PRÉCIS includes biomarker profiles for non-small cell lung and colorectal cancer that detect clinically relevant tumor biomarkers EGFR, ALK rearrangement, KRAS, BRAF, c-MET, PIK3CA and 10q23 deletion to aid in characterizing disease behavior and therapeutic effectiveness.
PRÉCIS Non-Small Cell Lung Cancer (NSCLC) Profile
PRÉCIS Colorectal Cancer (CRC) Profile
PRÉCIS Indications for Use and Limitations
PRÉCIS tests are indicated for use in tumor specimens from patients diagnosed with cancer who are being considered for targeted therapy. Results should be interpreted in conjunction with other laboratory and clinical findings. Performance characteristics refer to the analytical performance of the test. Polymorphisms or mutations at locations not tested (see Methods) that may be associated with drug efficacy or patient outcome will not be detected. bioTheranostics policy is to provide physicians with flexibility to choose appropriate tests and to assure that the convenience of ordering a multi-test profile does not prevent physicians from making informed decisions regarding which tests are medically necessary. Each of the tests offered in the bioTheranostics test profile portfolio may be ordered individually using the bioTheranostics Test Requisition. This test was developed and performance characteristics have been determined by bioTheranostics, Inc. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. How this information is used to guide patient care is the responsibility of the physician. bioTheranostics is certified under the Clinical Laboratory Improvement Amendments of 1988 as qualified to perform high complexity clinical laboratory testing.
©2012 bioTheranostics, Inc. PRÉCIS is a service mark of bioTheranostics, Inc.