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bioTheranostics Introduces KRAS Testing, Expands CancerTYPE ID Database

bioTheranostics, a bioMerieux company that discovers, develops and commercializes molecular diagnostic tests in oncology, has launched an expanded tumor-type database for its CancerTYPE ID and introduced KRAS mutational testing.

CancerTYPE ID is a diagnostic test which predicts cancer origin in patients whose primary cancer was initially ‘unknown or uncertain’ using conventional diagnostics. Knowing the site where the cancer originated impacts physicians’ therapeutic decisions, and the results of the CancerTYPE ID assay can help physicians select optimal therapies earlier in the diagnostic process.

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%. The 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.

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.

In tissue samples for which CancerTYPE ID returns a positive result for colorectal cancer, the availability of KRAS, a companion diagnostic test for anti-EGFR therapy, enables medical professionals to obtain additional valuable information and make individualised treatment decisions. KRAS will also be offered as a stand-alone test.

Richard Ding, chief executive officer of bioTheranostics, said: “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. 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.”