Accurate Tumor Identification

Determining a primary site of origin in metastatic cancer patients can be especially challenging for physicians. Despite advances in imaging and pathology, a diagnosis remains uncertain or unknown in ~30% of metastatic cases.1-3 Using CancerTYPE ID in conjunction with other tools may provide a more accurate diagnosis, which has the potential to:

  • Decrease time to diagnosis
  • Clarify therapy options
  • Avoid treatment toxicity and safety issues
  • Prevent unnecessary additional testing
  • Preserve tissue for further biomarker testing
  • Identify patients for clinical trials

CancerTYPE ID classifies the following tumor types:

Adrenocortical carcinoma
Breast adenocarcinoma
Cervix adenocarcinoma
Endometrial adenocarcinoma
Gastroesophageal adenocarcinoma
Germ Cell
Gastrointestinal stromal tumor (GIST)
Head & Neck salivary gland carcinoma
Colorectal adenocarcinoma
Small intestine adenocarcinoma
Chromophobe renal cell carcinoma
Clear cell renal cell carcinoma
Papillary renal cell carcinoma
Liver hepatocellular carcinoma
Lung adenocarcinoma
Islet cell carcinoma
Small/large cell lung carcinoma
Merkel cell carcinoma
GI carcinoid
Lung carcinoid
Serous adenocarcinoma
Endometrioid adenocarcinoma
Clear cell adenocarcinoma
Mucinous adenocarcinoma
Gallbladder adenocarcinoma
Pancreatic adenocarcinoma
Prostate adenocarcinoma
Malignant fibrous histiocytoma
Primitive neuroectodermal (PNET)
Synovial sarcoma
Sex cord stromal tumor
Skin basal cell carcinoma
Squamous cell carcinoma
Head & Neck / Skin
Medullary carcinoma
Follicular/papillary carcinoma
Urinary Bladder

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

Gynecological Tumors
Cervical vs. Endometrial vs. Ovarian vs. Breast
Neuroendocrine Tumors
Pancreatic Islet Cell vs. Merkel Cell vs. Small/Large Cell Lung Carcinomas vs. Gastrointestinal Carcinoid vs. Lung Carcinoid
G.I. Tract Tumors
Pancreaticobiliary vs. Intestine
Squamous Cell Carcinomas
Head and Neck vs. Lung
Tumors in the Peritoneum
Ovarian vs. Colorectal vs. Pancreaticobiliary

CancerTYPE ID Indications for Use and Limitations
CancerTYPE ID is indicated for use in tumor specimens from patients diagnosed with malignant disease and is 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. 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. 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.

1.) Erlander MG, et al. Performance and clinical evaluation of the 92-gene real-time PCR assay for tumor classification. J Mol Diagn. 2011: 13. 2.) Schroeder, BE et al. Pathological Diagnoses in Cases of Indeterminate or Unknown Primary Submitted for Molecular Tumor Profiling. Mod Pathol 2012;25(suppl 2; abstr 429). 3. ) Greco FA, Hainsworth JD. Cancer of unknown primary site. In: DeVita VTJ, Hellman S, Rosenberg SA, editors. Cancer: Principles and Practice of Oncology. 9th ed. Philadelphia, PA: Lippincott Willinams & Wilkins; 2011. p. 2033-51. 4.) Kerr SE et al. Multisite Validation Study To Determine Performance Characteristics of a 92-gene Molecular Cancer Classifier. Clin Cancer Res. 2012 May 30.