This story has been updated to include additional comments from Illumina.
NEW YORK – The US Federal Trade Commission said on Tuesday that it intends to challenge Illumina's plan to buy liquid biopsy firm Grail for $8 billion.
In a statement, the FTC said it will file a complaint in the US District Court for the District of Columbia seeking a temporary restraining order and preliminary injunction to stop the deal, pending an administrative trial. The trial is scheduled to begin on Aug. 24, 2021. FTC alleged that the deal would diminish innovation in the US for multi-cancer early detection (MCED) tests. The agency said that Illumina's next-generation sequencing platforms are the only viable option for these types of tests.
"As the only viable supplier of a critical input, Illumina can raise prices charged to Grail competitors for NGS instruments and consumables; impede Grail competitors' research and development efforts; or refuse or delay executing license agreements that all MCED test developers need to distribute their tests to third-party laboratories," FTC said in a statement. "For the specific application at issue in this matter — MCED tests — developers have no choice but to use Illumina NGS instruments and consumables."
The complaint, which FTC had not yet made public at press time, alleges that even if a viable substitute to Illumina's NGS platform entered the market, it would take years for MCED test developers to switch to a platform other than Illumina's because they would have to reconfigure their tests to work with the new platform, and in some situations, conduct new clinical trials.
"Illumina will vigorously defend its acquisition of Grail because we strongly believe it is in the best interest of patients," a company spokesperson said in an email. The San Diego-based sequencing firm said it "disagrees with, and will oppose, the [FTC's] challenge" and will "pursue its right to proceed with the transaction, the impact of which would accelerate the adoption of a breakthrough multi-cancer early detection blood test."
"Illumina's commitment to advancing human health by innovating next generation sequencing is unwavering. Improving early cancer detection is the most promising approach to bending the cancer mortality curve," CEO Francis deSouza said in a statement. "We have a deeply vested interest in ensuring that all organizations have equal and fair access to high quality, reliable, and cost-effective sequencing to enable them to develop breakthrough products, such as liquid biopsy, and make them accessible to the greatest number of patients possible, quickly, and safely."
The Illumina spokesperson also said the company will "always support customers across the entire breadth of the sequencing market," and will guarantee particular terms to all clinical oncology customers in the US if the acquisition closes, including "contractual guarantees of equal and fair access to sequencing for six years after the close of the acquisition, and a commitment to drive down prices by more than 40 percent by 2025," amongst others.
Illumina added that it believes acquiring Grail will accelerate patent access to liquid biopsy testing, "save billions of dollars in US healthcare costs, which we intend to pass directly to patients," and will actually be "procompetitive" and accelerate the market as a whole.
The FTC's actions have spelled trouble for Illumina's growth plans in the past. Illumina is barely a year removed from abandoning a deal to acquire fellow sequencing instrumentation manufacturer Pacific Biosciences, following pressure from FTC and regulators in the UK.
In afternoon trading on the Nasdaq, shares of Illumina dropped 6 percent to $370.53 on news of the FTC complaint.
In June 2020, Illumina successfully acquired bioinformatics firms BlueBee Genomics and Enancio.
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