RESEARCH TRIANGLE PARK – A new blood test that can detect more than 50 types of cancer in a single blood draw is now available by prescription in the United States.
And it’s all thanks to a biotech company with strong ties to the Triangle.
The test, called Galleri, was developed by the California-based biotech company GRAIL, which is building a manufacturing facility in Research Triangle Park.
With a list price of $949, it is hailed as “groundbreaking.”
“Finding cancer early, when treatment is more likely to be successful, is one of the most important opportunities we have for reducing the burden of cancer,” said Joshua Ofman, MD, medical director and chief of external affairs at GRAIL.
The news came last week on the same day the company released the first results of its interventional PATHFINDER study evaluating Galleri. GRAIL, presented at ASCO’s 2021 annual meeting, said the results support Galleri’s performance in clinical settings.
It analyzed 6,629 individuals aged 50 or older, an age group at increased risk of cancer, but the subjects had no suspicion of active cancer.
The company said the test accurately detected 29 cancers in 13 types: breast, colon or rectum, head and neck, liver and biliary tract, lung, lymphoid leukemia, lymphoma, ovary, pancreas, plasma cell neoplasm, prostate, small intestine and Waldenstrom macroglobulinemia.
Of the newly discovered cancers, 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 prediction of the origin of the cancer signal was 96.3% accurate, with a median observed time to cancer diagnosis of 50 days.
“These data suggest that the Galleri test, if used widely alongside existing screening tests, could have a profound impact on how cancer is detected and, ultimately, on public health,” Ofman said.
“Most importantly, it can detect cancers for which there are no recommended screening tests today, and more than two-thirds of cancers are not screened for this reason,” added Tomasz M. Beer, MD, deputy director at Oregon Health & Science University Knight Cancer. Institute and presenting author.
“These results are a critical step toward expanding early detection to many more types of cancer.”
Cancer is expected to become the leading cause of death in the United States this year, largely because most cancers are discovered 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 US have no recommended screening for early detection,” the company said in a press release.
PATHFINDER participants will be followed for 12 months, with final results expected in the first half of 2022.
Meanwhile, Galleri will be offered to eligible patients in the UK later this year as part of a partnership with the UK’s National Health Service.
Strong triangular tires
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 at RTP.
Three months after the RTP announcement, San Diego-based Illumina, which founded GRAIL in 2016 and then spun off as a standalone company, came back into the picture. Illumina announced plans to buy back GRAIL for $8 billion. And the RTP project remained a “go”.
In April, GRAIL held a virtual facility open house. It is now open to some of its new hires, with plans to begin lab operations there this fall.
GRAIL actively employs 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 vacancies at Janice Leung and Jen Montalvo.
(C) NC Biotech Center