Administrative Law Judge Rules in Favor of Illumina in FTC Challenge of GRAIL Deal

WASHINGTON, Sept. 1, 2022 /PRNewswire/ -- Illumina, Inc. (NASDAQ:ILMN), today received a favorable decision from the Administrative Law Judge (ALJ) presiding over the Federal Trade Commission's (FTC) challenge of the GRAIL acquisition. In the decision, the ALJ ruled for Illumina and rejected the FTC's position that the deal would adversely affect competition in a putative market for multi-cancer early detection (MCED) tests.

"Reuniting Illumina and GRAIL will transform the detection and treatment of cancer by facilitating widespread, affordable access to GRAIL's life-saving Galleri test. This decision is a step toward making that vision a reality," said Francis deSouza, Chief Executive Officer of Illumina. "Too many of us have experienced or witnessed the devastating effects of cancer when it is diagnosed too late. Our mission in bringing Illumina and GRAIL back together is to save many thousands of lives by working to ensure that everyone can find and afford a Galleri test."

"As we've stated from the outset, this transaction is procompetitive, will advance innovation, lower healthcare costs and save lives. We are pleased that, after considering the evidence, the ALJ has reached the same conclusion," said Charles Dadswell, General Counsel of Illumina.

GRAIL was founded by Illumina seven years ago with the goal of developing an early screening test for multiple types of cancer. The transaction will reunite Illumina and GRAIL at a critical time. GRAIL needs Illumina's scale and expertise to overcome significant hurdles to the widespread adoption of Galleri, including obtaining regulatory approval and insurance reimbursement as well as scaling production and distribution of the test.

Cautionary Note on Forward-Looking Statements

This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) the commercial success of the Galleri test; (ii) the risks and costs associated with the integration of, and our ability to integrate, GRAIL's business successfully to achieve anticipated synergies, including the restrictions on integration during any hold separate period or any delay in integration following any hold separate period; (iii) the risk that disruptions from the consummation of our acquisition of GRAIL or any associated legal or regulatory proceedings or obligations will harm our business, including current plans and operations; (iv) potential adverse reactions or changes to business relationships resulting from the consummation of our acquisition of GRAIL; (v) the risk of incurring fines associated with the consummation of our acquisition of GRAIL and the possibility that we may be required to divest all or a portion of the assets or equity interests of GRAIL on terms that could be materially worse than the terms on which we acquired GRAIL, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. GRAIL, LLC, is a wholly-owned subsidiary of Illumina, which is currently being held and operated separately in order to comply with the interim measures order imposed by the European Commission during the pendency of its ongoing merger review. To learn more, visit illumina.com and connect with us on Twitter, Facebook, LinkedIn, Instagram, and YouTube.

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SOURCE Illumina, Inc.