GRAIL and UK Government to Make Galleri Multi-Cancer Early Detection Blood Test Available to Patients

• GRAIL and NHS Partner to Transform Cancer Outcomes in First-of-Kind Program
• Agreement Aims to Help UK Meet its Goal of Diagnosing Three-Quarters of All Cancers at an Early Stage by 2028

MENLO PARK, Calif.--(BUSINESS WIRE)-- GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, today announced a partnership with the United Kingdom’s (UK) National Health Service (NHS) to help transform cancer outcomes by making GRAIL’s multi-cancer early detection blood test, Galleri™, available to UK patients starting in 2021.

The commercial partnership program aims to confirm Galleri’s clinical and economic performance in the NHS system as a precursor to its routine use by the NHS.

The partnership program will involve approximately 165,000 people in the UK and includes two groups. The first will include 140,000 people over the age of 50 without any suspicion of cancer, and the second will include 25,000 people aged 40 and above with suspicious signs or symptoms of cancer. Based on data from this program, access to the test could be expanded to around one million people across 2024 and 2025 and may roll out to a larger population thereafter.

In a clinical validation study in the U.S., an earlier version of Galleri detected over 50 types of cancer with a low false positive rate of less than 1% through a single blood draw. Modeling data show that adding Galleri to existing standard of care has the potential to decrease the number of cancers diagnosed at late stage by nearly half, which could reduce the total number of cancer deaths in the UK by approximately one-fifth.

“Every year, nearly 200,000 people in the UK die from cancer. Many of these people are diagnosed too late for treatment to be effective,” said Lord David Prior, Chair of NHS England. “This collaboration between the NHS and GRAIL offers the chance for a wide range of cancers to be diagnosed much earlier and could fundamentally change the outlook for people with cancer.”

“We are building a world-leading diagnostics industry in the UK -- not just for coronavirus, but for other diseases too,” said Matt Hancock, Health and Social Care Secretary. “This exciting and ground-breaking new blood test from GRAIL will give us another tool to give more people the very best chance of survival, demonstrating how the UK continues to lead the way in using the latest innovative treatments to help patients. Many of us know a loved one who has battled against cancer and have seen first-hand the impact of this deadly disease.”

Cancer is projected to soon become the world’s leading cause of death, with more than 1,000 people in the UK receiving a cancer diagnosis every day. The majority of cancers are found too late when outcomes are often fatal, because most deadly cancers have no available screening tests. In the UK, more than 80% of all cancer deaths are from cancers which don’t currently have any available recommended screening.

“The collaboration between GRAIL, NHS England, and the UK Government represents a novel approach to taking on one of the world’s biggest public health challenges,” said Hans Bishop, Chief Executive Officer at GRAIL. “We are excited to partner with the UK Government to support the NHS Long Term Plan for earlier cancer diagnoses, and we are eager to bring our technology to patients in the UK, and potentially save many lives.”

“The Long Term Plan for cancer is one I’ve been immensely supportive of since it was published in 2019, and I applaud the UK Government and the NHS for setting out these ambitious goals and road map to diagnosing cancers earlier,” said Sir Harpal Kumar, President of GRAIL Europe. “Galleri, a simple blood test that’s capable of detecting more than 50 types of cancers, is a ground-breaking and potentially life-saving advance that could have a tremendous human and economic benefit.”

Galleri is expected to be commercially available in the U.S. in 2021. It is currently available under investigational use in GRAIL’s first interventional study, PATHFINDER, where it is being used to guide clinical care.

About GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on saving lives and improving health by pioneering new technologies for early cancer detection. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges with Galleri™, GRAIL’s multi-cancer early detection test. An earlier version of Galleri demonstrated the ability to detect more than 50 types of cancers -- over 45 of which lack recommended screening tests today in the U.S. -- with a low false positive rate of less than 1%. When a cancer is detected, Galleri localizes the cancer signal with high accuracy, all from a single blood draw. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

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