AMAC Exclusive – By Andrew Abbott
As COVID case numbers bust all records early in this new year and surge past a million positive tests a day—a number previously thought unimaginable—Americans might be tempted to believe there is no good news on the health front. But while the pandemic continues to vex us, there are some genuinely thrilling developments to be excited about in the battle against another killer that has been around far longer than COVID – cancer. A new test, known as Galleri and developed by the California-based healthcare company GRAIL, may hold the key to identifying some of the hardest to detect cancers in the human body – and do so using just a simple blood sample.
While many Americans undergo regular screening for certain types of cancer like breast cancer and prostate cancer, 71% of all cancer deaths are from cancers that are not commonly screened for. Moreover, these types of cancers are often deadly because they are not detected until they have spread to other parts of the body, which dramatically increases the fatality rate. In the United States alone, cancer accounts for around 600,000 deaths annually – significantly more than the number of people who died from COVID-19 last year. The Galleri test is hoping to change that by detecting more than 50 types of cancer from a single blood draw.
A 2021 study done in partnership with the Mayo Clinic, which tested the blood of 6,600 patients, revealed just how revolutionary the test may be. These individuals sent two vials of blood to the clinic. Researchers detected “29 signals from these samples, and accurately diagnosed them as cancer. The test results were available after an average of only ten days. Another study reported a false positive rate of less than 1 percent.” What this means in practice is that someone who may have a cancer that previously would have likely gone undetected until it was dangerously late was able to catch it early and seek treatment. To date, 134,000 patients have participated in clinical trials using the test.
Historically, blood testing has been largely ineffective in detecting cancer. Laboratory blood testing has been unreliable even in cancers that explicitly affect the blood, like lymphoma. That’s why so many cancer experts are calling the GRAIL test a “game-changer” when it comes to finding hard-to-detect cancers. According to Dr. Sandip Patel, a medical oncologist at UC San Diego, “The ability to detect cancer before imaging or clinical exam is, as the namesake of this test suggests, one of the holy grails in cancer care.”
The innovative test works by analyzing parts of the patient’s DNA found in their blood, which contains a DNA “signature.” When cancer cells replicate, they release a unique DNA signature that the Galleri test recognizes as different from normal DNA. According to GRAIL’s Dr. Julia Feygin, “We can find and sequence these tiny bits of tumor-derived DNA in the blood and, based on the patterns we see, we can reveal if there is a signal for cancer present. We can predict with very high accuracy wherein the body this cancer signal is coming from.”
For Feygin, this has been a deeply personal undertaking. When she was 13, she lost her father to pancreatic cancer when he was just 40 years old.
While the GRAIL team is actively working on making the test available to as many individuals as possible, there are still some limitations. The test has not received full FDA approval and is unlikely to get it anytime soon. As of December, the test was authorized only for people at an elevated risk of cancer, which includes the majority of individuals over the age of 50. Currently, it is available by prescription only, which can be obtained by talking with a healthcare provider or utilizing a telehealth provider (more information can be found on the company’s website). The test is not covered by insurance, and out-of-pocket costs are around $950.
Although the team behind the breakthrough acknowledges there is still a great deal of work left to do before reaching mass adoption of the test, the exciting development does provide a glimmer of hope for a future when cancers are detected early when treatment is most effective. Someday soon, this simple blood test may become as routine a part of preventative care for Americans as a prostate exam or mammogram, potentially saving hundreds of thousands of lives each year.
Andrew Abbott is the pen name of a writer and public affairs consultant with over a decade of experience in DC at the intersection of politics and culture.
Medical error is the third or fourth leading cause of death in this country. You are at greater risk in your Doctor’s office then driving on the freeway. How many false positives will this new test cause?
When will it be generally available and how much will it cost?
Theres always more work to do, but i would somehow fork out the 950
I am a full supporter of reliable blood tests to detect the possibility/probability of cancer. In my case, a blood test led to an MRI which led to a biopsy which led to treatment beginning during Stage II. Yea !!
The key word here is reliable.
The $950 question for most AMAC members is: “When will Medicare authorize reimbursement for the Galleri blood test ?”
The answer is: “When the test proves that it is more likely than not to lead to the detection of early stage cancers.”
While we are not there yet, in the interim, it makes sense to discuss the status of the research for the Galleri blood test with your personal physician. If the Galleri blood test passes the reliability test, it will be a game changer.
Sounds a lot like the Theranos hoax/fraud. Allow me to be skeptical until/if it’s independently verified.
Hope this is a reality and not another Theranos type scam.
This is very true. You have to be specific when ordering blood tests to find the cancer. When I had a patient and was doing a simple over all check on him, I noticed his sclerae were yellow. I asked his surgeon why. He was going to discharge him. He jumped up and ran in and checked. He immediately came back and ran certain labs. Turned out he had liver cancer AFTER he had had gall bladder removal. Wasn’t found previously. A simple physical assessment would have found that. As a nurse, giving that assessment, I had noticed. Should have rephrased, it was found, AFTER he had gall bladder removal. It was Stage II. He was started on chemo the next week.
Leave it to the FDA and they may not approve it… there might be too much money lost if someone actually came up with early cancer detection! Funny how insurance doesn’t cover something THIS accurate as well.$$$$$$$