The European Commission has approved, in accordance with the EU Mergers Regulation ("EUMR"), Illumina's plan to sell GRAIL after remedial measures requiring Illumina to terminate the completed acquisition of GRAIL. The commission made the decision on the sale in October 2023.
In September 2022, the commission banned the acquisition of GRAIL by Illumina due to concerns that it would stifle innovation and reduce choice in the emerging market for blood-based early cancer detection tests. Illumina and GRAIL illegally completed the merger, violating EU rules on merger control. In July 2023, the commission fined both companies for this violation. In October 2023, Illumina made decisions to sell GRAIL in order to restore the competitive situation that existed before the completion of the transaction. These decisions should have been submitted to the Commission for approval.
The Commission approved the GRAIL sale plan submitted by Illumina. In accordance with the recovery measures, the sale plan provides that Illumina can choose the appropriate method of sale (either through a trade sale or through a capital market transaction). The Commission found that the plan, including the possibility of choosing between different sales methods, meets all the conditions set out in its decision to introduce remedial measures for Illumina and GRAIL. In particular, GRAIL's independence from Illumina will be restored to the same level as GRAIL had before the acquisition and will eliminate possible damage to competition arising from Illumina's ability and incentives to delay or put GRAIL's competitors at a disadvantage.
The sale plan ensures that GRAIL can continue to operate as a viable and competitive business after the sale, as it did before the acquisition of Illumina. This ensures that the innovation race between GRAIL and its competitors can continue under conditions similar to those that existed before the deal.
The sale options outlined in the sale plan can be implemented in a timely manner, within strict deadlines and with sufficient confidence, so that the situation that existed before the transaction can be quickly restored. Therefore, the commission decided to approve the plan for the sale of Illumina.
The sale plan does not affect the transitional measures that Illumina and GRAIL must comply with until Illumina terminates the transaction, as prescribed by the commission in its October 2023 decision, and confirms their applicability before the sale is completed. Such measures will ensure the separation of Illumina and GRAIL until the transaction is completely cancelled in order to prevent further integration of GRAIL into the Illumina business and, as a result, cause irreparable damage to competition.
Illumina, headquartered in the United States, is a global genomic company that develops, manufactures and commercializes next-generation sequencing systems ("NGS"), including sequencing tools, supplies and related services. Illumina's NGS systems are medical devices used in a variety of fields, including by clients in the field of oncology, who develop and perform blood—based tests that can detect cancer or select appropriate treatment for cancer patients.
GRAIL, which is also headquartered in the United States, is a medical company developing blood—based cancer tests based on genomic sequencing and data analysis tools. GRAIL's flagship product is Galleri, an early diagnosis test for several types of cancer that aims to detect cancer in asymptomatic patients from a blood sample. In April 2021, GRAIL initiated limited commercialization of Galleri in the United States. GRAIL has 2 additional products: a cancer diagnostic test tool used to confirm the diagnosis of cancer in patients with symptoms, and a minimal residual disease test to detect potential recurrence in patients after cancer treatment. GRAIL was founded by Illumina in 2016 and was spun off later that year.
