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European Union to Review Illumina's Planned Grail Acquisition Under New Guidance

NEW YORK — The European Commission's Directorate-General of Competition said on Tuesday that it will review Illumina's $8 billion bid to acquire Grail under the EU's merger regulation.

The deal will be one of the first major test cases of new guidance from the commission issued last month that allows it to demand notification of a deal even when the laws of member states may not require notification for review.

"Without prejudice to the outcome of its investigation, the Commission considers that the transaction meets the criteria for referral … In particular, the combined entity could restrict access to or increase prices of next-generation sequencers and reagents to the detriment of Grail's rivals active in genomic cancer tests following the transaction," the commission said in a statement. "A referral of this transaction is appropriate because Grail's competitive significance is not reflected in its turnover," as evidenced by the size of the deal.

"Genomic cancer tests, having the potential to identify a wide variety of cancers in asymptomatic patients, are expected to be game changers in the fight against cancer," the EC wrote. "It is therefore important to ensure that patients get access to this technology as quickly as possible, from as wide sources as possible, and at a fair price."

"We do not believe that the European authorities have jurisdiction to review the Grail acquisition and look forward to resolving this matter expeditiously," Francis deSouza, CEO of Illumina, said in a statement. "Reuniting Grail and Illumina will allow us to bring Grail's breakthrough early detection multi-cancer test to patients across the world faster and consequently save lives."

San Diego-based Illumina added that it remains committed to the transaction and "will continue to work with the Directorate-General to bring the investigation to conclusion."

France technically initiated the referral under Article 22(1) of the EU Merger Regulation, a provision that "allows member states to request examination of a merger that does not have an EU dimension but affects trade within the single market and threatens to significantly affect competition within the territory of the member state making the request," the EC said in a statement. Belgium, Greece, Iceland, the Netherlands, and Norway later joined in referring the deal.

Illumina spun off Grail in 2016 and proposed last year to buy the liquid biopsy test maker for $8 billion in cash and stock. The US Federal Trade Commission said last month that it will try to block the deal, and an administrative trial is set for August.

As noted in an April 8 blog post from New York-based law firm Skadden, Illumina's Grail deal is the first case to fall under new EU guidance that "focuses on deals that involve high-value target entities that have low or no revenue and therefore fall below the merger control thresholds for review by the EC and most EU member states."