The American Society of Clinical Oncology Publishes Genetics Sequencing Best Practices

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The American Society of Clinical Oncology has published a new statement on when and how oncologists working in the trenches of cancer care should use genetic testing in care delivery, and calling on regulatory support to drive adoption. The new guidance is a revision of an ASCO statement published in 1996 addressing the potential clinical uses of early genetic tests. That statement was updated in 2003, and again in 2010 to incorporate new findings from genetic research.

In 2014, ASCO formed a workgroup to revise the statement again, this time to address the potential use of next-generation sequencing. Next-generation sequencing, or high-throughput sequencing, is an umbrella term used to describe several techniques that have led to the rapid decrease in the cost associated with DNA sequencing. With genetic testing now dropping to a level that would make it a financially affordable clinical tool, ASCO is weighing in on how the technology should be deployed. Specifically, the new statement focuses on the potential use of next-generation sequencing to develop personalized treatment plans and to screen for increased risk levels for certain cancers.

“More than 200 genetic tests are currently clinically available to help determine the risk of developing a variety of different cancers,” says the new guidance, though the labs offering these tests use a wide variety of techniques that cause problems for oncologists trying to interpret the results. Initially, labs performing DNA testing fell under Clinical Laboratory Improvement Amendment (CLIA) oversight, but CLIA had no technical standards to regulate the collection of samples, processing of tests, or reporting of results in the emerging DNA sequencing market. As a result, the FDA stepped in issuing warnings to labs that it intended to regulate the market through a risk-based framework that would establish standards for testing and results reporting. ASCO explicitly supports these steps in its guidance and goes on to recommend additional precautions the FDA could take when establishing its framework.

ASCO also recommends continued education for oncologists focused on genetics tests and their use in care delivery, and has updated its core competencies to include “competency in genetic testing for high-risk individuals,” and adequate knowledge of molecular genetics.

Lastly, ASCO is recommending an increase in coverage for certain patients that would benefit from genetic testing, noting that despite evidence that certain tests are reliable, many payers continue to provide inadequate access to these services. The statement argues that while ACA required that genetic testing and counseling for BRCA1/2 be covered as an essential service by payers, no other genetics testing was made required and has resulted in a pay gap in services oncologists would like to leverage and those that payers will reimburse for.


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