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Illumina Launches Four New Systems; Provides Financial, Dx Update at JP Morgan

SAN FRANCISCO (GenomeWeb) – Illumina today announced the launch of three new sequencing systems and provided an update on its diagnostic plans in the noninvasive prenatal testing and oncology markets.

Speaking at the JP Morgan Healthcare Conference, CEO Jay Flatley preannounced fourth quarter revenues of $512 million, as well as $1.86 billion in FY 2014 revenues, representing 31 percent year-over-year growth. He said the firm expects revenue growth of 20 percent in FY 2015.

He also unveiled the HiSeq X Five System, the HiSeq 3000 and 4000 Systems, and the NextSeq 550 System, an NGS system enabled for array scanning.

The HiSeq X Five is a scaled down version of the X Ten, which was launched at last year's JP Morgan conference. It consists of five individual HiSeq X instruments, enabling more "capital-constrained" customers to adopt high-throughput whole-genome sequencing with a lower capital investment, Flatley said. The X Five provides the throughput to sequence more than 9,000 genomes a year, he noted, and will cost $6 million per system. Customers will be able to produce a genome for around $1,400 with the system, which will launch in the second quarter of 2015.

Flatley said that the firm sold far more X Ten systems in 2014 than it had initially anticipated. In total, he said the firm signed up 18 customers and sold 201 X Ten units during the year, including 37 sold in the fourth quarter.

The HiSeq 3000 and 4000 systems build on the capabilities of the HiSeq 2500 System and leverage the patterned flow cell technology developed for the HiSeq X Ten System.

The HiSeq 3000 uses a single flow cell while the HiSeq 4000 uses dual flow cells and offers a lower price per data point than the HiSeq 2500. The HiSeq 4000, which will sell for $900,000 per instrument, can sequence up to 12 genomes, 100 whole transcriptome samples, or 180 exomes in three and a half days or less. And the HiSeq 3000, which will sell for $740,000, can produce half the throughput (750 G) at the same price per sample as the HiSeq 4000, said Flatley.

He said that while Illumina continues to sell the HiSeq 2500, the firm anticipates customers will migrate to the 3000 and 4000 platforms over the next few years.

The NextSeq 550 combines microarray scanning with the NextSeq 500 Sequencing System and its initial applications are for cytogenetics and prenatal genetic diagnosis. The system will begin shipping in Q2 2015 and will sell for $275,000.

Asked about the firm's array business and that market in general during the Q&A after Illumina's presentation, Flatley said that some parts of the market are fast growing, though he didn't elaborate. He said the firm continues to invest in R&D for arrays and anticipates investing more in that business in 2015 than it has in recent years.

NIPT and oncology

Flatley also provided an updated strategy for Illumina's NIPT business. The firm will launch the VeriSeq NIPT Solution, a 48-sample NIPT assay based on paired-end sequencing, in Europe in Q2 2015.

Illumina also has altered its focus from a submission of the HiSeq 2500 and an existing NIPT assay to the US Food and Drug Administration, and instead will aim for CE-IVD marking of NIPT software in Europe in early 2015, as well as for CE-IVD marking of the new VeriSeq NIPT assay and associated software in in the first half of this year. Flatley said the firm is working with the FDA to determine the claims and required datasets for an NIPT assay for use in the high-risk and average-risk populations. He said the company is aiming for late 2015/early 2016 for FDA registration as an "open platform."

He also noted that the company has exited the retail business in NIPT and is focusing its efforts on partnerships. It has such deals with Laboratory Corporation of America, Counsyl, Emory, Baylor, and Berry Genomics in China.

He noted that Illumina processed around 43,000 NIPT samples in the fourth quarter.

In oncology, Illumina is conducting R&D in circulating tumor DNA. It plans to release research-use-only kits in 2015, and operate a laboratory developed test to gather clinical evidence for eventual regulatory submission. It is also planning to update the intended use for the MiSeqDx for use with FFPE samples.

Flatley also noted its OncoPanel partnerships with Janssen, Sanofi, and AstraZeneca. As with the NIPT strategy, he said Illumina doesn't intend to be a retail assay provider and will focus on partnerships.

In addition, the firm today announced a partnership with Lockheed Martin to combine its sequencing tools with Lockheed Martin's expertise in large-scale information systems and integration in an offering to countries that are beginning to integrate genomics into their national health systems. Flatley said the partnership will focus on certain unnamed countries in which Lockheed Martin already has a presence.

This article has been updated from a previous version to correct the number of NIPT samples Illumina processed in the fourth quarter.