GRAIL

Company Overview

GRAIL, founded in 2016 by Illumina, now operates as a standalone company. The company introduced Galleri, a clinically validated multi-cancer early detection test for over 50 types of cancer using a blood test. In 2021, Illumina announced the acquisition of GRAIL; however, the deal faces many regulatory hurdles from the European Commission and Federal Trade Commission (FTC). In April 2023, the FTC issued an Opinion and Order requiring Illumina to divest GRAIL to protect competition and innovation in the U.S.’s multi-cancer diagnostic tests industry. Nearly 4,500 Galleri tests were ordered by healthcare providers in 2022. The company is conducting a PATHFINDER study to assess the clinical utility of the Galleri test. The provider-reported cancers detected with the commercial use of Galleri include pancreatic, head and neck, endometrial, esophageal, and gastrointestinal stromal cancers in stage I cancers and rectal, liver, and head and neck in stage II cancers. In 2022, GRAIL completed the enrollment of the NHS-Galleri trial, a randomized, controlled study of Galleri in 140,000 participants. Based on the interim results, the NHS may offer Galleri to eligible populations in England.

Financial Highlights (FY 2023)

Company's Business Segments

• Screening revenue : Screening revenue includes Cancer Screening Testing Services provided to patients.
• Screening revenue - related parties : Screening revenue includes Cancer Screening Testing Services provided by related parties to the patients.
• Development services revenue : Development services revenue includes development activities performed in partnership with biopharmaceutical companies.