Pharmaceutical Business review

Columbia University and Rosetta seek approval for cancer test

The test is designed to differentiate squamous from non-squamous non-small cell lung cancer (NSCLC). Once approved by the New York State Department of Health, the test will be made available nationwide through Columbia University Medical Center’s High Complexity Molecular Pathology Laboratory.

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% and sensitivity of 96%. This is the first test utilizing microRNAs’s unique sensitivity and specificity as biomarkers that may offer a standardized and objective method for cancer classification.

Dalia Cohen, chief scientific officer of Rosetta Genomics, said: “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. This is a great advancement in terms of physicians’s 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.”