Early Cancer Detection Test Found Very Accurate

A California healthcare company whose mission is to detect cancer early, when it can be cured, announced validation data for its multi-cancer early detection blood test.

Published in Annals of Oncology on April 1, 2020, these data demonstrate GRAIL’s technology can detect more than 50 cancer types across all stages through a single blood draw, with a false-positive rate of less than 1 percent.

When a cancer signal is detected, the test can also identify where the cancer is located in the body with about 93 percent accuracy, said GRAIL’s press release.

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 cancer and identify the tumor’s tissue of origin. 

GRAIL believes its sequencing database of cancer and non-cancer methylation signatures is the largest of its kind.

Today, most cancers have progressed to late stages when chances of survival are much lower. When cancer is diagnosed after it has spread, the 5-year cancer-specific survival rate is 21 percent, compared to 89 percent when the cancer is diagnosed early.

“At GRAIL, we believe that multi-cancer early detection has the potential to significantly reduce cancer mortality,” said Alex Aravanis, M.D., Ph.D., Chief Scientific Officer of GRAIL. 

“The data published in Annals of Oncology further support GRAIL’s approach and commitment to clinical and scientific rigor.”

The publication includes data from GRAIL’s foundational Circulating Cell-free Genome Atlas (CCGA) study, which included more than 15,000 participants with or without a diagnosis of cancer. 

In the sub-study reported in today’s publication (N=6,689), results from the validation set (N=1,969) showed that GRAIL’s proprietary targeted methylation technology achieved high specificity (99.3%), across more than 50 cancer types. 

The detection rate for a pre-specified set of 12 deadly cancer types, that together account for approximately 63 percent of U.S. cancer deaths annually, was 67.3 percent across stages I-III.

When a cancer signal was detected, a tissue of origin result was provided for 96 percent of the samples, and of these, the test correctly identified the tissue of origin in 93 percent of cases. 

Importantly, the performance of the test was consistent across training and validation sets. 

Minetta Liu, M.D., Research Chair and Professor, Department of Oncology, Mayo Clinic, co-lead author and investigator in the CCGA study, said in the press release, “In addition, the high accuracy in identifying the anatomic origin of primary cancer, in conjunction with detection of a positive cancer signal in the blood, will allow providers to efficiently direct next steps for each individual’s diagnostic work-up and subsequent clinical care.”

The impact of early detection on cancer mortality can be modeled using data from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program. 

GRAIL also published new data modeling the most recent SEER statistics in Cancer Epidemiology, Biomarkers & Prevention, showing that if all cancers currently diagnosed at stage IV could be diagnosed earlier, evenly distributed across stages I-III, cancer fatalities could fall by 24 percent. 

These findings support the potential significant public health benefit of an accurate and highly specific multi-cancer early detection test.

Joshua Ofman, M.D., MSHS, Chief Medical Officer at GRAIL, said: “These validation data suggest that GRAIL’s test could be one of the first examples of a technology derived from insights from the Human Genome Project to have an impact at the broader population level, and could facilitate an important transition from screening for individual cancers to screening individuals for all cancer types.”  

The CCGA data from the second sub-study were previously presented at the European Society for Medical Oncology 2019 Congress and American Society of Clinical Oncology 2019 Breakthrough and are available on GRAIL’s website.

Cancer Detection news published by Precision Vaccinations.