NEW YORK (GenomeWeb) – The American Society of Clinical Oncology released an updated policy statement today recommending ways in which advanced genomic testing tools may be utilized appropriately for assessing cancer risk.
In the statement, published in the Journal of Clinical Oncology, ASCO also recommended "appropriate regulation of tests that detect inherited genetic variants," provided its support for risk-based US Food and Drug Administration-regulation of laboratory-developed tests (LDTs) and commercial assays, and called for improved insurance coverage for genetic counseling and cancer risk assessments.
The new statement comes out of ASCO's recognition of the growing availability of advanced genomic tools in cancer diagnosis and treatment. The group estimates that 10 percent of all cancers have links to an inherited mutation. However, "new technology is introducing great complexity," and presenting challenges for doctors, patients, and the overall healthcare system, ASCO's cancer prevention and ethics committees said in JCO.
One disruptive technology is next-generation sequencing, which is being increasingly used to guide treatment strategies for cancer patients. However, these types of tests can also identify germline mutations associated with future cancer risk, which can be passed on to children. Given the breadth of these testing capabilities, ASCO supports further research on how incidental findings should be delivered to patients, as well as on patient preferences and informed consent procedures.
The American College of Medical Genetics and Genomics' current policy is that qualified healthcare professionals should obtain written consent from patients for clinical exome or genome sequencing, explain the uncertainty and privacy issues associated with such testing, and discuss the potential impact results could have on family members. Additionally, the group has recommended analysis and reporting of variants in 56 "highly medically actionable" genes associated with 24 inherited conditions, but patients can opt out of this analysis.
The Association for Molecular Pathology also weighed in earlier this year on what it calls secondary findings from genome sequencing tests.
According to ASCO's latest policy, labs conducting such secondary analysis should develop procedures for reporting only somatic mutations for cancer patients who don't wish to learn about their inherited risks. Furthermore, providers should educate patients prior to testing that it could potentially reveal germline markers, and discuss the limitations and risks of this information.
Test panels that gauge multiple genes may reveal markers that confer risk for cancers that the patient wasn't anticipating learning about, or markers with unclear recommendations or uncertain links to cancer. This might lead to inappropriate care or increased stressed for the patient, ASCO observed. As such, the group recommended that "providers with particular expertise in cancer risk assessment" order and interpret multi-gene panels that include such markers, and encouraged research into optimal use of these tests.
According to the ASCO, oncologists often assess patients' inherited cancer risks as part of their jobs, but the field is moving so fast and the science is becoming so complex that they need more education. The association recommended programs teach new trainees "a set of core skills" and practicing oncologists take continuing medical education courses to stay up to date in the field.
Regulation and reimbursement
ASCO estimates there are currently more than 200 genetic tests available for assessing cancer risk. However, labs performing these tests use different methods for classifying and reporting detected variants, which can make it hard for providers to interpret results for patients.
Calling for "appropriate regulation" of genetic tests for inherited cancer risk, ASCO said it supports risk-based regulation of LDTs and commercial assays by the US Food and Drug Administration in ways that doesn't hinder innovation or patient access. The agency has proposed a draft framework for LDTs, but the guidance has been controversial among lab industry players and pathologists.
However, ASCO said in a statement that the "absence of a uniform regulatory framework for new genetic sequencing technology could lead to compromises in patient care." The association further backed efforts to create open-access databases for annotating genomic variants — a project that the NIH has undertaken with the Clinical Genome Resource, or ClinGen.
Additionally, ASCO said that insurance coverage policies for genetic counseling and testing have improved over the years, but coverage is still lacking. "Some payors still provide inadequate access to these services," ASCO said, noting that policies should facilitate access to prevention services and cancer risk assessment for those suspected to be at heightened genetic risk.
"ASCO opposes any payment policies that have the potential to negatively impact the care of cancer patients by serving as a barrier to the appropriate use of genetic testing services," the group said.