Biotheranostics, a leader in molecular diagnostics for cancer, announced results from a study developing a functional workflow for gene expression profiling using blood samples, providing insights into the potential for circulating tumor cell-based cancer classification that may help reduce dependency on tissue specimens. The study was presented at the American Association for Cancer Research (AACR) annual meeting, April 16-20, in New Orleans.

“This initial research is an important first step for Biotheranostics as we evaluate the potential application of our proven cancer biomarkers in liquid biopsy diagnostics,” said Nicolas Barthelemy, President and CEO of Biotheranostics. “Obtaining enough tissue from a biopsy or cytology specimen to perform diagnostic and biomarker testing can be challenging, and tissue conservancy is increasingly important in oncology given the number of emerging biomarkers. We look forward to continued study of our CancerTYPE ID molecular test and its possible role in cancer classification using blood specimens.”

In the analysis, technical feasibility studies for cancer cell enrichment and RNA viability were conducted by purifying cancer cells spiked into donor blood. Quantitative RT-PCR and immunoflourescence monitored cells harvested at different steps of the workflow, and gene expression profiling was performed using CancerTYPE ID. Results showed that an integrated workflow was established that allows for molecular characterization of cancer cells purified from blood. The process resulted in efficient recovery of cells within the technical specifications of CancerTYPE ID.

The abstract, “Gene expression profiling for cancer classification in circulating tumor cells,” was presented as a poster session (Abstract No. 1391) Monday, April 18. Biotheranostics conducted the study in collaboration with Celsee Diagnostics, which provided the microfluidic chip for cancer cell enrichment and research support.

CancerTYPE ID is the market-leading gene expression-based test focused on the classification of metastatic cancer and is intended to aid in the diagnosis of the tumor type and subtype of cancers with diagnostic uncertainty, in conjunction with standard clinical and pathological assessment. Commercially launched in 2010, CancerTYPE ID is a standardized, objective molecular test based on the differential expression of 92 genes that classifies tumors by matching the gene expression pattern of a tumor specimen to a database of known tumor types and histological subtypes. CancerTYPE ID is able to classify 50 cancer types and subtypes, representing more than 95 percent of all solid tumors based on incidence.

About Celsee Diagnostics, Inc.

Celsee Diagnostics, a privately held Michigan-based company, develops automated systems for rare CTC enrichment and single-cell analysis. The company’s precise, accurate, and reliable platform for research and clinical diagnostics development will allow healthcare professionals more time to focus on their patients’ therapeutic treatment and outcomes. The label-free Celsee PREP platforms perform all the required processing steps to isolate and execute downstream single-cell analysis including immunochemistry, DNA FISH and mRNA FISH, while the Celsee ANALYZER scans and analyzes the prepared slide automatically. For more information, visit celsee.com.

About Biotheranostics

Biotheranostics, Inc., is a leader in helping physicians improve the care of cancer patients, offering a suite of proprietary molecular diagnostic tests that allow treatment to be tailored to individual patients. The company’s CancerTYPE ID® is the most rigorously validated gene expression test for metastatic patients with diagnostic ambiguity, helping physicians determine optimal site-directed treatment regimens with the goal of improving patient outcomes. Its Breast Cancer Index℠ helps oncologists make difficult decisions about extended endocrine therapy for ER+ breast cancer patients based on its unique ability to predict risk of late disease recurrence and identify which patients are likely to benefit from continuing therapy beyond five years. Biotheranostics is based in San Diego.