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Panacea Pharmaceuticals Initiates GMP Manufacturing of Prostate Cancer Diagnostic Test Kits
Date:12/11/2007

GAITHERSBURG, Md., Dec. 11 /PRNewswire/ -- Panacea Pharmaceuticals, Inc. has initiated manufacturing of PC Detect(SM) kits, the Company's diagnostic test for prostate cancer, under GMP conditions. Data on the performance of the PC Detect(SM) kit will be included in a Premarket Approval (PMA) application for this diagnostic test to be filed with the U.S. Food and Drug Administration in early 2008. To date, PC Detect(SM) has demonstrated sensitivity and specificity of greater than 90 percent in identifying men with prostate cancer. PC Detect(SM) was initially launched in May 2007 as a laboratory service by Panacea Laboratories, a division of Panacea Pharmaceuticals; Panacea Laboratories is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. FDA approval of a PC Detect(SM) kit will facilitate the wider distribution and availability of this diagnostic test through clinical laboratories and hospitals across the U.S. The Company is seeking to identify one or more partner companies to facilitate the distribution and commercialization of the PC Detect(SM) kit in the U.S. and other countries.

The PC Detect(SM) kit, as with the PC Detect(SM) laboratory service, requires a small serum sample and measures blood levels of Human Aspartyl (Asparaginyl) Beta-Hydroxylase (HAAH), a cancer biomarker. HAAH has been established as an excellent biomarker for many types of cancer, including prostate cancer. The protein is typically undetectable in sera from cancer-free individuals, thus, an elevated serum protein level of HAAH is highly diagnostic for cancer. PC Detect(SM) is recommended as an adjunct to the prostate specific antigen (PSA) test and the digital rectal examination (DRE), the currently recommended prostate cancer screening methods. The addition of PC Detect(SM) to the current screening methods should improve the diagnosis of prostate cancer among men with prostate specific antigen (PSA) values below
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SOURCE Panacea Pharmaceuticals, Inc.
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