Healthcare Professionals

Most Clinically Validated Gene Expression Test for Resolving Diagnostic Ambiguity

Rigorously Validated

CancerTYPE ID® is a validated diagnostic tool with demonstrated 87% accuracy in a large, blinded, multi-institutional (Mayo Clinic, UCLA, MGH) validation study1

In a multi-institutional validation trial, CancerTYPE ID showed consistent, high accuracy across clinically relevant subsets.1*
Overall Accuracy = 87%
DISEASE TYPE

No Difference (P=0.157)

HISTOLOGIC GRADE

No Difference (P=0.577)

SPECIMEN TYPE

No Difference (P=0.161)

Highly accurate even with extremely limited tissue

*Study conducted at the Mayo Clinic, Massachusetts General Hospital, and UCLA Medical Center.

Only gene expression test with prospective outcomes evidence

In a prospective trial led by the Sarah Cannon Research Institute, CancerTYPE ID:2

  • Provided a molecular diagnosis in 98% of patients

  • Improved overall survival by 37%, relative to historical controls

Primary endpoint:

37% increase in overall survival with assay-directed therapy

Assay directed (n = 194)
Median survival: 12.5 months
Empiric treatment (n = 396)
(historial control)
Median survival: 9.1 months

Demonstrated superiority vs. IHC in head-to-head study

CancerTYPE ID showed significantly higher (P = 0.019) accuracy over IHC in poorly differentiated, primarily metastatic cases in a blinded clinical study led by City of Hope3

CancerTYPE ID overall accuracy: 79%
IHC/morphology overall accuracy: 69%

Performance ≥ IHC in all tumor types examined

Tumor type CancerTYPE ID IHC/morphology
GI (n = 26) 92% 92%
Lung (n = 24) 75% 67%
Kidney (n = 13) 77% 77%
Bladder (n = 11) 82% 45%
Breast (n = 11) 73% 55%

Tumor types with > 10 case

Number of IHC stains performed: mean = 7.9; median = 8, range 2 - 15

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. Kerr S, et al. Clin Cancer Res. 2012;18(14):3952 – 60.
  2. Hainsworth J, et al. J Clin Oncol. 2013;31(20)217 – 23.
  3. Weiss, et al. J Mol Diagn. 2013;15(2):263-9.