Illumina, Inc. announced it would divest Grail, Inc. following a U.S. Court of Appeals for the Fifth Circuit decision that supported the Federal Trade Commission’s determination that the acquisition threatened competition in the market for cancer detection tests.

Federal Trade Commission Bureau of Competition Director Henry Liu issued the following statement:

“This is a major win for the FTC as it works to protect competition in health care.  Illumina’s decision to unwind its acquisition of Grail ensures the market for cancer detection tests remains competitive and delivers a choice of high-quality tests for patients and physicians, ultimately saving lives.

The Fifth Circuit’s unanimous ruling in this case recognizes how vertical deals can threaten competition and provides a clear roadmap for future cases. The ruling is also a victory for patients who need affordable, high-quality quality cancer detection tests. I applaud FTC staff for their dedication to this case and effort to ensure this critical health care market remains competitive.”

The FTC challenged Illumina’s acquisition of Grail in March 2021 alleging the deal would diminish innovation in the U.S. market for multi-cancer early detection (MCED) tests while increasing prices and decreasing choice and quality of tests.

In April 2023, the Commission issued an opinion and order reversing the Administrative Law Judge’s dismissal of the proceeding and requiring Illumina to divest Grail. In June 2023, Illumina petitioned the Fifth Circuit to review the Commission’s order and opinion, and the Fifth Circuit heard arguments in the case in September 2023.  

On December 15, 2023, the Fifth Circuit issued an opinion in the case finding that there was substantial evidence supporting the Commission’s ruling that the deal was anticompetitive. The Fifth Circuit vacated the Commission’s order and remanded it for further proceedings based on the standard the Commission applied when reviewing one aspect of Illumina’s rebuttal evidence. On December 17, 2023, Illumina then announced it would divest Grail.

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