Despite 50 years since waging the war on cancer, it is soon to be the world’s number one killer. This is because most are detected too late. The status quo in cancer screening is simply unacceptable, as we screen for only five cancers, we look for individual cancers rather than what cancer an individual may have, we use decades-old technology, and compliance is suboptimal. The overall survival rate for cancer is four times higher when cancer is found before it spreads, but unfortunately most cancers are detected when individuals become symptomatic after their cancer has metastasized. There are only five commonly available individual cancer screening tests, each searching for one cancer at a time, while cancers without widespread screening recommendations represent 85% of all cancer diagnoses.¹ and approximately 70% of cancer deaths.²˒³

We believe new approaches, including multi-cancer early detection (MCED) tests, are the new front in the war on cancer, and we believe our best chance to bend the cancer mortality curve. MCED tests will simultaneously screen for more cancers at earlier stages when there is a better chance for successful treatment. These blood tests, including GRAIL’s Galleri® test, are fundamentally different from existing screening approaches in that they leverage genomic and machine learning technologies to look for a shared cancer signal in the blood, allowing for simultaneous screening for multiple cancer types. Importantly, this shared signal has been shown to carry a single false-positive rate less than 1%, whereas using multiple single cancer tests, each with false positive rates of approximately 10%, results in an accumulation of each of the false-positive rates to unacceptable levels.

GRAIL’s next-generation sequencing technology was developed within Illumina, and was spearheaded by Dr. Richard Klausner, who directed the National Cancer Institute from 1995 to 2001. The research he launched at GRAIL was among the largest unbiased exploration of genomic cancer signals in blood ever undertaken. This work is the foundation of GRAIL’s technology.  

In clinical studies, GRAIL’s Galleri test has shown a false positive rate under 1%, and an ability to predict where the cancer signal originated with 89% accuracy. The Galleri test has detected more than 50 types of cancers in a clinical study. Conservative modeling using contemporary cancer incidence and mortality data from Surveillance, Epidemiology, and End Results (SEER) and MCED test performance estimated that adding an MCED test to recommended cancer screening care could avert approximately 1 in 4 lives expected to be lost to cancer within five years of diagnosis⁴.

The Galleri clinical development program consists of studies that collectively include more than 300,000 participants – and what we believe are the largest linked datasets of genomic and clinical data in the cancer field. Our program includes using intermediate endpoints that are considered scientifically and clinically acceptable, such as a reduction in late-stage diagnoses, thought by experts to be a prerequisite for a mortality reduction. To that end, we are conducting NHS-Galleri, an ongoing randomized controlled trial, in partnership with England’s National Health Service, with the primary objective of reducing late-stage cancer diagnoses, in-line with the UK’s overarching goal of finding cancer early for its population. Mortality benefits will take decades to achieve, and in that time we will lose approximately 600,000 people every year to cancer.⁵ Galleri was designed with the goal of dramatically increasing the cancer detection rate in the population while minimizing harms. Given the war on cancer and the revitalized Cancer Moonshot initiative, as well as the potential to dramatically improve cancer detection while minimizing harms, a decades-long delay in making validated MCED testing available to patients, is unreasonable and unnecessary.

The Galleri test is performed in GRAIL’s clinical laboratory, which is certified under the Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP). In addition, the Galleri test was approved by the New York State Department of Health, whose standard represents one of the most rigorous levels of validation required for laboratory developed tests. The Galleri test, available by prescription only, does not detect all cancers and is intended to be used in addition to existing screening tests, such as mammography and colonoscopy. 

We believe making validated multi-cancer early detection tests available will help enable us to dramatically increase cancer detection from screening in the population, and improve public health. We feel a tremendous responsibility and sense of urgency to make this groundbreaking technology available to patients and providers.

References:

1. Hackshaw, A., Cohen, S.S., Reichert, H. et al. Estimating the population health impact of a multi-cancer early detection genomic blood test to complement existing screening in the US and UK. Br J Cancer 125, 1432–1442 (2021).
2. American Cancer Society. Cancer Facts & Figures (2021). Published online 2021.
3. GRAIL, LLC. Data on File
4. Hubbell E, Clarke CA, Aravanis AM, Berg CD. Modeled Reductions in Late-stage Cancer with a Multi-Cancer Early Detection Test. Cancer Epidemiology Biomarkers & Prevention. 2021;30(3):460.
5. Siegel, RL, Miller, KD, Fuchs, HE, Jemal, A. Cancer statistics, 2022. CA Cancer J Clin. 2022. https://doi.org/10.3322/caac.21708.