The abstract of the study may be viewed online at The Oncologist website: http://theoncologist.alphamedpress.org/cgi/content/abstract/theoncologist.2010-0305v1
The study consisted of a proof-of-concept phase and a validation phase. In the proof-of-concept phase, brain and spine metastases from known primary tumors were analyzed with the miRview™ mets assay. In the validation phase, a cohort of brain and spine metastatic samples of true Cancer of Unknown Primary patients were studied, and concordance between results generated by miRview™ mets and the clinical and pathological evaluation was examined.
Results from the validation phase demonstrated that primary origin prediction from miRview™ mets was in agreement with the clinical or pathological evaluation in 80% of the cases.
Underscoring the value of miRview™ mets, the study describes a case of a breast cancer patient with brain metastasis. When analyzed with miRview™ mets, the origin of the metastasis was surprisingly diagnosed as melanoma. Additional pathology testing supported this diagnosis. Based on these findings, the primary breast cancer was also tested with the miRview™ mets assay as well as additional pathology testing, and was found to be melanoma misdiagnosed as breast cancer.
"Metastatic cancer can present a significant diagnostic challenge to pathologists searching for the primary origin," noted Dr. Wolf C. Mueller from the Department of Neuropathology at Heidelberg University, who led the study. "The diagnostic process can be time-consuming, and can lead to limited results. Our study demonstrated that miRview™ mets is a powerful tool for diagnosing cancer of uncertain or unknown primary, and may also offer new diagnostic avenues to explore."
"This study, along with the recently completed study by researchers from M. D. Anderson, are two post-marketing validation studies conducted by leading cancer centers that demonstrate the ability of miRview™ mets to accurately identify the origin of metastases in cancer cases with unknown or uncertain primaries. We are pleased with the consistently strong performance of our microRNA-based assay in diagnosing cancer of true uncertain or unknown primary," noted Kenneth A. Berlin, President and CEO of Rosetta Genomics. "Our unique microRNA-based technologies have enabled us to recently launch miRview™ mets², and we firmly believe that with its expanded tumor panel and enhanced classifiers, it will further improve physicians' ability to accurately diagnose cancer of unknown or uncertain primary origin in order to optimize treatment options for patients."