GRAIL

GRAIL is a biotechnology company that develops tests for early cancer detection using next-generation sequencing technology, population-scale clinical studies, and data science. Its lead product Galleri is a multi-cancer early detection blood test launched in June 2021. The company is also developing a diagnostic aid for cancer (DAC) designed to provide a fast diagnostic result for suspected cancer patients. Additionally, it is working on an early-stage blood-based test for cancer recurrence monitoring and minimal residual disease (MRD)—a small number of cancer cells left in the body after treatment. GRAIL’s DAC test will launch as a laboratory test in 2H 2022.

The Galleri test can detect more than 50 types of cancer across all stages from a single blood draw. It does this by detecting fragments of DNA in a blood sample to identify DNA methylation (distinct patterns associated with particular cancers), potentially providing information on where the disease originated. The Galleri test could increase cancer detection threefold, as other tests in the market can only screen for five types of cancer. The test costs USD 950 out-of-pocket and was available in the US by prescription as a laboratory-developed test for use in asymptomatic patients over 50 years. 

In November 2023, GRAIL initiated a study on the impact of its Galleri multi-cancer early detection test, specifically for Medicare beneficiaries from racially and ethnically diverse backgrounds in underserved communities. Medicare was expected to cover the cost of the test and associated services for participants in the study.

Key partnerships and customers

The company collaborates with health systems and academic medical centers to conduct clinical studies on its products, including Cleveland Clinic, Dana-Farber Cancer Institute, Intermountain Healthcare, Mayo Clinic, and Sutter Health. In January 2021 , GRAIL announced collaborations with global biopharmaceutical companies Amgen, AstraZeneca, and Bristol Myers Squibb to evaluate GRAIL’s methylation-based technology for the detection of MRD. In January 2022, the company partnered with PINC AI , the technology and services platform of healthcare improvement group Premier Inc., to identify patients that may benefit from using Galleri.

In October 2022 the company partnered with digital health company Carrum Health to include its Galleri test in Carrum’s oncology offering to self-insured employers. In August 2023 it collaborated with non-profits Whitman-Walker Institute and Cancer Support Community (CSC) on a study aimed at advancing health equity in cancer screening and care using. .

Funding and Financials

GRAIL was founded by genetic testing company Illumina and later spun out as an independent company in 2016 for fundraising purposes. In August 2021, Illumina finalized the takeover of GRAIL for a total consideration of USD 8 billion. After a year-long review by antitrust regulators in the US and EU, a ruling in favor of Illumina was announced in September 2022, while the EU blocked the acquisition because it could lead to anticompetitive practices.In response to the decision, Illumina was exploring possibilities of divesting GRAIL and appealing the decision.