Feldman S, Krishnamurthy S, Gillanders W et al.; US One Step Nucleic Acid Amplification Clinical Study Group.
Columbia University College of Physicians and Surgeons, New York, NY, USA.
Cancer 2011;117:2599–607.
Editor’s note: These authors prospectively evaluated the performance of a proprietary molecular testing platform using one-step nucleic amplification (OSNA) for the detection of metastatic carcinoma in the sentinel lymph nodes (SLNs) in a large multicenter trial, and compared the OSNA results with the results of detailed postoperative histopathological evaluation and intraoperative imprint cytology. The study was conducted prospectively at 11 US clinical sites and consisted of 1044 SLN samples from 496 patients. Alternate 1-mm sections were subjected to either detailed histopathological evaluation with hematoxylin–eosin and pan-cytokeratin immunostaining or the OSNA Breast Cancer System (Sysmex Corporation, Kobe, Japan), which was calibrated to detect tumor deposits >0.2 mm and cytokeratin 19 (CK19) mRNA.