Before the pandemic, most people had never heard of Illumina, the California-based sequencing behemoth whose machines generate upwards of 90% of the world’s DNA data. And while Illumina might still not be a household name, over the last 15 months the technology it sells has become standard dinner table fare. Genetic vaccines, coronavirus variants, wastewater surveillance — never before has the world of sequencing spilled over so forcefully into mainstream public consciousness.
“People are talking about mutations and variants, it’s now become part of the public lexicon,” said CEO Francis deSouza said Tuesday at the STAT Health Tech Summit. “I think it’s accelerated the field by maybe five years, because genomics has been instrumental in this pandemic from the very beginning.”
In December 2019, Illumina teams were called into Wuhan to help local authorities identify the source of the outbreak of a mysterious pneumonia, said deSouza. From there, samples were sent to Shanghai, where Illumina’s scientists worked with researchers there to sequence and publish the first viral genome in early January. The next day, Moderna and BioNTech began using that genetic blueprint to start developing Covid-19 vaccines.
“Those mRNA vaccines are completely based on the genomic sequence coming off an Illumina machine,” deSouza said.
The pandemic has also accelerated other innovations in healthcare — from telemedicine to remote patient monitoring to the rise of at-home-testing. That’s another place where Illumina sees its business growing, specifically with its planned acquisition of leading liquid biopsy company GRAIL, which has been challenged by U.S. and European regulators.
Ilumina formed GRAIL in 2016 with $100 million in financing, including from Bill Gates and Jeff Bezos, before spinning it off a year later while retaining a 14.5% stake. But a full takeover would deepen its reach into the clinical testing market, which Illumina estimates could reach $75 billion by 2035.
GRAIL has spent the past five years developing Galleri, a blood-based test that screens for 50 different kinds of cancer. In March 2020, the company demonstrated that Galleri can also pinpoint where the tissues where the tumor is lurking 93% of the time.
Last fall, shortly after GRAIL went public, Illumina announced plans to reacquire its former spinout for $8 billion. But the Federal Trade Commission quickly stepped in to block the deal, arguing that the move would allow Illumina to stifle competition in the nascent but crowded liquid biopsy industry. Less than a month later, the European Commission’s directorate general for competition launched its own investigation. Illumina is currently fighting back against both.
“We believe that by acquiring GRAIL, in the end, it will be procompetitive for that category as it emerges,” said deSouza. That’s because he sees Illumina as a trailblazer — when it comes to both regulatory approvals and reimbursement for liquid biopsy tests — that can establish a path for the rest of the industry to follow behind.
deSouza pointed to what happened in 2013, when Illumina acquired non-invasive prenatal testing company Verinata Health. Industry analysts fretted over a potential Illumina takeover of NIPT testing. Instead, “the number of players in that space went up, the number of tests ordered by expectant numbers went up, and reimbursements went up,” said deSouza.
“We’ve seen that play out before and that’s what we want to see for cancer screening. We think there’s room for many different types of tests in this space,” he said.
GRAIL, for its part, is set to launch a laboratory version of its cancer test in the coming weeks. Illumina’s footprint in more than 140 countries could facilitate a faster and farther-reaching rollout of the test, he said. But to get broad distribution of the cancer screening tool both in the US and abroad, developing testing kits that can be deployed in community hospitals or rural clinics will be key. And that requires regulatory approval, a process that Illumina could help guide.
“We can make a cleared version of the GRAIL test more quickly than they would be able to on their own,” said deSouza. “We believe that acquiring GRAIL will save lives because it accelerates getting that test into the hands of people around the world.”