A U.S. Food and Drug Administration advisory panel voted in favor of recommending that the agency approve a blood test for multiple cancers on Wednesday. The assay, called the Galleri test, is designed to help screen for cancers before symptoms appear, according to its maker, Grail.
The 10-person panel unanimously agreed that Grail showed that the Galleri test was safe, but there was less agreement over whether it was effective or had benefits that outweighed the risks: the panel voted 6–4 in favor of effectiveness and 7–2 in favor of the question of benefits, with one panelist abstaining from the latter.
The panel’s favorable vote “represents an important step forward for the field,” says Ajay Goel, a professor and chair of the department of molecular diagnostics and experimental therapeutics at City of Hope, a cancer research and treatment organization.
Ultimately, however, he says that “I would still view it as an encouraging step rather than the final word on the clinical value of this type of testing.”
Some cancer screening tools exist on the market already—including for breast, lung, prostate and other cancers—but no early-detection tests for multiple types of cancer have been approved by the FDA, according to the American Cancer Society. Having such a test would be clinically useful, enabling doctors to potentially detect a variety of cancers early and affording people more time to respond to a diagnosis. Galleri is currently designed for people age 50 and older.
“The test, experts say, is promising but not perfect. In a study of more than 35,000 participants that was published on Tuesday in the journal Nature Medicine, Galleri detected signs of cancer in 287 people, about 60 percent of whom were later diagnosed with the disease. The test was also able to accurately predict the area of the body where the cancer originated in about 91 percent of true-positive cases.”
Master-Event-1643 | 7 hours ago
The future of healthcare is really really exciting
blobbilby | an hour ago
It surely could or can be but MAHA has me questioning this optimism.
[OP] scientificamerican | 7 hours ago
A U.S. Food and Drug Administration advisory panel voted in favor of recommending that the agency approve a blood test for multiple cancers on Wednesday. The assay, called the Galleri test, is designed to help screen for cancers before symptoms appear, according to its maker, Grail.
The 10-person panel unanimously agreed that Grail showed that the Galleri test was safe, but there was less agreement over whether it was effective or had benefits that outweighed the risks: the panel voted 6–4 in favor of effectiveness and 7–2 in favor of the question of benefits, with one panelist abstaining from the latter.
The panel’s favorable vote “represents an important step forward for the field,” says Ajay Goel, a professor and chair of the department of molecular diagnostics and experimental therapeutics at City of Hope, a cancer research and treatment organization.
Ultimately, however, he says that “I would still view it as an encouraging step rather than the final word on the clinical value of this type of testing.”
Some cancer screening tools exist on the market already—including for breast, lung, prostate and other cancers—but no early-detection tests for multiple types of cancer have been approved by the FDA, according to the American Cancer Society. Having such a test would be clinically useful, enabling doctors to potentially detect a variety of cancers early and affording people more time to respond to a diagnosis. Galleri is currently designed for people age 50 and older.
Riversmooth | 6 hours ago
“The test, experts say, is promising but not perfect. In a study of more than 35,000 participants that was published on Tuesday in the journal Nature Medicine, Galleri detected signs of cancer in 287 people, about 60 percent of whom were later diagnosed with the disease. The test was also able to accurately predict the area of the body where the cancer originated in about 91 percent of true-positive cases.”
randomaccount173 | 5 hours ago
On the same day Elizabeth Holmes is released.. suspicious
chadius333 | 4 hours ago
Apparently she’s starting a new company and has been advising from prison. I’m not joking.