SAN DIEGO, July 27, 2011 /PRNewswire/ -- bioTheranostics, a bioMerieux company that develops innovative oncology diagnostic tests to support targeted disease management, announced today study results published in the next issue of the Journal of Molecular Diagnostics related to the clinical validity and the clinical utility of CancerTYPE ID®, its 92-gene molecular classification test to aid in the determination of the origin of a tumor. The company also announced Medicare reimbursement coverage.
The study, Performance and Clinical Evaluation of the 92-Gene Real-time PCR Assay for Tumor Classification, demonstrates that CancerTYPE ID classifies 30 main tumor types and 54 histological subtypes, covering over 95% of all solid tumors. A database of 2206 specimens with a median of 62 samples per tumor type allowed for the increase in tissue coverage. The 92-gene classification algorithm demonstrated sensitivities of 87% for the 30 main tumor types and 85% for the 54 histological subtypes.
"Our study featured a 300 consecutive clinical case series in which CancerTYPE ID classified 22 types and 36 different subtypes, which included several rare tumors. This real-world clinical finding shows the importance of having a comprehensive scope of reportable tumor types to resolve differential diagnosis, to avoid the risk of misclassification and for overall clinical applicability," said Richard Ding, Chief Executive Officer of bioTheranostics. "This study provides more evidence that CancerTYPE ID is establishing a new standard in the emerging field of molecular cancer classifiers."
Additional highlights from the study showed that CancerTYPE ID can discriminate among tumor types that pose diagnostic dilemmas including neuroendocrine subtypes, squamous carcinomas (head and neck vs. lung), tumors present in the ovary (ovarian mucinous vs. GI tumor), and gynecological tumors (cervical vs. ovarian). "Thought leaders in the field and our physician customers have provided us valuable input regarding essential tumor types for molecular classifiers. We are pleased that CancerTYPE ID can address their diagnostic challenges," said Mark Erlander, PhD, Chief Scientific Officer of bioTheranostics. "Target therapies for metastatic cancers require precise knowledge of both tissue origin and underlying pathways. Our product provides critical information as a part of cancer management."
bioTheranostics also announced that CancerTYPE ID is now a covered benefit for Medicare Part B patients following a coverage determination by Medicare's administrative contractor Palmetto GBA. "This coverage decision was based on a review of the evidence supporting the analytical validity, clinical validity and clinical utility of CancerTYPE ID, making it one of the few molecular cancer tests supported by a Medicare coverage decision," Ding said. "It's another milestone in the history of bioTheranostics as we continue to improve existing products and bring additional high medical value products to market."
Advancing Molecular Diagnostics in Oncology
bioTheranostics discovers, develops and commercializes molecular diagnostic tests for cancer patients. Leveraging its unique expertise in expression profiling and algorithm development, bioTheranostics provides innovative tests to the oncology community to support targeted disease management. The company operates a CLIA-certified, CAP-accredited diagnostic service laboratory in San Diego, CA to perform its proprietary molecular diagnostic tests: Breast Cancer Index(SM), which provides risk stratification in patients with estrogen receptor (ER)-positive, lymph-node negative breast cancer; and CancerTYPE ID, a cancer classification assay that provides molecular classification of cancers with indeterminate, uncertain, or differential diagnoses to aid in the determination of the tumor site of origin. For more information call Client Services at 1-877-886-6739 or visit www.bioTheranostics.com.
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Advancing Diagnostics to Improve Public Health
A world leader in the field of in vitro diagnostics for over 45 years, bioMerieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. In 2009, revenues reached euro 1.223 billion with 85% of sales outside of France.
bioMerieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
bioMerieux is listed on the NYSE Euronext Paris market (Symbol: BIM – ISIN: FR0010096479). Other information can be found at www.biomerieux.com.
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