FDA Advisory Panel Recommends New Multi-Cancer Blood Test

An advisory committee for the U.S. Food and Drug Administration (FDA) has recommended the approval of the Galleri blood test. This test is designed to detect many different types of cancer using a single blood sample. The recent vote by the committee of genetics experts marks a major step forward for this new medical technology, which aims to change how doctors screen for cancer.

According to MedPage Today, the panel voted in favor of the test’s effectiveness and safety. While the committee was unanimous in its decision that the test is safe, the vote on whether the test is effective was closer. Some members of the panel admitted they struggled with their decision. Jason Dominitz, a doctor at the VA Puget Sound Health Care System, noted that while the test can find cancers, it is not yet clear if finding these cancers leads to a better long-term health outcome for patients. He explained that he changed his vote twice before deciding to support it.

Other experts were more critical. Stanley Lipkowitz of the National Cancer Institute voted against the test. He argued that as an oncologist—a doctor who specializes in treating cancer—he needs to see clear data on patient outcomes. He stated that because the Galleri test is a new and transformative tool, the requirements for approval should be very high. He noted that the current data does not yet prove that the test provides a clear clinical benefit.

Despite these concerns, other panel members felt the benefits of the test were too important to ignore. Danil Makarov of the NYU School of Medicine explained that his support was driven by the test's ability to screen for cancers that currently have no other screening options. For many types of cancer, such as thyroid or ovarian cancer, there are no standard tests available to catch them early. The panel members who voted in favor of the test pointed out that the Galleri test has a high positive predictive value, which means it has a low rate of false positives—a situation where a test incorrectly says a person has a disease.

The Galleri test works by looking for specific signs of cancer in the blood. It uses a process called next-generation sequencing, which is a high-tech way to read biological information in the blood to find patterns linked to tumors. The test has been studied in several large trials, including the PATHFINDER 2 study and the NHS-Galleri study. While these studies showed that the test could detect cancers, some data presented at a recent meeting of the American Society of Clinical Oncology showed that the test did not fully meet its primary goal of reducing the number of cancers found at late stages, such as stage III or IV.

However, the application for approval focused on the test's performance and safety results from the first year of these trials. The results showed that the test was very good at identifying the origin of the cancer signal, which helps doctors know where to look for the tumor. This high level of accuracy in identifying the location of the cancer helped convince some panel members to support the recommendation.

This recommendation is the latest in a series of discussions regarding the Galleri test. As previously reported, the panel’s decision follows a period of intense debate among medical professionals about how to balance innovation with the need for clear proof. The FDA will now consider the committee's advice as it decides whether to grant official approval for the test. If approved, the test could provide a new way to screen for many cancers at once, potentially helping doctors find diseases much earlier than is currently possible. For now, the medical community remains divided on whether the current evidence is enough to support widespread use, but the panel’s vote shows a clear move toward bringing this technology to patients.