Affymetrix said this week that Laboratory Corporation of America will use its technology in a molecular cytogenetic-testing service that will correlate deletions, gains, and other chromosomal rearrangements with disorders such as pediatric autism, mental retardation, and developmental delay.
Last week, the company separately announced that its Drug Metabolizing Enzymes and Transporters panel is now available as a service through its South San Francisco, Calif., Services Laboratory and Clinical Data subsidiary Cogenics. A catalog version of DMET, a 1,069-biomarker panel for drug-metabolism studies, will become available later this year, Affy said.
Both the LabCorp deal and the DMET roll-out could help build Affy’s presence in the clinical testing and pharmacogenomics markets at a time when the bulk of its annual revenues come from the research community, as opposed to biotechs and pharmas.
In terms of the agreement with LabCorp, the reference lab giant upgraded to Affy’s platform from its existing comparative genomic hybridization platform that it first launched in 2005. That original service used chips from Spectral Genomics, now owned by PerkinElmer, to diagnose more than 80 genetic mutations associated with mental retardation and learning disabilities (see BAN 9/28/2005).
LabCorp Spokesperson Eric Lindblom told BioArray News this week that the company decided to switch platforms because “the region of the genome that is covered with the new array is greatly expanded,” and that LabCorp “evaluated a variety of platforms and arrays and chose Affy because, overall the company, the product, and the evaluation and validation met our expectations and needs.”
According to Francisco Cifuentes, a senior product marketing manager at Affy, LabCorp initially will use the firm’s GeneChip Human Mapping 250K Nsp Array in its services, though LabCorp will transition to Affy’s 1.8-million-feature SNP Array 6.0 product in the “near future once the validation process is completed.”
Affy is interested in building a role for itself in the array-based cytogenetic-testing market, which includes services offered through firms such as CombiMatrix Molecular Diagnostics, Signature Genomic Laboratories, and Empire Genomics, as well as catalog products from companies like Blue Gnome and Spectral Genomics. Additionally, other array vendors, like Agilent Technologies, have been manufacturing custom arrays for labs that offer cytogenetic testing.
Cifuentes pointed out that Affy’s arrays are already “being used for this kind of testing in several laboratories around the world.” He also referred to the July formation of the European Cytogenetic Research Initiative, a collaboration between Affy, the University of Nijmegen in the Netherlands, the University of Tuebingen in Germany, and the National Health Service Regional Genetics Laboratory in Birmingham, UK. The collaborators are using Affy SNP chips to identify the specific causative mutations in mentally retarded children as well as for diagnostic purposes (see BAN 7/17/2007).
While Affy looks to raise its profile in the molecular cytogenetic testing space, the company is also looking to expand its pharmacogenomics offering. Last week the firm launched its DMET panel as a service through its labs and Cogenics’, and according to the firm it will most likely expand access to the drug-metabolism assay in the coming months.
DMET is currently available as a service through Affymetrix’ South San Francisco Services Laboratory and Cogenics, according to Tommy Broudy, senior marketing manager for pharmacogenetics at Affy.
“Both of these providers successfully completed a six-week training and certification program to ensure that data is complete, accurate and reproducible,” Broudy told BioArray News in an e-mail this week. “Additional worldwide service providers will be certified and announced in the near future.”
Affy has positioned the panel as a tool to “help pharmaceutical scientists make more informed decisions and improve clinical trial efficiencies,” said Broudy. In addition, DMET should become available as a catalog product for customers to run in their own lab in the “second half of this year.”
The DMET panel is not Affy’s first foray into the pharmacogenomics testing arena. In 2005, the US Food and Drug Administration cleared the AmpliChip CYP450, a drug metabolism assay created by Roche to run on the Affymetrix platform, for clinical use (see BAN 1/4/2005). Affy has been offering the AmpliChip CYP450 assay, as well as other molecular tests, through its clinical service laboratory in Sacramento, Calif., which came online last year (see BAN 4/24/2007).