Healthcare Professionals

Achieving an accurate diagnosis for metastatic patients with cancer of unknown primary is critical to informing targeted treatment.

The importance of achieving an accurate diagnosisis.

There are more than

85,000 NEWLY DIAGNOSED METASTATIC PATIENTS

with unclear diagnosis in the U.S. each year1-3

IHC fails to identify an accurate diagnosis in

1 out of 3

metastatic patients4,5

DEFINITIVE DIAGNOSIS OF TUMOR TYPE DOES MATTER

A clear diagnosis is critical to inform on-label targeted treatment of metastatic cancer patients

Biomarker Drug Tumor Type Prevalence Drug Efficacy in Patients
BRAF V600E
Mutation
Zelboraf®
Vemurafenib
Melanoma 40-60% YES8
Colorectal 15% NO9
KRAS
Mutation
Erbitux®
Cetuximab
Colorectal 24% YES, for KRAS wildtype10 - 12
Head & Neck <5% YES, independent of KRAS status13
Biliary Tract 51% NO14
HER2
Amplification
Herceptin®
Trastuzumab
Breast 20-25% YES15
Gastric 11% NO16
Estrogen
Receptor
Tamoxifen Breast 80% YES17
Melanoma 43% NO18, 19

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.

References
  1. Fong TH et al. J Clin Oncol. 2008;26 (Suppl):22159.
  2. Laouri M et al. J Clin Oncol. 2011;29(suppl; abstr e21103).
  3. CancerMPact, Kanter Health 2014.
  4. Anderson GG et al. Appl Immunohistochem Mol Morphol. 2010;18:3-8.
  5. Weiss LM et al. J Mol Diagn. 2013;15(2):263-269.
  6. Kantar CancerMPact®, (2014) Data for Stage IV Cancers.
  7. Chapman PB, et al. N Engl J Med. 2011;364:2507-16.
  8. Chapman PB et al. N Engl J Med 2011;364:2507-16.
  9. 9. Kopetz S et al. J Clin Oncol 2010;28(15s Suppl):abstract 3534.
  10. Di Fiore F et al. Br J Cancer 2007;96:1166-9.
  11. Lievre A et al. Cancer Res 2006;66:3992-5.
  12. Amado RG et al. J Clin Oncol 2008;26:1626-34.
  13. Bissada E et al. Int J Otolaryngol. 2013;2013:848021.
  14. Malka D et al. Lancet Oncol. 2014;15(8):819-28.
  15. Slamon DJ, et al. Science 1989;244:707-12.
  16. Hecht JR et a. J Clin Oncol 31, 2013 (suppl; abstr LBA4001).
  17. Fisher B et al. N Engl J Med 1989;320:479- 84.
  18. Falkson CI et al. J Clin Oncol 1998;16:1743-51.
  19. Rusthoven JJ et al. J Clin Oncol 1996;14:2083-90.