Grail, a biotechnical company based out of California and with locations in Washington, DC, Research Triangle Park NC, and London, UK, has developed new multi-cancer early detection (MCED) test that checks a person’s blood for cancer. The company has conducted many clinical studies with over 380,000 participants.
The Galleri test can detect 50+ types of cancer before a person has any symptoms including cancers that do not currently have recommended screening. This is important because 7 out of 10 deaths from cancer are from the types of cancer that do not have recommended screening. You can find a list of the types of cancer the test can detect on the Galleri website.
How can a blood test show signs of cancer? Cancer cells “shed DNA fragments” that can show up in blood. Grail testing uses a combination of machine learning algorithms and pattern recognition to read patterns. The test’s three scientific steps are:
- Extract and sequence the DNA fragments from the blood to “read” the methylation patterns (assay)
- Determine if DNA fragments may have originated from cancerous cells (machine learning classifier)
- If cancerous DNA fragments are identified, use pattern recognition to predict the organ associated with the DNA fragments (cancer signal origin prediction, or CSO)
Just about a week ago, on September 23rd, the U.S. Food and Drug Administration (FDA), voted in favor of approving Grail’s multi-cancer early detection (MCED) test. Back in 2018 the FDA designation Galleri as Breakthrough Device.
This test is not intended to replace routine screening your healthcare provider recommends, but to be used in addition to routine screening. It is recommended for people over the age of 50 and who have an elevated risk of cancer.
While, as with any medical test, there can be false positive or negative results, a clinical study showed a cancer diagnosis after the Cancer Signal Origin (CSO) test was accurate 93.4% of the time. That is important considering that many cancers are not detectable by normal means until the cancer is at a late stage and may be hard to treat or unable to be treated. About 50% of the cancers that the Galleri test can detect are found at an early stage where the cancer is more treatable.
Catching cancer early can save on the costs of treating cancer later, so this test is worth keeping an eye on to see if it may be right as a benefit for employees.
Sources: grail.com; wsj.com; galleri.com