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

December 1, 2017 by Marilynn Marchione
FDA approves first-of-a-kind test for cancer gene profiling
In this Aug. 15, 2017 file photo, patient Alison Cairnes, foreground, looks at images with her doctor Shumei Kato at the University of California San Diego in San Diego. Tumor profiling that sequenced Cairnes' cancer genes helped identify a treatment that proved effective for her gastric cancer. On Thursday, Nov. 30 the U.S. Food and Drug Administration approved one such test by Foundation Medicine. (AP Photo/Gregory Bull, File)

U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what's driving a patient's tumor and aiding efforts to match treatments to those flaws.

The U.S. Food and Drug Administration approved Foundation Medicine's test for with advanced or widely spread cancers, and the Centers for Medicare and Medicaid Services proposed covering it.

The dual decisions, announced late Thursday, will make tumor-gene profiling available to far more patients than the few who get it now, and lead more insurers to cover it.

"It's essentially individualized, precision medicine," said Dr. Kate Goodrich, chief medical officer for the Medicare oversight agency.

Currently, patients may get tested for individual if a drug is available to target those mutations. It's a hit-and-miss approach that sometimes means multiple biopsies and wasted time. In alone, for example, about half a dozen genes can be checked with individual tests to see if a particular drug is a good match.

The new FoundationOne CDx test can be used for any solid tumor such as prostate, breast or colon cancer, and surveys 324 genes plus other features that can help predict success with treatments that enlist the immune system.

"Instead of one or two, you have many" tests at once from a single tissue sample, said the FDA's Dr. Jeffrey Shuren. The tests give better and more information to guide treatment and can help more patients find and enroll in studies of novel therapies, he said.

"This will be a sea change" for patients, said Dr. Richard Schilsky, chief medical officer of the American Society of Clinical Oncology, the association of doctors who treat the disease.

"On balance I think this is good," but there is a risk that spotting a mutation will lead doctors and patients to try treatments that haven't been proven to work in that situation and promote more off-label use of expensive drugs, he said.

A better outcome in those situations is to guide people into studies testing drugs that target those genes, Schilsky said.

Foundation Medicine, based in Cambridge, Massachusetts, and others have sold tumor profiling tests for several years under more lax rules governing lab-developed tests. But insurers have balked at paying for the tests, which cost around $6,000.

Now, the FDA's approval gives assurance of quality, Shuren said, and the government's proposed coverage for Medicare and other public insurance programs means private insurers will more likely follow.

Public comments on the coverage proposal will be taken for 30 days. A final decision is expected early next year followed by setting a price for reimbursement.

Coverage is proposed for patients with recurrent, widely spread or advanced cancers, in people who have decided with their doctors to seek further treatment and who have not previously had a gene sequencing test.

"A lot of these folks have run out of treatment options," but the tests may point to something new that might help, Goodrich said.

The impact is expected to be greatest on lung cancer, since so many of those tumors are found at an advanced stage and multiple gene-targeting drugs are available to treat it.

Evidence isn't strong enough to warrant using these gene profiling tests for earlier stages of cancer. Patients get standard, guideline-based care in those cases.

In mid-November, the FDA also approved a gene-profiling test developed by Memorial Sloan Kettering Cancer Center, but it's used almost exclusively on patients at that cancer center and is not envisioned to be a widely available commercial test.

The federal decisions will make gene sequencing a more routine component of cancer care, "just like we normally look with a microscope" to classify the stage of a patient's disease, said Dr. David Klimstra, pathology chief at the .

Another leader in this field, Caris Life Sciences, says it also intends to pursue FDA approval for its widely used tumor profiling , sold now through lab certifications. It's also working on a newer tool to profile tumor genes from a blood sample. Many companies already sell these so-called liquid biopsy tests, though none are FDA-approved yet.

Explore further: Ultra-personal therapy: Gene tumor boards guide cancer care

Related Stories

Ultra-personal therapy: Gene tumor boards guide cancer care

October 18, 2017
Doctors were just guessing a decade ago when they gave Alison Cairnes' husband a new drug they hoped would shrink his lung tumors. Now she takes it, but the choice was no guesswork. Sophisticated gene tests suggested it would ...

Researchers find genetic pathways to individualized treatment for advanced prostate cancer

November 1, 2017
Researchers at Mayo Clinic Center for Individualized Medicine have uncovered genetic clues to why tumors resist a specific therapy used for treating advanced prostate cancer. This discovery can guide health care providers ...

Tumor gene test results can differ in same patients

December 15, 2016
A preliminary study comparing two commercially available, next-generation genetic sequencing tests in the same cancer patients shows results can differ widely. The findings are reported Dec. 15 in JAMA Oncology.

The big question: Will cancer immune therapy work for me?

September 20, 2017
Dennis Lyon was a genetic train wreck. Cancer was ravaging his liver, lungs, bones and brain, and tests showed so many tumor mutations that drugs targeting one or two wouldn't do much good. It seemed like very bad news, yet ...

Novel government cancer study will test precision medicine

June 1, 2015
The federal government is launching a very different kind of cancer study that will assign patients drugs based on what genes drive their tumors rather than the type.

New approach to genetic testing leads to dramatic response in MET fusion lung cancer

August 30, 2017
There are many ways a gene can be altered and there are many genes that, when altered, can cause cancer. Testing individually for each possible alteration in every cancer-related gene is not feasible as it would require hundreds ...

Recommended for you

Drug suppresses spread of breast cancer caused by stem-like cells

December 12, 2017
Rare stem-like tumor cells play a critical role in the spread of breast cancer, but a vulnerability in the pathway that powers them offers a strategy to target these cells using existing drugs before metastatic disease occurs, ...

MRI scans predict patients' ability to fight the spread of cancer

December 12, 2017
A simple, non-invasive procedure that can indicate how long patients with cancer that has spread to the brain might survive and whether they are likely to respond to immunotherapy has been developed by researchers in Liverpool.

Insights on how SHARPIN promotes cancer progression

December 11, 2017
Researchers at Sanford Burnham Prebys Medical Discovery (SBP) and the Technion in Israel have found a new role for the SHARPIN protein. In addition to being one of three proteins in the linear ubiquitin chain assembly complex ...

Glioblastoma survival mechanism reveals new therapeutic target

December 11, 2017
A Northwestern Medicine study, published in the journal Cancer Cell, has provided new insights into a mechanism of tumor survival in glioblastoma and demonstrated that inhibiting the process could enhance the effects of radiation ...

A new weapon against bone metastasis? Team develops antibody to fight cancer

December 11, 2017
In the ongoing battle between cancer and modern medicine, some therapeutic agents, while effective, can bring undesirable or even dangerous side effects. "Chemo saves lives and improves survival, but it could work much better ...

Liver cancer: Lipid synthesis promotes tumor formation

December 11, 2017
Lipids comprise an optimal energy source and an important cell component. Researchers from the Biozentrum of the University of Basel and from the University of Geneva have now discovered that the protein mTOR stimulates the ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.