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A partnership between the University of Oxford and GRAIL, LLC will evaluate the use of a new, non-invasive, multi-cancer early detection test known as Galleri in suspected cancer patients.

  • The national SYMPLIFY study aims to demonstrate this revolutionary technology can benefit patients and detect many cancers earlier.
  • Ultimately Galleri could be used in routine visits with GPs to detect multiple types of cancer early, which may improve the chance of successful treatment and potentially decrease unnecessary invasive biopsies and expensive imaging.

The University of Oxford has announced a partnership with GRAIL, to evaluate the use of a new multi-cancer early detection (MCED) test in the NHS. The nation-wide SYMPLIFY study will investigate a MCED test developed by GRAIL, known as Galleri, for patients with non-specific symptoms that may be a result of cancer. 

The aim of the SYMPLIFY study is to demonstrate how the test could be used to increase cancer detection rates and simplify diagnostic pathways. Beginning in Summer 2021, SYMPLIFY seeks to recruit around 6,000 symptomatic patients from sites across England and Wales, who have been referred by their GP for testing of their blood samples with Galleri. Results of the Galleri tests will then be used for test validation purposes.

Galleri is a blood test that can detect over 50 types of cancers — over 47 of which lack recommended screening in the UK today — with a low false positive rate of less than 1 percent, all through a single blood draw. Using revolutionary next-generation sequencing technology, Galleri has the potential to complement existing screening programmes and current tests to enhance early stage diagnosis, when cancers can be treated more successfully.

Professor Mark Middleton, Lead researcher from the University of Oxford says:

 

The process of diagnosing cancer can often be lengthy and involve expensive imaging or invasive biopsies specific to only one cancer. Often this happens after a patient presents with symptoms and a cancer is more progressed. If we can intervene at an earlier stage and detect a cancer using minimally invasive tests, such as Galleri, we have the potential to accelerate cancer diagnoses and reduce the number of diagnostic procedures.

Ultimately these tests could transform cancer patient care within the next 5 years by improving the chance of successful treatment and survival. 

SYMPLIFY will assess how Galleri can be used to benefit patients with non-specific symptoms that may be a result of cancer. The SYMPLIFY study is one of the UK-based clinical trials that GRAIL is supporting, along with the recently announced NHS-Galleri trial, from which the collective results may see the MCED technology included in routine visits with healthcare providers, such as to a GPs and other non-hospital settings.

 

About the SYMPLIFY & NHS-Galleri clinical trials

Galleri™ is designed to detect cancers in early stages, when the chance of survival is higher than if cancer has progressed. Clinical data have shown the ability of this technology to detect more than 50 types of cancer with a very low false positive rate of less than one percent. Galleri was designed to minimize false positives in order to limit associated harms, including patient anxiety and unnecessary diagnostic workups. When a cancer signal is detected, the test is able to identify where in the body the cancer is located with high accuracy, an important step to guiding diagnostic next steps and care. 

GRAIL’s methylation-based technology preferentially targets the most informative regions of the genome and is designed to use its proprietary database and machine-learning algorithms to both detect the presence of the cancer signal and the location of the cancer in the body.

The SYMPLIFY study is being implemented by the University of Oxford in partnership with GRAIL. The trial aims to recruit over 6,000 patients from July to September 2021, and assess best practice in relation to distribution, age at testing, benefit in the detection of specific cancers and implementation into GP surgeries. The trial will source patients from existing cancer pathways, such as the award-winning Suspected Cancer Pathway (SCAN) at the Oxford University Hospitals NHS Trust. Results of the patient’s Galleri tests will not be returned to the participants, but will then be used for test validation purposes. SYMPLIFY is currently recruiting at sites across the UK, including 13 NHS Trusts in England and 19 district hospitals in Wales coordinated by Velindre University NHS Trust.

The NHS-Galleri trial, recently announced by GRAIL, will be assessing the same technology in a non-symptomatic population. Together, the SYMPLIFY study and the NHS-Galleri trial will determine best practice for the implementation of MCED testing in the general population, based on age and symptomatic status.

About GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. 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 enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL, a wholly-owned subsidiary of Illumina, Inc., is located in Menlo Park, California and Washington, D.C. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com (opens in new window).

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