Europe Digs in Its Heels Over Cancer Testing Competition

The reach of European Union competition law has been graphically demonstrated by its move to protect European cancer diagnosis options by prohibiting a merger between two US companies. In early September, the European Commission's vice president, Margrethe Vestager, issued a decision outlawing the acquisition of GRAIL by Illumina. As the worlds of clinical trials and of diagnosis increasingly overlap in the wake of rapid technology advances, the decision carries implications for health technology developers everywhere.

GRAIL's products, based on next-generation sequencing (NGS) and data science tools, include not only its Galleri test designed to detect around 50 cancers in asymptomatic patients from a blood sample, but also a diagnostic aid to confirm a diagnosis of cancer in symptomatic patients, and a minimal residual disease test to detect potential relapse in patients after cancer treatments. And while it may seem paradoxical that the EU claims the power to intervene in competition cases where none of the parties is based in Europe, in another demonstration of the ever-more interconnected world of innovation, it does, and it can. The governing factor is whether any particular action will have an impact on European patients and businesses.

Vestager, the designated chief for EU competition law, said this merger risks stifling innovation, and reducing choice in the emerging market for blood-based early cancer detection tests—expected to exceed $50 billion per year by 2035. If GRAIL's tests prove successful, they will revolutionize the fight against cancer and save millions of lives—but the Illumina takeover would give it a stranglehold over the market, she claimed. She is planning to go further, even by obliging Illumina—which in 2021 jumped the gun on this merger by going ahead before the EU ruling—to divest the interest it acquired in GRAIL. "GRAIL's independence now needs to be restored," she said in a statement announcing her ruling.

Detection is crucial to the success of Europe's recently adopted “Beating Cancer Plan,” she emphasized, with the "revolutionary" prospect of detecting cancer from DNA of asymptomatic patients using a simple blood draw.

"The more companies engage in a competitive race to develop the most accurate test, the better the chances we have to detect cancer early on, at the lowest possible cost,” said Vestager. “Our decision means that the innovation race between developers of NGS-based cancer detection tests will continue. In the future, Europeans will be able to access this promising technology at competitive prices and have a choice of suppliers."

Illumina has a powerful market position, she acknowledged, because it is the keysupplier of the reliable high-throughput NGS technology essential to run these tests, and all test developers currently depend on its platform. With GRAIL in its pocket, Illumina could cut off direct competitors from access to its technology, in effect putting a halt to rival developers and, Vestager claimed, "lead to less innovation, less choice, and higher prices for European citizens and healthcare systems." GRAIL's rivals may develop new tests, potentially better and cheaper than that of GRAIL, and they deserve protection, she argued.

Proposals that Illumina has made to ease these concerns have been dismissed by Vestager and her officials. The offer of a licence granting access to some of Illumina's NGS patents, for instance, failed to reassure the EU of the early emergence of a credible alternative that rivals to GRAIL could use. Similarly, a commitment to agree a standard contract with GRAIL's rivals still carried the risk that Illumina might choose to degrade technical support for its NGS systems. Vestager is now examining whether to use her powers to dissolve the merger, impose fines, or take other measures.