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One assay, 242 genes
LEXINGTON, Mass.—RainDance Technologies Inc. and Ambry Genetics have launched a comprehensive targeted sequencing panel to screen genes involved with drug absorption, distribution, metabolism and excretion (ADME) research.
The ADMESeq Research Screening Panel enables researchers to simultaneously interrogate 242 known pharmacogenetic genes using next-generation sequencing (NGS) systems.
In recent years, biotechnology and pharmaceutical companies have been genotyping ADME genes earlier in the drug development pipeline to help reduce the significant costs associated with failed drug trials and hospitalizations due to adverse events. However, RainDance points out that current genotyping tools interrogate only a small number of known biomarkers and lack the genomic coverage to detect important variants across a wide range of genes implicated with ADME.
The new panel includes pharmacokinetic and pharmacodynamic genes, as well as VIP genes and biomarkers associated with the FDA 's top 25 approved drugs.
"Pharmacokinetics can be defined as what the body does to the drug and pharmacodynamics as what the drug does to the body," says Dr. Andy Watson, vice president and chief marketing officer at RainDance. "A PharmGKB (Pharmacogenomics Knowledge Base) VIP gene is defined as a gene that has well-documented information about its involvement in the pharmacodynamics or pharmacokinetics of a drug. There are a total of about 200 well-documented VIP genes that were selected by pharmacogenomics experts for PharmGKB to annotate. Genetic screening of ADME genes can be important, as loss of function in any of these genes (or increased function through copy number increases) can lead to a number of undesirable outcomes, including reduced response or side effects.
"Furthermore," Watson adds, "many of these mutations can be 'rare' in a population, which means that they aren't detected using genotyping methods, which only target 'common' mutations. The use of a comprehensive DNA sequencing approach to ADME, such as those offered by RainDance, allows the identification of any change, not just the common ones."
Scientists interested in analyzing ADME genes can now look far beyond what existing genotyping panels reveal and discover the novel chromosomal changes and rare variants associated with drug metabolism and molecular pharmacology, Watson adds.
"Through our collaboration with Ambry Genetics, we are providing customers with a solution that puts the most advanced ADME research tool within reach of the many organizations focused on understanding the phenotypic effects of mutations in these genes and reducing the significant costs associated with failed drug trials," he says.
The new ADMESeq Research Screening Panel provides scientists with the capacity to perform sequence analysis of entire coding regions of 242 key drug metabolism-linked genes, including 44 membrane transporters, 42 VIP genes from the Pharmacogenomics Knowledge Base and 86 FDA-identified pharmacogenomics biomarker genes.
Ambry Genetics is a CAP- accredited and CLIA-certified commercial clinical laboratory with headquarters in Aliso Viejo, Calif. Since the company's inception in 1999, it has provided genetic services focused on clinical diagnostics and genomic services, particularly sequencing and array services.
"We are confident that our pharmaceutical, biotechnology and research customers will be eager to utilize this novel predictive toxicology tool to enhance their drug safety strategies and reduce the costs associated with performing ADME analysis," says Ardy Arianpour, Ambry's vice president of business development.
The new panel, provided as part of the Ambry ADME sequencing service, leverages RainDance's proprietary primer design methods and single-molecule microdroplet-based PCR platform to allow high specificity, even amongst highly homologous genes. The panel runs on both the RainDance RDT 1000 and ThunderStorm Systems. The ThunderStorm System is a new, fully automated, high-throughput targeted sequencing solution that enables researchers to process more samples and generate high- quality data faster and easier than ever before, RainDance claims.