CancerTYPE ID^®

Changing the way you identify cancer

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:

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:

1. When addressing a differential diagnosis with two or more choices, each with a different optimal treatment regimen
2. When IHC is equivocal, and standard clinical and diagnostic procedures are unable to conclusively identify a primary site of tumor origin
3. When the clinical presentation is atypical
4. When tumor is poorly differentiated
5. When determining whether a cancer is a distant metastasis from a current or previous cancer vs a new primary
6. When the biopsy tissue sample is limited

CancerTYPE ID can assist physicians with common diagnostic dilemmas including differential diagnoses. Some common examples include but are not limited to:

• lung (NSCLC) vs. breast
• lung squamous cell vs. head/neck squamous cell
• mesothelioma vs. lung
• lung adenocarcinoma vs. lung squamous cell
• upper GI vs. lower GI
• small intestine vs. colorectal
• renal cell carcinoma (kidney) vs. transitional cell carcinoma (bladder)
• melanoma vs. sarcoma vs. poorly differentiated carcinoma
• primary hepatocellular vs. metastatic adenocarcinoma
• cholangiocarcinoma vs. pancreas vs. small intestine
• colorectal carcinoma vs. ovarian mucinous adenocarcinoma
• merkel cell carcinoma vs. other neuroendocrine
• ovarian vs. cervical vs. breast
• prostate adenocarcinoma vs. transitional cell or adenocarcinoma (bladder)
• lymphoma vs. small cell carcinoma

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.