Frequently Asked Questions

CancerTYPE ID® provides molecular data that a physician may use, in conjunction with other clinical and diagnostic procedures to help identify the tumor type and histological subtype of tumors. This test may be useful:

• When addressing a differential diagnosis with two or more tumor types, each with a different optimal treatment regimen
• When Immunohistochemistry (IHC) and other standard clinical and diagnostic procedures are unable to conclusively identify a primary site of tumor origin i.e. the patient has a diagnosis of Cancer of Unknown Primary or CUP
• When the clinical presentation is atypical and does not align with the pathology report
• When determining whether a malignant lesion is a distant metastasis from a current or previous cancer vs. a new primary
• When a biopsy tissue sample contains minimal tumor tissue, limiting the number of standard diagnostic tests that can be performed before exhausting the sample

1. IHC is the process of detecting antigens (e.g. proteins) in cells of a tissue section through the use of antibodies that bind to specific antigens. IHC staining is widely used in the diagnosis of malignant tumors as specific combinations of antigens are characteristic of distinct tumor types. Atypical antigen presentations are common however (e.g. TTF-1 negative NSCLC) and can result in diagnostic challenges. Advanced and high grade malignancies in particular can lose typical characteristic antigens as the disease progresses
2. CancerTYPE ID® measures the differential expression of 92 genes that are related to cell processes such as differentiation and cell lineage and code for cell functions, such as transcription factors. These genes were selected through genome wide profiling to identify genes that are differentially expressed between tumor types
3. In a head-to-head study1 comparing the accuracy of CancerTYPE ID® to IHC in cases typically referred for a 2nd pathology opinion i.e. poorly to undifferentiated tumors, CancerTYPE ID demonstrated significantly higher accuracy (79% vs 69%, p=0.03) in correctly identifying the tumor type
4. In this study, the ability to obtain a diagnosis using IHC decreased substantially if a diagnosis was not established with the first 9 IHC stains used, suggesting this is a reasonable point at which CancerTYPE ID® testing should be considered

1. In a prospective trial2, CancerTYPE ID® was used to predict the site of origin of tumors and direct site-specific therapy for patients with CUP
2. CancerTYPE ID® predicted a tissue of origin in 98% (247 of 252) of patients with CUP. 26 different tissues of origin were predicted with the most common being biliary tract, urothelial, colorectal and non-small-cell lung
3. Subsequent CancerTYPE ID®-directed site-specific therapy resulted in an overall survival of 12.5 months, a substantial improvement over the historic control of empiric CUP chemotherapy regimen (9.1 months OS)
4. Four patients were identified as having potentially curable germ cell tumors in the study

CancerTYPE ID® provides molecular classification that may be used, in conjunction with other clinical and diagnostic procedures, to help identify the tumor type and histological subtype of tumors. Knowledge of the primary tumor type and subtype is fundamental to guiding and optimizing both site-specific chemotherapy and targeted treatment selection for patients

CancerTYPE ID® can differentiate between 50 different tumor types and sub-types that together represent over 95% of all solid tumors by incidence

The CancerTYPE ID® test requires a very small sample of the FFPE tumor tissue removed during a biopsy procedure. This is typically the same tissue already examined by a pathologist, so no additional procedure is required. That sample is sent to the certified laboratory of Biotheranostics where the CancerTYPE ID® test is performed

Test results are provided to the ordering physician 5-7 business days after Biotheranostics receives the sample

The genes that are examined are different and what the tests actually reports are fundamentally different:

• Genes examined: The 92 genes measured by CancerTYPE ID® are related to cell processes such as differentiation and cell lineage and are not necessarily linked to malignancy; they are not genes containing typical driver mutations (e.g. BRAF, EGFR) found in NGS panels such as FoundationOne®. They are genes that code for cell functions, such as transcription factors. These genes were selected through a genome wide process of elimination as they do not vary significantly between cells of a particular tumor type
• What the tests report: CancerTYPE ID® measures the differential expression of 92 genes (RNA) to provide a prediction of tumor type and subtype while NGS panels such as Foundation One® looks at DNA to tell you what mutations (e.g. EGFR) are present in the tumor. Both pieces of information may be valuable for the treatment decision, and thus the tests are complementary and not competitive

No. The results of the CancerTYPE ID® test are used together with the results of other laboratory tests to evaluate and classify cancer.

• Billing information for Health Care Professionals can be found here
• Billing information for patients can be found here
• Health Care Professionals can also find ICD-10 code information here

Patient Assistance Program:
Our robust Patient Assistance Program can help lower the bill for patients. This requires patients to provide a paystub, W-2 or other documentation of income. To discuss our Patient Assistance Program and eligibility requirements, contact our Patient Advocate Team at 1(877) 886-6739, select prompt 2

Payment Plans:
We offer a discounted “direct pay” price for patients who wish to pay cash for our testing. We offer a 6 month interest free payment plan option for patients who need to make payments in installments

Additional billing information for Health Care Professionals can be found here
Additional billing information for patients can be found here