy statement update also called for health insurance coverage policies that ensure access to cancer risk assessment and prevention services for patients suspected to be at increased genetic risk for cancer. “Coverage of cancer genetic counseling and testing has improved over the last several years, but some payers still provide inadequate access to these services,” the authors wrote.
Oncologists also need to be better prepared to interpret and explain gene test results to their patients, in part because there are too few genetic counselors to meet increasing demand, Dr. Robson suggested in a May 2015 interview.