CancerTYPE ID®
Diagnostic dilemmas occur when the information obtained from biopsy specimens using standard histopathologic procedures is incomplete or equivocal. CancerTYPE ID provides molecular classification of cancers with indeterminate, uncertain, or differential diagnoses.
CancerTYPE ID measures and integrates the expression of 92 genes to distinguish 30 tumor types and 54 histological subtypes. Based on analytical validation of the CancerTYPE ID reference database, the overall sensitivity and specificity of the CancerTYPE ID test is 87% and >99%, respectively, at the main tumor type level (30 classes) and 85% and >99%, respectively, at the histologic subtype level (54 classes).1,2 CancerTYPE ID uses a comprehensive database and computational algorithm to classify samples in a single assay leading to standardized, objective results. Tests are performed at bioTheranostics’ own CLIA-certified, CAP-accredited clinical laboratory.
CancerTYPE ID classifies the following tumor types:
| Adrenal adrenocortical carcinoma adrenal pheochromocytoma Brain Breast adenocarcinoma of breast Cervix cervical adenocarcinoma cervical squamous cell carcinoma Cholangiocarcinoma Endometrium endometrial adenocarcinoma Esophagus esophageal squamous cell carcinoma GIST gastrointestinal stromal tumor Gallbladder adenocarcinoma of gallbladder Gastroesophageal gastroesophageal adenocarcinoma Germ Cell seminomatous germ cell tumor nonseminomatous germ cell tumor Head Neck salivary gland squamous cell carcinoma Intestine colorectal adenocarcinoma small intestine adenocarcinoma Kidney clear cell renal cell carcinoma chromophobe renal cell carcinoma papillary renal cell carcinoma Liver hepatocellular carcinoma Lung lung adenocarcinoma (large cell) lung squamous cell carcinoma |
Melanoma Meningioma Mesothelioma Neuroendocrine small/large cell lung cancer pancreatic islet cell tumor merkel cell carcinoma gastrointestinal carcinoid lung carcinoid Ovary clear cell adenocarcinoma endometrioid adenocarcinoma mucinous adenocarcinoma serous adenocarcinoma Pancreas pancreatic adenocarcinoma Prostate prostate adenocarcinoma Sarcoma malignant fibrous histiocytoma primitive neuroectodermal tumor leiomyosarcoma liposarcoma osteosarcoma synovial sarcoma Sex-cord-stromal-tumor Skin basal cell carcinoma skin squamous cell carcinoma Thymus Thyroid follicular/papillary carcinoma medullary carcinoma UrinaryBladder transitional cell carcinoma adenocarcinoma of bladder squamous cell carcinoma of bladder |
CancerTYPE ID provides molecular data that a physician may use, in conjunction with other clinical and diagnostic procedures to help identify the site of origin and histological subtype of tumors. This test may be useful:
CancerTYPE ID can assist physicians with common diagnostic dilemmas including differential diagnoses. Some common examples include but are not limited to:
References:
1. Ma, et al. Molecular Classification of Human Cancers Using a 92-Gene Real Time Quantitative Polymerase Chain Reaction Assay. Archives of Pathology and Laboratory Medicine, 130: 465-473, 2006.
2. Data on file, Technical Report 021510, bioTheranostics.
CancerTYPE ID Indications for Use and Limitations
CancerTYPE ID is indicated for use in tumor specimens from patients diagnosed with malignant disease and intended to aid in the classification of the tissue of origin and tumor subtype in conjunction with standard clinical and pathological assessment by a qualified physician. CancerTYPE ID is not intended to predict patient survival benefit, treatment efficacy or to distinguish between benign versus malignant lesions. Tumor types not included in the CancerTYPE ID reference database may exhibit RNA expression patterns that are similar to RNA expression patterns within the reference database.