2022 was a remarkable year of growth for GRAIL, driven by the early adoption of GalleriⓇ, our multi-cancer early detection (MCED) blood test. To support the growth of the business, we more than doubled our employee base as we grew our commercial, medical and laboratory operations teams. We also added several key leadership hires to support continued technology innovation, commercial growth, medical leadership and organizational effectiveness.
We are seeing strong early adoption of Galleri, which was designed for population screening by enabling the detection of many types of cancer, while maintaining a low false-positive rate of less than 1%. Galleri is the first clinically validated MCED test available and detects a shared cancer signal across more than 50 cancer types that can be localized to specific tissues or organs to help clinicians focus their diagnostic evaluation. We are excited to see the impact Galleri is making in the clinic. Provider-reported cancers detected with the commercial use of Galleri include, among others, stage I pancreatic, head and neck, endometrial, esophageal, and gastrointestinal stromal cancers and stage II rectal, liver, and head and neck cancers. For these cancers, and many others that Galleri can detect, there are no recommended screening options available.
We are making strong progress with our extensive clinical development program, which consists of studies that collectively include more than 300,000 participants and includes case-controlled, observational and interventional studies. We believe that these studies have developed the largest linked datasets of methylation and clinical data in the cancer field. We are proud of the robust and rigorous scientific approach we have taken to product development and evidence generation, and are excited to continue to read out additional clinical data over time.
Beyond early detection, we are energized by the opportunity to improve outcomes for patients already diagnosed with cancer. In 2022, we expanded our biopharmaceutical research partnerships to use our proprietary methylation platform in the development of research technology solutions for clinical trials and patient care across the cancer continuum. We additionally announced our first strategic and companion diagnostic partnership with AstraZeneca. We are excited to work with AstraZeneca to demonstrate the value of our technology in applications such as prognosis, assessment of minimal residual disease, and early recurrence monitoring.
2022 business highlights include:
- Published over 20 manuscripts in clinical and scientific journals, and 45 abstracts at global congresses including seminal new data from our PATHFINDER study at the European Society for Medical Oncology Congress 2022.
- Completed enrollment of more than 140,000 individuals in the National Health Service (NHS)-Galleri trial, the largest MCED trial and one of the largest cancer screening trials ever conducted. Year two follow up testing has commenced. We also progressed enrollment in our prospective, interventional PATHFINDER 2 study.
- Brought online our 200,000 square foot CAP-accredited and CLIA-certified laboratory facility in North Carolina. We processed more than 150,000 clinical and commercial tests, including more than 50,000 commercial Galleri tests.
- Broadened our clinical engagement, educating more than 40,000 providers and administrators about Galleri and more than tripling Galleri prescribing providers.
- Entered into more than 40 commercial partnerships with employers, health systems, and other stakeholders.
- Initiated innovative partnerships to improve early cancer detection rates in underserved populations, such as our partnerships with Ochsner Health and the U.S. Department of Veterans Affairs Veterans Health Administration, America’s largest integrated health care system, and the Veterans Health Foundation.
- Secured coverage for Galleri by forward-leaning self-insured employers in the technology, healthcare, financial services, entertainment and other industries.
- Secured coverage by insurers such as Fountain Health Insurance and Point32Health, the parent company of Harvard Pilgrim Health Care.
- Partnered with Munich Re and John Hancock to offer Galleri as a benefit to existing life insurance policyholders.
- Announced our first strategic partnership and companion diagnostic collaboration with AstraZeneca to demonstrate the value of GRAIL’s proprietary methylation technology in applications following a diagnosis of cancer, such as prognosis, early disease recurrence monitoring, and assessment of minimal residual disease.
GRAIL was founded in 2016 with a mission to detect cancer early, when it can be cured. We are extremely proud of the progress we have made in a short time, and are looking forward to significant acceleration in the coming years. Going forward, we are focused on:
Expanding access to Galleri prior to broad U.S. reimbursement
The Galleri test is intended for use in adults with an elevated risk for cancer, such as those aged 50 or older. In 2022, we saw ordering providers triple as compared with 2021 and to date we have received provider orders for more than 60,000 commercial tests. We are planning to continue to work with clinics and health systems to accelerate adoption, and grow utilization and reimbursement by self-insured employers and progressive health insurers.
Galleri is currently offered as an laboratory developed test in our CAP-accredited and CLIA-certified laboratory. We have a Breakthrough Device designation with the FDA and have begun the modular submission process, which we expect to conclude with data from our ongoing pivotal trials. Additionally, there is exciting progress being made by stakeholders in Washington, D.C. to advance legislation providing the Centers for Medicare and Medicaid Services with authority to cover FDA-approved MCED tests.
Completing the NHS-Galleri trial and commencing implementation in the NHS in England
In 2022, we announced completion of enrollment of the NHS-Galleri trial, a randomized, controlled study of Galleri in 140,000 participants. The study enrolled in just over 10 months, and we expect interim data from this study in 2024. Based on these results, the NHS may offer Galleri to a million people in England.
Leveraging our technology platform in additional applications
Our proprietary methylation platform has a number of potentially ground-breaking applications across the cancer care continuum, including helping clinicians detect cancers when patients present with nonspecific symptoms and in driving forward precision oncology. We are at the early phase of building out our biopharmaceutical business and are excited to partner with oncology leaders to develop solutions for the high-growth precision oncology market, to help deliver meaningful outcomes for cancer patients.
Continuing to scale
Over the last several years, GRAIL has made significant investments to support product and market development for our innovative cancer detection technology and build the scalable infrastructure to meet future demand. Over the next five years, we expect to drive Galleri market expansion and our biopharma business to achieve a compound annual growth rate (CAGR) of revenue of 60-90% and approach breakeven, before broad U.S. reimbursement.
This business update contains forward-looking statements within the meaning of federal securities laws, including statements regarding our clinical program, our initiated and planned partnerships, our plans to accelerate adoption of Galleri with clinics and health systems and to grow utilization and reimbursement with employers and insurers, potential legislative developments around multi-cancer early detection, potential decisions by the National Health Service in the United Kingdom to offer Galleri to certain people in the United Kingdom; our expansion into partnerships with biopharmaceuticals; our expected investments into different areas of our business and overall cash burn; and the compound annual growth rate we expect to see in our business over the next several years. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect our financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this business update. These risks and uncertainties include our ability to obtain sufficient financing for our planned operations; the outcome of the proceedings currently pending before the European Commission relating to the acquisition of GRAIL by Illumina; the outcomes of our ongoing and planned clinical trials; our ability to execute on our marketing and sales goals; our ability to enter into partnerships and execute on partnerships that have been entered into; our ability to obtain reimbursement for our products and general market and economic conditions, along with other risks and uncertainties. The forward-looking statements in this business update are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements provided to reflect any change in expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this business update.