GRAIL, with Large Presence in RTP, Launches ‘Groundbreaking’ Early-Detection Cancer Test

GRAIL logo
.

A new blood test that can detect more than 50 types of cancer in a single blood draw is now available in the United States with a prescription.

And it’s all thanks to a biotech firm with strong ties to the Triangle. 

The test, called Galleri, is developed by the California-based biotech firm GRAIL, which is building a manufacturing facility in Research Triangle Park.

With a list price of $949, it’s being hailed as “groundbreaking.”

“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,” said Joshua Ofman, M.D., chief medical officer and head of external affairs at GRAIL.

Galleri package
-- GRAIL images

The news comes the same day that the company released the first results from its interventional PATHFINDER study evaluating Galleri. Presented at the 2021 ASCO Annual Meeting, GRAIL said the results support Galleri’s performance in clinical settings.

It analyzed 6,629 individuals aged 50 years or older, an age group at elevated risk for cancer, but the test subjects had no suspicion of active cancer.

The company said the test accurately detected 29 cancers across 13 types: breast, colon or rectum, head and neck, liver and bile duct, lung, lymphoid leukemia, lymphoma, ovary, pancreas, plasma cell neoplasm, prostate, small intestine, and Waldenstrom macroglobulinemia.

Of the new cancers detected, nearly 40% (9/23) were localized (stage I-II), and more than half (13/23) were detected before distant metastases (stage I-III). 

When cancer was confirmed, Galleri’s first or second cancer signal origin prediction was 96.3% accurate, with a median observed time to cancer diagnosis of 50 days.

“These data suggest that, if used at scale alongside existing screening tests, the Galleri test could have a profound impact on how cancer is detected and, ultimately, on public health,” Ofman said.  

“Most importantly, it can detect cancers that have no recommended screening tests today, and more than two-thirds of cancers go unscreened for this reason,” added Tomasz M. Beer, M.D., deputy director at the Oregon Health & Science University Knight Cancer Institute and presenting author.

“These results are a pivotal step toward extending early detection to many more types of cancer.”

Cancer is expected to become the leading cause of death in the United States this year, in large part because most cancers are found too late, when outcomes are poor. 

GRAIL said recommended screening tests save lives, but only cover five cancer types in the United States. “In fact, 71% of cancer deaths in the U.S. have no recommended early-detection screening,” the company said in a news release. 

PATHFINDER participants will continue to be followed for 12 months, with final results expected in the first half of 2022.

Galleri, meanwhile, will be offered to eligible patients in the United Kingdom later this year as part of a partnership with the UK National Health Service.

Strong Triangle ties

Last June, GRAIL, headquartered in Menlo Park, California, announced it would invest $100 million and create nearly 400 new jobs over four years in a new 200,000-square-foot lab, office, and warehouse facility in RTP. 

GRAIL RTP facility
GRAIL's RTP facility rendering.

Then three months after the RTP announcement, San Diego-based Illumina, which founded GRAIL in 2016 and then spun it off as a standalone business, reentered the picture. Illumina announced plans to buy GRAIL back for $8 billion. And the RTP project remained a “go.”

This April, GRAIL held a virtual open house of the facility. It’s now opened to some of its new employees, with plans to begin laboratory operations there this fall.

GRAIL is actively hiring laboratory scientists and technologists; equipment, quality, and automation engineers; and supply chain and warehouse personnel. The company encourages candidates to visit www.grail.com/careers to view and apply for open positions with Janice Leung and Jen Montalvo.

Chantal Allam, NCBiotech Writer
Fri, 06/04/2021 - 16:22