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Illumina to Seek FDA OK for MDx System This Year

SAN FRANCISCO (GenomeWeb News) – Illumina hopes to receive US Food and Drug Administration clearance of its BeadXpress system for molecular diagnostic applications in the second half of 2009, President and CEO Jay Flatley said today at the JPMorgan Healthcare Conference held here.

Flatley said that the firm would initially target blood typing, pharmacogenomics, and pre-natal testing as the primary applications for the system. Illumina also intends to sign up partners to develop assays for the BeadXpress system, as well as work on diagnostic applications for its Avantome technology.

Partnering is one part of Illumina’s three-prong strategy for the molecular diagnostics market, which is currently estimated at around $2.5 billion but is growing rapidly. The other two parts of its strategy include establishing its own CLIA-certified lab and efforts to discover oncology markers for use in MDx tests.

Flatley reiterated previous comments from Illumina officials that the company intends to file for regulatory approval of its CLIA lab during the second quarter of 2009, and expects the lab to be operational sometime during the second half of this year.

The firm’s efforts in oncology will first focus on ovarian and gastric cancer, he noted.

According to Flatley, Illumina is working on improving sample preparation for better automation and reliability in diagnostic applications.

He also noted that the company expects to report some molecular diagnostic revenues in 2010, but such revenues “won’t move the needle.” Such revenues are also far off from overtaking revenues from research applications as the majority of Illumina’s turnover, he said.

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