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At the annual meeting of the North-Central American Urological Association, Mark Stovsky, MD, Case Western Reserve University School of Medicine -- Case Medical Center, and principal investigator, presented positive data combining the AnalizaDx SIA technology with the Nanosphere Verisens(TM) ultra-sensitive PSA assay (research use only). Nanosphere is collaborating with AnalizaDx -- which has developed a proprietary platform to screen for protein biomarkers in serum and other biological fluids -- on development of next-generation PSA tests for prostate cancer.
Data presented for blood serum showed that at a sensitivity of 100%, the specificity was 76%, with a negative predictive value of 100% (ruling out patients who do not have prostate cancer) and a positive predictive value of 84% (likelihood that a patient ruled in would have cancer based on biopsy). The use of the Nanosphere Verisens(TM) ultra-sensitive PSA assay achieved sensitivity and specificity required for prostate cancer diagnosis, that is not possible with existing commercial assays.
In addition to Case Western, the academic investigators were from Cleveland Clinic, the Veterans Administration Healthcare System in Boston, and the National Cancer Institute.
About Verisens(TM) PSA (RUO)
Verisens(TM) PSA is an in-vitro diagnostic assay for the high-sensitivity detection and quantification of prostate specific antigen (PSA). The assay was developed in collaboration with the International Institute for Nanotechnology at Northwestern University. Currently, it is intended to be performed as a testing service for research use only (see research-use notification below).
Solvent Interaction Technology (SIA) is a highly promising technology with the potential to discover and screen for structural changes in circulating proteins in serum and other biological fluids. SIA assay chemistries can be developed directly from actual clinical samples, and without requiring a priori structural or mechanistic assumptions. Furthermore, the technology is highly automatable, and once validated, could be readily transferred to the clinic.
For additional information regarding the PSA assay, please contact Nanosphere at
Nanosphere is also engaged in other cancer research and validation for protein biomarkers, independently and with commercial collaborations.
For additional information regarding the cancer protein biomarkers and commercial collaborations, please contact Nanosphere at
RESEARCH USE NOTIFICATION
Nanosphere, Inc. is required by the U.S. Food and Drug Administration (FDA) to certify in writing that its customers, who purchase or who are supplied with products labeled "For Research Use Only," acknowledge and understand that such products are not for use in diagnostic or therapeutic procedures. Tests performed with in vitro products intended for "Research Use Only" are tests used in a preclinical or nonclinical setting. While research tests may be performed using either clinical or nonclinical materials, research use devices have no intended clinical use and the testing performed is not designed to provide data addressing or demonstrating safety and effectiveness. We advise our customers to monitor the use of these products, to ensure that they are used for research purposes only. Please contact Nanosphere if you have questions.
Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene(R) system, for ultra-sensitive protein, human genetic and infectious disease detection. This easy to use and cost effective platform enables simple, low cost and highly sensitive testing on a single platform.
Nanosphere is based in Northbrook, IL.
For more information, please click here
Winton Gibbons, SVP, Business Development
Arnon Chait, Ph.D., President and CEO
The Torrenzano Group
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