The European Union’s highest court sided with Illumina, agreeing that the European Commission had no authority to review the acquisition of liquid biopsy company Grail. The ruling comes after Illumina stopped challenging antitrust litigation, opting to instead spin out Grail as a standalone company.
Providence recently launched a study to help learn more about how health systems can use multi-cancer detection tests in clinical care. Three years ago, Providence became the first health system to use Grail’s Galleri test, which screens patients for more than 50 kinds of cancer.
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Liquid biopsy company Grail is now an independent, publicly traded company. While the separation from Illumina ends a protracted antitrust battle, Grail is still in the early stages of a long-term strategy to win regulatory validation and payer coverage for its multi-cancer early detection test.
Illumina has decided against further appeals of U.S. and European antitrust litigation challenging its acquisition of liquid biopsy company Grail. Illumina expects to have terms of the divestiture set by the end of the second quarter of 2024.
European Union regulators ordered Illumina to divest Grail. Illumina is appealing antitrust findings in Europe and the U.S., but the DNA sequencing giant revealed that divesting all or part of Grail is an option even if it wins both legal challenges.
Illumina must pay a €432 million fine for closing its Grail acquisition before the European Commission finished its inquiry into the tie-up. The penalty is the maximum amount the regulator can impose on a company for breaching European merger rules.
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The Federal Trade Commission has ordered Illumina to divest Grail, the liquid biopsy company it acquired for more than $7 billion. The agency said Illumina’s proposed remedies are insufficient and the tie-up is likely to reduce competition in the R&D and commercialization of new cancer tests.
Through the new collaboration, Carrum Health is offering GRAIL's cancer test called Galleri as a benefit option for employers. It is an early-detection test for more than 50 types of cancer.
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Grail, a company focused on early cancer detection, introduced its test that screens for more than 50 kinds of cancer last year. At AWS' Thursday conference for healthcare and life sciences innovation, the company's chief security officer explained how the company is evaluating the test in clinical trials and preparing to file for its FDA approval.
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In closing its Grail acquisition before U.S. and European regulators sign off, Illumina is taking a chance the deal will pass regulatory muster. It’s a potentially pricey gambit, as Illumina could face fines for its early action and there are no assurances that regulators will agree that the deal is not anticompetitive.
The Federal Trade Commission and the European Union are reviewing the soundness of this acquisition. But if Illumina acquires Grail, the company that it spawned back in January 2016, will it squeeze the nascent liquid biopsy market?
The Federal Trade Commission is opposing Illumina’s proposed $7.1 billion Grail acquisition, arguing that it will reduce competition for multi-cancer early detection tests. Illumina disagrees with the regulator’s position and will oppose the FTC’s challenge.
Following years of research and investment, liquid biopsies are steadily accumulating FDA approvals. The tests are being used in molecular profiling of solid tumors and as companion diagnostics for targeted cancer therapies.
Illumina originally spun off Grail in early 2017. Grail plans to launch its test for early detection of cancers, Galleri, next year. Illumina already owns 14.5% of the company, which it started in 2016.