AP story suggests liquid biopsies may be 'a new frontier in cancer screening for healthy people'

Liquid biopsies, or blood tests that look for cancer by checking for DNA fragments shed by tumor cells, are being billed "as a new frontier in cancer screening for healthy people."

A story in this week's San Francisco Chronicle by Associated Press medical writer Carla K. Johnson notes that these tests already are being "used in patients with cancer to tailor their treatment and check if tumors come back."

But one California-based company, Grail, is promoting the $949 test, the article says, "as a way to detect tumors in the pancreas, ovaries and other sites that have no recommended screening method."

Most insurance companies do not cover the cost, and the tests are being marketed "without endorsements from medical groups or a recommendation from U.S. health authorities," Johnson's piece says.

The Associated Press also observes that Federal Drug Administration "authorization, clearance or approval of such tests is required by law, but the agency historically has not enforced most regulatory requirements for ones – like Grail’s – that are designed, manufactured and used within a single laboratory."

The story quotes FDA spokesman Jim McKinney as reporting that the agency is working with Congress on legislation "to update the regulatory framework, which would include active oversight for such tests."

Although Grill intends to get FDA approval, it currently is marketing its test "as it submits data to the agency."

Meanwhile, Johnson's piece says, "U.S. government researchers are planning a large experiment — with 200,000 participants and possibly lasting seven years — to see if the blood tests can live up to the promise of catching more cancers earlier and saving lives."

Dr. Lori Minasian

"They sound wonderful, but we don't have enough information," the story quotes Dr. Lori Minasian of the National Cancer Institute's Division of Cancer Prevention, 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."

Whereas screening tests — mammography, PAP, colonoscopy, for example — look for one cancer at a time, claims Dr. Joshua Ofman, an executive at Grail, the new blood tests look for many cancers at once, a definite advantage.

More information on testing for disease can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

15,000 results from Silicon Valley startup studied

Will new liquid biopsies replace painful, risky, invasive tumor tests? Perhaps, research says

Are painful, risky biopsies on the way out?

Maybe.

According to a recent story by Andrew Pollack in The New York Times, a new test known as a liquid biopsy can detect cancer mutations — with results that apparently agree, generally, "with those of an invasive tumor biopsy."

Conventional biopsies mean a needle or surgery extracts a piece of a tumor. But both those methods can lead to complications.

The liquid biopsies, the Times piece says, "take advantage of the fact that DNA fragments from tumors can be found in tiny amounts in the blood of patients with cancer."

Dr. Philip C. Mack

The story quotes researcher Philip C. Mack, Ph.D. director of molecular pharmacology at the U.C. Davis Comprehensive Cancer Center, who presented his result at the annual meeting of 
the American Society of Clinical Oncology.

The findings come from a study that looked at the results of more than 15,000 liquid biopsies performed by Guardant Health, a Silicon Valley startup, on people with breast, lung, colorectal and other cancers.

So far, the liquid test only monitors disease progression or detects the genetic mutations "that could suggest which drug should be used," according to The Times, and is not yet used to diagnose cancer.

And it isn't cheap — with a list price of $5,800.

Dozens of companies, The Times notes, "are now developing or offering liquid biopsies, and tissue biopsy companies are trying to defend their turf."

Cancer research is extensive. To learn more about it, check out "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.