Prospective Study Shows that Therapy Guided by bioTheranostics’ CancerTYPE ID® Molecular Test Improves Survival in Cancer of Unknown Primary Patients

Sarah Cannon Research Institute prospective trial published in Journal of Clinical Oncology demonstrates value of molecular profiling in management of metastatic cancer

SAN DIEGO--(BUSINESS WIRE)-- A four-year prospective study showed that bioTheranostics’ CancerTYPE ID® molecular test successfully predicted the site of origin in patients diagnosed with cancer of unknown primary (CUP), helping to direct site-specific treatment and improve survival. The first-ever prospective evaluation of molecular tumor profiling in the clinical management of CUP was published online Monday in the Journal of Clinical Oncology.

In the study, Drs. John Hainsworth, F. Anthony Greco, and colleagues at the Sarah Cannon Research Institute (SCRI) assessed biopsy specimens from previously untreated CUP patients using CancerTYPE ID, a 92-gene real-time RT-PCR assay. Results show that the site of origin was predicted in 98 percent of the assays performed. Patients for whom a primary cancer site was predicted and who were treatment candidates were assigned standard site-specific first-line therapy.

In the 194 patients who received CancerTYPE ID-directed, site-specific treatment, median survival was 12.5 months versus historical SCRI CUP trials of 9.1 months for patients receiving empiric therapy. When CancerTYPE ID predicted tumor types that were clinically more responsive, the median survival was significantly improved compared with predictions of more resistant tumors (13.4 versus 7.6 months, p = .04), providing additional validation of the accuracy of the assay while highlighting the increasing clinical utility of CancerTYPE ID as more site-directed therapies are becoming available.

According to Dr. Hainsworth, metastatic cancers are among the most challenging for oncologists. “When the primary site of the cancer is unknown or uncertain, non-specific ‘empiric’ therapy often is used, but the survival of most patients receiving empiric therapy continues to be poor,” he said. “While previous studies have validated the accuracy of CancerTYPE ID, this is the first study to confirm that these molecular predictions can guide the selection of more effective therapy and improve the survival of CUP patients.”

Study investigators concluded that, “…the body of evidence is sufficient to support the use of molecular tumor profiling in the standard management of patients with CUP.”

Richard Ding, CEO of bioTheranostics, said this pivotal prospective study demonstrating a patient survival benefit is a major chapter in the growing body of evidence supporting the use of CancerTYPE ID. This includes recent studies showing superior accuracy compared with immunohistochemistry in metastatic tumors and the largest validation study for a molecular classifier, which demonstrated its ability to identify tumors without loss of performance between primary and metastatic tumors, between small and large specimen quantities, or based on histological grade.

“These studies reinforce the importance of CancerTYPE ID as an integral part of metastatic cancer patient management,” Ding said. “Metastatic solutions require knowing the site of origin and the use of predictive biomarkers to get patients on the right therapy the first time. bioTheranostics offers a complete solution for metastatic cancer with CancerTYPE ID and PRÉCIS biomarkers—providing a full integration of molecular diagnostics.”

The study, “Molecular Gene Expression Profiling to Predict the Tissue of Origin and Direct Site-Specific Therapy in Patients with Carcinoma of Unknown Primary Site: A Prospective Trial of the Sarah Cannon Research Institute,” can be accessed here. Preliminary results were presented at the American Society of Clinical Oncology meeting in June.

About bioTheranostics

bioTheranostics is the leading solution provider for metastatic cancer management, leveraging its unique expertise in expression profiling to develop a growing array of molecular diagnostic tests for cancer patients. The company operates a CLIA-certified, CAP-accredited diagnostic laboratory to perform its proprietary tests: the CancerTYPE ID® molecular classification test; PRÉCISSM Precision Medicine, which includes biomarker profiles for non-small cell lung and colorectal cancers; and Breast Cancer IndexSM, which quantifies risk of recurrence of estrogen receptor positive, lymph node negative breast cancer. bioTheranostics, a bioMérieux company, is based in San Diego. Learn more

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Source: bioTheranostics