Grail (styled GRAIL) is an American biotechnology company, which began in 2015 as a

start-up A startup or start-up is a company or project undertaken by an entrepreneur to seek, develop, and validate a scalable business model. While entrepreneurship refers to all new businesses, including self-employment and businesses that never intend t ...

in San Francisco,

California California is a U.S. state, state in the Western United States, located along the West Coast of the United States, Pacific Coast. With nearly 39.2million residents across a total area of approximately , it is the List of states and territori ...

, 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 San Diego ( , ; ) is a city on the Pacific Ocean coast of Southern California located immediately adjacent to the Mexico–United States border. With a 2020 population of 1,386,932, it is the eighth most populous city in the United States ...

. Their

liquid biopsy A liquid biopsy, also known as fluid biopsy or fluid phase biopsy, is the sampling and analysis of non-solid biological tissue, primarily blood. Like traditional biopsy, this type of technique is mainly used as a diagnostic and monitoring tool for ...

, which was launched in June 2021 and is called the 'Galleri test', detects fragments of DNA in a blood sample via

next-generation sequencing Massive parallel sequencing or massively parallel sequencing is any of several high-throughput approaches to DNA sequencing using the concept of massively parallel processing; it is also called next-generation sequencing (NGS) or second-generation s ...

, which identifies

DNA methylation DNA methylation is a biological process by which methyl groups are added to the DNA molecule. Methylation can change the activity of a DNA segment without changing the sequence. When located in a gene promoter, DNA methylation typically acts t ...

, 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 multicancer screening tests under investigation; the other two being the CancerSEEK assay and the PanSeer assay. On 27 November 2020, Grail announced a commercial partnership with the

National Health Service (England) The National Health Service (NHS) is the Publicly funded health care, publicly funded healthcare system in England, and one of the four National Health Service systems in the United Kingdom. It is the second largest single-payer healthcare s ...

(NHS), to trial the Galleri test, reporting in 2026.

Origin

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 DNA sequencing is the process of determining the nucleic acid sequence – the order of nucleotides in DNA. It includes any method or technology that is used to determine the order of the four bases: adenine, guanine, cytosine, and thymine. Th ...

machines that scientists use to study human biology and diagnose rare genetic diseases. Grail's chairman is Jay Flatley. According to ''

Forbes ''Forbes'' () is an American business magazine owned by Integrated Whale Media Investments and the Forbes family. Published eight times a year, it features articles on finance, industry, investing, and marketing topics. ''Forbes'' also re ...

'' 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 The Federal Trade Commission (FTC) is an independent agency of the United States government whose principal mission is the enforcement of civil (non-criminal) antitrust law and the promotion of consumer protection. The FTC shares jurisdiction ov ...

sued to block the vertical merger. In September 2022, an administrative judge ruled against the FTC's position on antitrust grounds.

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 A cancer biomarker refers to a substance or process that is indicative of the presence of cancer in the body. A biomarker may be a molecule secreted by a tumor or a specific response of the body to the presence of cancer. Genetic, epigenetic, pro ...

Galleri test

Grail calls its

for early cancer the 'Galleri test' or the 'Galleri multicancer early detection (MCED) test', one of three multicancer 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

, which identifies

, 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. In November 2020 Grail announced a commercial partnership with the

(NHS), to trial the 'Galleri test'; several scientists responded to the news. The NHS England interventional

randomised controlled trial A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical t ...

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 31 August 2021, with primary completion date estimated at 15 July 2024 and study completion on 28 February 2026. at least seventeen clinical trials were in progress to investigate the performance and clinical utility of multicancer early detection tests, six of them involving Grail.

Investors

Investors in the company have included: *

ARCH Venture Partners ARCH Venture Partners (ARCH) is an American venture capital firm based in Chicago. Background In 1986, the ARCH Development Corporation was initially created by the University of Chicago and the Argonne National Laboratory as an non-profit i ...

Jeff Bezos Jeffrey Preston Bezos ( ;; and Robinson (2010), p. 7. ''né'' Jorgensen; born January 12, 1964) is an American entrepreneur, media proprietor, investor, and commercial astronaut. He is the founder, executive chairman, and former preside ...

Bill Gates William Henry Gates III (born October 28, 1955) is an American business magnate and philanthropist. He is a co-founder of Microsoft, along with his late childhood friend Paul Allen. During his career at Microsoft, Gates held the positions ...

Johnson & Johnson Johnson & Johnson (J&J) is an American multinational corporation founded in 1886 that develops medical devices, pharmaceuticals, and consumer packaged goods. Its common stock is a component of the Dow Jones Industrial Average and the company i ...

Bristol Myers Squibb The Bristol Myers Squibb Company (BMS) is an American multinational pharmaceutical company. Headquartered in New York City, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the ''Fortune'' 500 list of the lar ...

Merck Merck refers primarily to the German Merck family and three companies founded by the family, including: * the Merck Group, a German chemical, pharmaceutical and life sciences company founded in 1668 ** Merck Serono (known as EMD Serono in the Unite ...

McKesson Ventures McKesson Corporation is an American company distributing pharmaceuticals and providing health information technology, medical supplies, and care management tools. The company delivers a third of all pharmaceuticals used in North America and emplo ...

* Varian Medical Systems *

Tencent Tencent Holdings Ltd. () is a Chinese multinational technology and entertainment conglomerate and holding company headquartered in Shenzhen. It is one of the highest grossing multimedia companies in the world based on revenue. It is also the w ...

Amazon Amazon most often refers to: * Amazons, a tribe of female warriors in Greek mythology * Amazon rainforest, a rainforest covering most of the Amazon basin * Amazon River, in South America * Amazon (company), an American multinational technology c ...

Celgene Corporation Celgene Corporation is a pharmaceutical company that makes cancer and immunology drugs. Its major product is Revlimid ( lenalidomide), which is used in the treatment of multiple myeloma, and also in certain anemias. The company is incorporated in ...

References

{{Reflist Pharmaceutical companies of the United States 2021 mergers and acquisitions American corporate subsidiaries