FAQs

What is CancerTYPE ID^®?
CancerTYPE ID is a standardized, objective molecular test based on the differential expression of 92 genes that classifies tumors by matching the gene expression pattern of a patient’s tumor tissue to a database of known tumor types and histological subtypes.^1,2

How is the test performed?
CancerTYPE ID is performed on formalin-fixed paraffin-embedded (FFPE) biopsy material obtained from the patient, including small core biopsy samples of tumor tissue.

When should CancerTYPE ID be used?
CancerTYPE ID provides information 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:

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

Has the accuracy of the CancerTYPE ID test been measured?
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

How can the CancerTYPE ID test be ordered?
Click on How to Order a Test for complete instructions. bioTheranostics will perform the test in its CLIA certified laboratory and send the results back to the ordering physician and/or other healthcare professionals.

How long does it take to get the results?
Test results are usually available 5 business days after bioTheranostics receives the specimen. The results can only be released to the ordering physician and/or other healthcare professionals.

How are the results reported?
The test result will provide the clinician with the top primary cancer site predictions based on the gene expression of the tumor sample or biopsy. Physicians can also discuss results with the medical director of bioTheranostics. Click on CancerTYPE ID Test Report to view a sample report.

Does CancerTYPE ID replace other standard laboratory or imaging tests for metastatic cancer?
No, this test should be incorporated with other laboratory and imaging tests in the complete evaluation of metastatic cancers.

What if my patient doesn’t have insurance or the insurance doesn’t completely cover the test?
bioTheranostics believes that every eligible patient should have access to the CancerTYPE ID test. Programs for uninsured and qualified underinsured patients, and payment plans that can be tailored to meet specific financial needs, are available.

What if my patient needs additional information or help on reimbursement?
A Client Services Representative can help determine the patient coverage available through insurance plans. An assistance program is available. For more information on insurance coverage, contact bioTheranostics Customer Service at 877-886-6739.

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.