SAN DIEGO, Calif., March 4 /PRNewswire/ -- bioTheranostics, a bioMerieux company that discovers, develops and commercializes innovative molecular diagnostic tests in oncology, announces the launch of an expanded tumor-type database for its flagship product, CancerTYPE ID(R), and the launch of KRAS mutational testing.
The larger CancerTYPE ID database allows for an increase of reportable tumor types from 39 to 54, while maintaining overall accuracy. Specificity across all tumor types remains high at >99 percent. This new database enhances the ability of the CancerTYPE ID assay to discriminate between clinically relevant metastatic tumors occurring within the GI tract, head and neck, lung (squamous, non-squamos adenocarcinoma, and mesothelioma), and intestine, while incorporating coverage of certain tumor types that frequently present diagnostic challenges such as cholangiocarcinoma, ovarian-mucinous adenocarcinoma, and small intestinal carcinoma.
“Since the CancerTYPE ID molecular classifier became available two years ago, we’ve carefully tracked both our customer feedback and our own clinical laboratory experience to identify important, emerging diagnostic opportunities,” said Richard Ding, bioTheranostics’ chief executive officer. “The addition of these new tumor types and the KRAS assay are significant steps in addressing the evolving needs of our customers and making the CancerTYPE ID assay the leading molecular solution for clinicians and patients.”
The CancerTYPE ID assay is a 92-gene molecular cancer classifier. It is particularly useful for oncologists and pathologists managing metastatic cancer patients whose primary tumor is either poorly differentiated or undifferentiated following assessment using conventional diagnostic tests. The results of the CancerTYPE ID assay can guide physicians in selecting optimal therapies for these individuals and potentially improve treatment outcomes. CancerTYPE ID can be run on a variety of tissue specimens including FFPE blocks from surgical resections, excisional biopsies, fine needle aspirates (FNA) and biopsy, core needle biopsies, cell blocks (pleural effusions, ascites, and FNAs), and bone marrow. A minimum of 300-500 viable tumor cells is required for testing.
bioTheranostics discovers, develops and commercializes molecular diagnostic tests for cancer patients. Leveraging its unique expertise in genomic profiling and proprietary algorithms, bioTheranostics provides innovative tests to the oncology community that help drive personalized treatment. The company operates a CLIA-certified, CAP-accredited, diagnostic service laboratory in San Diego, California, to perform its proprietary molecular diagnostic tests: CancerTYPE ID(R), a molecular cancer classifier particularly helpful for patients diagnosed with metastatic cancer whose tumor origin is either uncertain or unknown through conventional diagnostic testing; and the Breast Cancer Index(R), which refines and improves risk stratification in patients with estrogen receptor (ER)-positive, lymph-node negative breast cancer. More information is available at www.biotheranostics.com.
Advancing Diagnostics to Improve Public Health
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.
bioTheranostics
