Galleri looks for signals associated with more than 50 types of cancer from a single blood draw; panel vote does not represent final FDA approval
A blood test designed to identify signals associated with dozens of types of cancer has taken an important step in the U.S. regulatory process.
An advisory panel to the Food and Drug Administration voted Wednesday, September 23, in favor of the overall benefit-risk profile of Galleri, a test developed by Grail.
The vote, however, does not mean the test has received final FDA approval. The agency still must decide on the company’s formal application.
How Galleri works
Galleri is a blood test that looks for specific DNA methylation patterns associated with cancer.
The technology was developed to identify a signal shared by different types of tumors and, when such a signal is detected, attempt to identify where the cancer may have originated.
The goal is to search for multiple cancers using a single blood draw, including some cancers for which routine screening programs currently do not exist.
Panel reviewed safety and effectiveness
The FDA panel’s 10 voting members evaluated safety, effectiveness and the overall balance of benefits and risks.
The vote on safety was unanimous.
On effectiveness, six members voted in favor and four voted against.
When asked whether the benefits outweighed the risks, seven voted yes, two voted no and one abstained.
Studies included more than 165,000 participants
Documents submitted to the FDA include data from studies involving more than 165,000 participants.
In two studies cited in the regulatory materials, sensitivity for detecting cancer episodes over a 12-month period was approximately 32% to 35%.
Specificity was above 99%.
For a group of 12 cancers responsible for a large share of cancer deaths in the United States, sensitivity was higher, exceeding 50% in the studies presented.
Test does not replace mammograms or colonoscopies
Galleri was developed to complement existing recommended cancer screening tests.
That means even if it receives approval, it would not replace mammograms, colonoscopies or other screening methods recommended based on age and individual risk factors.
The test is already available in the United States under specific laboratory regulations but is still awaiting the FDA’s final decision on its approval application.
Sources: U.S. Food and Drug Administration, Reuters and Grail.
