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Illumina Seeks to Solve PCR Reagents Puzzle

By Tony Fong

NEW YORK (GenomeWeb News) – Fresh off the acquisition of its PCR business, Illumina today said that the next step is to build out a reagent business around the platform.

At the UBS Global Life Sciences Conference today, the company's CEO Jay Flatley, while calling next-generation sequencing the firm's largest growth market, also provided color on the purchase of Helixis, a PCR instruments firm, whose acquisition was announced during Illumina's second-quarter earnings release in July.

The acquisition of the company and subsequent launch of its Eco Real-Time PCR System address a PCR market valued at about $2 billion, Flatley said. Priced at $13,900 the Eco platform competes directly with competitors' platforms sold in the $50,000 price range.

The lower price for the instrument is the main driver for sales of the instrument, Flatley said, and would allow ownership of a PCR instrument to many researchers, who currently have to share a platform.

In the short-term, Eco's target segment is in the research market, though eventually he expects it to be used for diagnostics developments, as well, Flatley said.

The weakness in Illumina's PCR portfolio, he added, is that currently the company has no reagents business around the instrument, something that it is now figuring out how to solve.

"We need to build a reagents business there," he said.

On its next-generation sequencing business, Flatley reiterated that it remains Illumina's key business driver and projected the market as a whole to grow to $2.1 billion in 2013 from $1.5 billion this year.

Earlier this year, the company launched its HiSeq system, and Flatley today said that demand for the platform remains high. Through the second quarter, more than 100 systems had been shipped, and a backlog is expected into the fourth quarter even as efforts in the manufacturing and supply chain processes have been made to try to address it, Flatley said.

He added that the company may be seeking approval from the US Food and Drug Administration for the HiSeq.

During the summer, Illumina announced it was cutting the pricing for its individual genome sequencing service by as much as 60 percent. The service is intended for physicians and their patients and was introduced a year ago at a price of $48,000. In June, the company reduced the price to 19,500 for an individual, $14,500 per person for a group of five or more individuals, and $9,500 for direct clinical sequencing, which targets individuals with serious illnesses.

So far, 24 individuals have had their genomes sequenced through the service, Flatley said, adding that the direct clinical sequencing service had become "an interesting price point." Eight individuals who fall into that price category have had their genomes sequenced, mostly those with cancer, and also young children.

As data from direct clinical sequencing begins to be published, that is expected to create greater interest for that business, Flatley said.

The company today also launched its World Personal Genome Registry website, a database of consumers who have had their genomes sequenced. To date, the database contains 38 genomes, evenly split between those individuals who have chosen to identify themselves, and those who are remaining anonymous.

Flatley also said that the company is continuing to talk with the FDA over the agency's concerns about direct-to-consumer sequencing services. In June, Illumina and four genomics service providers received letters from FDA saying that they were selling unapproved diagnostics services.

Illumina received the letter because Decode and 23andMe uses its Infinium HumanHap 550 arrays on their genetic tests for customers.

Today, Flatley said that the idea that Illumina proposes is that it would do the analytical validation for the array, while the consumer DNA firms offering the test would do the clinical validation of the markers.