GRAIL Statement on Divestiture
December 17, 2023

On December 17, 2023, Illumina announced it will divest GRAIL through a third-party sale or capital markets transaction, consistent with the European Commission’s divestiture order, with the goal of finalizing the terms by the end of the second quarter of 2024. 

“Throughout the regulatory process and as an independent and separate company, GRAIL delivered significant progress and advanced the field of multi-cancer early detection. Next year will be transformative for GRAIL as we expect expanded access to Galleri through partnerships, further development of our robust clinical evidence program, completion of the third year of the NHS-Galleri study, and initiation of the unprecedented Galleri-Medicare study,” said Bob Ragusa, GRAIL’s CEO.

Importantly, Illumina’s CEO Jacob Thaysen noted that Illumina is “committed to an expeditious divestiture of GRAIL in a manner that allows its technology to continue benefiting patients.” As mentioned in the European Commission’s October 12, 2023 press release, the European Commission is committed to ensuring that any divestment scenario supports GRAIL’s ongoing viability and competitiveness. In the instance of a capital markets transaction, Illumina announced that it must capitalize GRAIL at the time of the transaction with two-and-a-half years of funding based on GRAIL’s long-range plan. GRAIL will continue to be held separate with committed funding from Illumina for GRAIL’s business through the divestment process. 

GRAIL has made significant progress while being held separate from Illumina since 2021. Under GRAIL’s management team, GRAIL has:

  • Deployed a multi-channel commercial strategy to drive Galleri adoption pre-reimbursement;
  • Established more than 100 commercial partnerships with health systems, employers, life insurance organizations and other stakeholders across the healthcare ecosystem in the U.S.;
  • Returned results for more than 150,000 Galleri commercial tests; 
  • Entered the third year of the 140,000+ participant NHS-Galleri trial; The NHS will review early metrics from the first screening round of the study in 2024, and based on those results may commence the commercial implementation of the Galleri test in up to one million patients in England over two years;
  • Published the PATHFINDER and SYMPLIFY multi-cancer early detection studies in The Lancet and Lancet Oncology, respectively, and a comprehensive DNA methylation atlas in Nature;
  • Enrolled more than 25,000 participants in the PATHFINDER 2 trial in the U.S.;
  • Announced plans to initiate the Galleri-Medicare (REACH) study, a first-of-its-kind real-world study designed to evaluate the clinical impact of Galleri among 50,000 Medicare beneficiaries. Medicare will cover the costs of Galleri and related and routine items and services for study participants;  
  • Continued to progress our PMA application for Galleri with the U.S. FDA; 
  • Grown our biopharmaceutical precision oncology business, generating revenues from multiple partners and launching our Research Use Only solution; 
  • Expanded our CAP-accredited, CLIA-certified Research Triangle Park laboratory and capabilities in preparation for continued Galleri adoption; and 
  • Received several high-profile national accolades, including recognition by Time and The Atlantic as a top breakthrough of 2022 and being named to the Fortune Change the World list in 2023.