Overview
Clinical Data
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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)
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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 a sample CancerTYPE ID test report
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.5-8 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.9-11 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.*
Accurate Molecular Diagnosis of Tumor Type and Subtype
Biomarker Profile Based
on Tumor Type
Personalized
Treatment Plan
CancerTYPE ID
NeoTYPE
Cancer Profiles
Incorporated with individual patient's clinical information
* 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.
Supported by Extensive Validation
CancerTYPE ID is the only molecular cancer classifier that has demonstrated improved patient outcomes.
87%
Validated Accuracy12
98%
Tumor Type Identified13
37%
Improved Survival13
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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).12
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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 therapy.13
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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.5
Impact on Clinical Decision-Making and Treatment Options
~50%
Treatment Decisions Changed14-15
38%
Classified as Immunotherapy Eligible16
- 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.14-15
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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.16 Results revealed 38% of cases classified by CancerTYPE ID were predicted to have an immunotherapy-eligible tumor type (N=9,350).16
For Providers
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1-877-886-6739
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For Patients and Caregivers
Limited Tissue is Required to Provide Quick Results
Limited tissue required
Only 300 non-necrotic tumor cells are required to generate a result
Quick turnaround
Test results are reported in 5 business days once the specimen and required information have been received by our laboratory
Coverage
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)
*Testing CANNOT be performed on regular glass slides. To request Leica Membrane slides, please contact Client Services.
Intended Use: CancerTYPE ID Intended 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.
References:
1. American Cancer Society. Key Statistics for Cancers of Unknown Primary. American Cancer Society website. Last reviewed January 12, 2021. Accessed August 5, 2021. https://www.cancer.org/cancer/cancer-unknown-primary/about/key-statistics.html. 2.Thomas SP et al. Molecular diagnosis with the 92-gene assay (92-GA) and decision-impact on treatment: Final results from a prospective, multi-disciplinary study. J Clin Oncol. 2015;33(15 suppl): e15206-e15206. doi.org/10.1200/jco.2015.33.15_suppl.e15206 3. Pavlidis N et al. Diagnostic and therapeutic management of cancer of an unknown primary. Eur J Cancer 2003;39(14):1990-2005. doi.org/10.1016/S0959-8049(03)00547-1 4. Erlander M et al. Performance and Clinical Evaluation of the 92-Gene Real-Time PCR Assay for Tumor Classification. J Mol Diagn. 2011;13(5):493-503. doi.org/10.1016/j.jmoldx.2011.04.004 5. Weiss, et al. Blinded comparator study of immunohistochemical analysis versus a 92-gene cancer classifier in the diagnosis of the primary site in metastatic tumors. J Mol Diagn. 2013;15(2):263-269. doi.org/10.1016/j.jmoldx.2012.10.001 6. Conner JR, Hornick JL. Metastatic carcinoma of unknown primary: diagnostic approach using immunohistochemistry. Adv Anat Pathol. 2015;22(3):149-167. doi.org/10.1097/PAP.0000000000000069 7. Anderson GG, Weiss LM. Determining tissue of origin for metastatic cancers: meta-analysis and literature review of immunohistochemistry performance. Appl Immunohistochem Mol Morphol. 2019;00(00):1-6. 8. Middleton LP, et al. Second-opinion pathologic review is a patient safety mechanism that helps reduce error and decrease waste. J Oncol Pract. 2014;10(4):275-280. doi.org/10.1200/JOP.2013.001204 9. Hyman et al. Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations N Engl J Med. 2015;373(8):726-36. doi.org/10.1056/NEJMoa1502309 10. Le Tourneau et al. Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicentre, open-label, proof-of-concept, randomised, controlled phase 2 trial. Lancet Oncol. 2015;16(13):1324-34. doi.org/10.1016/S1470-2045(15)00188-6 11. Stockley et al. Molecular profiling of advanced solid tumors and patient outcomes with genotype-matched clinical trials: the Princess Margaret IMPACT/COMPACT trial. Genome Medicine. 2016;8(109):1-12. doi.org/10.1186/s13073-016-0364-2 12. Kerr S, et al. Multisite Validation Study to Determine PerformanceCharacteristics of a 92-Gene Molecular Cancer Classifier. Clin Cancer Res. 2012;18(14):3952-3960. doi.org/10.1158/1078-0432.CCR-12-0920 13. Hainsworth J, et al. Molecular gene expression profiling to predict the tissue of origin and direct site-specific therapy in patients with carcinoma of unknown primary site: a prospective trial of the Sarah Cannon research institute. J Clin Oncol. 2013;31(2)217-223. doi.org/10.1200/JCO.2012.43.3755 14. Thomas S et al. Multi-Institutional, Prospective Clinical Utility Study Evaluating the Impact of the 92-Gene Assay (CancerTYPE ID) on Final Diagnosis and Treatment Planning in Patients With Metastatic Cancer With an Unknown or Unclear Diagnosis. JCO Precis Oncol. 2018;2;1-12. doi.org/10.1200/PO.17.00145 15. Kim B, et al. Physician-Reported Clinical Utility of the 92-Gene Molecular Classifier in Tumors With Uncertain Diagnosis Following Standard Clinicopathologic Evaluation. Personalized Med Onc. 2013;2(2):68-76. 16. Raghav et al. Defining a Distinct Immunotherapy Eligible Subset of Patients with Cancer of Unknown Primary Using Gene Expression Profiling with the 92-Gene Assay. The Oncologist. 2020;25(11):e1807-e1811. doi.org/10.1634/theoncologist.2020-0234 17. CMS.gov. Medicare Coverage Database. Centers for Medicare & Medicaid Services. Last Reviewed December 6, 2019. Accessed on January 5, 2022. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=35025&ver=91 18. CMS.gov. Medicare Coverage Database. Centers for Medicare & Medicaid Services. Last Reviewed September 9, 2021. Accessed on January 5, 2022. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=53101&ver=34&LCDId=35025&bc=CAAAAAAAIAAAAAAA&
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