Page 28 - ARUBA TODAY

A28 SCIENCE
Tuesday 5 december 2017

FDA approves first-of-a-kind test for cancer gene profiling

By MARILYNN MARCHIONE Coverage is proposed for
AP Chief Medical Writer patients with recurrent,
U.S. regulators have widely spread or advanced
approved a first-of-a-kind cancers, in people who
test that looks for mutations have decided with their
in hundreds of cancer doctors to seek further
genes at once, giving a treatment and who have
more complete picture of not previously had a gene
what’s driving a patient’s sequencing test.
tumor and aiding efforts to “A lot of these folks have run
match treatments to those out of treatment options,”
flaws. but the tests may point to
The U.S. Food and Drug something new that might
Administration approved help, Goodrich said.
Foundation Medicine’s test The impact is expected
for patients with advanced to be greatest on lung
or widely spread cancers, cancer, since so many of
and the Centers for those tumors are found at
Medicare and Medicaid an advanced stage and
Services proposed covering multiple gene-targeting
it. drugs are available to treat
The dual decisions, it.
announced late Thursday, Evidence isn’t strong
will make tumor-gene In this Aug. 15, 2017 file photo, patient Alison Cairnes, foreground, looks at images with her enough to warrant using
profiling available to far doctor Shumei Kato at the University of California San Diego in San Diego. Associated Press these gene profiling tests
more cancer patients than for earlier stages of cancer.
the few who get it now, CDx test can be used for officer of the American tests for several years under Patients get standard,
and lead more insurers to any solid tumor such as Society of Clinical more lax rules governing guideline-based care in
cover it. prostate, breast or colon Oncology, the association lab-developed tests. But those cases.
“It’s essentially cancer, and surveys 324 of doctors who treat the insurers have balked at In mid-November, the FDA
individualized, precision genes plus other features disease. paying for the tests, which also approved a gene-
medicine,” said Dr. Kate that can help predict “On balance I think this is cost around $6,000. profiling test developed by
Goodrich, chief medical success with treatments good,” but there is a risk Now, the FDA’s approval Memorial Sloan Kettering
officer for the Medicare that enlist the immune that spotting a mutation gives assurance of quality, Cancer Center, but it’s
oversight agency. system. will lead doctors and Shuren said, and the used almost exclusively on
Currently, patients may get patients to try treatments government’s proposed patients at that cancer
tested for individual genes if “Instead of one or two, you that haven’t been proven coverage for Medicare center and is not envisioned
a drug is available to target have many” tests at once to work in that situation and and other public insurance to be a widely available
those mutations. It’s a hit- from a single tissue sample, promote more off-label use programs means private commercial test.
and-miss approach that said the FDA’s Dr. Jeffrey of expensive drugs, he said. insurers will more likely The federal decisions will
sometimes means multiple Shuren. The tests give better A better outcome in those follow. make gene sequencing a
biopsies and wasted time. and more information to situations is to guide people Public comments on the more routine component
In lung cancer alone, guide treatment and can into studies testing drugs coverage proposal will of cancer care, “just like
for example, about half help more patients find and that target those genes, be taken for 30 days. A we normally look with a
a dozen genes can be enroll in studies of novel Schilsky said. final decision is expected microscope” to classify
checked with individual therapies, he said. Foundation Medicine, early next year followed the stage of a patient’s
tests to see if a particular “This will be a sea change” based in Cambridge, by setting a price for disease, said Dr. David
drug is a good match. for patients, said Dr. Richard Massachusetts, and others reimbursement. Klimstra, pathology chief at
The new FoundationOne Schilsky, chief medical have sold tumor profiling the cancer center.q