NEW YORK (GenomeWeb News) – Sequenom is building a new 7,000-square-foot CLIA laboratory at its headquarters in preparation of a planned launch of its Trisomy 21 diagnostic test.
Ian Clements, senior director of investor relations for the San Diego-based molecular diagnostics company, told GenomeWeb Daily News today that the lab is slated to be up and running in the fourth quarter and will be outfitted with sequencing platforms from Illumina. The San Diego Union-Tribune broke the news about the new lab yesterday.
The new lab will perform validation for Sequenom's T21 non-invasive Down syndrome test. The company is currently collecting samples as part of a clinical study, and about 4,000 samples will be run at the new facility in connection with the final validation of the T21 test, Clements said.
After the launch of the test, planned for the latter half of next year, the test will be run out of the new lab.
Sequenom has a CLIA-certified and CAP-accredited lab, the Sequenom Center for Molecular Medicine, in Grand Rapids, Mich., which runs the company's cystic fibrosis and SensiGene Fetal Rhesus D Genotyping tests. A test for age-related macular degeneration, to be launched in the first half of 2011, will also be run out of the Grand Rapids facility.
Those tests are run on Sequenom's MassArray technology, however, while the T21 test will run on sequencing technology.
"This is basically an expansion of our lab network," Clements said. "The core of our sequencing expertise and knowledge is here in San Diego, hence it made sense to expand our network and build a CLIA lab here."
Sequenom anticipates getting CLIA certification and CAP accreditation for the San Diego lab in Q4 2010, he added.
It has not yet been decided whether the new space will be outfitted with Illumina's newest platform, the HiSeq systems, or its Genome Analyzer technology, though Sequenom has both platforms, Clements said.
He declined to disclose the cost of the new facility, but said "it's a reasonably modest investment." Space for the new lab is being converted from existing space that had been used for other R&D research.
He also declined to say how many employees will be manning the space.