Detecting Cancer Early, When It Can Be Cured

As a healthcare company with a mission to detect cancer early, when it can be cured, GRAIL seeks to not only transform cancer detection, but to utilize our proprietary technology platform to revolutionize healthcare more broadly.

early cancer detection grail older woman hugging

Early Cancer Detection Shows Promise

Today, cancer is a leading cause of death worldwide. That’s in large part because there is no screening available for the vast majority of life-threatening cancers, and as a result, most cancers are detected too late when outcomes are often fatal.

Guideline recommended screening tests save lives, but they cover just five cancers and each one screens for a single cancer at a time. Cancers responsible for approximately two-thirds of cancer deaths have no recommended early detection screening.

Multi-cancer early detection (MCED) is one of the most promising new tools we have in the war on cancer. Recent next-generation sequencing and machine learning advances have enabled the development of multi-cancer early detection tests – single tests that can identify a signal for many cancers from a single blood draw.

Multi-cancer early detection blood tests analyze DNA that has been shed by all cells, including cancer cells, into the bloodstream, looking for abnormal methylation patterns on those cell-free DNA fragments that indicate the presence of cancer. The test can also accurately predict the part of the body from which that cancer originated.

Early Cancer Detection Shows Promise

Patients with cancer are not statistics. They’re real people with hope for the future. GRAIL is working to back up that hope with commercially-available solutions.

The Promise of a Better Future

Recent research shows that adding annual testing with multi-cancer early detection blood tests to the currently recommended screening tests may shift cancers that can be detected to earlier stages, and over five years may lead to a 39 percent reduction in cancer deaths for cancers that can be detected (or an approximate 26 percent reduction in overall cancer deaths).

GRAIL’s first product, the Galleri® test, is a groundbreaking multi-cancer early detection blood test with the potential to help save lives and transform cancer care by detecting a common cancer signal across more than 50 types of cancer, over 45 of which have no recommended screening today. Using the Galleri test as a complement to recommended screenings has the potential to make a tremendous, positive impact on public health.

Learn more about the Galleri test

Fast Facts

2016

Year founded

Menlo Park, CA

Headquarters

Locations

Washington, D.C., Research Triangle Park, N.C., and the U.K.

1,200+

Number of employees

>50

Number of cancer types Galleri has identified in clinical studies with a common signal

Higher overall 5-year survival rate when diagnosed early ^1,2

GRAIL: From Idea to Innovation

Breakthrough Discoveries are Changing the Face of Cancer Diagnosis

Advances like multi-cancer early detection tests usher in a new front in the war on cancer, one that promises to restore lives and livelihoods around the world. At GRAIL, we feel a tremendous responsibility to get our groundbreaking technology into the hands of patients and providers, and are working to make early detection accessible to as many people as possible.

2015

Journal of the American Medical Association (JAMA) publishes discovery of cancer signals found in the blood of asymptomatic women.

2016

GRAIL is founded in January. Early backers include Jeff Bezos and Bill Gates.

2018

At the American Association for Cancer Research (AACR) data supporting multi-cancer early detection is presented. GRAIL enrolls more than 100,000 participants in clinical study program.

2019

In May, GRAIL earns Breakthrough Device designation from FDA for MCED test. Validation data is presented at the ASCO Breakthrough meeting in October.

2020

PATHFINDER study begins enrolling to evaluate MCED test in clinical practice. In March, the Annals of Oncology publishes validation data showing a MCED test detects a common cancer signal across 50+ cancers.

2020

In November, GRAIL partners with UK’s National Health Service.

2021

In December, a manuscript published in AACR models the MCED test showing a reduction in late-stage diagnoses by more than half.

2021

2021: GRAIL announces Providence is first healthcare system to offer Galleri.

2021

In June, the interim analysis for the PATHFINDER Study is presented at American Society of Clinical Oncology (ASCO), which returned results to healthcare providers and reported on the primary objective and the secondary objectives. The same month, Galleri is introduced to the broader public.

The World’s Largest Genomic Medicine Program

Overview of Studies

With the target of ~335,000 participants and counting, our studies aim to develop, validate, and demonstrate the broad applicability of GRAIL’s multi-cancer early detection technologies. As part of our efforts, GRAIL has partnered with leading community and academic medical centers around the globe.

Our data set grows with each MCED test that we process, along with additional clinical trials and studies. To date, the database has exceeded over 30 PB (petabytes) – and it has the potential to grow in orders of magnitude.

Our Rigorous Approach to Transforming Cancer Care

GRAIL is working to develop new technologies for early cancer detection using the power of next-generation sequencing (NGS), along with population-scale clinical studies and state-of-the-art computer and data science. Our rigorous approach is exactly what it will take to transform cancer care.

Our foundational study, the Circulating Cell-free Genome Atlas Study (CCGA) (clinicaltrials.gov), was designed to develop, train, and validate a cell-free DNA-based MCED test. CCGA began enrolling in August 2016 and enrolled more than 15,000 participants.

Our STRIVE Study (clinicaltrials.gov)was designed to clinically validate our test in women not known to have cancer. STRIVE enrolled approximately 100,000 participants and the study is expected to be completed in May 2025.

Our SUMMIT Study (clinicaltrials.gov)was designed to clinically validate our test in individuals at high-risk levels for lung cancer. SUMMIT enrolled approximately 13,000 participants. A 24-month follow up is ongoing through 2023, with completion anticipated in 2030.

Our PATHFINDER Study (clinicaltrials.gov) was designed to assess the clinical implementation of our MCED test. PATHFINDER enrolled 6,662 participants. A 12-month follow up is ongoing.

The NHS-Galleri Trial aims to confirm Galleri’s clinical and economic performance in England’s NHS system as a precursor to its routine use. Approximately 140,000 participants will enroll. Initial results of the study are expected by 2023.

Our REFLECTION Study (clinicaltrials.gov)was designed to accumulate and study real-world data about the long-term efficacy and benefits of the test. REFLECTION will follow approximately 35,000 individuals who take the Galleri test over five years. Initial results of the study are expected by 2028.

Our PATHFINDER 2 Study (clinicaltrials.gov) was designed to evaluate the safety and performance of our test. Approximately 20,000 eligible participants will enroll over 10 months at up to 40 clinical institutions. Participants will be actively followed for approximately 3 years.

What if You Found Cancer Early Enough to Make a Difference?

Today, many cancers are found too late, when outcomes are often deadly. Multi-cancer early detection enables you to proactively test for many cancers, increasing the chances of finding cancer early. Finding cancer early is important to improve treatment outcomes and survival. The vast majority of cancers show no symptoms until later stages, when treatment options may be limited.

Learn More About the Galleri Test

How GRAIL’s Technology Impacts Cancer Care

Our Partners

We collaborate with leading health systems, academic medical centers, and industry partners around the world to bring our innovative technology to patients. With our partners, we are on the front lines of innovation by transforming cancer care through early detection. Together, we can accomplish more.

1: Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence — SEER 18 Regs Research Data. Nov 2018 Sub. Includes persons aged 50 – 79 diagnosed 2006 – 2015. “Early/Localized” includes invasive localized tumors that have not spread beyond organ of origin. “Late/Metastasized” includes invasive cancers that have metastasized beyond the organ of origin to other parts of the body.)

2: Noone AM, Howlader N, Krapcho M, et al. (eds). SEER Cancer Statistics Review, 1975 – 2015, National Cancer Institute, Bethesda, MD, http://seer.cancer.gov/csr/1975_2015/, based on November 2017 SEER data submission, posted to the SEER website April 2018.)