Grail, an Illumina-owned maker of a blood test that screens for 50 different types of cancer before symptoms arise, has inked a deal with John Hancock where the cost of Grail’s test will be reimbursed for certain, existing life insurance customers.
The pilot project makes John Hancock the first life insurer to pay for Grail’s Galleri test, which was launched on a limited basis in mid-2021 and costs roughly $950. The pilot will include just under 10,000 participants.
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Using advance genomic sequencing technology from Illumina, Galleri can detect dozens of cancers from a single blood draw, including many with no recommended early detection screening available today. Galleri also can narrow down where cancer may be located in the body, enabling faster and presumably more successful treatment.
John Hancock’s goal is to gauge customer adoption and the user experience of the test before deciding how to move forward. It emphasized that Galleri does not replace recommended routine cancer screenings.
“Almost everyone has experienced the devastating effects of cancer in some way and by making this early screening technology available, we can help change the cancer narrative for some of our customers,” said Brooks Tingle, president and chief executive of John Hancock in a statement.
According to the American Cancer Society, more than 600,000 people die from cancer each year in the U.S. In many cases, symptoms don’t emerge until later stages, when treatment options are limited. So early detection is seen as having potential to save lives.
Galleri doesn’t have U.S. Food and Drug Administration approval. That requires significant clinical trial data and is still likely a few years away. FDA authorization is crucial to widespread health insurance reimbursement, including from Medicare.
But Galleri has been launched commercially as a laboratory developed test. While not as expansive as full FDA approval, laboratory developed tests do face federal validation criteria, including requirements for test accuracy and lab best-practices standards. Many diagnostic tests launch commercially as laboratory developed tests without FDA approval.
Up until now, Grail has been targeting self-insured employers such as U-Haul and Point32Health, concierge medicine practices, health systems and institutions that focus on preventative health care as its initial customers. It has performed 38,200 Galleri tests to date, said Joshua Ofman, Grail’s president.
“This is a self-paid test,” said Ofman. “Our initial target was large self-insured employers. They are payers. They pay for the health insurance benefits of their employees, and we have many employers who are providing Galleri to their employees free of charge.”
Ofman added that health systems such as Providence, the Knight Cancer Institute at Oregon Health & Science University, Mercy, Community Health Network, Ochsner Health, and Intermountain also are providing Galleri either subsidized or at no cost to their health system members.
Illumina is the top maker of genomic sequencing hardware, software and chemistry — particularly advanced next-generation sequencing technology. It founded Grail internally in 2015 but spun out the company into a standalone business a year later so it could solely focus on developing its multi-cancer test.
Illumina maintained a 12 percent ownership stake in Grail. In August 2021, Illumina re-acquired Grail for $7.1 billion.
That homecoming has been in the crosshairs of antitrust regulators in the U.S. and Europe. Illumina won a legal round against the U.S. Federal Trade Commission last month when an administrative law judge ruled that the takeover didn’t violate U.S. competition laws — a decision that FTC is expected to appeal.
Meanwhile, the European Commission recently ruled that Illumina’s acquisition of Grail was illegal under its competition laws. It likely will seek to unwind the acquisition.
European regulators are requiring Illumina to operate Grail as a separate entity overseen by an independent monitoring trustee. Illumina said it intends to appeal the European Commission’s jurisdiction to block a merger between two American companies where one, Grail, doesn’t do business there. Illumina also will challenge the commission’s antitrust findings in a European court.
John Hancock will offer the Grail’s Galleri test as a new feature to certain customers in its Vitality Program, in collaboration with re-insurer Munich Re Life US. Vitality offers incentives to encourage healthy living.
Galleri tests will be reimbursed at 50 percent to 100 percent of cost, according to a John Hancock spokesperson. Its Vitality program has two tiers — one offered to all life insurance customers at no additional cost and a more premium version with expanded rewards for healthy eating, exercise and medical checkups.
“What has really impressed us is John Hancock’s desire to address cancer, which is soon to be the leading cause of death among men and women worldwide,” said Ofman of Grail. “They have been investing in these benefits programs for their policyholders around health and wellness. They have the Vitality program. So tests like Galleri fit nicely into their effort to improve health and wellness in their population.”