Overview

Biodesix is changing the paradigm of companion diagnostic development. Our hypothesis-independent approach has demonstrated the ability to classify patients into groups correlated with specific outcomes using mass spectra obtained from serum or plasma samples.  Partner with us for rapid companion diagnostic development and timely turnaround of projects to:

  • realize greater efficiency in clinical development by predicting responses to therapy
  • increase probability of success for pivotal trials and reduce attrition rates
  • identify patient populations that will experience the greatest benefit from new therapies
  • achieve greater market share, faster

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Performing clinical trials in unselected patient populations carries the risk that any statistically significant treatment benefit may occur in only a small proportion of patients, with efficacy obscured by a larger number of patients experiencing no benefit.  In this scenario, the drug would be considered a  failure despite providing benefit for some patients. Companion diagnostics can help identify patient subsets that respond to specific therapies, and thus its benefit in selecting appropriate patients for targeted therapy is widely accepted.  However, development of these tests– usually based on the identification and validation of one or a small number of biomarkers– has been lengthy, arduous, and largely unsuccessful.

Overcoming the Biomarker Challenge

For a variety of reasons, the presence of the biological target or diagnostic marker does not always translate into efficacy of the drug directed against that target:

  • the pathophysiology of a disease is not fully reflected in the patient’s genotype or in a single protein, but rather in the complex profile of proteins actually expressed[1]
  • expression or presence of the target in the tissues where it is measured may not be representative of the distribution of that target in other sites [2],[3]
  • other factors such as the tumor microenvironment, angiogenesis, tumor heterogeneity and temporal profile, and host immune responses also contribute to the growth and metastasis of cancer and therefore the patient’s response to targeted therapies[4],[5]

The Biodesix approach to companion diagnostic development utilizes the power of mass spectrometry, state-of-the-art techniques, and proprietary technology to identify clinically meaningful differences between specific groups of patients in easily obtained biological samples.

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[1] National Cancer Institute, “Clinical Proteomic Technologies for Cancer – Annual Report” 2007

[2] Fidler IJ. “Tumor heterogeneity and the biology of cancer invasion and metastasis.” Cancer Res. 1978 Sep;38(9):2651-60.

[3] Gomez-Roca C, et al. “Differential Expression of Biomarkers in Primary Non-small Cell Lung Cancer and Metastatic Sites.” J Thorac Oncol. 2009 Aug 14.

[4] Kumar S, Weaver VM. “Mechanics, malignancy, and metastasis: the force journey of a tumor cell.” Cancer Metastasis Rev. 2009 Jun;28(1-2):113-27.

[5] Lopez JI, Mouw JK, Weaver VM. “Biomechanical regulation of cell orientation and fate,” Oncogene. 2008 Nov 24;27(55):6981-93.