Liquid biopsy technology is emerging as an enormously promising tool in the fight against cancer. Because it can detect changes in tumor genetics well before imaging reveals changes in growth, it has the potential to enable earlier intervention or treatment modification. With at least three dozen liquid biopsy diagnostics currently under development, this new technology is on track to becoming a new clinical standard.
Liquid biopsy offers a less invasive, less expensive and less time-consuming alternative to tumor biopsies. Genetic information about a tumor is gathered from a patient’s blood or other body fluid rather than his or her tissue, thereby eliminating the need for a surgical procedure.
Contract research organizations with specialized oncology and diagnostics experience will play a significant role in realizing the potential of this technology in clinical trials. I recently sat down with DDNews to discuss the state of liquid biopsies and their implementation in clinical trials. Here are a few excerpts from that conversation:
Most effective use of liquid biopsies in clinical trials:
I believe (liquid biopsies) would provide the most value immediately in the screening of patients for studies of targeted treatments. Currently, patients in whom a fresh core needle biopsy is not feasible and for whom adequate archival tissue samples are not available are excluded from studies of targeted therapies, since it cannot be confirmed their cancer carries the targeted mutation or antigens. Liquid biopsy may provide a pathway to an effective treatment for patients who would otherwise not be considered for targeted treatment studies.
Special protocol implications of implementing liquid biopsies:
Sponsors intending to use liquid biopsies know patient safety is paramount and protocols must generate evidentiary data to document certainty and reproducibility of the new technology performance and relationship to patient outcomes. Currently, redundancies with using tissue biopsies, imaging technology and other diagnostics are necessary, which can impact trial timelines and resources. One strategy for ongoing long-term trial sponsors or those with near-term study launches might be to amend their approved protocols and patient consent to add experimental endpoints that use liquid biopsies, even if retroactively on stored samples.
Best practices for advancing trials of liquid biopsy tests seeking FDA regulatory approval:
Both in terms of regulatory clearance and reimbursement, agencies are expecting clear evidence of improved clinical outcomes (overall survival, progression-free survival, etc.). This may be approached in the context of directing a more effective course of treatment targeted to the patient, or perhaps in the earlier diagnosis of cancer at a stage when treatment outcomes are improved. Processing assays under CLIA-approved conditions and well documented SOPs is essential.
For more of my thoughts about the way to harness liquid biopsies during clinical development, read the DDNews article, or for a more in-depth treatment, I recommend reading our white paper “The Promise of Liquid Biopsy Technology.”