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Biotech / Medical : DiagnoCure noninvasive prostate cancer PCA 3 test -- Ignore unavailable to you. Want to Upgrade?


To: gg cox who wrote (3)1/29/2006 4:57:47 PM
From: gg cox  Read Replies (1) | Respond to of 6
 
uPM3™ click on slide show.

UPM3™ TEST – A UNIQUE MOLECULAR BIOLOGIC ASSAY FOR DETECTING PROSTATE CANCER IN URINE SPECIMENS

uPM3™ - Slide Show

What is uPM3™ testing?

The uPM3™ test is a molecular biologic assay for detecting the RNA expression of the PCA3 (DD3) gene in urine specimens using the Nucleic Acid Sequence Based Amplification (NASBA) technique. The test is performed on the first voided urine obtained after careful digital rectal examination of the prostate by a physician. uPM3™ testing is indicated for patients with an elevated PSA and previous negative biopsies.

Why do I need uPM3™ testing?

Currently, early detection of prostate cancer is mainly based on measurement of serum prostate specific antigen (PSA) and, to a lesser extent, on digital rectal examination, with biopsy for any sign of abnormality. T he U.S. Preventive Services Task Force do not recommend routine screening, because of the potential harm resulting from the lack of specificity with current screening methods. For example, in 2 of 3 men with a serum PSA level of 4 ng/mL or greater, biopsies are negative. More prostate cancer-specific biomarkers are needed.

PCA3(DD3) is one of the most prostate cancer-specific genes described so far, with overexpression in 95% of prostate cancers tested and a median 66-fold increase in cancer compared with benign prostatic tissues. uPM3™ testing has combined high sensitivity (67%) and specificity (89%), and an overall accuracy of 81% for detection of prostate cancer compared with approximately 40% for PSA (see table) . The uPM3™ test provides some answers to the current dilemmas of early prostate cancer detection.

Clinical Studies:

Table 1. Sensitivity and Specificity of uPM3™ in Predicting Prostate Cancer in Follow-up Biopsies Among 443 Patients

Serum PSA
Number of Patients
uPM3™ Sensitivity (%)
uPM3™ Specificity (%)

PSA < 4.0
94
74% (14/19)
91% (68/75)

PSA 4.0-10.0
243
59% (50/85)
91% (144/158)

PSA >10
106
79% (37/47)
80% (47/59)

Over-all uPM3™
443
67% (101/151)
89% (259/292)


Table 2. Comparison of PSA and uPM3™ in Predicting Prostate Cancer in Follow-up Biopsies Among 443 Patients

Markers
Positive Predictive Value (PPV)
Negative Predictive Value (NPV)
Accuracy

PSA > 2.5
37%
89%
43%

PSA > 4.0
38%
80%
47%

PM3
75%
84%
81%


What does my uPM3™ result mean?

A negative uPM3™ test result indicates that prostatic cells are present in your urine specimen and the PCA3 (DD3) RNA level is within normal range. This suggests that you are at a lower risk for prostate cancer. You should repeat this test or a PSA test as advised by your physician.

A positive uPM3™ test result indicates that prostatic cells are present in your urine specimen and the PCA3 (DD3) RNA level is increased beyond normal range. This suggests that you are at a higher risk for prostate cancer. Prostate biopsy might be needed. Your doctor will discuss with you the next steps to take.

References :

1) De Kok JB, Verhaegh GW, Roelofs RW, Hessels D, Kiemeney LA, Aalders TW, Swinkels DW, Schalken JA. DD3(PCA3), a Very Sensitive and Specific Marker to Detect Prostate Tumors. Cancer Res 2002;62(9):2695-8

2) Fradet Y, Saad F, Aprikian A, Dessureault J, Elhilali M, Trudel C, Masse B, Piche L, Chypre C. uPM3, a new molecular urine test for the detection of prostate cancer. Urology. 2004 Aug;64(2):311-5.

3) Tinzl M, Marberger M, Horvath S, Chypre C. DD3PCA3 RNA analysis in urine--a new perspective for detecting prostate cancer. Eur Urol. 2004 Aug;46(2):182-6.

For more information on uPM3™ click here




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Immunohistochemistry
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