On March 30, 2021 Illumina, Inc. (NASDAQ: ILMN), reported that it disagrees with, and will oppose, the U.S. Federal Trade Commission (FTC)’s challenge to its previously announced acquisition of GRAIL, a pre-commercial company founded to accelerate early screening of cancer (Press release, Illumina, MAR 30, 2021, View Source [SID1234577380]). Illumina 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.

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Cancer kills around 10 million people annually worldwide and 600,000 people in the United States alone. Survival rates are higher when cancer is detected early. Seventy-one percent of all deadly cancers do not currently have a screening test. GRAIL’s Galleri test is able to detect more than 50 cancers across all stages, more than 45 of which do not have recommended screening in the United States. And, in 93 percent of the positive results, the test correctly identified the tissue of origin – all with a specificity greater than 99 percent.

"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," said Francis deSouza, Chief Executive Officer of Illumina. "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."

Illumina originally founded GRAIL five years ago and the two companies do not compete in any way. In reuniting the two organizations, Illumina will leverage its global scale of manufacturing and clinical capabilities, as well as its global regulatory and reimbursement expertise, to bring early-stage, multi-cancer testing to patients more quickly and more affordably, resulting in more lives being saved.

"Combining GRAIL’s innovative multi-cancer early detection test with Illumina’s experience and scale will enable more patients in both the United States and worldwide to garner access to GRAIL’s test faster," said Hans Bishop, Chief Executive Officer of GRAIL. "We continue to believe that together we could transform cancer care by catching more cancers earlier."

Illumina strongly believes that acquiring GRAIL is in the best interest of patients, is procompetitive, and benefits the multi-cancer early detection field as a whole. The FTC’s challenge to the proposed transaction is a marked departure from longstanding antitrust precedent. Illumina intends to pursue all legal options in order to complete the acquisition and deliver the strategic benefits to its stakeholders. For clinical oncology customers, Illumina has offered contractual guarantees of equal and fair access to Illumina sequencing, and a commitment to drive down prices by more than 40 percent by 2025.