New Era of Cancer Screening - The Galleri Test by Grail

Greetings! Back in May Harper Health began offering a new revolutionary blood test for early cancer detection. The test is called Galleri (by GRAIL). This cutting-edge technology allows for the EARLY detection of up to fifty different types of cancer before it would otherwise be found. Tests like these could be the “Holy Grail” of the cancer screening world.

One of Harper Health’s key missions is to promote wellness and be on the leading edge of preventive healthcare. This test has already had an impact our patients’ health. With one of our patients the test identified the presence of breast cancer cells. We were subsequently able to find a small new breast cancer in a patient in between her usual screening mammograms. It has already been a game changer.

We know that we are more likely to survive cancer if we find it at an earlier stage. However, effective screening protocols to find cancer at an early stage have only been approved for a few types of cancer: colon, breast, cervical, lung in smokers, and prostate in discussion with patients. So, unfortunately, most types of cancer are detected only when symptoms present themselves, when survival rates are much lower. In fact, 70% of cancer deaths in America are in cancers that we DON’T screen for. My father died of one of those cancers.

Galleri changes this paradigm.

GRAIL’s first-to-market cancer detection panel went live in May, and Harper Health was one of the nation’s first private clinics to offer it. At this time it is a cash-only test (around $1000) so if it fits in your budget we recommend the Galleri test for adults aged 50 or older or for younger individuals with a higher-than-usual risk of cancer. The Galleri test is intended to be used in addition to, but not replace, other cancer screening tests that are currently recommended.

How does it work? We send GRAIL a sample of your blood and they use the Galleri test to look for the genetic changes that happen to the DNA when a normal cell turns to cancer. When a cancer cell finishes its lifespan, it releases this abnormal DNA into the blood stream. “Cell-free DNA” is then isolated by the Galleri test for identification. Galleri detects the actual presence of cancer; not simply th risk for cancer as is included in other genomic tests we have offered. If the test identifies cancer, further scans, biopsies, and other procedures will be necessary to confirm and then stage the cancer.

Powerful new technology like this has many implications, some unforeseen. We have tried to think through the practical application of this test and anticipate potential problems. For example, the test is highly specific, having a less-than 1% false positive detection rate. Approximately one out of 100 tests will be abnormal and of those, half will be a true cancer. So, this means that in some siutations the test will suggest the presence of a particular cancer, but we won’t be able to find it on further testing. One can imagine the anxiety and uncertainty that this would bring. We, along with GRAIL, have protocols in place to deal with this rare situation.

We emphasize, though, that for the other cancers we screen for (listed above) we accept a false positive rate significantly higher than this. How many times have you heard that a loved one had to go back to have more x-rays taken of her breast because they saw something the first time. How many times was it nothing? Significantly more often than not. Grail does better.

Furthermore, it remains unclear how the insurance industry will receive this enhanced capability for detection. Will insurance cover the necessary imaging studies due to a positive Galleri test result? It’s so early that we don’t know that answer yet but will work with you on getting the subsequent workup as economically as possible.

To make sure that test implications and possibilities are fully understood it is imperative that you have a discussion with your Harper Health clinician prior to ordering. So, Harper Health is making the Galleri test an optional part of your annual exam. Let us know if you’d like to do the test outside of that event.

We understand that not everyone will opt for the test due to some of the issues raised above, and that is completely understandable. As of now, Galleri is not covered by Medicare or any third-party health plan. It takes approximately two weeks to get the results, and we will follow up with you as soon as the results come to us. It is recommended by GRAIL to get the Galleri test annually, which you can discuss with your provider.

We hope you share our enthusiasm for this unique and innovative screening test for cancer. It promises to offer innovative, safe, and effective technology that can transform cancer screening and cancer care. Please visit the Galleri website (www.galleri.com) to review frequently asked questions and view the brief animated video:What is the Galleri Test?

We anticipate many questions. As always, we will be available to answer them.

More to come,

Dr. Will