It’s one of the holy grails of medicine—the ability to detect cancer before it becomes deadly —hence the company’s name. Now, red hot diagnostics company Grail has snagged three top tier partners to pave the way for using its technology to this end. Amgen, AstraZeneca, and Bristol Myers Squibb are all teaming up with Grail to apply its targeted methylation platform for early, blood-based, cancer detection.
Simultaneously, the company announced it would introduce Galleri, it’s multi-cancer early detection blood test in the second quarter of 2021. Galleri, the company reports, will be a laboratory developed test (LDT). If all goes as planned, this is a revolution for cancer care.
“Research has shown that we can improve outcomes across cancer types by treating patients as early as possible and intervening early if cancer recurs, which underpins our strategy,” said Carl Barrett, vice president, Translational Science, Oncology R&D, AstraZeneca. “This collaboration with GRAIL will allow us to test a promising approach for monitoring MRD and detecting recurrence – tools that will provide critical information that we hope can optimize patient treatment plans.”
It was just in September that Grail filed to go public with backers that included Microsoft co-founder Bill Gates and Amazon CEO Jeff Bezos, both of whom invested in a $100 million Series A round for the company four years ago. In the IPO filing the company stated that Galleri would launch in 2021. Shortly after announcing its planned IPO, partial investor Illumina announced it would acquire the company for up to $8 billion.
“GRAIL has developed and validated a novel approach to detect early cancer signals in blood and now we are excited to collaborate with leading companies Amgen, AstraZeneca, and Bristol Myers Squibb to evaluate the benefits of using our technology to find minimal residual disease after treatment or to detect early recurrent cancers,” said Joshua Ofman, M.D., MSHS, Grail chief medical officer and head of external affairs.
Cancer minimal residual disease (MRD) testing is used in clinical and research applications. Many MRD tests for solid tumors require tissue samples and development of patient-specific assays, which leads to longer turnaround times and potential delay in treatment decisions. All the more reason for a blood-based test.
And Grail has beem=n doing its homework. In December, the company completed the enrollment of PATHFINDER, a prospective, 6,600-participant multi-site interventional study conducted under an FDA Investigational Device Exemption application to evaluate the implementation of Galleri in clinical practice. PATHFINDER has completed its second planned independent Data and Safety Monitoring Board review. Presentation of initial results from that study and validation data from GRAIL’s foundational Circulating Cell-free Genome Atlas (CCGA) study, are expected in the first half of 2021.
GRAIL is also conducting a clinical study involving more than 134,000 participants. According to a company press release, “An earlier version of Galleri demonstrated the ability to detect more than 50 types of cancers — over 45 of which lack recommended screening tests today — with a low false positive rate of less than 1%. When a cancer signal is detected, Galleri can determine where in the body the cancer is located with high accuracy, all from a single blood draw.”