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


NeoGenomics and Biotheranostics, Inc. 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. 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.


Downloads

Printable ordering information including specimen requirements


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 follows:

CancerTYPE ID Result

NeoTYPE Profile Reflex

Brain, Meningioma

NeoTYPE Brain Tumor Profile

Breast Adenocarcinoma

NeoTYPE Breast Tumor Profile

Cervix Adenocarcinoma

NeoTYPE Cervical Tumor Profile

Intestine - Colorectal

NeoTYPE Colorectal Tumor Profile

Endometrial Adenocarcinoma

NeoTYPE Endometrial Tumor Profile

Gastroesophageal Adenocarcinoma

NeoTYPE Gastric Tumor Profile

Gastrointestinal Stromal Tumor (GIST)

NeoTYPE GIST Profile

Liver Hepatocellular Carcinoma

NeoTYPE Liver/Biliary Tumor Profile

Lung Adenocarcinoma, Squamous Cell Carcinoma - Lung

NeoTYPE Lung Tumor Profile

Lymphoma

NeoTYPE Lymphoma Tumor Profile

Melanoma

NeoTYPE Melanoma Tumor Profile

Ovary

NeoTYPE Ovarian Tumor Profile

Sarcoma

NeoTYPE Soft Tissue Tumor Profile

Thyroid

NeoTYPE Thyroid Profile

Adrenal
Germ Cell
Head & Neck Salivary   
         Gland Carcinoma
Intestine - Small Intestine  
          Adenocarcinoma 
Kidney
Mesothelioma
Neuroendocrine
Pancreaticobiliary
Prostate Adenocarcinoma
Sex Cord Stromal Tumor
Skin Basal Cell Carcinoma
Squamous Cell Carcinoma – 
Cervix
Squamous Cell Carcinoma – 
Head & Neck/Skin 
Thymus
Urinary Bladder
NeoTYPE Other Solid Tumor Profile
IndeterminateNeoTYPE Precision Profile for Solid Tumors + MSI 



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).