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News

M D Anderson Cancer Center studies microRNA-based test for locating cancer

Rosetta Genomics : 12 August, 2008  (Company News)
Rosetta Genomics has initiated a clinical validation study with The University of Texas M D Anderson Cancer Center (MDACC).
The study will focus on Rosetta Genomics' microRNA-based test that identifies the primary site of cancer of unknown primary (CUP). The study will include one hundred patients who are diagnosed with CUP at MDACC, and who meet the eligibility criteria. Rosetta Genomics expects the test to be submitted for regulatory approval in the second half of 2008.

'The initiation of this validation study is an integral part of the commercialisation roadmap for our diagnostic tests, as we advance them towards use in a clinical setting,' said Amir Avniel, president and chief executive officer of Rosetta Genomics. 'We believe the initiation of this study for our CUP Assay with a leading cancer research center such as M D Anderson attests to the critical unmet need this test addresses.' CUP is a heterogeneous group of cancers that constitutes three to five percent of all cancers with a poor median survival of six to 10 months. Each year, approximately 70,000 patients in the USA are diagnosed with CUP. A patient is typically diagnosed with CUP only after undergoing a wide range of tests, including various imaging tests such as x-ray, CT, MRI, and PET, which often fail to identify the origin of the cancer.

Presently, the choice of treatment for metastatic cancer is largely dependent on the nature of the primary tumour. Patients with CUP pose a therapeutic dilemma and treatment is often empiric with a ‘trial and error’ approach. In the era of rapidly growing effective cytotoxic and targeted therapies for known cancers, quicker and more accurate methods of identifying the tissue of origin of CUP cases would permit the use of these therapies, thereby improving the chances of achieving a response and possibly extending the patient's survival.

'The current gold standard diagnostic evaluation for CUP consists of a careful history and physical examination, laboratory tests, imaging studies, invasive studies when necessary, and thorough pathologic evaluation. This process is lengthy and exposes the patient to unnecessary toxicities,' noted Dr Gauri Varadhachary of M D Anderson. 'Rosetta Genomics' microRNA-based CUP Assay may present an alternative test to current diagnostic practices. This study aims to validate their Assay as well as compare its performance with current tests for CUP.'
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