Grail (company)

Grail (styled GRAIL) is an American biotechnology company in Menlo Park, California. It was previously a subsidiary of Illumina started as a startup seeking to develop an early cancer screening test for people who do not have symptoms. Grail was spun-out from Illumina on June 24, 2024.

Their liquid biopsy (also called multi-cancer early detection test ) which was launched in June 2021 and is called the Galleri test, detects fragments of DNA in a blood sample via next-generation sequencing, which identifies DNA methylation, distinct patterns of which are associated with particular cancers, potentially allowing for the early detection of cancer and providing information of the origin of the cancer. It is one of three multi-cancer screening tests under investigation; the other two being the CancerSEEK assay and the PanSeer assay.

History
Grail began as a San Francisco biotechnology and pharmaceutical startup company in 2015, the parent company being Illumina of San Diego, which produces most of the DNA sequencing machines that scientists use to study human biology and diagnose rare genetic diseases. Richard Klausner, then chief medical officer at Illumina and former director of the National Cancer Institute, advocated for the new business. According to the San Francisco Business Times, he correctly predicted how DNA sequencing technology would make it possible to detect evidence of a tumor from a blood sample. He also joined Grail's board of directors. According to Forbes in 2017, 20% of Grail's profits are kept by Illumina.

In September 2020, Illumina announced an agreement to purchase Grail outright for $7.1 billion.

On November 27, 2020, Grail announced a commercial partnership with the National Health Service (England) (NHS), to trial the Galleri test, reporting in 2026.

In March 2021, the Federal Trade Commission (FTC) sued to block the vertical merger. In September 2022, an administrative judge ruled against the FTC's position on antitrust grounds.

In June 2023, Grail disclosed that its telemedicine vendor PWNHealth mailed letters to 408 patients incorrectly informing them that they may have cancer. The company blamed the incident on PWNHealth, saying that it was due to a software configuration issue, not due to incorrect Galleri test results.

In July 2023, it was reported that three separate lawsuits were filed against Grail by former female employees; the allegations included that Grail created a "frat house” culture and a “sexually charged, hostile work environment”.

In October 2023, the European Commission ordered Grail to be divested from Illumina within the next twelve months. The European Commission (EC) has since approved Illumina's divestment plan for separating from Grail. Illumina has set a goal of finalizing the divestment terms by the end of the second quarter of 2024. In April 2024, the EC approved Illumina's plan, allowing Illumina to explore either a trade sale or a capital markets transaction (spin-off) to divest Grail. In May 2024, Illumina publicly filed a Form 10 registration statement with the U.S. SEC, a necessary step for a potential capital markets separation of Grail. If a capital markets transaction occurs, Illumina must capitalize Grail with around $1 billion to fund 2.5 years of operations per the EC's divestment plan.

Activities
Illumina's own research showed that repeatedly sequencing DNA in the bloodstream made it possible to detect floating bits of DNA from cancer cells more accurately. It initially aimed to recruit greater than 100,000 people into its clinical trials in order to accumulate the sizeable data required to detect and interpret cancer biomarkers.

Galleri test
Grail calls its liquid biopsy for early cancer the Galleri test or the Galleri multi-cancer early detection (MCED) test, one of three multi-cancer screening tests under investigation and being validated as of November 2020; the other two being the CancerSEEK assay and the PanSeer assay. The Galleri test detects fragments of DNA in a blood sample via next-generation sequencing, which identifies DNA methylation, distinct patterns of which are associated with particular cancers, potentially allowing early detection of cancer and providing information of the origin of the cancer.

Grail's first clinical trial for the Galleri test is the 'Circulating Cell-free Genome Atlas Study'. The study looked at more than 50 distinctive cancer types in blood and tumour tissue samples from 15,254 people from 142 locations in North America, including people with new cancer and blood samples from people without a cancer diagnosis. Subsequently the Galleri test entered into a further three trials; STRIVE, SUMMIT, and PATHFINDER studies. Results from PATHFINDER presented in September 2022 showed a 43.1% positive predictive value for the detection of early-stage cancer, with the test predicting the cancer signal origin with 97% accuracy in less than three months' time.

Galleri received breakthrough device designation from the U.S. Food and Drug Administration in May 2019. The test does not diagnose cancer; rather, it detects possible signs of cancer in order to help direct follow-up diagnostic testing. Galleri is not yet approved by the FDA, but it is available by prescription under the agency's provision for laboratory developed tests.

In November 2020 Grail announced a commercial partnership with the National Health Service (England) (NHS), to trial the Galleri test; several scientists responded to the news.

The NHS England interventional randomised controlled trial includes two groups of participants; a group of 140,000 people aged 50 to 79 identified through NHS records who have no symptoms, who will have a yearly blood test over three years, and a second group of 25,000 people with possible cancer symptoms. The trial started on August 31, 2021, with primary completion date estimated at July 15, 2024, and study completion on February 28, 2026. In June 2021, the company began selling Galleri tests in the U.S.

at least seventeen clinical trials were in progress to investigate the performance and clinical utility of multi-cancer early detection tests, six of them involving Grail.