User:MaryGaulke/sandbox/GRAIL mockup

Grail (styled GRAIL) is an American biotechnology company, which began in 2016 as a start-up in San Francisco, California, seeking to develop an early cancer screening test for people who do not have symptoms. Its headquarters is in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the UK. Its parent company is Illumina in San Diego, California.

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

Background
Grail began as a San Francisco biotechnology and pharmaceutical startup company in 2016, 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. Dr. Richard Klausner, then chief medical officer at Illumina and former director of the National Cancer Institute, championed the new business and joined its 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. In March 2021, the Federal Trade Commission sued to block the vertical merger. In September 2022, an administrative judge ruled against the FTC's position on antitrust grounds.

The company sponsored the Galleri Classic golf tournament in Rancho Mirage, California, in March 2023.

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.

Technology
Grail calls its multi-cancer early detection test the Galleri 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 predicting the origin of the cancer.

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.

Research
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. The study found that the number of cancer detections doubled when multi-cancer screening was included in the standard of care screening, compared to using only standard screening. The test also predicted the cancer signal origin with 97% accuracy. Of the more than 6,000 participants in PATHFINDER, 35 were diagnosed with cancer, and 71% of those diagnosed were diagnosed with cancer types for which no routine screening is available.

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 a separate NHS trial in collaboration with Oxford University, the SYMPLIFY study is evaluating the test's utility for symptomatic individuals. Initial results shared in June 2023 showed that the test correctly detected two out of three cancers among 5,000 individuals who presented with symptoms. The test also accurately predicted the cancer signal origin in 85% of those cases.

In May 2021, Grail announced that Providence Health & Services would be the first health system in the U.S. to offer access to the Galleri test. The next month, the company began selling Galleri tests in the U.S., making it the first commercially available multi-cancer early detection test. Point32Health, parent of Tufts Health Plan and Harvard Pilgrim Health Care, became the first commercial insurance provider to offer the test in November 2022.

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.

In June 2023, Grail disclosed that its telemedicine vendor PWNHealth mistakenly informed 408 of its patients that they may have cancer. The company asserted that the incident was due to a software configuration issue at PWNHealth, not due to incorrect Galleri test results. Grail stated that more than half of the people who received erroneous letters had not yet had their blood drawn for the test.