GRAL's Galleri Cancer Test Clears FDA Panel Safety Vote, Splits On Effectiveness

(MENAFN- AsiaNet News)

• The Molecular and Clinical Genetics Devices Panel voted that the test looks safe.
• The 10 voting members, however, split 6-4 on whether it is effective.
• The U.S. Food and Drug Administration (FDA) still has to finish its review of GRAIL's January premarket application and is not bound by the panel.

A U.S. Food and Drug Administration (FDA) advisory panel on Wednesday backed GRAIL's Galleri multi-cancer blood test for adults aged 50 and older, voting that it looks safe and that its benefits outweigh its risks, while splitting 6-4 on effectiveness.

The stock was on a trading halt during the committee meeting. It rallied about 34% on Monday after the FDA posted briefing papers that did not raise major safety or analytical flags, though staff questioned whether the data support calling Galleri an“early detection” test.

What The Panel Decided

Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted in three parts on the use of Galleri to screen adults 50 and older. The questions asked whether there is reasonable assurance of safety and effectiveness.

All 10 voting members said the test looks safe. They split 6-4 on whether it is effective. They voted 7-2, with one abstention, that benefits outweigh risks. The votes are advice, not approval.

The FDA still has to finish its review of GRAIL's January premarket application and is not bound by the panel. A decision is expected in the coming months. Galleri has had Breakthrough Device status since 2018.

What Galleri Does

Galleri is a prescription blood test. It looks for chemical marks on DNA shed into the blood that can signal many cancers, including some that have no routine screening, then points doctors toward a likely origin so they can order follow-up tests. It is meant to sit alongside mammograms, colonoscopies and other standard checks.

What The Studies Showed

FDA reviewers focused on two large trials. In the U.S. PATHFINDER 2 study, the test caught about 35% of cancers found over the next year and almost never raised a false alarm (about 0.15% of people). When it flagged a signal, cancer was confirmed in about three of four cases. A larger U.K. trial, NHS-Galleri, showed similar accuracy. That study did not, however, prove that screening cut late-stage cancers - a miss that sent the stock down more than 40% in February.

Performance also varies by cancer type and is weaker for some common early-stage tumors. Positive results can still lead to extra scans and procedures.

Why It Matters For GRAIL

Galleri is already sold in the United States as a lab test. FDA approval would let GRAIL market it more widely and would be the main gateway to insurance and Medicare coverage.

CEO Josh Ofman said the committee vote backs the evidence GRAIL has built and that the company will keep working with the agency.

How Did Retail Traders React?

On Stocktwits, retail sentiment around GRAL stock stayed in 'extremely bullish' territory over the past 24 hours, while message volume remained 'extremely high.'

A Stocktwits user expressed optimism for a major rally at the market open on Thursday.

View this Stocktwits post

Another user expressed hope for eventual FDA approval of the test.

View this Stocktwits post

GRAL stock has gained 27% year-to-date. 

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