GRAIL Announces Positive Validation Data for Its Multi-Cancer Early Detection Test October 7, 2019

GRAIL, a health care company whose mission is to detect cancer early, announced new data validating the performance of its investigational multi-cancer early detection blood test for the first time in an independent cohort of participants. The results from the validation analysis demonstrates that GRAIL’s technology can detect more than 20 cancer types across all stages with a single, very low false positive rate.

When cancer was detected, the GRAIL test also identified where the cancer was located in the body—the tissue of origin—with high accuracy. In a pre-specified group of 12 deadly cancer types, which are responsible for approximately two-thirds of all cancer deaths, there was an even greater detection rate.

The 12 deadliest cancer types for which the GRAIL test is screening are anal, bladder, colorectal, esophageal, head and neck, liver/bile duct, lung, lymphoma, ovarian, pancreatic, plasma cell neoplasm, and stomach.

GRAIL’s large-scale clinical study program is designed to train and develop a multi-cancer early detection test as well as validate its performance. The new analysis evaluated the performance of the test in an independent group of participants. Performance in the validation analysis was consistent with previously reported results from data used to train the GRAIL cancer detection algorithm to classify cancer and non-cancer signals.

“Today, cancer remains the second leading cause of death worldwide, and we believe an effective multi-cancer early detection technology has the potential to transform the cancer care landscape,” said GRAIL CEO Hans Bishop. “We are excited to present these new validation data that support the potential clinical applicability of our targeted methylation technology, and reinforce our ongoing efforts to bring our multi-cancer early detection test to the clinic to begin returning test results to patients.”

The new data show strong performance at high specificity (99.3%), representing a very low false positive rate. A low false positive rate is important for test designed for use at population scale in order to minimize unnecessary testing and associated harms.

In the group of high-mortality cancers, a tissue of origin result was provided for 97 percent, and of these, the test correctly identified the tissue of origin in 93 percent of cases. Accurately identifying where the cancer originated in the body is critical to inform the diagnostic work-up and next steps.

The new data from GRAIL will be presented at the inaugural ASCO 2019 Breakthrough in Bangkok, Thailand, taking place October 11-13.

Read the original press release here.

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