The CancerTYPE ID^® test report

Performed with no pre-conceived clinical bias, the CancerTYPE ID test offers results that are objective and quantifiable. Specimens are optimally analyzed through bioTheranostics’ CLIA-certified, CAP-accredited diagnostic service laboratory. Test reports arrive in one week with a prediction of tumor site and histological subtype, representing greater than 95% of all solid tumors, in an easy-to-read format.

Assay specifics

The CancerTYPE ID assay is a real time RT-PCR assay of 92 genes (87 tumor-associated genes and 5 reference genes). Total RNA is isolated from tumor-enriched portions of formalin-fixed paraffin embedded tissue sections. First strand cDNA synthesis is primed using an oligo-dT primer containing the T7 promoter sequence. Subsequent priming with exogenous random primers yields double-stranded cDNAs that are purified and used as templates in an in-vitro transcription reaction to generate amplified antisense RNA (aRNA). The aRNA product from each sample is then reverse transcribed to generate cDNA for a 92-gene real time PCR.

Gene expression measurements of 87 genes are then normalized to five reference genes, and a sample’s gene expression profile is compared to a previously built tumor gene expression data set encompassing 54 tumor types¹.

Reading the results

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 . Our proprietary algorithm generates a report indicating the most likely cancer type and histological subtype. Importantly, the algorithm also assigns a probability for each classification result, which is a measure of the confidence level for the result.

CancerTYPE ID Sample Test Report
Guide: How to read the Test Report

References
1. 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.