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Illumina Focuses on Reproductive Health; May Modify MiSeq/HiSeq for Different Clinical Needs

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Shedding light on its strategy to tap into the nascent clinical sequencing market, Illumina's CEO Jay Flatley this week emphasized the company's focus on reproductive health, discussing its intentions to integrate programs from its recent BlueGnome and Verinata acquisitions and its attempts to resolve ongoing patent disputes in the noninvasive prenatal testing space.

Additionally, Flatley said this week that the company may look to segment the clinical sequencing market further by developing slightly different sequencing systems for different clinical needs.

Currently, the company sees the biggest opportunity for sequencing in reproductive health and cancer, with infectious disease, virology, microbiology, and forensics following close behind, Flatley said during a conference call discussing the company's 2012 fourth-quarter earnings.

While Illumina recently submitted a version of its MiSeq instrument, dubbed MiSeqDx, to the US Food and Drug Administration for 510(k) clearance, Flatley said that the company would consider developing "more systems that address more targeted segments of the market," for instance, "designing a system for a specific set of tests."

"We'll create more variations of the instrument over time that will be particular to market segments," he added, such as reproductive health or cancer.

Illumina submitted its MiSeqDx system to the FDA both on its own and in conjunction with a cystic fibrosis assay. Flatley said that the company has not yet received a response from the FDA on the submission, but expects to receive one in the second quarter of this year.

Also on the call, Flatley said that the company's services business is increasingly serving the clinical and translational markets and it is in discussions about sequencing genomes for large hospitals. In the fourth quarter, the company shipped 2,500 genomes through its FastTrack services business. Illumina also plans to hire 50 additional sales representatives this year, some of whom will focus on the clinical market.

Reproductive Health

Earlier this month, Illumina announced its intention to acquire Verinata Health, which markets a sequencing-based fetal trisomy test on Illumina's HiSeq, for up to $450 million (CSN 1/9/2013).

On this week's call, Flatley said that with the acquisition the company is "uniquely positioned to lead the NIPT market." He said that Illumina will seek in vitro diagnostic designation from the FDA for the Verifi test.

"Once we've compiled the necessary data, we'll be submitting the test for regulatory approval," he said. "An IVD test will significantly expand the global market and enable all providers to be successful in the field."

Two other US companies currently have trisomy tests on the market. Sequenom is the market leader with its MaterniT21 test, although Ariosa has been making significant strides with its Harmony Prenatal Test and said recently that it has reached a 100,000-test annualized run rate.

Sequenom, Ariosa, and a third NIPT company, Natera, which plans to launch a test soon, all run their tests on Illumina's HiSeq instrument. When Illumina announced its intention to purchase Verinata these other companies expressed some surprise and concern (CSN 1/16/2013).

On this week's call, Flatley reiterated Illumina's intention to honor all its supply agreements with these firms. Additionally, he said that the company continues to have "significant discussions" with them to "address concerns about supply agreements."

The four companies are also involved in legal disputes over intellectual property held in the space. Flatley said Illumina is interested in resolving the disputes outside of the courts "in a way that's rational for everyone." He anticipated that the company "will have a shot at this in the first quarter," and if the negotiations were not successful, then Illumina will "'proceed along the legal tracks."

Flatley said the Verinata acquisition will also complement BlueGnome, which Illumina acquired last fall (CSN 9/19/2012).

BlueGnome develops microarray-based products for prenatal implantation genetic screening and cytogenetics, as well as interpretation software.

The work the company plans to do with the Verinata acquisition, including investing in clinical trial work to submit the Verifi test as an IVD and incorporating subchromosomal abnormalities into future versions of the test, will be "integrated very tightly with what we're doing at BlueGnome," Flatley said. In particular, there is a "clear intersection" with the work each of the companies is doing on subchromosomal analysis. In the future, "those programs will become more integrated," he said.

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