Studies Further Demonstrate Clinical Utility & Cost-Effectiveness of bioTheranostics’ CancerTYPE ID® Molecular Test in Metastatic Cancer

Data released at 2013 ASCO meeting highlight impact of CancerTYPE ID on cancer management

FOR IMMEDIATE RELEASE…May 31, 2013…CHICAGO…bioTheranostics today announced that a number of studies on its CancerTYPE ID® molecular cancer classifier are being featured at the 2013 American Society of Clinical Oncology (ASCO) annual meeting. Findings from these studies add to the growing body of evidence supporting the clinical utility of CancerTYPE ID, demonstrating its impact on therapeutic decision making, cost-effectiveness and favorable quality of life, and particular utility in limited-tissue specimens. The studies are among 11 clinical trials and economic analyses released during the ASCO meeting that reinforce the clinical utility, prognostic performance, and cost-effectiveness of the company’s molecular diagnostic tests.

Key studies about CancerTYPE ID include:

  • A physician survey study led by the University of California, San Francisco, School of Medicine, showed that CancerTYPE ID influenced therapeutic decision making and that CancerTYPE ID results were concordant with the final clinical diagnosis in 84 percent of cases. In one-third of these cases, the diagnosis had not been considered prior to molecular testing. Results from pre-and post-testing showed that 81 percent of oncologists agreed that CancerTYPE ID was helpful and aided in determining treatment selection.
  • In a cost-analysis study completed with the Partnership for Health Analytic Research, a comprehensive health economic model was developed to project the cost and effectiveness of standard care for metastatic tumors using CancerTYPE ID. Overall, the gene assay increased the percentage of patients treated correctly and decreased the percentage of patients treated with nonspecific “empiric” therapy. Correct treatment provided an additional 5.4 quality-adjusted months of survival. Results showed that using CancerTYPE ID as a part of standard of care for metastatic cancer diagnosis is cost-effective (ICER of $50,273/QALY), particularly if integrated after initial immunohistochemical stains fail to provide a definitive diagnosis.
  • A third study assessed the use of CancerTYPE ID in limited-tissue specimens, which can pose a challenge for comprehensive diagnostic testing and individualized care. Analysis of 438 cases with indeterminate diagnosis showed that CancerTYPE ID provided a molecular diagnosis in 86 percent of specimens. The findings demonstrate the suitability and high reporting rate of the assay in cases with limited tissue and successful use of downstream biomarker testing in appropriate cases.

“Clinicians are increasingly relying on CancerTYPE ID as a routine part of clinical practice when faced with difficult-to-diagnose metastatic cancers,” said Richard Ding, president and CEO of bioTheranostics. “We have published extensive clinical validation and patient outcome studies that lay the scientific foundation for CancerTYPE ID. These new cost-effectiveness and clinical utility studies have opened a new chapter for our innovative products. Collectively, the clinical evidence supports a broad and standard application of CancerTYPE ID in metastatic cancer management.”

Abstracts for the 11 ASCO studies concerning bioTheranostics’ molecular tests can be accessed on the ASCO website.

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; PRÉCIS® Precision Medicine, which includes biomarker profiles for non-small cell lung and colorectal cancers, and other 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. For more information, visit www.biotheranostics.com.