Be a hero to your pharma clients by getting more out of every biopsy in the trials you run for them.

When you design a clinical trial protocol for your clients who are entrusting you with their investment in their oncology drug candidates, are you creating a protocol that maximizes collectable data? When a patient in an oncology drug trial undergoes a routine core needle biopsy, are molecular testing results always available, or are the visual pathology report and Immunohistochemistry (IHC) reports sometimes the only data generated? How often are molecular testing results unavailable because the report comes back Quantity Not Sufficient (QNS)? If the answers to those questions are anything other than “Always” and “Never,” isn’t it time to consider integrating the Crow’s Nest Biopsy Catchment System into the biopsy workflow in your clinical trial protocols?

If you happen to have any clients who are pursuing the development of antibody-drug conjugant (ADC) therapeutics, consider the impact on the tissue core specimens of the additional IHC sectioning required for ADC cellular interaction confirmation. Those patients’ biopsy specimens will have even less tissue remaining and therefore available for molecular testing. You can increase the chances of molecular testing being possible for each biopsy specimen if a second specimen – a liquid specimen containing DNA directly from the tumor, conveniently stable at room temperature with no special storage requirements – is available for every biopsy data point in your trial design. 

And if your clients’ drug development goals include investigating fusion mutations, a liquid specimen containing stable RNA is likely going to be even more useful and important to your data collection. Fusion mutation results in a chimeric RNA transcript, where parts of two different genes are abnormally joined together. RNA sequencing can directly capture and identify an abnormal transcript, which may not be detectable at the DNA level. DNA fusions can be hard to detect due to large intronic regions (especially in genes like ALK, RET, ROS1, and NTRK). RNA testing avoids these intronic sequences and focuses on the exonic regions that form the functional fusion transcript. So you are going to want to design a protocol that yields specimens with usable RNA. Chances are low of recovering RNA from formalin-fixed specimens.