True Diagnostics Receives CE Mark for TrueDX(TM) PSA Test
• February 05, 2013
SAN DIEGO, CA: True Diagnostics, Inc.™ (www.TrueDiagnostics.com) announces it has received a CE Mark for TrueDX™PSA, its quantitative PSA (Prostate Specific Hormone). With the TrueDX™PSA 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, TrueCX™PSA, 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 TrueDX™Platform with a CE Mark already for its TrueDX™TSH test, and an sFDA approval for TrueDX™TSH 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 TrueDX™Platform with its quantitative tests throughout the U.S.
Jerry Lee, President/CEO of True Diagnostics notes, “With our TrueDX™PSA, 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) Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. The PSA test measures the level of PSA in a man’s blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. The blood level of PSA is often elevated in men with prostate cancer, and the PSA test was originally approved by the FDA in 1986 to monitor the progression of prostate cancer in men who had already been diagnosed with the disease. In 1994, the FDA approved the use of the PSA test in conjunction with a digital rectal exam (DRE) to test asymptomatic men for prostate cancer. Men who report prostate symptoms often undergo PSA testing (along with a DRE) to help doctors determine the nature of the problem. In addition to prostate cancer, a number of benign (not cancerous) conditions can cause a man’s PSA level to rise. The most frequent benign prostate conditions that cause an elevation in PSA level are prostatitis (inflammation of the prostate) and benign prostatic hyperplasia (BPH) (enlargement of the prostate). There is no evidence that prostatitis or BPH leads to prostate cancer, but it is possible for a man to have one or both of these conditions and to develop prostate cancer as well.
About the Company For the $21 billion point-of-care market, the power of the TrueDX™Platform lies in its simplicity: tests have a 24-month shelf life; they do not need refrigeration; and, laboratory quality results from small samples can now be available to doctors in minutes. The TrueDX™Platform’s simplicity, portability, and affordability also allow it to be easily adopted into emerging markets. The platform’s flexible design additionally permits it to quickly commercialize a myriad of new biomarkers discoveries for cancer, autism, alzheimer’s, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections, and more. In essence, any biomarker discovery utilizing traditional lab methods, such as an ELISA process, can now be developed into a simple, fast, and portable assay which can offer quick diagnosis and treatment at the point-of-care, point-of-incidence and remote-of-care settings.
For more information, call 760-683-9158 or go to www.TrueDiagnostics.com
David Larson, CFO/COO
True Diagnostics, Inc.
2774 Loker AvenueWest, Carlsbad, CA 92008
David Larson, CFO/COO