Healthcare Professionals

Differential Tumor Diagnosis and Metastatic Cancer with CancerTYPE ID

Helping Physicians Eliminate Cancer of Unknown Primary (CUP) with Diagnostic Differential Tumor Testing

CancerTYPE ID identified a primary tumor site in 98% of cases1

87% Accuracy2

  • Test results available in 5-7 business days
  • Covered 100% by Medicare
  • Approximately 300 cells needed for testing

Providing a Second Opinion for Metastatic Cancer Diagnostic Testing

IHC fails to identify an accurate cancer type diagnosis in

1 OUT OF 3

metastatic patients3,4


of pathology second opinions result in a change from the initial diagnosis5
In a study evaluating cases typically referred for 2nd opinion, CancerTYPE ID demonstrated significantly higher accuracy than pathology review with IHC (P=0.019)4


In a head-to-head comparison of CancerTYPE ID vs. IHC evaluating poorly differentiated cancer cases4

  • 90
  • 80
  • 70
  • 60
  • 50
  • 40
  • 30
  • 20
  • 10
  • 0
  • 1-6 IHCs
  • 7-9 IHCs
  • P = 0.03
    10-15 IHCs

Overall Accuracy

CancerTYPE ID 79%
IHC/Morphology 69%
  • CancerTYPE ID
  • IHC/Morphology
  • IHC performance declines significantly when >7-9 IHCs used, but CancerTYPE ID maintains high accuracy

CancerTYPE ID Helps Resolve Common Diagnostic Dilemmas That Impact Metastatic Cancer Treatment Decisions

  • Unclear/differential cancer diagnoses
  • New primary cancer vs. cancer recurrence
  • Unusual presentations
  • Limited tumor biopsy specimen


Lung Adenocarcinoma vs. Lung Squamous Cell Carcinoma?

New Lung Primary vs. Breast Cancer Recurrence?

1. Hainsworth JD et al. J Clin Oncol, October 2013;31:217-23.
2. Kerr SE et al Clin Cancer Res 2012;18(4):3952-60.
3. Anderson GG et al. Appl Immunohistochem Mol Morphol 2010;18:3-8.
4. Weiss LM et al. J Mol Diagn 2013; 15(2):263-269.
5. Allen T. Arch Path Lab Med 2013; 137: 310-311.

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.