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 The guidelines aim to educate doctors about the risks and benefits
of new genetic tests, argue for regulation to assure quality and
call for more equitable reimbursement of the cost of the tests from
private and public insurers.
The falling price of genome sequencing has made it possible for
cancer doctors to cheaply test for a wide variety of mutated genes
that could guide treatment or predict a person's risk for cancer.
The multi-gene tests can help doctors identify ways to treat the
genetic drivers of cancer or guide treatment for people born with
genes that raise their cancer risk. But often the tests turn up
unexpected or ambiguous results, leaving patients and doctors
wondering what the results mean.
"It's like having an all-you-can-eat buffet, and is that a good
thing?" said Dr. Noralane Lindor, an oncologist and geneticist from
Mayo Clinic Center for Individualized Medicine and an ASCO
Prevention Committee member.
Lindor was one of several authors of the guidelines issued on Monday
by ASCO and published in the Journal of Clinical Oncology.
One key area in the study is the new practice of testing tumors for
mutations driving cancer growth. The tests can help suggest drugs
that target these mutations. But, depending on how they are done,
the tests can also uncover inherited cancer genes that could affect
other family members.
When doctors order these tests, ASCO recommends that patients are
informed about this possibility and be given the chance to opt out
of these findings if they choose.
The new guidelines also take on the area of multi-gene panel testing
for cancer susceptibility, such as genes linked to breast cancer.
The tests, produced by Myriad Genetics Inc, Ambry Genetics, Invitae
Corp and Illumina Inc and others, cover roughly 25 to 40 genes
suspected of contributing to breast cancer risk.
They have become increasingly popular since June 2013, when the U.S.
Supreme Court invalidated patents held by Myriad on BRCA1 and BRCA2,
two well-characterized genes that increase the risk for breast,
ovarian and other cancers.
"There are some genes on these panels that we know almost nothing
about," Lindor said.
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In the hands of an oncologist who does not fully understand the
findings, patients could be treated aggressively with surgery to
remove her breasts or ovaries for having mutations that would never
have caused them harm, said Lindor. "The possibility of doing harm
is very real."
The ASCO guidelines also call for better regulation of the tests to
assure quality without hampering access to them. The U.S. Food and
Drug Administration is considering regulating lab-developed tests,
which include most genetic tests.
Currently, these tests fall under guidelines established by the
Clinical Laboratory Improvement Amendments (CLIA) of 1988. Under
CLIA, such tests are not required to prove clinical validity or
utility, meaning information that aids patient care.
ASCO also recommends that cancer doctors and other health
professionals ordering cancer risk tests seek out additional
training in genetics.
In addition, the group wants insurers to establish coverage policies
that support genetic testing services to assess inherited cancer
risks. Currently, such coverage is uneven, Lindor said, with
Medicare, Medicaid and some private insurers putting up barriers to
patients receiving testing and counseling services.
(Reporting by Julie Steenhuysen; Editing by Bill Rigby)
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