Clinical need

The clinical challenge

Treatment selection is dependent upon a clear diagnosis
Securing a clear diagnosis in patients with lung cancer is particularly important since different treatment modalities exists. In general, SCLC is much more responsive to chemotherapy and consequently this comprises the mainstay of treatment. This is in contrast to NSCLC which is relatively chemoresistant and thus primarily treated with surgical resection for local disease. Certain targeted therapy agents are more effective in patients with squamous NSCLC and others are more appropriate for those with non-squamous NSCLC^1,2. In addition, some agents may be associated with a greater risk of adverse effects in patients with squamous NSCLC compared with those with non-squamous NSCLC³. For example; patients with squamous NSCLC cannot receive Avastin because of a 30% mortality rate due to fatal hemoptysis^4,5.

Current gold standard methods of classification have severe limitations
Routine histopathology is the current standard of lung tumor classification but has demonstrated limited concordance among pathologists. In one study up to 40% of squamous or adenocarcinoma of the lung were reclassified when evaluated by a second pathologist⁶. In another study the number of cases classified correctly was 66% for adenocarcinoma and 53% for squamous cell carcinoma⁷. Immunohistochemistry's (IHC) performance is limited by the variable sensitivity and specificity of each marker^8,9. While p63 is a sensitive marker for squamous cells, it is not highly specific; up to 30% of adenocarcinomas and 37% of large cell undifferentiated carcinomas also express p63, probably due to the expression of p63 in basal cells¹⁰. As a result, misclassification is a significant problem. Furthermore, the tests used to classify and diagnose these patients are primarily subjective and there is a lack of objective results.

A better diagnostic method is needed
The shortcomings associated with current methods of classifying lung cancer and further sub-classifying NSCLC^11,12 point to the need for a highly accurate, objective, reproducible, and standardized classification tool in lung cancer diagnosis.

Introducing miRview® lung—a sensitive and accurate diagnostic test
miRview® lung is a cutting-edge, microRNA-based molecular diagnostic tool that accurately differentiates SCLC, carcinoid, squamous NSCLC and non-squamous NSCLC. It offers

High accuracy
Simple interpretation
Objectivity
Standardization
Quantitative analysis
Cutting-edge molecular biology

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Khayyata S, Yun S, Pasha T, Jian B, McGrath C, Yu G, Gupta P, Baloch Z.Value of P63 and CK5/6 in distinguishing squamous cell carcinoma from adenocarcinoma in lung fine-needle aspiration specimens. Diagn Cytopathol. 2009:37(3):178-83.
Wang BY, Gil J, Kaufman D, Gan L, Kohtz DS, Burstein DE. P63 in pulmonary epithelium, pulmonary lung neoplasms, and other pulmonary tumors. Hum Pathol. 2002;33(9):921-926.
Maeshima AM, Omatsu M, Tsuta K, Asamura H, Matsuno Y. Immunohistochemical expression of TTF-1 in various cytological subtypes of primary lung adenocarcinoma, with special reference to intratumoral heterogeneity. Pathol Int. 2008;58(1):31-37.
Au NH, Gown AM, Cheang M, et al. p63 expression in lung carcinoma: a tissue microarray study of 408 cases. Appl Immunohistochem Mol Morphol. 2004;12(3):240-247.
Field RW, Smith BJ, Platz CE, et al. Lung cancer histologic type in the surveillance, epidemiology, and end results registry versus independent review. J Natl Cancer Inst. 2004;96(14):1105-1107.
Perelman M, Rosenwald S, Spector Y, et al. MicroRNA biomarkers for differential diagnosis of lung tumors. Presented at: United States and Canadian Academy of Pathology Annual Meeting; March 7-13, 2009; Boston, MA. Abstract 1630.