Grail Stock Soars 33% Ahead of Multi-Cancer Blood Test Review From FDA

Grail stock surges ahead of the biotech’s meeting with the Food and Drug Administration this week. (Dreamstime)

Key Points

• Grail surges Monday ahead of a FDA advisory panel meeting this week to review the company’s multi-cancer blood test.
• The FDA panel will evaluate premarket approval for the test, which aims to detect multiple cancer types early.
• If approved by the FDA, Galleri will become the first-of-its-kind in the country.

Shares of Grail soared ahead of the diagnostic company’s meeting with the Food and Drug Administration this week to evaluate premarket approval for its landmark blood test designed to spot multiple types of cancer early.

A FDA advisory panel will meet on Wednesday to review Grail’s application for Galleri, a blood test that aims to catch cancers before symptoms appear. In particular, the test targets high-risk types with no current routine screening options, such as pancreatic, ovarian, or esophageal cancer.

Grail stock surged 33% to $107.55 on Monday. It was on pace for its largest daily percentage gain on record, according to Dow Jones Market Data.

If eventually approved by the FDA, Galleri would become the first officially authorized Multi-Cancer Early Detection (MCED) blood test in the country.

Galleri consists of a single blood draw that looks for chemical signatures, or DNA methylation patterns, given off by cancer cells. If the test detects a symptom, it will use artificial intelligence to predict where in the body the cancer is located, helping doctors target follow-up diagnostic tests.

The test aims to target unscreened cancers since standard screening protocols only cover a handful of cancer types, Grail said earlier in a press release. The biotech said that 70% to 80% of cancer deaths stem from cancers that have no current screening guidelines at all.

Galleri is intended to be used alongside existing routine checks for cancers, like mammograms and colonoscopies, as opposed to a complete substitute for them.

Currently, Galleri is available as a Laboratory Developed Test. A doctor can order it but it lacks formal FDA premarket approval.

In February, Grail stock sank 50% after a trial aiming to significantly reduce late-stage cancers over three years failed to hit its primary goal.

Write to Mariapaula Gonzalez at mariapaula.gonzalez@barrons.com

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