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Illumina Touts New Partnerships, Sequencing Technology at JP Morgan Healthcare Conference

NEW YORK ­– Illumina announced a bevy of new business partnerships, products, and technology advances Monday at the 2022 JP Morgan Healthcare Conference, held virtually this week.

Illumina is partnering with German pharmaceutical company Boehringer Ingelheim on companion diagnostics, with Agendia on in vitro diagnostic assay kits, with health services firm Optum on studies to demonstrate the efficacy of genomics-based testing, and with Nashville Biosciences on drug development. Its Grail division partnered with Premier PINC AI to augment its clinical decision support technology and identify patients who might benefit from the Galleri early cancer detection test.

New products coming down the pike include TruSight Oncology Comprehensive (TSO Comp), a distributed IVD kit based on the content of the TSO 500 comprehensive genomic profiling assay; a minimal residual disease test from Grail; and the NovaSeq Dx, a clinical version of Illumina's highest-throughput next-generation sequencing platform. Illumina will also release a new product aimed at undercutting the long-read sequencing market, providing data on genomic regions up to 10 kb in length.

"Illumina had a very strong 2021 across our platforms and applications," CEO Francis deSouza said in his JP Morgan conference presentation. "We have tremendous momentum entering 2022, with multiple large growth opportunities spanning existing and larger emerging global markets." Illumina's track record in R&D positions it well to take advantage of these opportunities, he added.

The company also released preliminary fourth quarter and full-year 2021 financial results. Fourth quarter revenues grew 25 percent to $1.19 billion, year over year. Full-year revenues grew 39 percent to $4.52 billion, approximately $500 million ahead of internal expectations and beating the consensus Wall Street estimate of $4.42 billion. 

There are several reasons to expect Illumina's business will grow in 2022 and beyond, particularly in the oncology segment. For example, deSouza noted that the $14 billion market for cancer therapy selection alone could grow 20 percent in the next three years. 

This year, Illumina is expecting revenues in the range of $5.15 billion to $5.24 billion, representing growth of 14 to 16 percent, and adjusted EPS in the range of $4 to $4.20.

Clinical sequencing is now Illumina's biggest market, and several of Illumina's announcements were made with those customers in mind. "We want to make sure they have content for our platforms," Phil Febbo, Illumina's chief medical officer, said in an interview. The Agendia partnership is "enabling them to put [the] MammaPrint [assay] and intrinsic subtyping on the MiSeq Dx," he said, noting that Illumina has a total of 41 tests in development with 34 partners, including Agendia.

The Boehringer Ingelheim deal illustrates Illumina's drive to create a companion diagnostic assay for new cancer treatments. Under the terms of the agreement, Illumina will codevelop a CDx for a Boehringer Ingelheim investigational drug, but the companies will also plan to add specific CDx claims to the TSO Comp assay Illumina is developing.

TSO Comp, built on the TSO 500 research assay, will run on the NextSeq Dx and could eventually carry CDx claims for other cancer therapies from Illumina's 11 partners. The TSO 500 assay has "exceeded our expectation, in terms of how many customers we have up and going on that platform," Febbo said. Illumina declined to disclose how many customers use the assay, though deSouza said revenues from TSO 500 grew 79 percent in 2021.

Illumina is also preparing to obtain CE-IVD marking and US Food and Drug Administration approval for TSO Comp. Febbo declined to provide a timeline, citing COVID-19-related delays in the regulatory process, but said the assay could be available in Europe "shortly."

Grail has engaged with 14 different pharmaceutical companies regarding its minimal residual disease test, which it plans to launch in 2023. Like Galleri, this assay is based on methylation, so it does not require exome or genome sequencing of a tumor biopsy sample. It should work for about 50 cancer types and have a two- to threefold shorter turnaround time than other MRD assays, deSouza said.

The Optum collaboration offers the chance to work with a subsidiary of the largest private payor in the US, UnitedHealth, and could help "bring genomics into clinical practice faster," deSouza said. Initial studies, already underway, will focus on oncology as well as cardiovascular disease and rare disease. Future studies could include hematologic cancers, organ transplantation, and polychronic patients.

Under its new partnership with Vanderbilt University Medical Center spinout Nashville Biosciences, Illumina will sequence 250,000 patients who have been consented for whole-genome testing. "What we know is that we want to be a partner for drug companies," Febbo said, and these data will provide insights for connecting genotypes to phenotypes, he said.

On Tuesday, Barclays upgraded shares of Illumina to an Equal Weight rating from Underweight.

In Tuesday morning trading on the Nasdaq, shares of Illumina were up 7 percent at $388.63.