While it has not yet received FDA approval, I expect this to follow.
How good is this test and should you get tested?
Blood tests have been used before to look for asymptomatic cancer. The grand daddy is the PSA (prostate specific antigen) test that has been used for almost 40 years to look for early prostate cancer. (Its value is still controversial after all this time.)
Other cancer markers have proven to only detect advanced cancer and are used to monitor patients with known cancers, but are not recommended for screening. Examples would be the CEA test, elevated in colon, pancreas, breast, ovarian and other cancers and CA125, elevated in ovarian and other cancers.
Two DNA tests are now approved to look for asymptomatic colon cancer: Shield and SimpleScreen. These very similar tests have the common problem of being very good at detecting advanced cancer but not very good at detecting precancerous polyps or small stage 1 cancers. They are recommended for screening only in people who refuse colonoscopy.
What about Galleri?
Large trials have shown that about 1% of people over 50 with no symptoms to suggest cancer will have a positive test. About half of those with a positive test do have cancer. The test is also able to identify the origin of the cancer in most cases.
The problem? The test is much better at detecting advanced cancers than stage 1 cancers. The trial failed its goal of reducing the numbers of stage 3 and 4 cancers in those tested compared to those not tested.
Should you ask for the test? You can get it now with a doctor’s prescription but must pay for it yourself, at a cost of $800-$950. Once it has FDA approval, many insurance companies will pay for the test but are not required to do so.
Until a better test is available that reliably picks up very early cancers, I do not plan to have one of these tests done. You may feel differently. It is a personal decision.
Whether you do or do not, it is crucial that you get regular mammograms and colonoscopies, which have been shown to detect cancers early, when the results are best. Galleri is not a substitute for these proven screening tests.
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