Denovo Biopharma

A Novel Strategy to Discover Clinical Biomarkers Retrospectively with Archived Samples

Many drugs unfortunately fail after expensive Phase 3 studies have been completed, largely due to lack of efficacy or undesirable adverse effects. Our technology can enable drug developers to design new clinical trials in smaller and targeted patient populations at lower cost than the previous studies, providing a personalized medicine approach.

A highly novel aspect of this technology is that plasma samples (almost always retained for PK studies) can be used to identify novel genetic biomarkers by scanning the entire human genome and conducting a proprietary data analysis developed internally by Denovo. This type of testing has not been possible in the past using other technologies. This process can be completed in as rapidly as 90 days at an affordable cost that can generate an attractive return on investment.

If no patient informed consent exists, we can utilize double blind sample processing procedure that we have developed to meet FDA guidance on further testing of stored clinical samples.
We will support a partner throughout the development process through approval and launch of the drug together with the companion diagnostic test.
 

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