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Illumina, Inc., and GRAIL, Inc., In the Matter of

The Federal Trade Commission filed an administrative complaint and authorized a federal court lawsuit to block Illumina’s $7.1 billion proposed acquisition of Grail—a maker of a non-invasive, early detection liquid biopsy test that can screen for multiple types of cancer in asymptomatic patients at very early stages using DNA sequencing. Illumina is the only provider of DNA sequencing that is a viable option for these multi-cancer early detection, or MCED, tests in the United States.

The complaint alleges the proposed acquisition will diminish innovation in the U.S. market for MCED tests, which could be used to detect up to 50 types of cancer. Most of these types of cancer are not screened for at all today, and the MCED test could save millions of lives around the world. The trial began on Aug. 24, 2021. On May 20, 2021, the FTC authorized staff to dismiss its federal court complaint for Preliminary Injunction and Temporary Restraining Order.

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.

Type of Action
Last Updated
FTC Matter/File Number
201 0144
Docket Number
Case Status