Healthcare Professionals

The Technology Behind 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 patients tumor tissue to a database of known tumor types and histological subtypes. The test analyzes the expression of a panel of 92 genes from a tumor specimen of under ~300 cells through a unique technique called RT-PCR. A high-throughput, real-time RT-PCR method was developed to analyze the expression of select genes.

Step 1: Patient tissue sample is attained

Formalin-fixed paraffin embedded tissue block from patient is sectioned to prepare an H&E slide and three unstained slides. Pathologist inspects the H&E slide to determine tumor regions for microdissection.

Step 2: Microdissection (Micro/Manual)

Pathologist delineates tumor areas destined for microdissection. Trained histotechnologists perform dissection (micro/manual) to acquire tumor cells indicated by pathologist.

Step 3: RNA is extracted

Dissected tumor regions from patient samples are incubated in a proprietary extraction solution to prepare a tissue lysate. RNA from each sample is purified from each tissue lysate using a commercially available RNA purification kit.

Step 4: Real-time RT-PCR is performed

The purified RNA from each patient is converted to cDNA and preamplified. The preamplified cDNAs are distributed onto individual wells of PCR assay plates to run the 92-gene Taqman PCR assays.

Step 5: 92-gene assay comparison

The output from the 92-gene assay Taqman PCR run is fed into an algorithm that processes the data and compares the expression pattern of the unknown patient sample to the expression pattern of known tumors in a reference database that contains over 2000 samples.

Step 6: Predict tumor type and subtype with rule-out of over 95% confidence

The algorithm reports the most likely tumor and tumor subtypes. In addition, it lists excluded tumor types that can be ruled-out with greater than 95% confidence.

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.