ENLO PARK，Calif.--（BUSINESS WIRE）--GRAIL，LLC，healthcare company whose mission is to detect cancer early when it can be cured，announced today that the NHS-Galleri trial successfully completed enrollment in just over10months.The trial，which is the largest-ever study of a multi-cancer early detection（MCED）test，has enrolled140000healthy volunters aged50-77 from select regions throughout England who have not had a cancer diagnosis or undergone treatment for cancer in the last three years。

The NHS-Galleri trial is a randomized，controlled clinical trial being conducted in England alongside standard cancer screening with diagnostic follow-up in the NHS’clinical practice setting.Regions were selected to include areas of high cancer mortality，socioeconic disparities，and ethniver， using innovative methods to enroll a study population with participants traditionally less likely to take part in medical research.Participipcipants visited one of 150 mobile clinics operating at locations around and were recruited through activities including community group briefings，leaflet distributing community， engagement through community champpins，and targeted social media campaigns。

“Meeting the goal of enrolling 140000 people is a significant achievement，allowing us to evaluate an unprecedented number of volunters without symptoms of cancer and representing diverse socio-economic and ethnic populations，”said Charles Swanton，MD，PhD，a cancer researcher and oncologistat University College London and the Francis Crick Institute，chief clinician Cancer，and co-chief investigator of the study.“Whilst the first year of the trial may pick up cancers that have existed for some time，the second and third years provide the best opportunity to explore the expected benefits of picking up new cancers at an early stage when treatment is generally more successful.by screening participants annually over three years，we will be able to explore how MCED tests can be used alongside existing NHSscreening.”

The study’s aim is to determine if the Galleri test，alongside standard cancer screening， can find asymptomatic cancers at earlier stages than they are found in clinical care today.The study will assess absolute numbers of stage3and4cancers diagnosed following three annual Galleri tests.The first screen will aim to identify the prevalent cancers in the population， while the second and third screens will aim to identify cancers that have newly emerged。

“NHS-Galleri has set a new standard in the speed of set-up and recruitment to clinical trials，”said Professor Peter Sasieni，Director of The Cancer Research UK&King’s College London Cancer Prevention Trials Unit and one of the trial’s lead investigat ators.”Previous trials of this magnitude would calpityhas。Accelerating research means that we will find out sooner whether new technology has a role in the control of cancer and，if it does，introducing it within the NHS quickly so that more people can benefit.”

This trial supports the NHS Long Term Plan ambition to catch three quarters of cancers at an early stage，when they are less advanced，and treatment has a higher chance of being successful and potentially curative.Based on initial results，the NHS may roll out the test to an additional1 million people。

“Today marks an important milestone in our long-term efforts to catch and treat cancer earlier，”said Amanda Pritchard，chief executive at NHs.“We know that certain cancers are harder to detect and a late diagnosis can be devastating for patients and their families，and this trial means thousands could benefit from a diagnosis even before symptoms appear.”

In a previous密封箱，密封箱单击功能区上，the Galleri test demonstrated the ability to detect a shared signal from more than 50types of cancer，many of which lack recommended screening tests today in the UK.Early clinical trials report that GRail’s Galleri test has afalse positive rate under1%and can predict where a cancer signal iginactest has afalse positive rate underactive under。

“We are so grateful for the public’s enthusiasm for this trial and to all those who have voluntered，”said Sir Harpal Kumar，president at GRAIL Europe.“We are hopeful Galleri will work well alongside existing cancer screening in the UK，can provide clinicians with an accurate prediction of where the cancer is located in the body，and help the NHS reduce the number of cancers detected at a late stage.“

The study is sponsored by GRAIL and is being run by The Cancer Research UK and King’s College London Cancer Prevention Trials Unit（UK），in collaboration with eight cancer alliance in England The study design of the trial was presented at the American Society of Clinical Oncology（ASCO）Annual#06 e2022。

About NHS-Galleri Trial

For the prospective，blinded，randomized controlled trial，study participants will provide a blood sample during three annual visits to a mobile health clinic—at baseline，year1and year2.After the first visit， participants are randomized1:1into either the intervention or control arm.Particpants in the intervention arm will have their blood tested by the Galleri test.Blood samples from subjects in the control arm will not be tested immediately， but will be stored for potential future testing.If a cancer signal is detected for those in the intervention arm， research staff will explain the result and schedule an appointment for follow-up tests at an NHS hospital local to the participant.All participants in the study will be followed for cancer and other related outcomes via NHS databases and will be reminded to continue to have guideline-recommended cancer screenings。

About GRAIL

GRAIL is ahealthcare 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-nergenculation，incleporation，udies，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 is headquartered in Menlo Park，CA with locations in Washington，D.C.，North Carolina，and the United Kingdom.Gialis，llumina，Inc.（NASDAQ:ILMN）currently held separate from Illumina Inc.under the terms of the Interim Measures Order of the European Commission dated29 October 2021。

强制变形，养护grail.com。

About Galleri^®

The earlier that cancer is detected，the higher the chance of successful outcomes.The Galleri multi-cancer early detection test can detect signals across more than50 types of cancer，as defined by the American Joint Committee on Cancer Staging Manual，through aroutine blood draw.When cancer signal，ed， the Galleri test predicts the cancer signal origin，or where the cancer is located in the body，with high accuracy to help guide the next steps to diagnosis.The Galleri test requires a prescription from alicensed healthcare provider and should be used in addition to recommended cancer screenings such as mach as，scogy，scora，prostate-specific antigen（PSA）test，or cervical cancer screening.It is intended foruse in people with an elevated risk of cancer，such as those aged50 orolder。

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入口Galleri安全信息

The Galleri test is recommended for use in adults with an elevated risk for cancer， such as those aged 50 or older.The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by ahealthcare provider.Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located.使用of Galleri is not recommended in digns in dignt，21years old or younger，or undergoing active cancer treatment。

Results should be interpreted by ahealthcare provider in the context of medical history，clinical signs and symptoms.Atest result of“No Cancer Signal Detected”does not rule out cancer。Atest result of“Cancer Signal Detected”requires confirmatory diagnostic evaluation by medically established procedures（e.g。，imaging）to confirm cancer。

If cancer is not confirmed with further testing，it could mean that cancer is not present or testing was insufficient to detect cancer，including due to the cancer being located in a different part of the body。False-positive（acancer signal detected when cancer is not present）and false-negative（acancer signal not detected when cancer is present）test results do occur。Rx only。

实验室/测试信息

GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988（CLIA）and accredited by the College of American Pathologists。The Galleri test was developed，and its performance characteristics were determined by GRAIL.The Galleri test has not been clared or approved by the U.S.Food and Drug Administration.GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing.The Galleritest intendis for。

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