Joyce Ares had just turned 74 and was feeling fine when she agreed to give a blood sample for research. So she was surprised when the screening test came back positive for signs of cancer.
After a repeat blood test, a PET scan and a needle biopsy, she was diagnosed with Hodgkin lymphoma.
“I cried,” the retired real estate broker said. “Just a couple of tears and thought, ‘OK, now what do we do?’”
The Canby, Oregon, resident had volunteered to take a blood test that is being billed as a new frontier in cancer screening for healthy people. It looks for cancer by checking for DNA fragments shed by tumor cells.
Such blood tests, called liquid biopsies, are already used in patients with cancer to tailor their treatment and check to see if tumors come back.
Now, one company is promoting its blood test to people with no signs of cancer as a way to detect tumors in the pancreas, ovaries and other sites that have no recommended screening method.
It’s an open question whether such cancer blood tests — if added to routine care — could improve Americans’ health or help meet the White House’s goal of cutting the cancer death rate in half over the next 25 years.
With advances in DNA sequencing and data science making the blood tests possible, California-based Grail and other companies are racing to commercialize them.
And U.S. government researchers are planning a large experiment — possibly lasting seven years and with 200,000 participants — to see if the blood tests can live up to the promise of catching more cancers earlier and saving lives.
“They sound wonderful, but we don’t have enough information,” said Dr. Lori Minasian of the National Cancer Institute, who is involved in planning the research. “We don’t have definitive data that shows that they will reduce the risk of dying from cancer.”
Grail is far ahead of other companies with 2,000 doctors willing to prescribe the $949 test. Most insurance plans don’t cover the cost. The tests are being marketed without endorsements from medical groups or a recommendation from U.S. health authorities. Review by the Food and Drug Administration isn’t required for this type of test.
“For a drug, the FDA demands that there is a substantial-high likelihood that the benefits not only are proven, but they outweigh the harms. That’s not the case for devices like blood tests,” said Dr. Barry Kramer of the Lisa Schwartz Foundation for Truth in Medicine.
Grail plans to seek approval from the FDA, but is marketing its test as it submits data to the agency.
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Can cancer blood tests live up to promise of saving lives?