One assay, 242 genes
RainDance Technologies and Ambry Genetics launch new DNA sequencing panel for ADME research
The ADMESeq Research Screening Panel enables researchers tosimultaneously interrogate 242 known pharmacogenetic genes usingnext-generation sequencing (NGS) systems.
In recent years, biotechnology and pharmaceutical companieshave been genotyping ADME genes earlier in the drug development pipeline tohelp reduce the significant costs associated with failed drug trials andhospitalizations due to adverse events. However, RainDance points out thatcurrent genotyping tools interrogate only a small number of known biomarkersand lack the genomic coverage to detect important variants across a wide rangeof genes implicated with ADME.
The new panel includes pharmacokinetic and pharmacodynamicgenes, as well as VIP genes and biomarkers associated with the FDA's top 25approved drugs.
"Pharmacokinetics can be defined as what the body does tothe drug and pharmacodynamics as what the drug does to the body," says Dr. AndyWatson, vice president and chief marketing officer at RainDance. "A PharmGKB(Pharmacogenomics Knowledge Base) VIP gene is defined as a gene that haswell-documented information about its involvement in the pharmacodynamics orpharmacokinetics of a drug. There are a total of about 200 well-documented VIPgenes that were selected by pharmacogenomics experts for PharmGKB to annotate.Genetic screening of ADME genes can be important, as loss of function in any ofthese genes (or increased function through copy number increases) can lead to anumber 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 genotypingmethods, which only target 'common' mutations. The use of a comprehensive DNAsequencing approach to ADME, such as those offered by RainDance, allows theidentification of any change, not just the common ones."
Scientists interested in analyzing ADME genes can now lookfar beyond what existing genotyping panels reveal and discover the novelchromosomal changes and rare variants associated with drug metabolism andmolecular pharmacology, Watson adds.
"Through our collaboration with Ambry Genetics, we areproviding customers with a solution that puts the most advanced ADME researchtool within reach of the many organizations focused on understanding thephenotypic effects of mutations in these genes and reducing the significantcosts associated with failed drug trials," he says.
The new ADMESeq Research Screening Panel provides scientistswith the capacity to perform sequence analysis of entire coding regions of 242key drug metabolism-linked genes, including 44 membrane transporters, 42 VIPgenes from the Pharmacogenomics Knowledge Base and 86 FDA-identifiedpharmacogenomics biomarker genes.
Ambry Genetics is a CAP-accredited and CLIA-certified commercialclinical laboratory with headquarters in Aliso Viejo, Calif. Since thecompany's inception in 1999, it has provided genetic services focused onclinical diagnostics and genomic services, particularly sequencing and arrayservices.
"We are confident that our pharmaceutical, biotechnology andresearch customers will be eager to utilize this novel predictive toxicologytool to enhance their drug safety strategies and reduce the costs associatedwith performing ADME analysis," says Ardy Arianpour, Ambry's vice president ofbusiness development.
The new panel, provided as part of the Ambry ADME sequencingservice, leverages RainDance's proprietary primer design methods andsingle-molecule microdroplet-based PCR platform to allow high specificity, evenamongst highly homologous genes. The panel runs on both the RainDance RDT 1000and ThunderStorm Systems. The ThunderStorm System is a new, fully automated,high-throughput targeted sequencing solution that enables researchers toprocess more samples and generate high-quality data faster and easier than everbefore, RainDance claims.