CancerTYPE ID®

Resolve ambiguous diagnoses, reveal therapeutic targets, and identify clinical trial options with one sample submission.

NeoGenomics and Biotheranostics, Inc., a Hologic Company, are pleased to provide a combined test offering for metastatic cancer patients with an unknown or unclear diagnosis.  CancerTYPE ID® with reflex to NeoTYPE® Cancer Profile enables tumor type classification and identification of actionable biomarkers in a seamless, single-order process that is available from either company.

Testing helps establish a final diagnosis and follow-up care options in the following situations:

  • Poorly differentiated tumors
  • New primary vs. recurrence
  • Unusual presentation

CancerTYPE ID® is performed and billed separately by NeoGenomics’ contracted reference laboratory, Biotheranostics, Inc., an independent CLIA-licensed and CAP-accredited reference laboratory. CancerTYPE ID® may be ordered as a stand-alone test directly from Biotheranostics, Inc. a Hologic Company. Please see www.cancertypeid.com.

CancerTYPE ID® Performance

CancerTYPE ID® is a proprietary molecular assay using RT-PCR to measure expression of 92 genes. To classify the tumor, the gene expression profile is matched to a database of more than 2000 known tumor types and subtypes. Using this technology, CancerTYPE ID® can identify 50 different tumor types and subtypes, covering >95% of all solid tumors based on incidence.1 The test reports a main cancer type with the highest probability, as well as a list of tumor types that may be ruled out with 95% confidence.

Extensively validated, CancerTYPE ID® has demonstrated 87% accuracy in a multi-institutional validation study led by three Centers of Excellence: UCLA, Mayo Clinic, and MGH.2 A comparison vs. standard of care IHC also showed that when more than 7-9 stains were required for analysis, 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.3 In a prospective clinical trial led by the Sarah Cannon Research Institute, CancerTYPE ID® identified a primary tumor type in 98% of cases and therapy based on the CancerTYPE ID® result improved overall survival by 37%.4

Clinical Significance

Determining a single tumor type diagnosis is essential for an oncologist’s ability to effectively treat his or her patient. Although recent studies have investigated whether molecular alterations alone are sufficient to direct treatment, results have had limited actionability due to inconsistent efficacy of the treatments across multiple tumor types.5 Thus, a definitive diagnosis of the tumor type remains a critical first step for appropriate treatment.

While IHC is the standard of care method used to establish an initial pathologic diagnosis, metastatic disease often poses diagnostic challenges, resulting in over 100,000 cases per year that still have some degree of diagnostic ambiguity.6-8 For these difficult-to-diagnose metastatic cases, CancerTYPE ID® provides important tumor type information to resolve diagnostic dilemmas. It can help narrow a differential diagnosis so that clients may confidently report a single final diagnosis9 and efficiently identify targetable mutations in genes pre-selected for their known impact in that tumor type.

Pairing of Classifications with Tumor Profiles

When CancerTYPE ID® and NeoTYPE® Cancer Profiles are ordered together, the NeoTYPE® profile performed will be based on the CancerTYPE ID® result as shown in the table below. If Neo Comprehensive – Solid Tumor is the preferred and ordered test, Neo Comprehensive – Solid Tumor will be performed instead of a NeoTYPE® profile (for non-New York).

CancerTYPE ID® Result NeoTYPE® Profile Reflex
Bladder, urothelial cancer NeoTYPE® Other Solid Tumor Profile plus Targeted Solid Tumor NGS Fusion Panel
Brain, meningioma NeoTYPE® DNA & RNA - Brain
For New York
NeoTYPE® Discovery Profile for Solid Tumors plus 1p/19q Deletions FISH
Brain, non-meningioma NeoTYPE® DNA & RNA - Brain
For New York
NeoTYPE® Discovery Profile for Solid Tumors (molecular only) plus Brain NGS Fusion Panel plus MGMT Promoter Methylation plus PD-L1 LDT
Breast adenocarcinoma NeoTYPE® Breast Tumor Profile
Cervix, adenocarcinoma or squamous cell carcinoma NeoTYPE® Cervical Tumor Profile
Cholangiocarcinoma NeoTYPE® Cholangiocarcinoma plus Cholangio/Pancreatic Carcinoma NGS Fusion Panel
Endometrial adenocarcinoma NeoTYPE® Endometrial Tumor Profile
Gastroesophageal adenocarcinoma NeoTYPE® Gastric Tumor Profile
Gastrointestinal stromal tumor (GIST) NeoTYPE® GIST and Soft Tissue Tumor Profile
Head & neck, skin/squamous cell carcinoma NeoTYPE® Head & Neck Profile
For New York
NeoTYPE® Precision Profile (molecular only) plus HPV RNA ISH 16/18 plus PD-L1 22C3 FDA (KEYTRUDA®) for HNSCC (Head & Neck)
Intestine, colorectal NeoTYPE® Colorectal Tumor Profile
Liver, hepatocellular carcinoma NeoTYPE® Liver/Biliary Tumor Profile
Lung, adenocarcinoma or squamous cell carcinoma NeoTYPE® DNA & RNA - Lung
For New York
NeoTYPE® Discovery Profile for Solid Tumors
Lymphoma NeoTYPE® Lymphoid Disorders Profile
Melanoma NeoTYPE® Melanoma Tumor Profile
Ovary NeoTYPE® Ovarian Tumor Profile
Pancreaticobiliary, gallbladder adenocarcinoma, pancreatic adenocarcinoma NeoTYPE® Pancreas Tumor Profile
Prostate, adenocarcinoma NeoTYPE® Precision Profile plus Prostate NGS Fusion Panel
Salivary gland carcinoma NeoTYPE® Other Solid Tumor Profile plus Salivary Gland NGS Fusion Panel
Sarcoma NeoTYPE® Discovery Profile for Solid Tumors (molecular only) plus Sarcoma Comprehensive NGS Fusion Panel
For liposarcoma, add MDM2 FISH
Thyroid NeoTYPE® Thyroid Profile plus Thyroid NGS Fusion Panel
Adrenal
Germ Cell
Intestine, small intestine adenocarcinoma
Kidney
Mesothelioma
Neuroendocrine
Sex cord stromal tumor
Skin, basal cell carcinoma
Thymus
Urinary bladder
NeoTYPE® Other Solid Tumor Profile
Indeterminate NeoTYPE® Discovery Profile for Solid Tumors

References:

  1. Erlander M, et al. J Mol Diagn. 2011;13(5):493-503.
  2. Kerr SE, et al. Clin Cancer Res. 2012;18(4):3952-60.
  3. Weiss LM, et al. J Mol Diagn. 2013; 15(2):263-269.
  4. Hainsworth JD, et al. J Clin Oncol. 2013;31:217-23.
  5. Le Tourneau, et al. Lancet Oncol. 2015;16(13):1324-34.
  6. Fong TH, et al. J Clin Oncol. 2008;26 (Suppl):22159.
  7. Anderson GG, Weiss LM. Appl Immunohistochem Mol Morphol. 2010;18(1)3-8.
  8. Shahda S. Metastatic patients with unclear diagnosis. CME presentation at ASCO Puerto Rico (October 2014).
  9. Thomas SP, et al. J Clin Oncol. 2015;33(Suppl 3; abst 249).
Client Services

NeoGenomics prides itself on our unparalleled customer support team. If you have questions regarding test information, specimen requirements, turnaround times, test add-on, and patient results, please feel free to reach out to a Client Services Advocate at client.services@neogenomics.com

CancerTYPE ID® Testing

Find printable ordering information as well as specimen requirements here.

ORDERING INFORMATION

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