THEROS CancerTYPE ID^®

Changing the way of identifying cancer

THEROS CancerTYPE ID^® is a molecular classification test that measures and integrates the expression of 92 genes in tumour samples. The test can classify up to 39 different tumour types and 64 subtypes¹ to help identify the origin of cancers with unknown or uncertain primary site.

Clinical situations where this clinically validated test may be useful:

• When the diagnosis is cancer of unknown primary (CUP)
• 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

THEROS CancerTYPE ID^® is exclusively available from Lab21 in the UK and Ireland.

When to use THEROS CancerTYPE ID^®
Tumour types classified by THEROS CancerTYPE ID^®
Case studies
Comparison of THEROS CancerTYPE ID^® and other molecular cancer classification tests
How to use the THEROS CancerTYPE ID^® service
Information on CUP
References

 

When to use THEROS CancerTYPE ID®

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A common dilemma for pathologists and oncologists is determining whether or not a tumour represents a primary or a distant metastasis from another site. Even after the most thorough diagnostic workup, accurate identification of the primary cancer site is often not possible. Less than 20% of patients with unknown or uncertain primaries have a primary site identified antemortem.^2-3

THEROS CancerTYPE ID^®:

• Guides differential diagnosis and classification of the primary cancer site
• Provides critical information to help select the most appropriate treatment regimen for individual patients
• Has demonstrated success rate for classification with high overall sensitivity of 86% and specificity of >99%^4-5
• Is an ideal adjunct to current diagnostic processes

THEROS CancerTYPE ID^® may also be able to reduce the cost and length of the diagnostic workup, and shorten the time to therapy decision.  In a study of 879 consecutive patients with a suspected cancer of unknown primary, survival duration was increased when the primary tumour site was identified and treatment was directed toward each primary tumour type.¹

Some examples of differential diagnosis provided by THEROS CancerTYPE ID^® that had a dramatic effect on therapeutic options:

• Primary lung or metastatic adenocarcinoma
• Mesothelioma or primary lung
• Primary hepatocellular carcinoma or adenocarcinoma
• Breast or ovarian
• Pancreatic or other GI
• Ovarian or colorectal

Integration of THEROS CancerTYPE ID^® into the cancer classification process

Tumour types classified by THEROS CancerTYPE ID®

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Adrenal (pheochromocytoma)	Meningioma
Brain	Mesothelioma
Breast	Osteosarcoma
Carcinoid-intestine	Ovary-clear
Cervix-adeno	Ovary-serous
Cervix-squamous	Pancreas
Endometrium	Prostate
Gall Bladder	Skin-basal-cell
Germ-cell-ovary	Skin-melanoma
GIST	Skin-squamous
Intestine	Soft-tissue-Liposarcoma
Kidney	Soft-tissue-MFH
Leiomyosarcoma	Soft-tissue-Sarcoma-synovial
Liver	Stomach-adeno
Lung-adeno-large-cell	Testis-other
Lung-small	Testis-Seminoma
Lung-squamous	Thyroid-follicular papillary
Lymphoma-B	Thyroid-medullary
Lymphoma-Hodgkins	Urinary Bladder
Lymphoma-T

Case studies

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Click below to view US case studies.

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 adenocarcinoma

Comparison of THEROS CancerTYPE ID® and other molecular cancer classification tests6-8

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How to use the THEROS CancerTYPE ID® service from Lab21

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THEROS CancerTYPE ID^® from Lab21

To order the test, the first point of contact is Lab21 Customer Services, who handle:

• Test requests and customer support
• Liaison with sample retention sites for sample retrieval
• Organisation of sample logistics for testing
• Reporting of the results - typically within 15 working days from receipt of sample at Lab21

Lab21 Customer Services can be contacted by email (cupcheck@lab21.com) or by phone:

UK: 0845 6778109
International: +44 (0)1223 395450

THEROS CancerTYPE ID^® requires a formalin-fixed paraffin embedded (FFPE) tumour sample. Tumour cells are laser micro dissected from the FFPE block, and mRNA is extracted for the 92-gene RT-PCR assay. The FFPE block is then returned to the customer.

You can click on the links below to view:
Test Request Form
Sample Preparation
Example Test Report

THEROS CancerTYPE ID^® is performed by bioTheranostics, a CLIA and CAP accredited service laboratory located in San Diego, US.

Information on CUP

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Websites on Cancer of Unknown Primary include:

CancerHelp UK
Jo’s Friends Cancer of Unknown Primary (CUP) Foundation
National Cancer Institute, US
American Society of Clinical Oncology

References

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1. Abbruzzese, JL et al. Analysis of a diagnostic strategy for patients with suspected tumors of unknown origin. J Clin Oncol., 13:2094-2103, 1995.
2. Varadhachary, GR et al. Diagnostic Strategies for Unknown Primary Cancer. Cancer. 100:1776-1785, 2004.
3. Schapira DV, Jarrett AR. The need to consider survival, outcome, and expense when evaluating and treating patients with unknown primary carcinoma. Arch Inter Med.;155:2050-2054, 1995.
4. 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, 130: 465-473, 2006.
5. Data on file, Technical Report 063008, bioTheranostics.
6. http://www.pathworkdx.com/TissueOfOriginTest/
7. http://www.prometheusoncology.com/miRview_mets/
8. Monzon FA, et al. J Clin Oncol. 2009;27:1-13; 9
9. http://www.biotheranostics.com/products-services/hcp/