Bob Ragusa, CEO of GRAIL

2022 was a remarkable year of growth for GRAIL, driven by early adoption of Galleri, our multi-cancer early detection (MCED) blood test. As a healthcare company with a mission to detect cancer early, when it can be cured, GRAIL seeks to improve public health by increasing the overall population cancer detection rate using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer and data science. We are extremely proud of the progress we are making in the field.

We are excited by the accelerating interest in MCED. When we launched Galleri in 2021, it was the first clinically validated test available for detection of 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. For the majority of these cancer types, there are no alternative screening options available. We believe that the transformative power of MCED is realized when Galleri detects and localizes a shared cancer signal, giving doctors the ability to efficiently diagnose more asymptomatic cancers in earlier stages, to ultimately save lives and reduce the growing burden of cancer.

Beyond early detection, we are excited by the opportunity to improve outcomes for patients already diagnosed with cancer. In 2022, we expanded our biopharmaceutical research partnerships, using our proprietary methylation platform in the development of tests for clinical trials and patient care across the cancer continuum. We believe that our technology will provide critical information to improve the selection of patients who will benefit from clinical trials and therapies and ultimately support improvements in patient care.

This year, GRAIL celebrated a number of milestones:

Galleri is gaining commercial traction
We are pleased to report that, to date, we have received physician orders for more than 60,000 Galleri tests and established more than 60 commercial partnerships with leading health systems, self-insured employers and other stakeholders across the healthcare ecosystem in the U.S. – more than 40 in 2022 alone. Through these partnerships, we secured coverage of Galleri with several forward-thinking self-insured employers in the technology, healthcare, entertainment, and other industries, as well as insurers such as Point32Health and the Harvard Pilgrim Health Care HMO in Maine. Additionally, we have partnered with Munich Re and John Hancock to offer Galleri as a benefit to existing policyholders.

The number of ordering providers has more than tripled from 2021 to 2022, and provider-reported cancers detected with Galleri include, among others, Stage I pancreatic, head and neck, endometrial, esophageal, and gastrointestinal stromal tumor (GIST) cancers and Stage II rectal, liver, and head and neck cancers. We share the sentiment of physicians and patients who are extremely grateful to have found these cancers early when treatments are often more effective.

In response to increasing demand, our medical teams have educated more than 40,000 providers and administrators on MCED and Galleri. As a physician-prescribed test, we launched GRAIL’s telemedicine offering, which made Galleri even more accessible to patients across the U.S. We have worked hard to ensure that our CLIA-certified laboratory services can provide the immediate capacity needed for our commercial and research and development needs.

We continue to be a leader in scientific and clinical research
GRAIL has taken a robust scientific approach since the inception of the company. In 2022, we published over 20 manuscripts in clinical and scientific journals, and 45 abstracts at global congresses.

We continue to progress our robust 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 are the largest linked datasets of methylation and clinical data in the cancer field.

In 2022, we enrolled more than 120,000 new participants in our prospective, randomized, controlled NHS-Galleri and prospective, interventional PATHFINDER 2 studies. We were excited to announce the completion of enrollment of more than 140,000 participants in the NHS-Galleri trial this summer, in just over 10 months.

Together with leading researchers in the field, we presented seminal new data from our PATHFINDER study at the European Society for Medical Oncology Congress 2022, demonstrating that when added to standard of care screening, Galleri testing more than doubled the number of cancers detected compared to standard screening alone. In fact, Galleri detected more cancers than all U.S. Preventive Services Task Force-recommended standard single cancer screenings combined. PATHFINDER data showed that Galleri detected, among others, Stage I cancers of the liver, small intestine, and uterus, and Stage II pancreatic, bone, and oropharyngeal cancers. Among the confirmed cancers, 71% of participants had cancer types that have no routine cancer screening available and nearly half of the non-recurrent cancers were found in early-stages (Stage I or II).

We are focused on MCED access
Higher rates of late-stage cancer diagnosis contribute to poorer outcomes for underserved communities. GRAIL is pursuing innovative partnerships to improve cancer early detection rates for underserved populations, such as our partnerships with Ochsner Health and the U.S. Department of Veterans Affairs (VA) Veterans Health Administration, America’s largest integrated health care system, and the Veterans Health Foundation.

We are encouraged by the excitement around the promise of MCED by government, academic, and clinical stakeholders. We applaud the decision of President Biden to make MCED a leading pillar of the Cancer Moonshot initiative this year.

We see promise in precision medicine
GRAIL continues to develop our biopharmaceutical partnership business. In 2022, we expanded our research-focused partnerships through projects with six leading oncology companies and achieved significant revenue growth compared to 2021. We expect our Research Use Only technology platform to be available to biopharmaceutical partners in early 2023.

This year, we also announced our first strategic partnership and companion diagnostic collaboration with AstraZeneca to demonstrate the value of GRAIL’s proprietary methylation technology in applications following an initial diagnosis of cancer, such as prognosis, early disease recurrence monitoring, and assessment of minimal residual disease. We were honored when the collaboration with AstraZeneca won ‘Best Partnership of the Year’ at the 2022 Scrip Awards.

We are building a strong culture and team
This year, Galleri was recognized by Fast Company as one of the World Changing Ideas of 2022, by The Atlantic as one of the Breakthroughs of the Year, and by TIME as one of The Best Inventions of 2022.

None of these achievements or accolades would be possible without the passion and dedication of our team, which has grown to more than 1,300 over the last year. We made several key leadership additions to support continued technology innovation, commercial launch success, and organizational effectiveness. We grew critical teams including commercial, medical, and operations, more than doubling our employee base as compared to 2021. We have implemented several programs and initiatives to reinforce diversity, equity, and inclusion, introduced new benefits, including a 401(k) match, and are working to continuously improve the employee experience. GRAIL was voted a Best Place to Work by several organizations this year, including BuiltIn and Comparably.

Moving into 2023, we will continue to seize the opportunities in front of us and work tirelessly for patients in pursuit of our mission. On behalf of GRAIL’s leadership team and employees, we thank you for your continued support of our work to drive the field forward.