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Written by Julie Steenhuisen
CHICAGO (Reuters) – U.S. cancer diagnostic testing company Grail, which will list its shares on the Nasdaq on Tuesday after being separated from Illumina (NASDAQ:), is betting that business partnerships with health systems, employers and its life insurance companies will boost screening tests. Cancer expects its near-term growth as an independent company.
The blood test, called Galleri, can detect multiple types of cancer early and looks for 80% of cancers that are not currently screened for, Grail CEO Bob Ragusa said in a phone interview Monday.
“The long-term goal is to deploy this technology widely around the world,” Ragusa said, adding that would come with regulatory approvals in the United States and elsewhere.
Ragusa estimates that there are about 100 million people in the United States at high risk of cancer, with another 90 million in the United Kingdom, 160 million across the European Union, and about 50 million in Japan.
“This is really a tremendous opportunity that we are looking forward to, so we will do everything we can to open this opportunity over the next two years,” Ragusa said.
Galleri is a so-called laboratory-developed test that is currently sold only in the United States, with a test price of $949.
The company is promoting the test as a way to detect cancer at an early stage, when it is most likely to be cured. The company is conducting two large clinical trials, including one in the United Kingdom, which it will use to apply for FDA approval in early 2026. US approval could lead to its test being more widely adopted.
However, some groups, including the American Cancer Society, want proof that the GRIL test prevents deaths from cancer, something GRIL studies cannot prove.
Grail currently has more than 100 business partnerships that include health systems, employers and life insurance companies, Ragusa said.
Ragusa added that during Illumina’s battle with antitrust authorities in the United States and Europe, Grail initiated large-scale clinical trials, provided more than 180,000 commercial tests, and expanded its laboratory infrastructure.
Illumina founded and built Grail in 2016. Grail has gone on to raise funding from investors like Bill Gates and Jeff Bezos. Illumina acquired a 12% stake and in 2021 decided to acquire Grail to enter the early cancer detection market.
Antitrust regulators opposed the deal over concerns that Illumina would deny Grail’s competitors access to its technology to develop competing blood-based early cancer detection tests.
Illumina pursued the acquisition regardless, only to be hit with a €432 million ($463.19 million) fine by the European Commission, which ordered the company to sell Grail.
In December, Illumina said it would divest Grail either through an outright sale to a buyer or by spinning it off.
As part of the spin-off, Illumina provided Grail with funding to pursue its long-term strategy. Illumina will own a 14.5% minority stake in Grail, following the spin-off.
Grail shares are scheduled to begin trading on the Nasdaq on Tuesday under the symbol “GRAL.”
Morgan Stanley and law firm Latham & Watkins advised Grail on its spinoff from Illumina.
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