CancerTYPE ID® for CUP Diagnosis
CancerTYPE ID® Test
CancerTYPE ID® is a molecular classification test that measures and integrates the expression of 92 genes in formalin-fixed paraffin embedded (FFPE) tumour samples and is able to classify 54 different tumour types (Erlander et al, Greco et al) to help identify the origin of cancers with unknown or uncertain primary site. CancerTYPE ID® is available exclusively from Lab21 in the UK and Ireland.
CancerTYPE ID®:
- Guides differential diagnosis and classification of the primary cancer site
- Aids selection of the most appropriate treatment regimen
- Has high overall sensitivity of ≥85% and specificity of 100%
- Covers 95% of solid tumour types
- Is an ideal adjunct to current diagnostic processes
Clinical situations where this clinically validated test may be useful include:
- When the diagnosis is cancer of unknown or uncertain primary
- When determining whether a cancer is a distant metastasis or a new primary
- When addressing a differential diagnosis with two or more choices, each with a different treatment
- When diagnosis cannot be confirmed using conventional methods alone
- When the diagnosis may have implications for family members with hereditary cancers
CancerTYPE ID® is reimbursed by leading private medical insurance companies in the UK.
The test is performed at bioTheranostics, a CLIA and CAP accredited service laboratory located in San Diego, US.
Lab21 takes care of Test Requests, Customer Support, Sample Logistics and reporting of the Results.
Tumour types classified by CancerTYPE ID®
CancerTYPE ID® classifies 54 different tumour types from FFPE samples. Please click below to see tumour types included.
CancerTYPE ID® Brochure
Differential diagnosis by CancerTYPE ID®
CancerTYPE ID® is an excellent tool in aiding differential diagnosis between 2 or more possible cancer types. Please click below for examples.
Examples of differential diagnosis
Performance and clinical evaluation of CancerTYPE ID®
Performance of CancerTYPE ID® (Erlander et al) to classify 30 main tumour types and 54 subtypes:
- Overall sensitivity 87% for main cancer types
- Overall sensitivity 85% for cancer subtypes
- Specificity 100%
- N = 2,206
In an earlier study, the performance of CancerTYPE ID® was evaluated in CUP patients who had latent primary site clinically identified later in life (Greco et al):
- Included 20 metastatic cancer patients who had no detectable primary site of origin identified following standard clinical and pathologic - including IHC—workup, but who had a latent primary tumor site clinically identified later in life
- Tissue of origin predicted by CancerTYPE ID® was compared to the actual primary site identified clinically
- In 53% of the cases, CancerTYPE ID® prediction had the potential to change treatment
Treatment outcomes in patients with CUP of colorectal origin
A study by Hainsworth JD et al, 2011 describes the use of CancerTYPE ID® as an aid to select optimal therapy in CUP patients whose cancer was found to be of colorectal origin. The number of patients limited the power of the study, but the results were very encouraging:
- Site-directed therapy: 50% response rate, 8.5 month median progression-free survival
- Empirical CUP therapy: 17% response rate, and 6 month median progression-free survival
Median survival in patients receiving site-directed therapy was 27 months. This was similar to that reported for patients with metastatic colorectal cancer, and differs from the median survival of 8-11 months produced by current empirical regimens for CUP.
Use CancerTYPE ID® when IHC does not provide the answer
Immunohistochemical (IHC) staining of CUP tumour samples can suggest the primary cancer type in some patients, but often it is not specific for a single tumour type (Greco et al). CancerTYPE ID® can help pinpoint the exact primary cancer type.
Case studies
Click below to view:
UK Case Study 1: Joanne
Case Study 1: Resolving a differential diagnosis of metastatic malignant melanoma or malignant fibrous histiocytoma
Case Study 2: Resolving an uncertain diagnosis of adenocarcinoma favouring gastrointestinal origin
Case Study 3: Resolving a differential diagnosis of colorectal or pancreatic adenocarcinoma
Case Study 4: Distinguishing between recurrent breast cancer or a new primary adenocarcinomaIntegration of CancerTYPE ID® into the cancer classification process
References
- Hainsworth JD, Schnabel CA, Erlander MG et al. A retrospective study of treatment outcomes in patients with carcinoma of unknown primary site and a colorectal cancer molecular profile. Clin Colorectal Cancer. 2011 (10.1016/j.clcc.2011.08.001).
- Erlander MG, Ma X-J, Kesty NC et al. Performance and Clinical Evaluation of the 92-Gene Real-Time PCR Assay for Tumor Classification. The Journal of Molecular Diagnostics, 2011; 13 (5): 493-503.
- Greco et al. Molecular Profiling in Unknown Primary Cancer: Accuracy of Tissue of Origin Prediction. The Oncologist, 2010; 15: 500-506.
- McGee RS, Kesty NC, Erlander MG and Schnabel CA. Molecular tumor classification using a 92-gene assay in the differential diagnosis of squamous cell lung cancer. Community Oncology, 2010; 8(3): 123-131.
- Ma, et al. Molecular Classification of Human Cancers Using a 92-Gene Real Time Quantitative Polymerase Chain Reaction Assay. Archives of Pathology and Laboratory Medicine, 2006: 130: 465-473.
Please note that Lab21 is not responsible for the content of any external websites. Cancer of Unknown Primary
Cancer of unknown primary (CUP) is diagnosed in over 10,000 people in England and Wales every year, representing 3-5% of all diagnosed cancers. CUP is therefore not a rare cancer, and its incidence is higher than that for many known cancers such as pancreatic, ovarian, uterine, kidney, brain and cervical cancers.
In CUP, a metastatic tumour (or tumours) is found, but the primary cancer origin cannot be identified using standard methods. Even after the most thorough diagnostic workup, which can be lengthy and expensive, accurate classification of the primary cancer type is often not possible. Indeed, only 20% or fewer of patients with CUP have the primary cancer origin identified antemortem using standard methods.
For many patients and their families, diagnosis of CUP is especially difficult due to the uncertainty involved. All metastatic cancers have an origin, and knowing this origin may be required for the doctor to prescribe the best current treatment available. If the primary cancer type is not identified, treatment options may be more limited – although in some cases the treatment is the same in CUP and in a specific cancer type.
In order to find out more about Cancer of Unknown Primary, websites with more information include:
Please note that Lab21 is not responsible for the content of any external websites.
References
- National Institute for Health and Clinical Excellence: CG104 Metastatic malignant disease of unknown primary origin: Full Guideline, 26th July 2010.
- Schapira DV, Jarrett AR. The need to consider survival, outcome, and expense when evaluating and treating patients with unknown primary carcinoma. Arch Inter Med, 1995; 155: 2050-2054.
- Greco et al. Molecular Profiling in Unknown Primary Cancer: Accuracy of Tissue of Origin Prediction. The Oncologist, 2010; 15: 500-506.
- Abbruzzese, JL et al. Analysis of a diagnostic strategy for patients with suspected tumors of unknown origin. J Clin Oncol, 13:2094-2103, 1995.
- Ma, et al. Molecular Classification of Human Cancers Using a 92-Gene Real Time Quantitative Polymerase Chain Reaction Assay. Archives of Pathology and Laboratory Medicine, 2006: 130: 465-473.
- Erlander MG, Ma X-J, Kesty NC et al. Performance and Clinical Evaluation of the 92-Gene Real-Time PCR Assay for Tumor Classification. The Journal of Molecular Diagnostics, 2011; 13 (5): 493-503.
CancerTYPE ID® from Lab21
To request the test, the first point of contact is the dedicated Lab21 Customer Services Team who handles:
- Test Requests and Customer Support
- Liaison with Sample Retention Sites for sample retrieval
- Reporting of the Results
Typical test turnaround time is 15 working days from the receipt of sample by Lab21.
CancerTYPE ID® is reimbursed by leading private medical insurance companies in the UK.
CancerTYPE ID® is performed by bioTheranostics, a CLIA and CAP accredited service laboratory located in San Diego, US.
CancerTYPE ID® Service from Lab21
CancerTYPE ID® Customer Services
Other Services
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Lung Cancer
Breast and Ovarian Cancer
Cancer of Unknown Primary
Skin Cancer
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