Incorporating relevant biomarkers once human trials have begun presents a real challenge for biotechnology and pharmaceutical companies because hypothesis-based predictive biomarkers often fail during clinical validation.
Biodesix has designed and implemented a biomarker development process based on unbiased, rather than hypothesis-driven discovery. In this process, discovery of biomarkers can be rapidly advanced along with clinical drug development, or following failed pivotal trials. The Biodesix approach is label free, and has the ability to rapidly discover predictive tests (e.g. response to targeted therapy) using significantly smaller sample volumes than conventional approaches. In contrast to the shortcomings of genomic platforms, Biodesix’ phenotype analysis technology is highly reproducible and therefore performs as both the discovery and clinical testing platform.
In addition, because the process begins with outcomes data and a specific clinical question, development of clinical tests with Biodesix is far faster than traditional approaches.
Click the graph below to learn more about our typical collaboration workflow.
In early clinical development, Biodesix can develop classifiers which identify subpopulations of patients who may be most responsive or for whom a drug may have unacceptable toxicities. At all stages of drug development, our ProTS Platform and classifier development approach offer the fastest and most straightforward solution for companion diagnostics discovery, validation and commercialization. Advantages include:
- an unbiased discovery method that does not require a preliminary hypothesis about specific differentiating proteins
- a single platform for discovery, validation and commercialization that maximizes speed of implementation
The ProTS Platform is therefore able to generate high-clinical-value, multivariate tests which are fast, robust and reproducible. Additionally, Biodesix tests are generally non-invasive, require only small sample volumes (< 10µl), and do not require pretreatment or immunoassays.
Our CLIA-certified laboratory services also ensure that implementation of any co-developed tests can be seamlessly integrated into clinical trials and subsequently available for commercialization in the same timeframe as our partners’ drug therapies.
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