DNAnexus, which offers a cloud-based genomic data collaboration platform, just launched a clinical trial solution that integrates the genomics data obtained from next-generation sequencing (NGS) into clinical studies.
The idea DNAnexus has is that the clinical trials that have a target biomarker identified in early stage will be able to save cost and significantly increase success rate down the development road. And the ready availability of NGS provides an easier access to genomics data, enabling researchers to select participants who have the genetic biomarker and who are therefore likely to respond to the treatment.
It is the foundation of targeted therapy and companion diagnostics, and the backbone of the rising precision medicine movement. However, drug developers looking to incorporate human genome and microbiome-based insights into their clinical trial designs have been frustrated with the traditional way of managing high-throughput genomics data, said DNAnexus CEO Richard Daly in a statement.
DNAnexus’ new clinical trial solution aims to streamline the use of NGS and multiomic information in clinical trials. “[It] enables our customers to rapidly integrate genomics into adaptive trial design and significantly improve outcomes, ensuring consistency and reproducibility of results across geographical regions and research partners,” said Daly.
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Here’s how it works. Participants’ DNA samples are sequenced and uploaded to the platform for analysis. Study clinicians can monitor the progress of analyses. The platform is also integrated with clinical trial management system to retrieve and store genomic results. Bioinformaticians can test and validate their pipelines and reports associated with the trial.
For this new solution, DNAnexus is offering the same GxP-compliant service that powers the FDA’s precisionFDA web platform for NGS test evaluation and regulatory standard exploration.
Almac Diagnostics has become one of the first customers of the service. “DNAnexus offers the industry’s most comprehensive security and privacy framework, which provides our global labs auditability, data immutability, and scalability to implement a streamlined integration of genome-based biomarker delivery in clinical trials,” said Timothy Davison, the company’s VP of data sciences & biostatistics.