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True Diagnostics Receives CE Mark for Quantitative PSA Test
By: Marketwired .
Feb. 5, 2013 05:02 PM
SAN DIEGO, CA -- (Marketwire) -- 02/05/13 -- True Diagnostics, Inc. (www.TrueDiagnostics.com) announces it has received a CE Mark for TrueDXPSA, its quantitative PSA (Prostate Specific Hormone) Test. With the TrueDXPSA Test doctors can immediately determine the PSA level in a patient with only a finger prick of blood -- rather than wait days for lab results from an intravenous blood draw. This unique test enables doctors to gain access to diagnoses in minutes and immediately create an effective treatment plan. The Company has a CE mark for a qualitative PSA test, TrueCXPSA, as a quick screen for other-the-counter use to determine PSA levels greater than 5.0. True Diagnostics is actively engaging distribution partners throughout all EU markets, with initial focus in Germany, UK, France, Italy and Spain.
This is the third regulatory clearance for the TrueDXPlatform with a CE Mark already for its TrueDXTSH test, and an sFDA approval for TrueDXTSH in China. The Company expects to run short clinical studies in the U.S. this year and further submit for CLIA-waive and 510k FDA clearances to market the TrueDXPlatform with its quantitative tests throughout the U.S.
Jerry Lee, President/CEO of True Diagnostics notes, "With our TrueDXPSA, the Company provides general practitioners, urologists, and oncologists with a simple point-of-care tool they can use to measure their patients' prostate health immediately. This year we expect to announce many more quantitative TrueDX tests for the market. We are currently in process of establishing a distribution network across all EU markets."
About PSA (from the National Cancer Institute)
About the Company
For more information, call 760-683-9158 or go to www.TrueDiagnostics.com
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