The UC Santa Cruz Colligan Clinical Diagnostic Laboratory (CCDL) has achieved a significant milestone in pediatric cancer diagnostics with its recent CLIA certification from the California Department of Public Health, marking a crucial step forward in precision medicine for childhood cancers.
The laboratory will implement a groundbreaking clinically validated test that analyzes RNA abnormalities in patient samples, potentially identifying life-saving treatment options for pediatric cancer patients. This advancement represents a fundamental shift in cancer diagnostics, moving beyond traditional location-based classification to more precise molecular-level analysis.
Revolutionary RNA Analysis Approach
The lab's innovative Comparative Analysis of RNA Expression (CARE) has demonstrated remarkable potential in identifying treatment options. In a study of 144 tumor samples, CARE analysis identified potentially druggable targets in 68% of cases, significantly outperforming traditional DNA mutation analysis, which was useful in only 46% of the same samples.
"Our team is exceedingly motivated by the power of our specialized analysis," said Professor Olena Vaske, the lab's technical supervisor. "In the next ten years, we hope that this analysis can be offered to every pediatric patient, so that during one of the most difficult periods of their lives, more families will be able to hear someone say, 'we know exactly what this is and how to treat it.'"
Clinical Implementation and Future Plans
The initial phase of operations will focus on detecting gene fusions in patient RNA, which can produce faulty proteins known to drive certain cancers. The lab plans to process approximately six patient samples weekly, initially partnering with UCSF before expanding to other medical facilities.
The laboratory operates under the supervision of Dr. Patrick Devine, CCDL Medical Director and Associate Professor of Pathology at UCSF, with Treehouse Lab Manager Anouk van den Bout leading the clinical licensing efforts.
Expanding Diagnostic Capabilities
The Treehouse research and development team is actively working on developing additional novel tests to analyze tumor RNA for gene overexpression, an innovation that currently has no market equivalent. This development could provide crucial insights into difficult-to-treat cancer types.
Lauren Linton, Executive Director of the UC Santa Cruz Genomics Institute, emphasized the significance of this achievement: "Creating a clinical lab from scratch was a big lift, but the Genomics Institute has seen how incredibly transformative our RNA analyses can be for patients. Our ultimate goal is to revolutionize the standard of care offered to all pediatric cancer patients."
Impact on Pediatric Cancer Treatment
The CCDL's approach addresses a critical gap in pediatric cancer diagnostics. While adult cancers often develop through DNA mutations over time, childhood cancers frequently result from gene expression irregularities visible only in RNA analysis. This distinction makes the lab's RNA-focused approach particularly valuable for pediatric cases.
The next milestone for the facility will be obtaining College of American Pathologists (CAP) accreditation, which will enable the validation of more comprehensive RNA testing methods, potentially expanding the scope of identifiable treatment options for young patients.
