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Teaming up to interrogate genes about ADME
BRANFORD, Conn.—To help scientists capture known and unknown functional mutations associated with core sets of pharmacokinetic and pharmacology genes, Roche subsidiary 454 Life Sciences and Lexington, Mass.-based RainDance Technologies Inc. have signed a deal for developing and commercializing a targeted next- generation sequencing (NGS) solution for simple and cost-effective investigation of drug absorption, distribution, metabolism and excretion (ADME).
As part of the collaboration, RainDance and 454 Life Sciences plan to commercially launch a core ADME gene screening research panel that will be made available on both the 454 Life Sciences' GS Junior and GS FLX Systems. Financial terms of the deal were not disclosed.
"For the first time, researchers can look beyond the mutations found on current genotyping panels and discover novel chromosomal changes and rare mutations associated with drug metabolism and adverse drug events," said Roopom Banerjee, president and CEO of RainDance Technologies, in a news release about the deal. "Through our collaboration, Rain Dance and 454 Life Sciences are combining the power of our microdroplet technology with 454 Life Sciences' proven next-generation sequencing platforms to provide a robust and economical ADME sequencing solution."
Current ADME research products are primarily limited to genotyping common alleles, the companies note, and therefore lack the sensitivity, breadth of genomic coverage and ability to identify previously unknown variants that are important to drive scientific discovery and routine use.
RainDance and 454 Life Sciences maintain that their collaboration will enable researchers to interrogate a set of core pharmacokinetic and pharmacology genes, while at the same time to detect known and unknown functional mutations associated with drug metabolism and response.
"We started collaborating on a new ADME solution concept about a year ago," recalls James Brayer, RainDance's product manager for targeted sequencing. "The idea was born out of a mutual desire to bring the power of next-generation sequencing to ADME research. We have a number of mutual customers who are interested in an easy- to-use solution that targets all of the core ADME-related genes in a high-throughput fashion."
The impetus to deal with that concern wasn't simply a business opportunity for the two companies, but a push they felt from customers, adds Ulrich Schwoerer, 454 Life Sciences' head of global marketing, who tells ddn that "companies and research organizations involved in the discovery, development and manufacture of medicines are under increasing pressure to bring down costs and, more importantly, ensure the safety of products that are bound for, or already in, consumer markets."
In choosing 454 Life Sciences as a partner, RainDance was remaining true to its commitment to work with best-in-class partners, Brayer says, "to enable a number of new targeted sequencing applications that would benefit from the single-cell and single molecule resolution that is possible with our microdroplet-based platform. We also believe that our platform plays a central role in further advancing the routine use of next-generation sequencing in research areas that have been difficult to examine using previous technologies."
Looking at his own company's strategic goals, Schwoerer says that 454 Life Sciences' vision is to enable researchers, particularly in the area of medical research, to do their jobs far better and more efficiently.
"For the time being, targeted sequencing offers the most cost-effective and tractable approach to translate the use of genomic information into a medically relevant result," he says. "Targeted resequencing technologies such as RainDance's provide an opportunity to focus on the genomic regions with the highest likelihood of impacting research in a cost- and time-efficient manner."
The two men say their companies continue to evaluate other potential complementary applications and workflows, adding that they view this new ADME panel as a proof of principle illustrating the capability of coupling RainDance's targeting methods with 454 Sequencing Systems. RainDance's ability to custom-design PCR amplicon panels that fit into the 454 Sequencing workflow with minimal effort means that researchers can use this panel as a starting point, but also have the flexibility to target any region of the genome they are interested in, they say.
RainDance's proprietary primer design method reportedly enables highly accurate, consistent and reproducible next- generation sequencing in ADME research, which is required for large-scale drug metabolism studies. 454 Life Sciences' GS Junior and GS FLX Systems are said to provide high-quality, long-sequencing reads which enable higher levels of coverage, accuracy and quantitation with fewer dropouts, as well as detection of a wide range of genomic variations, including SNPs, insertions, deletions and multinucleotide polymorphisms.
"Our collaboration with RainDance will result in solutions that better equip scientists to leverage the GS FLX and GS Junior Systems to effectively predict and understand drug activity early in the drug development process," said Christopher McLeod, president and CEO of 454 Life Sciences, in a news release about the deal, adding that adverse drug events represent more than two million hospitalizations and approximately $1 billion in healthcare cost burden annually in the United States alone.
RainDance and Ambry Genetics ink ADME analysis deal
LEXINGTON, Mass.—RainDance Technologies Inc. also recently announced that it will collaborate with Ambry Genetics on the development and commercialization of a comprehensive drug absorption, distribution, metabolism and excretion (ADME) genetic screening panel for use on next-generation sequencing (NGS) systems.
The announcement was made at the Society of Toxicology's 50th Annual Meeting in Washington, D.C. Financial terms of the collaboration were not disclosed.
The new ADME panel will provide scientists with the capacity to perform sequence analysis of entire coding regions associated with more than 220 key drug metabolism-linked genes, including transporters, receptors, regulators and all pharmacodynamic and pharmacogenetic genes, as well as all U.S. Federal Drug Administration (FDA)-identified pharmacogenomic biomarker genes. The panel, provided as part of Ambry's ADME sequencing service, will leverage RainDance's primer design methods and microdroplet-based RDT 1000 platform, which according to RainDance provides the highly accurate, consistent and reproducible results required in ADME research and for most FDA drug applications.
"Scientists interested in analyzing ADME-linked 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," says Dr. Darren Link, RainDance's co-founder and vice president of research and development. "Through our collaboration with Ambry Genetics, we are providing a solution that puts the most advanced ADME research tools within reach of the many research organizations focused on reducing the significant costs associated with failed drug trials and avoidable hospitalizations."