GRAIL Announces Final Results From the PATHFINDER Multi-Cancer Early Detection Screening Study at ESMO Congress 2022 – QNT Press Release

Adding Multi-Cancer Early Detection (MCED) Screening to Standard of Care Screening More Than Doubled the Number of Cancers Detected

71% of Participants With MCED-Detected Cancers Had Cancer Types With No Routine Screening Tests Available

Approximately Half of the MCED-Detected New Cancers Were Stage I or II

MCED-Predicted Cancer Signal Origin Had 97.1% Accuracy and Enabled Targeted Diagnostic Evaluations

MCED Screening was Implemented in Adults With Elevated Cancer Risk Without Study-Related Serious Adverse Events

Participants Reported High Satisfaction and Low Negative Psychological Impact With MCED Screening

GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced final results from the interventional PATHFINDER study, which evaluated multi-cancer early detection (MCED) screening using a blood test and the clinical care pathways following a “cancer signal detected” MCED test result in 6,662 individuals aged 50 years or older, an age group at elevated risk for cancer. Results were presented in a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris .

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Galleri product photo (Photo: Business Wire)

“The PATHFINDER study is an exciting first step towards fundamental change in the approach to cancer screening. The study found cancer in about 1% of participants including types for which there is no established screening method. The study demonstrated the feasibility of this paradigm and solid test performance,” said Deb Schrag, MD, MPH, chair, Department of Medicine at Memorial Sloan Kettering Cancer Center in New York. “Although continued public health efforts to optimize adherence to existing screening strategies that have been proven effective are critical, this study provides a glimpse of what the future may hold—the opportunity for screening using blood tests to detect various types of cancers at their earliest and most treatable stages.”

PATHFINDER was a single-arm study that measured the time required to achieve diagnostic resolution (ie, healthcare provider-defined end to the diagnostic evaluation) following a “cancer signal detected” MCED blood test result and the number and types of diagnostic tests that were used (primary endpoint). MCED test performance was a key secondary endpoint, including positive predictive value (PPV, the percent of cancer signal detected results that were confirmed to be cancer) and the accuracy of the predicted cancer signal origin (CSO). Participants were followed for 12 months after enrollment. If a participant had a negative MCED test at enrollment but developed a cancer within the 12-month follow-up, it was counted as an MCED false negative.

Test performance was measured using both an earlier version of Galleri (MCED-E) and a refined version of Galleri (MCED-Scr). The earlier version of the test was refined to reduce the detection of pre-malignant hematologic conditions, which are fairly common, and improve prediction of the cancer signal origin. The study was completed with the earlier version of the test (MCED-E) and then the blood samples were retested in a pre-specified retrospective analysis using the refined Galleri test (MCED-Scr ).

“When added to standard of care screening, MCED testing more than doubled the number of cancers detected compared to standard screening alone. In fact, Galleri detected more cancers than all US Preventive Services Task Force-recommended standard single cancer screenings combined. These included Stage I cancers of the liver, small intestine, and uterus, and Stage II pancreatic, bone, and oropharyngeal cancers,” said Jeffrey Venstrom, MD, chief medical officer at GRAIL. “This is particularly notable given the PATHFINDER population was heavily screened with higher -than-average rates for mammography, colonoscopy, and low-dose CT lung scans.”

A cancer signal was detected in 92 participants, two of whom began workup prior to the return of their MCED test results. Of these, 35 participants were diagnosed with 36 cancers. Among the confirmed cancers, 71% (25/35) of participants had cancer types that have no routine cancer screening available. Nearly half (48%) of the non-recurrent cancers were found in early-stages (Stage I or II). Standard of care screening identified 29 cancers, and another 56 cancers …

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