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Should We Sequence the DNA of Every Cancer Patient?

To match cancer patients with drugs, one company plans to offer free genetic tests.

A startup called Strata Oncology says it plans to give away advanced genetic tests to 100,000 patients struggling with cancer. But there's a profit motive: it hopes to identify patients with specific rare DNA errors and steer them to drug companies.

Strata, which was founded last year and has raised $12 million from investors, says it is set up to run 50,000 next-generation sequencing tests a year. Such tests probe the DNA of tumor tissue, searching for mutations in hundreds of genes at once, hoping to surface clues about what drug a patient should be taking. 

Similar tests are already offered commercially to doctors by several companies, including Foundation Medicine of Cambridge, Massachusetts, and can cost $5,000 each.

Strata’s unusual business plan of giving the tests away arose as a way to solve a cancer Catch-22. Because DNA sequencing tests are considered experimental by insurers, they don’t always pay for them. But without such data, drug companies are having difficulty locating patients for trials of new precision drugs that target specific DNA mutations.

“The purpose of the company is to dramatically accelerate enrollment into clinical trials by removing sequencing as a barrier,” says Dan Rhodes, Strata’s CEO and formerly an executive at Thermo Fisher, which sells sequencing equipment and is supplying the startup with machines.

The company arose out of a National Cancer Institute study, called the Match trial, which since last year has been offering free biopsies and DNA tests to patients around the U.S. It then assigns patients to receive one of 20 targeted medicines based on their tumor’s DNA, whether they have skin, lung, or brain cancer.

“What we are trying to find out is [what happens] if you ignore the disease and just focus on the mutation,” says Robert Comis, co-chair of the ECOG-ACRIN Cancer Research Group, the Philadelphia research organization that administers the Match study.

The Match study is free to join: the government covers both the cost of the tests and of biopsies, which can run another $15,000. Companies provide the drugs. Response to the study was so great that doctors had to put it on pause.

There’s anecdotal evidence that the development of precision drugs is being slowed by the lack of routine DNA tests. GlaxoSmithKline says it had to test 11,000 patients to locate just 23 it needed for a study of a lung cancer drug. That drug targeted a particular DNA mutation which appears in only 1 to 2 percent of patients. The company predicted that a large Phase III study would take 14 years to find enough patients.

“We need to boil the ocean, find the genetic populations, and get them on the trials,” says Keith Flaherty, an oncologist at Massachusetts General Hospital who helped lead the Match study and is also a founder of Strata. 

Cancer treatment is undergoing a transition. Until now, tumors have been assessed based on what a pathologist sees through a microscope. But it’s actually mutations to DNA that cause cells to go haywire. Several cutting-edge cancer drugs already require a genetic test, but usually for just a single gene, to determine if patients should get it.

What remains disputed is whether all patients should get a wider scan of their tumor DNA in an attempt to steer their treatment. Insurers cite a lack of evidence that routine DNA tests help. “We are sort of trickling toward precision medicine. Sequencing isn’t reimbursed because it’s not proven clinically, but it’s hard to prove without a big population of sequenced patients,” says Rhodes.

The debate over testing has even reached the White House. Prominent cancer doctors advising Vice President Joe Biden, who this year was appointed to lead a federal “cancer moon shot,” have told him that Medicare should pay for genomic testing of all tumors. That would lay the groundwork, they say, for a national database linking DNA to how patients fare in their cancer struggles.

A national effort, or a commercial one like Strata’s, could also help decrease disparities in who gets tested and who gets into promising trials. A few big centers, like Mass General, now DNA test every cancer patient. But most Americans are treated at regional cancer centers where testing isn’t routine. Rhodes says his company intends to partner with smaller hospitals so they can also offer DNA sequencing to every patient as well.

Strata will also have to strike agreements with pharmaceutical companies to assign patients to their studies. Rhodes says the company will be paid depending on how quickly it can fill the studies.

“I think that if Strata can really provide the service for free, that will put them in a different realm that hasn’t existed outside of the government,” says Comis. “The key message for these rare mutations is, you need everyone to coöperate. The barriers need to be eliminated.”

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