iGenix, a Seattle-based contract research and laboratory services company, has launched its first diagnostic assay, which runs on Illumina's BeadXpress system.
The pharmacogenomic assay, which genotypes two genes in order to guide dosing of the anticoagulant warfarin, was built as a "proof-of-principle test" as part of the firm's effort to meet Washington State clinical laboratory regulations and is "one of several" in iGenix's pipeline, according to a company official.
Tera Eerkes, the company's chief scientific officer and cofounder, told BioArray News this week that the new test was reviewed by the Washington State Department of Health as part of the state's enforcement of the Clinical Laboratory Improvement Amendments.
Washington State is exempt from federal enforcement of CLIA, and labs are regulated at the state level for compliance, including oversight of high-complexity tests. iGenix's facility was certified as CLIA compliant in January. The new test received a positive assessment following review last week.
Eerkes said the assay is for common SNPs in CYP2C9 and VKORC1 and has "important clinical relevance" for dosing estimates for warfarin. "We chose this assay for initial CLIA review because it's well known to the regulatory community, and provided a relatively simple introduction to the methodology of using a platform like Illumina's BeadXpress," she said.
In addition, the assay has complement proficiency testing surveys available from the College of American Pathologists, which the firm also performed, Eerkes said.
Eerkes noted that the company plans to introduce additional assays on the BeadXpress platform.
"Our current R&D efforts are aimed at establishing the BeadXpress and other high-throughput platforms as standard tools for more complex diagnostic assays, for use in clinical trials, oncology, infectious disease, and other companion diagnostics," she said. "We're also evaluating the most effective way to introduce sequencing technology into a diagnostic setting," she added, though she declined to elaborate.
Founded in 2007, iGenix provides contract research and laboratory services to researchers and physicians. In particular, it touts its "expertise in biomarker evaluation," and has helped clients develop assays suitable for the BeadXpress platform. In addition, iGenix offers genotyping, expression, and methylation profiling on the Illumina iScan microarray system. The company became an Illumina certified service provider for the BeadXpress platform last year.
Illumina's BeadXpress system employs a dual-color laser detection system that identifies the unique holographic codes embedded in microbeads, and detects the signal intensity associated with each bead. Users can survey up to 384 loci per assay. The company claims that its BeadExpress-based warfarin test can genotype up to 90 clinical samples in a 24-hour period for less than $5 per sample.
According to Eerkes, iGenix believes its combination of genomics services and assay development will help it attract service deals with diagnostics and pharmaceutical developers.
"The future of successful pharmaceutical research will depend on decreasing the time and money spent to bring products to market, and better specifying the populations who will benefit from a particular compound," Eerkes said. "iGenix meets this two-fold need with a service offering that uses advanced molecular biology platforms to supply superior data, analysis, and process during R&D; and later leverage that technical expertise into rapid companion test development to go hand-in-hand with the launch of a new compound."
iGenix is one of a number of companies that are offering the BeadXpress in a CLIA-certified setting. Porto, Portugal-based CGC Genetics offers a menu of genetic tests that run on the platform.
Other companies that have adopted BeadXpress include Aliso Viejo, Calif.-based Ambry Genetics; Rockville, Md.-based BioReliance Genomics; and Madison, Wis.-based EraGen Biosciences (BAN 12/21/2010).
Illumina gained US Food and drug Administration clearance for the system last year (BAN 5/4/2010).
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