SAN DIEGO, Aug. 11, 2015 /PRNewswire/ -- Epic Sciences announced today the publication of its research in the Journal of Circulating Biomarkers validating the company's no cell left behind™ platform. The data published demonstrate reproducible and linear assay performance in CTC enumeration as well as additional utility in downstream molecular characterization of single CTCs, including protein biomarker analysis and single cell genomics. The study goes on to illustrate clinical feasibility through direct application of the Epic Sciences platform to analyze samples from metastatic castrate resistant prostate cancer patients. Validation of this highly sensitive platform with clinically relevant samples will enable a further level of precision in characterizing the cellular diversity of a patient's cancer and in detecting latent or early signs of drug resistance. Both capabilities could dramatically influence patient selection for clinical trials as well as the matching of patients to targeted or combination therapies.
"Today's cancer fighting drugs target single mutations and are used one at a time, even though many cancers result from multiple cell types, each with a unique mutation profile," said Murali Prahalad, Ph.D., President and CEO of Epic Sciences. "Epic Sciences' no cell left behind™ technology was specifically designed to detect all possible varieties of CTCs, many of which cannot be seen with other technologies. Furthermore, we can analyze individual CTCs for genetic and proteomic aberrations to provide real-time information about cancer heterogeneity to guide tailored and timely treatments, including combination therapies."
The study showed the analytical validation of Epic Sciences' no cell left behind™ CTC platform for assay accuracy, linearity, specificity, precision and repeatability across assay runs and multiple operators. This study also demonstrated that Epic Sciences' platform could accurately detect epithelial CTCs as well as non-epithelial CTCs. These additional CTC variants, including CTC clusters, small CTCs and apoptotic CTCs are clinically relevant in predicting drug response. Identifying all CTC variants and enabling their subsequent isolation one cell at a time is unique among CTC technologies. These capabilities are possible since the Epic Sciences platform does not require any initial sample enrichment. These data also validate the downstream capabilities enabled with Epic Sciences' technology including the analysis of cell morphology, protein biomarker analysis, DNA FISH and copy number variation all of which were performed at the single cell level. Furthermore, the platform was employed to generate data from a small cohort of metastatic prostate cancer patient samples to test clinical utility. These data revealed that 89 percent of patient samples examined had epithelial CTCs, whereas 100 percent of the samples had CTCs when including non-epithelial CTC variants. No CTCs were detectable from normal donors.
"Methods, such as tissue biopsies with genomic analysis and liquid biopsies that analyze circulating free DNA in the blood look at cancer in terms of averages. Cancer however, is a disease of multiple, rare cells types that occur simultaneously in patients. Individual clones develop resistance to therapies and continue to grow and evolve, resulting in metastatic cancers that are difficult to treat," said Dr. Prahalad. "Single cell analysis at the genomic level will enable a deeper understanding of cancer's clonal evolution in the context of individual patients through the assessment of which mutations are present in specific cell types at a particular point in time. This opens the door for a more customized sequencing of targeted or combination therapies. It will also allow the monitoring of therapeutic effectiveness over time, potentially well in advance of imaging results."
The study, titled "Analytical Validation and Capabilities of the Epic CTC Platform: Enrichment-Free Circulating Tumour Cell Detection and Characterization," is available here.
About Epic Sciences
Epic Sciences, Inc. is developing novel diagnostics to personalize and advance the treatment and management of cancer. Epic Sciences' mission is to enable the rapid and non-invasive detection of genetic and molecular changes in cancer throughout a patient's journey. The company was founded on a powerful platform to identify and characterize rare cells, including circulating tumor cells (CTCs). Epic Sciences' no cell left behind™ technology helps match patients to targeted therapies and monitor for drug resistance, so that the best treatment path can be chosen at every clinical decision point. Today, we partner with leading pharmaceutical companies and major cancer centers around the world. Epic Sciences' goal is to commercialize our technology to increase the success rate of cancer drugs in clinical trials and improve patient outcomes by providing physicians real-time information to guide treatment choices.
SOURCE Epic Sciences, Inc.