Fernando Alarcon Hardy: Why Early-Detection Evidence Will Matter After Galleri’s FDA Milestone?
Fernando Alarcon Hardy/LinkedIn

Fernando Alarcon Hardy: Why Early-Detection Evidence Will Matter After Galleri’s FDA Milestone?

Fernando Alarcon Hardy, Co-founder & CEO of Ilico Genetics, shared on LinkedIn:

“Cancer screening is moving forward.

On September 23, an FDA advisory panel voted in favor of GRAIL’s Galleri, the first multi-cancer screening test submitted for FDA premarket approval.

This is a strong step toward making noninvasive screening and early detection part of preventive healthcare.

The next step is to demonstrate early-detection performance for each cancer because performance varies by cancer type and stage.

The FDA asked the panel about both (FDA briefing, Section 9).

Take stomach cancer.

Across Galleri’s two pivotal studies, 11 stomach cancers were diagnosed among the participants analyzed, and only one was stage I (FDA briefing, Appendix 5).

That is too few to judge Galleri either way.

Gastric cancer is the one we work on at Ilico Genetics.”

You can also read: Why Gastric Cancer Spreads Across the Abdomen: The Biology of Peritoneal Metastasis

Fernando Alarcon Hardy: Why Early-Detection Evidence Will Matter After Galleri’s FDA Milestone?