SANTA CLARA, Calif.—Looking to promote the nascent market for high-throughput genotyping and gene expression in a clinical laboratory setting, Affymetrix Clinical Services Laboratory (ACSL), Agencourt Biosciences, Beckman Coulter Inc. and NuGEN Technologies announced a successful collaboration between the companies to bring forward an automated, reproducible service offering for DNA purification and genetic analysis.
Aimed initially at large pharma companies focused on drug development in clinical trials, government agencies conducting biomarker discovery, academia and core labs, ACSL officials say the successful technology integration for the service offering heralds a new era for the use of array-based studies in a CLIA-certified clinical services setting.
"The decision to launch the clinical services laboratory was very clear," says Cynthia French, VP of ACSL. "We wanted to be able to provide our customers with a regulated environment and a way to incorporate these complex molecular tests, utilizing a microarry platform, into clinical practice by helping derive those procedures, quality handling metrics and to be able to reduce those into workflows that would be applicable in any laboratory environment."
In order to do this, the four companies involved brought their core expertise to the table: Beckmann Coulter contributes its ArrayPLEX application on its Biomek FX liquid handling platform; Agencourt, its RNAdvance blood chemistry, RNAClean kit and SPRIPlate 9R Magnet plate; NuGEN, its Ovation Whole Blood Solution for RNA amplification and labeling; and Affymetrix its GeneChip technology.
"This system is geared toward those who are going to do large numbers of samples and want to do it on one system," says Lynn Doucette-Stamm, VP of business development at Agencourt. "The model [for ACSL] is very similar to our own model where we provide sequencing services and also provide the products for those who are conducting their own sequencing."
In this case, Affymetrix is looking to both be the one of the first players in the gene expression and genotyping clinical services market, as well as provide another sales channel for its GeneChip product line.
And while the company has already signed two customers since the launch of the service in September of last year, the intent is to offer the integrated solution as a package, complete with validated procedures, to pharma companies, CROs or any other organization interested in performing high-volume genotyping studies.
"This isn't an instrument in a box, because it is the early evolution of the technology," says French. "But what we tried to do is look at these alliances with the other companies that would include the chemistry and the automated platform, in an array-friendly solution. So, by working together, we are able to provide a solution for a lower cost to laboratories that is high-throughput and with [a set of] validation parameters."
Working together was not new for any of the four companies involved. Affymetrix has collaborated with each of the other three players in the past in relationships dating back five or more years, notes Andy Noble, Affymetrix spokesperson. This familiarity and understanding of the project at hand worked in favor of getting the platform up and running and procedures validated.
"Each of the partners contributed fully to the project," French notes. "There was rapid response to all the issues as they came up and upper management at all the companies supported the endeavor."
While there is no formal marketing agreement aimed at selling the platform to customers, the intent is for each company to promote it to individual customers who show an interest in setting up an in-house, high-throughput system. Further, because ACSL will be operating the system under a variety of service contracts at its own CLIA-certified lab, customers who choose to set up the same system can expect to benefit from the ongoing work at ACSL.
"Being CLIA-registered ensures that all the laboratory processes are standardized and it consistently meets all the federal and clinical laboratory standard and institute guidelines for accuracy, precision sensitivity, calibration and control," French says. "In addition, all the ACSL assays have been validated for clinical applications to ensure reproducible results."
Customers who choose the entire package for their in-house laboratory would have access to the base of knowledge, the standard operating procedures, which would be "laying out a critical path," French notes, for customers to also become certified in microarray clinical diagnostics.
