(Reuters) - Cancer detection test maker Grail, acquired by Illumina Inc last year despite ongoing antitrust challenges, on Tuesday said it would expand use of its flagship Galleri test through a new agreement with life insurer John Hancock, a division of Manulife Financial.
The test, designed to detect more than 50 types of cancer before symptoms appear, looks at the DNA in a patient's blood to determine whether any come from cancer cells. Data have shown that, across the 50 cancer types, including early-stage to late-stage, the Galleri test correctly identified the presence of cancer in 51.5% of cases.
Grail is selling the test, which must be prescribed by a doctor, for $949 in the United States, as a "laboratory developed test," a category of diagnostics that the Food and Drug Administration historically has not regulated. Grail, however, is in the process of seeking FDA approval.
Grail President Joshua Ofman told Reuters that the company's FDA submission, including data from an ongoing UK trial, will probably take "a couple years."
John Hancock said it is the first life insurance carrier to offer, under its wellness program, policyholder access to Grail's early cancer detection test. It said the test will be available to some customers at a 50% or 100% subsidy.
Galleri is covered by some small health insurers such as Point32Health, but large health insurers are likely to wait for additional data showing the test's accuracy, or regulatory approval, before deciding to pay for the new test, Ofman said.
Illumina, a San Diego-based maker of genetic analysis equipment, closed its $7.1 billion acquisition of Grail, a former subsidiary, in August 2021, despite antitrust challenges in the U.S. and Europe.
The European Commission, which acts as the competition enforcer in the 27-country European Union, earlier this month said its concerns that the deal would block competition were not adequately addressed and Illumina would need to divest Grail's European operations.
The U.S. Federal Trade Commission filed a lawsuit in March 2021 to stop the acquisition on the basis that it would slow innovation for cancer detection tests. Earlier this month, an FTC administrative law judge ruled the acquisition will not hurt competition.
Ofman declined to comment on the antitrust issues, but noted that Galleri is not currently available in Europe, aside from the UK study.
Illumina said it plans to appeal the EU decision. The FTC has challenged the judge’s ruling in support of the deal.
Shares of Illumina, which have fallen more than 48% so far this year, were down 1.5% at $195.83 in early trading on Tuesday.
(Reporting by Deena Beasley; Editing by Leslie Adler and Jonathan Oatis)
Reuters Health Information © 2022