In addition to RT-PCR, AltheaDx provides quantitative gene expression and genotyping services.
XP-PCR MULTIPLEXED METHOD AS PERFORMED ON THE BECKMAN COULTER GENOMELAB™ GEXP GENETIC ANALYSIS SYSTEM PLATFORM
In addition to RT-PCR, AltheaDx provides quantitative gene expression and genotyping services using the XP-PCR multiplexed method as performed on the Beckman Coulter GenomeLab™ GeXP Genetic Analysis System platform. This patented approach, which we have commercialized in partnership with Beckman Coulter as kits and reagents for use with the Beckman capillary system, provides many of the benefits of real-time PCR in terms of sensitivity, accuracy, and low cost per reaction, while breaking out of the 2 gene multiplex limit. The method, as implemented on the Beckman GeXP system, is routinely used to multiplex up to 35 genes in a single PCR reaction (up to 15 for FFPE-derived RNA or DNA), eliminating the need to select a single reference/control gene, and making it match well with the number of genes required to capture and differentiate a complex disease or drug response fingerprint. The performance of the assay as a single tube PCR reaction greatly reduces the sample handling complexity making it more amenable to standard clinical reference lab workflow.
The Beckman GeXP system is an integral part of the GenomeLab system that includes multiple automation and software components that can be utilized to simplify the entire PCR-based process including RNA sample preparation from tissue, RT-PCR setup and running, capillary analysis of PCR samples and data reporting. The Beckman systems exist as both research instruments and as an FDA cleared diagnostics platform called the Vidiera. These are complete solutions that can be placed in clinical reference labs. During the 2 years where AltheaDx worked with Beckman to create the GeXP product, our group developed 16 different multiplex PCR kits each of which contains on average 24 genes. All kit development at AltheaDx involved a rigorous assessment of assay performance for each multiplex and included the creation of multiple RNA standards. All kits were designed and developed using the same quality standards and standard manufacturing processes as Beckman applies to its own diagnostic products.