SAN DIEGO--(BUSINESS WIRE)--A new study demonstrates the high accuracy and success rate of Biotheranostics’ CancerTYPE® ID molecular cancer classifier in the diagnosis of cancer for specimens with limited tissue. Results from the study, published in the journal Oncotarget, support additional clinical utility for CancerTYPE ID in small biopsy and cytology cases.
Through collaboration with researchers at Massachusetts General Hospital, Mayo Clinic, and UCLA, the accuracy of CancerTYPE ID for molecular diagnosis of tumor type was evaluated in a blinded manner using 109 limited tissue samples such as cytology cell blocks, core biopsies, and other small tissue biopsies representing a range of tumor types and grades at a variety of primary and metastatic sites. Analytical success rate and diagnostic utility were measured through a subsequent series of 644 cytology cases submitted for clinical testing.
CancerTYPE ID predicted a molecular diagnosis in 95 percent of cases where a confirmed histopathologic diagnosis was available. It also demonstrated a 91 percent sensitivity for tumor classification, and performance of the test was consistent across biopsy types and histologic grades. In the clinical case series, a molecular diagnosis was reported in 87 percent of the 644 samples, identifying 23 different tumor types, and allowing for additional mutational analysis in selected cases.
According to Nicolas Barthelemy, President and CEO of Biotheranostics, tissue samples retrieved during minimally invasive procedures are decreasing in size, while demand for detailed diagnostic evaluation and molecular testing of these limited biopsy samples is increasing. “We are seeing increasing numbers of limited tissue samples sent from physicians on behalf of patients being treated in community and academic settings,” Barthelemy said. “The standard of care depends on appropriate management of these tumor tissue specimens for diagnosis and additional biomarker testing. This analysis demonstrates that CancerTYPE ID provides results that are as accurate as those generated from excisions/resections with ample tissue, allowing physicians to be confident that the dual goals of achieving an accurate diagnosis and managing limited tumor specimens are being met.”
The authors of the study included a proposed Tissue-based Diagnostic Algorithm that incorporates molecular testing in order to help preserve the tissue specimen and allow for further molecular evaluation, as needed (see Figure 4). To access the study, click here.
About CancerTYPE ID
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.
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 IndexSM 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. For more information, visit www.biotheranostics.com.