Identification of Tumor Origin in Metastatic Cancers.
Definitive Cancer Type Diagnosis. Actionable Results. Better Outcomes.
Helping reduce diagnostic uncertainty in metastatic cancer
Over 100,000 metastatic cancer cases per year have some degree of diagnostic ambiguity.1-3 CancerTYPE ID is a gene expression assay that helps physicians achieve a definitive diagnosis for metastatic patients when the tumor’s origin is uncertain. The test provides increased clarity by helping resolve the following diagnostic dilemmas that impact treatment decisions:
- Unclear/differential diagnoses
- Poorly-differentiated tumors
- Cancers of Unknown Primary (CUP)
- New cancer type vs. recurrence
- Unusual presentations
A proprietary gene expression assay for cancer classification
CancerTYPE ID uses real-time RT-PCR to measure the expression of 92-genes in the patient's tumor and classifies the tumor by matching the gene expression pattern to a database of over 2,000 known tumor types and subtypes. Using this technology, CancerTYPE ID can differentiate between 50 different tumor types and subtypes, covering >95% of all solid tumors based on incidence. The test reports a molecular diagnosis of the cancer type with the highest probability match, as well as a list of tumor types that may be ruled out with 95% confidence.4
Tour the Report
Supported by extensive validation, CancerTYPE ID is the only molecular cancer classifier that has demonstrated improved patient outcomes
- CancerTYPE ID has been rigorously validated, demonstrating 87% accuracy in a multi-institutional validation study led by three Centers of Excellence (UCLA, Mayo Clinic, and MGH).5
- In a prospective clinical trial led by the Sarah Cannon Research Institute, CancerTYPE ID identified a primary tumor type in 98% of cases. Furthermore, treatment based on the CancerTYPE ID result improved overall survival by 37% vs. empiric theory.6
- A study comparing CancerTYPE ID to standard of care IHC also showed that when more than 7-9 stains were required for a diagnosis, the accuracy of IHC fell below 50%, while CancerTYPE ID maintained significantly higher performance, and therefore may provide a tissue-sparing approach to establish the tumor type in these challenging cases.7
Impact on clinical decision-making and treatment options
- In a clinical utility study, CancerTYPE ID changed physician treatment decisions in approximately 50% of cases. In cases with two or more suspected sites, CancerTYPE ID identified a primary tumor type not previously considered in about 1 out of 4 patients.8-9
- A study of 24,426 cases from a large-scale research database of CancerTYPE ID clinical cases demonstrated the role of CancerTYPE ID in identifying CUP patients who may be eligible for immunotherapy based on tumor type determination.10 Results revealed 38% of cases classified by CancerTYPE ID were predicted to have an immunotherapy-eligible tumor type (N=9,350).10
Achieving a definitive diagnosis is fundamental to guide appropriate treatment in metastatic cancer
Determining a single cancer type diagnosis is essential for an oncologist’s ability to effectively treat his or her patient. While IHC is the standard of care method used to establish an initial pathologic diagnosis, metastatic disease often poses diagnostic challenges, resulting in about 1 out of 10 metastatic patients whose results remain inconclusive after standard diagnostic workup.7, 11-13 For these difficult-to-diagnose metastatic cases, CancerTYPE ID provides important tumor type information to help physicians gain diagnostic clarity.
Although recent studies have investigated whether molecular alterations alone are sufficient to direct treatment, results have demonstrated limited actionability of these markers. In fact, in studies with 1,000 patients, only 5-13% of cases had a clinically actionable genomic alteration and received a matched therapy, and efficacy of treatments based on these alterations alone has been shown to be inconsistent across different tumor types.14-16 Thus, a definitive diagnosis of the tumor type remains a critical first step for appropriate treatment.
Resolve ambiguous diagnoses, reveal therapeutic targets, and identify clinical trial options with one sample submission.
Time is critical for patients with metastatic cancer. Get comprehensive information as quickly as possible with our combined test offering available for metastatic patients with an unknown or unclear diagnosis. The option to reflex to a NeoTYPE Cancer Profile based on the CancerTYPE ID tumor type result enables determination of the cancer type and identification of applicable actionable biomarkers in a seamless, single-order process.*
* NeoTYPE Cancer Profiles are performed and billed separately by our reference laboratory, NeoGenomics, Inc.
For details about the NeoTYPE Cancer Profiles associated with CancerTYPE ID molecular diagnoses, visit neogenomics.com.
Limited tissue is required to provide quick results
- Only 300 non-necrotic tumor cells are required to generate a result
- Test results are reported in 5 business days once the specimen and required information have been received by our laboratory
- Covered by Medicare 17-18
CancerTYPE ID Specimen Requirements
- Formalin-fixed, paraffin-embedded (FFPE) tissue block, or
- 3-4 unstained, 7 micron sections on Leica Membrane slides, 1 H&E slide*
- Surgical resection
- Excisional biopsies
- Core needle biopsies
- Fine need aspiration (FNA)
- Cell blocks (pleural effusions & ascites)
- Bone marrow biopsies decalcified in EDTA or formic acid (not HCl)