Cambridge and US DNA sequencing power player Illumina has tied up the $8 billion cash and stock acquisition of GRAIL despite lacking clearance from the European Commission.
GRAIL is a healthcare company focused on life-saving early detection of multiple cancers; Illumina says it will hold GRAIL as a separate company during the European Commission’s ongoing regulatory review.
The San Diego giant first announced its intention to acquire GRAIL nearly a year ago, reuniting Illumina with GRAIL four years after it was spun off.
GRAIL’s Galleri blood test detects 50 different cancers before they are symptomatic. Illumina’s acquisition of GRAIL will accelerate access and adoption of this life-saving test worldwide.
Regulators in the EU are reviewing the transaction but a decision is projected after the deal expires. GRAIL has no business in the EU and the company believes that the European Commission does not have jurisdiction to review the merger as the EU merger thresholds are not met, nor are they met in any member state.
The General Court of the European Union will hear Illumina’s jurisdictional challenge later this year. By holding GRAIL separate while proceedings are ongoing, Illumina is positioned to abide by whatever final decision is reached in these legal processes.
There is no legal impediment to acquiring GRAIL in the US. Illumina is committed to working through the ongoing FTC administrative process, and as always, will abide by whatever outcome is ultimately reached in the US courts.
Right now, the Galleri test is available but costs $950 because it is not covered by insurance. Reuniting the two companies is the fastest way to make the test broadly available and affordable.
Illumina’s expertise in market development and access has already resulted in coverage of genomic testing for over one billion people around the world. This experience will help lead to coverage and reimbursement for the Galleri test.
GRAIL and Illumina have a long history. Illumina formed GRAIL and spun it out in 2016. GRAIL’s first employees were part of Illumina, which still owns 12 percent of the company. GRAIL and Illumina are not competitors – this is a vertical acquisition.
Based on past experience, when Illumina enters a market, the market expands. When Illumina entered the non-invasive prenatal testing space, prices dropped, reimbursement expanded, the number of providers increased and more expectant parents had access to testing.
Illumina’s acquisition of GRAIL is driven by the belief that this test should be available to as many people as possible as quickly as possible. From fighting the COVID-19 pandemic to matching cancer patients to therapies, Illumina’s mandate is to save lives and transform healthcare.
The first COVID-19 viral sequence was on an Illumina machine and now genomic surveillance has emerged as a critical tool in the global fight against the pandemic, with over 70 countries now using Illumina platforms for COVID-19 variant tracking.
Francis deSouza, Chief Executive Officer of Illumina, said: “Just as we are now able to screen for early-stage diabetes and high cholesterol, we will soon be able to conduct multi-cancer early detection with a simple blood test in your doctor’s office.
“Since early detection of cancer saves lives, this new genomic test will be nothing short of transformational for human health and the economics of healthcare.”
Hans Bishop, chief executive officer of GRAIL, added: “The merger with Illumina will get the Galleri test to people far faster. We aim to accelerate this process so the test will be available in doctors’ offices everywhere, fully reimbursed.
“A one-year acceleration of access to the Galleri test for the US population has the potential to save 10,000 lives over a nine-year period.”
