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Molecular based lung cancer test prepares for US launch

Rosetta Genomics : 04 April, 2008  (New Product)
The first molecular test based on Rosetta Genomics' proprietary microRNA technology, developed by Columbia University Medical Center (CUMC), has been submitted for approval by the New York State Department of Health.
The test is designed to differentiate squamous from non-squamous Non-Small Cell Lung Cancer (NSCLC) and is the first to use this technology to successfully classify two distinct types of the most common form of lung cancer.

Once approved by New York State Department of Health, the test will be made available nationwide through Columbia University Medical Center's High Complexity Molecular Pathology Laboratory, a laboratory licensed to use nucleic acids for better diagnosis of various cancers, which is part of the Department of Pathology and Cell Biology at CUMC.

'With advancements toward more targeted therapies for cancer, there is a growing need for better diagnostics,' said Amir Avniel, president and chief executive officer of Rosetta Genomics.

The test, performed on a sample of the patient's tumor and validated by Columbia University Medical Center, classifies squamous cell carcinoma of the lung with specificity of 90 percent and sensitivity of 96 percent. This is the first test utilising microRNAs' unique sensitivity and specificity as biomarkers that may offer a standardised and objective method for cancer classification.

The genetic classification can be especially important for selecting proper treatment as therapies have been shown to act differently depending on cancer type, such as the case between squamous (scalelike) and non-squamous non-small cell lung cancer (NSCLC). Approximately 185,000 people are diagnosed with either squamous or non-squamous NSCLC each year in the USA.

'The importance of accurately differentiating squamous cell from non-squamous NSCLC has recently been an issue of great interest and is gaining importance as new targeted therapies for NSCLC enter the market or proceed to late stages of development,' said Dr Dalia Cohen, chief scientific officer of Rosetta Genomics. 'This is a great advancement in terms of physicians' ability to better treat patients with targeted therapies, which are currently highly effective in some patients while being less effective and sometimes harmful for others.'

'We are excited to have performed the validation of the first diagnostic test based on microRNAs, and believe this endeavor is an important next step in bringing better diagnostics to patients and physicians,' noted Dr Mahesh Mansukhani, director of the Molecular Pathology Laboratory at Columbia University Medical Center, who has led the validation process and submission of the test to the New York State Department of Health for approval. 'Using a single microRNA biomarker, the test demonstrates high sensitivity and specificity, for squamous differentiation. Once approved, we will be pleased to offer this test through our pathology laboratory nationwide to doctors and patients as an objective aid in the classification of NSCLC. '

Data presented in peer reviewed publications has shown that two blinded expert observers, when asked to give an independent histological classification of NSCLC agreed only 74.7 percent of the time. Furthermore, sensitivity for squamous cell carcinoma was only 70.9 percent.

A second study looking at classification of squamous cell carcinoma showed that 40 percent of samples diagnosed as squamous cell lung cancer at regional labs were later reclassified as other lung cancers at central labs.

The ability of physicians to accurately differentiate squamous (scalelike) from non-squamous NSCLC is an important treatment guide. Bevacizumab, an angiogenesis inhibitor and an important new modality of therapy for non-squamous NSCLC, includes a black-box warning about substantially higher rates of severe or fatal hemorrhage among patients with squamous NSCLC histology compared with non-squamous NSCLC.

Currently, an estimated 60,000 patients per year are potential candidates for targeted therapy with Avastin, a market available angiogenesis inhibitor, in the USA.

Rosetta Genomics expects two additional tests based on its microRNA technology to be validated and submitted for regulatory approval during the second half of 2008 by laboratories in the USA.

One test is designed to differentiate mesothelioma, an asbestos-associated cancer that develops in the pleura, from adenocarcinomas that either arise in the lung or spread to the lung and pleura from other sites. Another test is designed to identify the origin of a metastasis in patients presenting with cancer of unknown primary (CUP) origin.
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