Helix Diagnostics is an emerging Contract Research Organization dedicated to providing testing support for oligonucleotide therapeutics developers.
Since the 2006 Nobel Prize was awarded for the discovery of RNA interference technology, a rapid expansion of companies developing RNA and DNA drugs has occurred, representing one of the fastest-growing sectors of the pharmaceutical industry. In order to prove these promising agents are safe and/or efficacious for humans, companies must engage in toxicology and safety studies and show the new drug agent is present in therapeutic quantities in recovered samples.
Helix specializes in providing these answers for Clients, using a proprietary high-throughput assay based on hybridization and capillary electrophoresis. The Helix assay is unique in that it provides not only Identity and Quantity of the oligonucleotide drug from any tissue type, but it also profiles any present Metabolite species – all from a single sample and a single assay. This “one stop” capability provides substantial value to drug developers as it avoids use of multiple methods and samples to get the same answer. Client savings in assay costs and tox/safety studies may be significant.
If your clinical development pipeline includes oligonucleotide therapeutics, Helix is ready to serve your bioanalytical needs – today!
In addition to identification and quantitation of the full-length drug Target, Helix is unique in that it provides – from the same sample – a profile of any present metabolites. Clients like our ability to provide an early indication of drug metabolism, or the “M” in ADME.
As shown below, Helix can readily hybridize these species with the same probe and from the same sample. Multiple animal studies, method(s) development, and validations are avoided.
Helix methods routinely provide excellent range and sensitivity for bioanalytical requirements. Success has been attained for nearly every tissue and modified oligonucleotide thus far.
With proprietary Helix assay services, only the most fundamental steps are required to capture all bioanalytical information for your DNA or RNA drug agent:
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