Metastatic Cancer FAQ

What is the CancerTYPE ID® test?
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 patients tumor tissue to a database of known tumor types and histological subtypes.

When should a physician consider CancerTYPE ID?
CancerTYPE ID provides molecular data 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:

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

Why is it important to identify the primary cancer site?
CancerTYPE ID provides molecular data 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. Knowledge of the primary tumor site is fundamental to guiding and optimizing treatment selection for patients.1

Is this test able to classify the most common types of cancer?
The 50 known cancer types that CancerTYPE ID is able to recognize represents over 95% of all solid tumors.

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

How long does it take to get the results of the test?
Test results are provided to your physician 5 business days after ranostics receives the sample.

Does the CancerTYPE ID test replace other laboratory tests or procedures?
No. The results of the CancerTYPE ID test are used together with the results of other laboratory tests to evaluate and classify cancer.

What if I don’t have insurance or my insurance doesn’t completely cover the test?
ranostics 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 I need 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.

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 ranostics, 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. ranostics is certified under the Clinical Laboratory Improvement Amendments of 1988 as qualified to perform high complexity clinical laboratory testing.


References:
1. National Cancer Institute Cancer Information Summaries: Adult Treatment.
http://www.cancer.gov/cancertopics/pdq/adulttreatment