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CUMC develops cancer diagnostic test based on microRNA technology

Rosetta Genomics : 23 July, 2008  (New Product)
The first molecular test based on Rosetta Genomics' proprietary microRNA technology, developed and validated by Columbia University Medical Center (CUMC), has been approved for clinical use by the New York State Department of Health Clinical Laboratory Evaluation Programme.
CUMC is now finalising the commercial aspects of this test and will announce its clinical availability to patients nationwide once details are finalised later this year.

The test differentiates squamous from non-squamous non-small cell lung cancer (NSCLC), classifying squamous-cell carcinoma of the lung with a sensitivity of 96 percent and specificity of 90 percent

This is the first CLIA approved test to use MicroRNAs' sensitivity as biomarkers for accurate diagnosis of lung cancer.

'This is a landmark event for us, marking the first step in the transformation of Rosetta Genomics into a commercial diagnostics company,' said Amir Avniel, president and chief executive officer of Rosetta Genomics. 'Our proprietary microRNA platform technologies, which this test is based on, have enabled Columbia University Medical Center's High Complexity Molecular Pathology Laboratory to develop a highly sensitive and specific test, which is a key for optimal administration of targeted therapies for this devastating cancer. As we move forward, we expect our development engines to enable the launch of additional tests based on our technology that have the potential to improve patient care worldwide.'

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

'We value our partnership with Columbia University Medical Center and we look forward to continuing this collaboration,' noted Ronen Tamir, chief commercial officer at Rosetta Genomics. 'At the same time, once we complete the previously announced acquisition of Parkway Clinical Laboratories in Pennsylvania, we plan to complement CUMC's commercial efforts by submitting the same type of test, developed and validated by Rosetta, for regulatory approval in the fourth quarter of 2008.'

The advent of targeted lung cancer therapies directed at specific cellular alterations now demands the most accurate classification possible for non-small cell lung carcinomas (NSCLC). A recently approved angiogenesis inhibitor (bevacizumab) for NSCLC has been shown to be less effective against squamous-cell lung cancer. Furthermore, this targeted therapy includes a black-box warning about substantially higher rates of severe or fatal haemorrhage among patients with squamous NSCLC histology compared with non-squamous NSCLC. This has led squamous-cell histology to be regarded by many as an exclusion criterion for this drug. In addition, several other targeted drugs for NSCLC currently under development may require this type of sensitive differentiation.

Approximately 185,000 people are diagnosed with Non Small Cell Lung Cancer each year in the USA, with an estimated 60,000 patients per year potential candidates for targeted therapy with bevacizumab 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).
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