GRAIL continues to execute on our strategy towards population scale early cancer detection, and we are pleased with our progress in building the market for Galleri, driving our robust evidence generation programs and advancing future product development.

Revenue for the fourth quarter of 2023 was $30 million and for the full year 2023 was $93 million, comprising Galleri test sales and biopharmaceutical partnerships revenue. Full year revenue increased 68% in 2023 as compared to 2022. 

Galleri adoption continues to grow, with more than 9,000 ordering providers and more than 150,000 commercial tests completed as of year end 2023. We have established early commercial leadership in multi-cancer early detection (MCED) and secured coverage of Galleri with several forward-leaning payers and self-insured employers in various sectors, such as technology, healthcare, life insurance, and financial industries. 

We were pleased to announce the groundbreaking Galleri-Medicare study (REACH), which will enroll 50,000 Medicare beneficiaries and evaluate the clinical impact of Galleri compared to a matched synthetic control. Findings will add to our robust body of evidence evaluating the potential for MCEDs to change the future of cancer detection, particularly in diverse populations. Medicare will cover the costs of Galleri and related and routine items and services for study participants. The Galleri-Medicare study will further enhance our expansive clinical evidence program, which includes our pivotal NHS-Galleri randomized clinical trial, bringing planned enrollment to more than 385,000 participants. We are in the final round of blood draws for the NHS-Galleri trial and expect to complete final study visits in the third quarter of this year. 

GRAIL’s proprietary targeted methylation platform combined with our growing body of clinical and real-world data provide us with unique insights into cancer biology that enable product improvements and new product introductions over time. Potential applications for our technology in a precision oncology setting include pre-treatment prognosis, post-treatment prognosis or minimal residual disease (MRD), recurrence and clinical monitoring, and novel biomarker discovery.

Recent Business Highlights

• Announced last November, the Galleri-Medicare study is a first-of-its-kind, real-world study designed to assess Galleri’s clinical impact in the Medicare population. Study recruitment will include a focus on Medicare beneficiaries from historically under-represented groups, including racial and ethnic minorities. In addition to robust clinical evidence from our NHS-Galleri and PATHFINDER 2 studies, the Galleri-Medicare study will generate large-scale real-world evidence of Galleri performance and outcomes in a diverse population. 

• In December, GRAIL and AstraZeneca shared GRAIL’s first lung adenocarcinoma data at the North America Conference on Lung Cancer. A novel prognostic test in early-stage lung cancer, our technology demonstrated the potential for a tissue-free diagnostic to identify patients at high risk of relapse prior to surgery or other treatment. 

• In January, GRAIL and BeniComp, a customized health plan provider, announced the availability of Galleri to eligible BeniComp Select members. BeniComp is a leader in preventive health solutions, offering innovative health plans that drive engagement, improve health outcomes, and often save groups millions of dollars per year. This partnership will integrate Galleri into BeniComps plans, providing better access to care, and equipping participants with proactive cancer screening tools.
  
• In February, GRAIL and Curative Insurance Company, a pioneering healthcare services company, announced the availability of Galleri to all Curative members, across all plan types, who are over the age of 50 and to all other members with risk factors for developing cancer. The Galleri test is part of the expansive list of benefit offerings available for $0 copay and $0 deductible on Curative’s health insurance plan. The Curative plan is currently available to employers headquartered in Texas and Florida with 50 or more eligible employees nationwide, with broad national network coverage and access to almost 1 million providers nationwide.