FWIW: More NSIX News
Wednesday July 15, 7:31 am Eastern Time
Company Press Release
SOURCE: Neuromedical Systems, Inc.
NSI Commences Its US Primary Screening Trial
- New Cytology Software Will Be Evaluated -
SUFFERN, N.Y., July 15 /PRNewswire/ -- Neuromedical Systems, Inc. (''NSI'') (Nasdaq: NSIX - news) today announced the commencement of its prospective multi-center PapNet(R) assisted primary screening trial. The trial has been designed to include two separate tracks, one for the conventionally prepared Pap smear and the other for liquid-based preparations, both of which will include high-risk patient populations. Given the size and complexity of the trial and the efficiencies gained by having the same sites participate in both tracks of the trial, the Company concluded it would be most effective to stagger the tracks. Therefore, the Company began the trial with the conventional track. The Company expects the data collection to take approximately six months for each track and anticipates approval from the Food and Drug Administration (FDA) for both tracks by the end of 1999.
The trial will include three investigational sites: Associated Pathologist Laboratory of Nevada; Diagnostic Pathology Services, Inc. of Maryland; and Clinical Laboratories of Hawaii/ Straub Clinic of Hawaii. The first phase of the protocol requires each trial site to begin with a ''dry-run''. The next phase, identical to the first, will generate the data that will be compiled and analyzed for the Pre-Market Approval (PMA) supplement. The third and final phase of the trial is the preparation and submission of the PMA supplement to the FDA which must be approved for the product to be marketed for this new use. Each site will screen 6500 conventionally prepared Pap smears, taken from the participating laboratory site's regular caseload, using PapNet assisted testing in a primary screening mode and each site will also screen the same smears using manual microscopic screening.
The new cytology software being used in the trial is intended to assist the laboratory in increasing both specificity and sensitivity. This software provides the cytologist with new interactive features which are intended to enable the cytologist to better evaluate the cell images. The trial is intended to demonstrate the effectiveness of this new software.
''The trial will compare the performance of PapNet assisted primary screening with manual microscopic screening, with any discordant diagnoses to be adjudicated by independent pathologists. The trial is designed to measure sensitivity, specificity, and positive and negative predictive values,'' said Ellen R. Bressel, Ph.D., Director of Clinical Research at NSI.
''Our dedicated Product Development group and Clinical Research team worked hard to achieve this milestone of the Company, and we are all very excited about the commencement of our primary screening trial,'' said Paul R. Sohmer, MD, President and CEO of NSI. ''We continue to remain focused on implementing strategies developed to support our customers and remain confident that we will continue to achieve our goals.''
Neuromedical Systems, Inc. focuses intelligent vision on medicine. It is the Company's objective to become the premier supplier of cytology screening and anatomic pathology diagnostic equipment to laboratories. NSI's first product, the PapNet Testing System, helps the laboratory increase the accuracy of cervical screening by displaying potentially abnormal cells for review and analysis by a cytology professional. For more information about PapNet testing or Neuromedical Systems, Inc. call toll free at 1-888-PAPNET2 or visit NSI on the World Wide Web at nsix.com. |
