The Pathfinder study involved 6600 participants that were aged 50 and older that were given the blood test along with other current screening methods in order to see whether the Galleri test could find cancers that were not being found in the traditional methods.
The test, which was developed by GRAIL, aims to detect these cancers at a time when the disease would be most vulnerable to treatments. Cancers that are found in stage I and stage II have a much higher survival rate, so diagnostics are truly a critical tool in preventing deaths from cancer, which is as high as 10 million around the world.
From the whole sample, the test was able to find cancer in 1% of people, and within that 1%, some types that were found do not have any current screening methods in place, meaning that these cancers could have continued to grow and develop way before they would have been detected. After the test was paired with other screening methods, the numbers grew exponentially.
Dr. Jeffrey Venstron, chief medical officer at GRAIL, shared in a statement: “When added to standard of care screening, MCED [Multi-Cancer Early Detection] testing more than doubled the number of cancers detected compared to standard screening alone. In fact, Galleri detected more cancers than all U.S. Preventive Services Task Force-recommended standard single cancer screenings combined. These included Stage I cancers of the liver, small intestine, and uterus, and Stage II pancreatic, bone, and oropharyngeal cancers. This is particularly notable given the PATHFINDER population was heavily screened with higher-than-average rates for mammography, colonoscopy, and low-dose CT lung scans.”
From the total sample, there were 35 participants that were diagnosed, of which there were 36 types of cancers, and 25 of those were cancers that did not have currently used screening tests. About half of the non-recurrent cancers were detected either at stage I or stage II, so effective treatment is likely to be found. Some of the cancers that were found include ovarian and pancreatic, which are usually detected at a much later stage with poor prognosis.
The cancer signaling test was found to have 97% accuracy in finding the cancer’s origin. The participants also noted that they had low levels of anxiety about test results, which is much better than testing methods like liquid biopsies. Fewer than 1% of the participants had false positive results.
Dr. Josh Ofman, the president of GRAIL said: “Every year, we lose more than 600,000 loved ones to cancer in the U.S. alone. Unfortunately, the burden of cancer will grow with the demographic tidal wave, as the absolute risk of developing any cancer increases as we get older.”
He continued: “Bending the cancer mortality curve will require earlier detection of more cancer. However, a world with more single cancer screening tests is simply clinically and economically untenable as each single cancer screening test has a false positive rate of 5-10 percent. We need to expand from screening for individual cancers to also screening individuals for cancer. We believe MCED tests can enable this paradigm shift by finding more types of cancer at earlier stages with a single blood test.”