Grail took a major step forward in its quest to deliver a single blood test capable of detecting the presence of multiple cancers with the long-awaited launch of its Galleri diagnostic.
Now available by prescription in the U.S., the test is meant to screen people who may already have an elevated risk for cancer, such as adults over the age of 50, the company said.
After years of development—plus about $2 billion in venture capital raised and clinical research programs spanning more than 115,000 people—Grail’s genomic Galleri test has made it the target of a contested $8 billion buyout by its former parent, Illumina, which has vowed to fight for the company’s return despite ongoing legal objections from the Federal Trade Commission and European antitrust regulators.
Designed to trace back the original organ location of as many as 50 different cancers by decoding fragments of tumor DNA found in the bloodstream, Galleri could be Illumina’s ticket to a deep foothold in the clinical testing market. The company has estimated the test could help screen as many as 50 million people after its initial debut, before Grail pursues a full FDA approval in 2023.
Earlier this year, Grail lined up lab testing giant Quest Diagnostics to pitch in on its national rollout. Quest will perform Galleri blood draws at more than 2,000 locations and through at-home visits via its ExamOne network of 5,000 mobile phlebotomists. Grail will also work with partnered health systems, medical practices and self-insured employers.
The launch catapults Grail to the front of a pack developing blood screening tests for different cancers—such as Freenome and Thrive Earlier Detection, which both made Fierce Medtech’s list of last year’s top medtech VC rounds. Along with companies such as Guardant Health, they’re all players in a nascent field the FTC said it aims to protect by placing itself between Illumina and its quarry.
Following the multibillion-dollar acquisition announcement last September, the U.S. competition watchdog moved to block the deal, saying the ownership of a proprietary oncology diagnostic could lead Illumina to throttle similar efforts by other test makers—many of which may already rely on the company’s DNA sequencing hardware, with Illumina instruments and consumables making up about 75% of the global market.
Illumina’s offer saw another setback earlier this month after a federal judge granted the FTC the ability to postpone its regulatory actions pending the outcome of separate challenges brought by the European Commission. The two-front legal battle prompted Illumina to sue the commission, claiming it has no jurisdiction over Grail’s U.S. business, all while the deal’s terms are set to expire before the end of December.
At this year’s annual meeting of the American Society of Clinical Oncology, Grail presented its first results from an interventional study of more than 6,600 participants, tracking the Galleri test’s use in real-world clinical settings, such as the steps oncologists take after the diagnostic returns a positive result.
The study pegged Galleri’s total positive predictive value at 44.6% and found that it accurately determined the cancer’s origin site 96.3% of the time.
“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,” said the study’s presenting author Tomasz Beer, M.D., deputy director at the Oregon Health and Science University’s Knight Cancer Institute. “These results are a pivotal step toward extending early detection to many more types of cancer.”
In addition, Grail said its test was better at detecting cancers that may be more aggressive than expected based on a person’s age and the tumor’s stage and type, according to a separate study published in the journal Clinical Cancer Research.
Grail also said it plans to establish a new registry study to gather real-world evidence following the clinical outcomes of 35,000 patients screened with the Galleri test in the U.S.
“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 Grail’s chief medical officer and head of external affairs, Joshua Ofman, M.D. “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.”