Oncology Trial Sponsors
Protect the substantial investment in resources you are placing in your clinical trial.
Is your organization developing a new antibody-drug conjugant (ADC) therapeutic? If so, the clinical trial that you will be sponsoring will require a protocol that calls for more Immunohistochemistry (IHC) staining than conventional drug trials have. Each additional IHC stain requires another slice of each tissue core from the trial subjects’ biopsies. And that means less tissue remaining with the tissue core – less tissue available for molecular testing or genomic sequencing. You run the risk that not all of the biopsy data points in your trial will yield molecular testing results. If that occurs, some of the enrolled subjects in your trial would have to be asked to undergo an additional biopsy procedure, or you will have a less-than-complete data set.
Is your organization developing a new antibody-drug conjugant (ADC) therapeutic? If so, the clinical trial that you will be sponsoring will require a protocol that calls for more Immunohistochemistry (IHC) staining than conventional drug trials have. Each additional IHC stain requires another slice of each tissue core from the trial subjects’ biopsies. And that means less tissue remaining with the tissue core – less tissue available for molecular testing or genomic sequencing. You run the risk that not all of the biopsy data points in your trial will yield molecular testing results. If that occurs, some of the enrolled subjects in your trial would have to be asked to undergo an additional biopsy procedure, or you will have a less-than-complete data set.
Instead, you could include a simple 30-second step in your trial’s biopsy procedure protocol – instructing the interventional radiologist, surgical oncologist, or pulmonologist to use the Crow’s Nest Biopsy Catchment System. If they do, each needle pass of each biopsy data point in your trial can yield not only the standard formalin-fixed solid tissue core, but also a second specimen consisting of a 5 mL liquid sample containing DNA and RNA, in pristine long-chain form, directly from the tumor tissue, easy to store because its stable at room temperature, available for molecular testing.
The bottom line is that when a patient in an oncology drug trial undergoes a routine core needle biopsy, molecular testing results always not always available. Sometimes the visual pathology report is all that is generated. Given the significant resources you put into recruiting and enrolling each human subject in a trial, doesn’t it make simple business sense to include biopsy catchment after each needle pass? You don’t want to exclude any subjects from your results data set due to molecular testing results being unavailable because the report comes back Quantity Not Sufficient (QNS). 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. For that reason alone, why not integrate the Crow’s Nest Biopsy Catchment System into the biopsy workflow in your clinical trial protocols?
So if you are developing an ADC drug candidate and your outcomes data include molecular testing, or if you a drug that is intended to treat patients whose tumor is caused by a fusion mutation, protect the substantial investment in resources you are placing in your clinical trial. Add this simple step to your biopsy protocols. It’s a tiny fraction of the cost of recruiting and enrolling additional patients to meet your n goals. Contact us today.
And if your 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.
