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 The test represents a first in the rapidly developing field of
"liquid biopsies," which use gene sequencing technology to screen
blood samples for trace amounts of DNA associated with different
cancers.
Several cancer diagnostic companies have been working on the tests,
a field that has recently been joined by makers of DNA blood
screening tests for fetal abnormalities after the tests detected
early cancers in expectant mothers. Cowen & Co estimates that use of
DNA blood tests for cancer screening will exceed $10 billion a year
by the end of the decade.
But the move by Pathway, a privately owned maker of genetic tests
ranging from cancer risk and heart health to drug response,
underscores a growing debate over how much genetic information
should be made available to healthy people if it is not yet clear
how it can improve their health.
The company has already run into trouble on a similar issue. In
2010, Walgreens pulled Pathway's genetic testing kits from its
pharmacies after U.S. health regulators warned patients might take
action without understanding the results.
Several oncology experts said liquid biopsy tests like Pathway's,
while exciting, still require large clinical studies proving they
help people beat cancer through early detection. Doctors will also
need a clear assessment of their accuracy.
"For any given test, the rate of false positives causing unnecessary
alarm and false negatives that provide false security should be
known," said Dr. Keith Stewart, an oncologist who heads Mayo
Clinic's Center for Individualized Medicine.
Pathway's screening test looks at 96 genetic markers associated with
major cancer types such as breast, ovarian, lung, colon and
melanoma. The company is focusing on mutations that are relatively
well-understood, and for which there are specific treatments, said
Chief Executive Jim Plante.
The cost to consumers begins at $299 to periodically check for DNA
in their blood that could act as an early warning sign of cancer.
The tests must be ordered by a doctor, based on a patient's risk
profile. A positive test will require additional checks to find
where the cancer is growing.
Pathway also launched a blood test for patients already diagnosed
with cancer to help determine whether a treatment is working, or
whether the disease is likely to return.
SCREENING VS MONITORING
Scientists have long known that cancers shed bits of genetic
material into the blood. Privately held Guardant Health and Personal
Genome Diagnostics Inc already offer blood tests for cancer
patients. Roche-backed Foundation Medicine Inc, Genomic Health Inc,
Illumina Inc and Sequenom Inc say they have similar tests in the
works.
But cancer experts say there are major differences between using
such tests to screen for cancer and monitoring patients who are
already known to have it.
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For example, some early cancers may not secrete DNA fragments into
the bloodstream and require other types of detection. A colonoscopy
can find and remove polyps before they pose a threat as colon
cancer.
"If we are relying on a test that can only detect cancer after it
has formed, we miss a huge opportunity to intervene," said Dr. Scott
Kopetz of the University of Texas MD Anderson Cancer Center.
Patients might be attracted to a less-invasive test for colon
cancer, but if it is less effective, it might result in more cases
of colon cancer, not fewer.
Another concern is that the tests may pick up on markers that are
never destined to be cancer, something already known to occur in
blood tests for prostate cancer, Kopetz said.
Pathway says its test is more than 99 percent accurate in detecting
mutations in blood samples that contain at least nine copies of a
tested mutation.
"We do expect to detect cancer DNA when the tumors are small - much
sooner than stage three or four," Plante said.
Dr. Bert Vogelstein, a cancer geneticist at Johns Hopkins University
in Baltimore, said Pathway's figure represents the test's technical
ability to detect DNA in the blood.
Doctors, however, need an indication of how many patients will get a
false positive result, something that can only be determined in a
very large clinical trial, said Vogelstein. He is advising two
companies developing liquid biopsy tests for cancer screening:
Sysmex and Personal Genome Diagnostics.
Plante said the company has started two clinical trials involving
patients but has yet to publish any results on how the tests perform
in people.
(Editing by Michele Gershberg and Matthew Lewis)
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