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Blood test for early detection of multiple cancers validated

Journal
Annals of Oncology
Reuters Health - 28/06/2021 - Final study results evaluating a blood test that can detect more than 50 types of cancer confirms its high accuracy and supports its use alongside established cancer-screening tests, researchers say.

The Galleri test from GRAIL, Inc., which funded the study, uses next-generation sequencing technology to detect DNA-methylation patterns associated with cancer in cell-free DNA.

"This study is validation of the prior discovery and refinement work on this assay and it shows robust performance," Dr. Eric Klein, chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic, in Ohio, told Reuters Health by phone.

"To me, this opens up the stage for using a simple blood test to screen individuals for multiple cancers, as opposed to what we do now, which is screening for individual cancers like prostate and colon cancer screening, so this is a paradigm shift. It won't replace screening but will supplement current screening," said Dr. Klein.

Final results from the Circulating Cell-free Genome Atlas (CCGA) study are published in Annals of Oncology. The test performance was evaluated in 2,823 people already diagnosed with cancer and 1,254 people without cancer.

The test's specificity for detecting a "cancer signal" was 99.5%, meaning that the test wrongly detected cancer in only 0.5% of cases.

The test detected cancer signals from more than 50 different types of cancer. Sensitivity was 51.5% overall and increased with increasing cancer stage: It was 16.8% at stage I, 40.4% at stage II, 77.0% at stage III and 90.1% at stage IV.

Stage-I-to-III sensitivity was 67.6% in 12 pre-specified cancers that make up two-thirds of cancer deaths in the United States annual (anal, bladder, bowel, esophageal, stomach, head/neck, liver/bile duct, lung, ovarian, pancreatic, lymphoma and cancers of white blood cells such as multiple myeloma).

In addition, the multi-cancer early detection test correctly identified the tissue of origin for the cancer in 88.7% of cases.

"These results support the feasibility of this blood-based multi-cancer early detection test as a complement to existing single-cancer screening tests," Dr. Klein and colleagues conclude in their article.

"Finding cancer early, when treatment is more likely to be successful, is one of the most significant opportunities we have to reduce the burden of cancer," Dr. Klein said in a news release.

"These data add to a growing body of literature that supports the use of next-generation sequencing for the detection of cell-free DNA in blood samples as a tool for earlier detection of common cancers that account for a significant number of deaths and other health problems worldwide. In addition, a screening test that requires only a simple blood draw could provide an option for communities that have poor access to medical facilities. I'm excited about the potential impact this approach will have on public health," Dr. Klein added.

Kelsey Grossman, director of corporate communications for GRAIL, Inc., told Reuters Health by email, "Galleri is now available in the U.S. by prescription only and as a complement to existing screenings supported by these latest CCGA findings along with interim data from the interventional PATHFINDER study presented at the 2021 ASCO Annual Meeting." (https://bit.ly/3gUGVhq)

The GRAIL laboratory is CLIA-certified (Clinical Laboratory Improvement Amendments) and CAP-accredited (College of American Pathologists), Grossman said.

The test has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) and the company is pursuing FDA authorization for the test while offering it as a Laboratory Developed Test (LDT) now to healthcare providers and patients, Grossman noted.

"The cost of the Galleri test may vary depending on the practice setting and healthcare provider that orders the test. The list price for Galleri is $949, and people may be able to use pre-tax dollars in their flexible spending account (FSA) or health savings account (HSA) to pay for the Galleri test," she told Reuters Health.

"It is our goal that the Galleri test be broadly accessible. It is new to the market and represents a significant innovation to cancer screening, and GRAIL is actively pursuing public and private insurance coverage pathways," Grossman added.

The CCGA study was funded by GRAIL Inc. More than 140 clinical sites in the United States and one site in Canada supported and participated in the study. Dr. Klein is a consultant for GRAIL Inc.

SOURCE: https://bit.ly/2Uzoiqx Annals of Oncology, online June 24, 2021.

By Megan Brooks



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