GRAIL to Present Final Multi-Cancer Early Detection Data from the PATHFINDER Interventional Study at ESMO 2022

MENLO PARK, Calif.–(BUSINESS WIRE)–GRAIL, LLC, a healthcare company whose mission is to find cancer early when it can be cured, today announced that final results from the PATHFINDER interventional study will be presented at Congress. 2022 from the European Society of Medical Oncology (ESMO) in Paris. PATHFINDER data evaluating the Galleri^® The Multi-Cancer Early Detection (MCED) blood test will be shared in a communications session on September 11. Participant-reported outcomes will also be presented, including satisfaction with MCED testing, continued adherence to screening standards of care, and information related to participants’ anxiety and distress. Interim results from the PATHFINDER study were presented at the 2021 Annual Meeting of the American Society of Clinical Oncology (ASCO).

The PATHFINDER single-arm interventional study was designed to assess clinical care pathways following a Galleri test result “cancer signal detected”, measure the time to diagnostic resolution (primary endpoint), and assess the implementation and performance of Galleri in a clinical setting. care setting.

“Despite 50 years of war on cancer, cancer is fast becoming the world’s number one killer, largely because most cancers are diagnosed too late. Although current screening tests save lives, they are not enough and the status quo in cancer screening is simply unacceptable. In the United States, we only routinely screen for five cancers, but most cancer deaths are from cancers we don’t screen for. Our current approach using decades-old technology with suboptimal adherence simply does not find enough cancers in the population. We need to move from just finding individual cancers to finding people for many cancers,” said Josh Ofman, MD, MSHS, president of GRAIL. “We are excited to share final results from PATHFINDER, which provide important insights into the feasibility of our first-of-its-kind MCED technology, clinical care pathways following a “cancer signal detected” result, and Galleri’s potential to detect more cancers in their early stages in addition to standard screenings.

The PATHFINDER study recruited 6,662 people aged 50 or older, an age group at high risk for cancer, but with no suspicion of active cancer. Participants were enrolled at 11 sites, including the Cleveland Clinic, Dana-Farber Cancer Institute, Mayo Clinic, Oregon Health & Science University, Sutter Health and the US Oncology Network. Results will be presented from both an earlier version of Galleri (MCED-E) and a predefined retrospective analysis evaluating the current version of the Galleri test (MCED-Scr) using banked blood samples.

Selected GRAIL presentations at ESMO include:

A Prospective Study of a Blood Test for the Early Detection of Multiple Cancers (Presentation #903O)

Session type: offered communication session

Date/Time: Sunday, September 11, 4:30 p.m. – 4:40 p.m. CEST (10:30 a.m. – 10:40 a.m. EST)

Location: 7.3.O – Orléans Auditorium

Speaker: Deborah Schrag, MD, MPH, Chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK)

Assessing Anxiety, Distress, and Satisfaction with an Early Detection Test for Multiple Cancers (Presentation #908P)

Session Type: Electronic Poster

Date/Time: Sunday, September 11

Speaker: Deborah Schrag, MD, MPH, Chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK)

Time to Diagnosis in Cancer Patients in the United States (Presentation #1318MO)

Type of session: Mini oral session

Date/Time: Monday, September 12, 5:10 p.m. – 5:15 p.m. CEST (11:10 a.m. – 11:15 a.m. EST)

Location: 7.3.M – Marseille Auditorium

Speaker: Matthew Gitlin, Doctor of Pharmacy, BluePath Solutions

Abstracts are available on the ESMO Congress 2022 website. Additional data from the PATHFINDER study will be presented at the congress.

About GRAIL’s MCED Clinical Development Program

The Galleri clinical development program consists of studies that collectively include more than 335,000 participants – and what are believed to be the largest linked datasets of genomic and clinical data in the field of cancer. GRAIL’s program includes the CCGA Core Development and Validation Study, the PATHFINDER and PATHFINDER 2 Interventional Studies, the NHS-Galleri Randomized Controlled Clinical Study, the STRIVE and SUMMIT Observational Studies, and the REFLECTION Real-World Registry. . The largest of these, the NHS-Galleri trial, recruited 140,000 participants with the primary aim of a reduction in late-stage cancer diagnoses, seen as a necessary precondition for a reduction in mortality .

About GRAIL

GRAIL is a healthcare company whose mission is to find cancer early, when it can be cured. GRAIL is focused on alleviating the global cancer burden by developing pioneering technology to detect and identify multiple types of deadly cancers early. The company uses the power of next-generation sequencing, population-scale clinical studies, and cutting-edge computing and data science to improve scientific understanding of cancer biology and develop its system early detection of multiple cancers. test. GRAIL is headquartered in Menlo Park, CA, with offices in Washington, DC, North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ: ILMN) currently held separately from Illumina Inc. pursuant to the European Commission’s Interim Measures Order dated October 29, 2021.

For more information, visit grail.com.

About Galléri^®

The earlier the cancer is detected, the higher the chances of success. Galleri’s Multi-Cancer Early Detection Test can detect signals in more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the origin of the cancer signal, or the location of the cancer in the body, with high accuracy to help guide the next steps in diagnosis. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) testing, or cancer screening of the cervix. It is intended for use in people at high risk of cancer, such as people aged 50 or over.

All cells – cancerous and healthy – release DNA, called cell-free DNA, into the bloodstream. One of the “characteristics of cancer” is the addition of methyl groups to DNA. It does not alter the DNA code but can alter gene expression. Methylation patterns on tumor-derived cell-free DNA carry cancer-specific signals and are therefore very useful in detecting cancer and determining its origin. Galleri uses next-generation sequencing and machine learning algorithms to analyze these cell-free DNA methylation patterns in blood.

For more information about Galleri, visit galleryi.com.

Important Galleri Safety Information

Galleri’s test is recommended for use in adults at high risk for cancer, such as those age 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare professional. Galleri is intended to detect cancer signals and predict where the cancer signal is located in the body. The use of Galleri is not recommended in people who are pregnant, aged 21 or younger or who are undergoing active cancer treatment.

Results should be interpreted by a healthcare professional in the context of medical history, clinical signs and symptoms. A “No Cancer Signal Detected” test result does not rule out cancer. A “Cancer Signal Detected” test result requires confirmatory diagnostic evaluation by medically established procedures (eg, imaging) to confirm cancer.

If the cancer is not confirmed by additional tests, it could mean that there is no cancer or that the tests were insufficient to detect the cancer, especially because the cancer is located in another part of the body . False positive (cancer signal detected in the absence of cancer) and false negative (cancer signal not detected in the absence of cancer) test results occur. Rx only.

Lab/Test Information

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 determined by GRAIL. The Galleri test has not been cleared or approved by the United States Food and Drug Administration. GRAIL’s clinical laboratory is regulated by the CLIA to perform high complexity testing. The Galleri test is intended for clinical purposes.