I’ve had the pleasure of covering GRAIL for several years. And no one can say that the company doesn’t get enough publicity.
But the coverage can at times be misguided and now and then it can just get downright clueless.
GRAIL, whose Galleri liquid biopsy test to detect cancer has achieved an enormous amount of publicity and success in the last several years, is a smart and ambitious company that is just getting started.
The company is easily the most discussed and misunderstood of all the new liquid biopsy concerns. But importantly they are already saving lives.
On the company website, it states the following:
Routine cancer screening looks for only 5 cancer types – breast, colorectal, cervical, prostate, and lung.
Many cancers are often found too late, when patients present with symptoms of late-stage disease, making prognosis poor and treatment more difficult.
The earlier that cancer is diagnosed, the greater the chance of successful treatment and survival. Routine screening improves the chances of finding cancer in earlier stages when treatment may be more successful.
What Can Galleri Do
Jeffrey Venstrom, MD, Senior Vice President of Medical Affairs and Chief Medical Officer at GRAIL, is guiding this company along with his fellow executives at a smart but deliberate pace. The company’s had a few road bumps.
But he is very optimistic about the company’s future.
Galleri is a multi-cancer early detection (MCED) test that has demonstrated the ability to detect a shared cancer signal across more than 50 types of cancer through a routine blood draw.
According to GRAIL, the Galleri test can improve the opportunity for asymptomatic early detection by screening for multiple cancers, most of which lack recommended screening tests.
Galleri has demonstrated a low false positive rate and high positive predictive value (the proportion of people with a positive screening result who are diagnosed with cancer) in asymptomatic people at an elevated risk for cancer.
The test uses next-generation sequencing and machine-learning algorithms to isolate cell-free DNA and analyze methylation patterns to detect if a cancer signal is present.
If a cancer signal is detected, the Galleri test predicts the cancer signal origin, or the tissue or organ where the cancer signal originated, to help guide diagnostic evaluation.
The Galleri test requires a prescription from a licensed health care provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening.
It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older.
For more information, visit grail.com.
For more information, visit galleri.com.
Most people want to know if they have cancer. And they also want to know what stage the cancer is. Liquid Biopsy companies are bringing that technology into the mainstream.
But it’s a challenge as the old guard tries to put up a fight.
With a simple blood draw used in addition to current single-cancer screenings, Galleri can identify DNA shed by cancer cells to help screen for some of the deadliest cancers that don’t have recommended screening today, including pancreatic, esophageal, ovarian, liver and others.
Studies have shown a 75% sensitivity for screening cancers responsible for two-thirds of cancer deaths, rising as high as 80% for the most serious cancers.
Galleri notes on the website that it can indicate the origin of the cancer with 88% accuracy, giving doctors a roadmap for where to explore further.
Galleri Saved His Life
Roger Royse wasn’t sick when he decided to do Grail’s Galleri test. But he cares deeply about his health, and as someone who is reaching his mid-60’s he knew he was in the age category in which cancers do begin to appear in the body.
He just wanted to be smart about his health and wanted to know if there were any lingering issues in his body. Two doctors refused to give him the test.
He eventually found a telemedicine doctor to order it. The test showed signals indicative of pancreatic cancer. Royse was diagnosed with stage 2B pancreatic cancer in July 2022.
He bought an MRI from prenuvo that day and was scanned at 6 am the next morning.
“It found a suspicious mass in my pancreas. A biopsy confirmed that it was Stage 2b,” he said when speaking to the Wall Street Journal and later told Breaking Cancer News.
Now Royse is in remission.
As he says to anyone who asks, “For those who say that early detection does not improve outcomes, I refute this by my own survival. I am exhibit A.”
One of the radiologists told Royse that he was the luckiest person he had ever met since he never would have had symptoms until it was very advanced.
He believes the FDA should approve these tests so doctors will prescribe them as matter of course just like other cancer tests like a prostate, breast, colon, etc.
Another Major New Study
Meanwhile, the company’s Galleri-Medicare study seeks to compare up to 50,000 Medicare beneficiaries who have received usual care plus an annual Galleri test with a matched comparator arm of beneficiaries who receive usual care alone.
Medicare will cover the costs of Galleri and related and routine items and services for study participants.
Although recommended cancer screening tests save lives, they are only available in the U.S. for three types of cancers for women, and two types for men, with an additional screening for those with a heavy smoking history.
“Multi-cancer early detection holds the promise to detect more cancers earlier, improve cancer outcomes, and reduce overall cancer costs, but only if accessible to all seniors,” said Bob Ragusa, chief executive officer at GRAIL in a press statement.
“The Galleri-Medicare study demonstrates our commitment to provide broad, equitable access to early cancer detection that is representative of the U.S. population, including groups that are often under-represented in clinical research.”
Added Ragusa, “GRAIL designed the Galleri-Medicare study to meet the aspirations of the Cancer Moonshot’s goal of advancing early detection, add to our robust ongoing real-world evidence generation, and continue to demonstrate Galleri’s clinical benefit for early detection.”
