This isn't meant to be exhaustive by any means I just wanted to show how ridiculous OTC's comment are on the Yahoo board. These are few tidbits from current R&D facilities/companies that are using urine for various prostate cancer detection either to be used with PSA or without, to detect malignancy, severity, or just detection in general. None of the preliminary studies would hold a candle to the numbers that HDVY's gene set has produced in efficacy or accuracy and none of these companies have the weight of Quest or Abbott behind them. It's like comparing Quicky Mart to WalMart. The common theme here is the use of a DRE which will almost certainly be used in HDVY's test. Don't believe the bull that is spewed by flippers and traders the longs will be rewarded. Don't forget to read the last part too. These are all seperate studies/tests 1 in bold, italic, then underlined.
Prostate cancer biomarkers are enriched in urine after prostatic manipulation, suggesting that whole cells might also be detectable for diagnosis. We tested multiplex staining of urinary sediments as a minimally invasive method to detect prostate cancer. Urine samples were collected from 35 men who had prostatic massage (attentive digital rectal examination) in a urology clinic and from 15 control men without urologic disease and without massage, for a total of 50 specimens (27 cancer-positive cases and 23 cancer-negative cases). LNCaP prostate cancer cells spiked into urine were used for initial marker optimization. Urine sediments were cytospun onto glass slides and stained. Multiplex urine cytology was compared with conventional urine cytology for cancer detection; anti–α-methylacyl-CoA racemase antibody was used as a marker of prostate cancer cells, anti-Nkx3.1 as a marker of prostate epithelial cells, anti-nucleolin as a marker of nucleoli, and 4′-6-diamidino-2-phenylindole to highlight nuclei. Prostate cancer cells were successfully visualized by combined staining for α-methylacyl-CoA racemase, Nkx3.1, and nucleolin. Of the 25 informative cases with biopsy-proven prostate cancer, 9 were diagnosed as suspicious or positive by multiplex immunofluorescence urine cytology, but only 4 were similarly judged by conventional cytology. All cases without cancer were read as negative by both methods. The multiplex cytology sensitivity for cancer detection in informative cases was 36% (9/25), and specificity was 100% (8/8). In conclusion, we have successfully achieved multiple staining for α-methylacyl-CoA racemase, Nkx3.1, nucleolin, and 4′-6-diamidino-2-phenylindole to detect prostate cancer cells in urine. Further refinements in marker selection and technique may increase sensitivity and applicability for prostate cancer diagnosis.
The PCA3 test is performed on prostate cells loosened during a digital rectal examination (DRE) and then washed out by urine. The assay is designed to detect a certain gene that is highly overexpressed in prostate cancer cells.
DD3 was initially described in 1994 at the Congress of the European Society for Urolological Oncology and Endocrinology in Berne, Switzerland. Further development of PCA3 was performed in the laboratories of Jack A. Schalken, Bussemakers’ supervising professor at University Hospital, Nijmegen, the Netherlands. Among the important contributions from Nijmegen were the first clinical demonstration of the specificity of PCA3, its measurability in urine, and the importance of denoting PCA3 expression vis-á-vis a background of normal prostate epithelial genetic material.5,6 Interest in urinary prostate cells, which had been generally abandoned years before, was then resurrected, and urinary PCA3 research studies were soon instituted by Yves Fradet in Laval University in Canada. A prototype urine assay known as uPM3 was developed at DiagnoCure. During this time, the nomenclature for DD3 was formally changed to PCA3.
Purpose: We assess the feasibility of a urinary test for prostate cancer detection in a high-risk patient cohort based on methylation-specific PCR analysis of the π class glutathione S-transferase (GSTP1) gene promoter.
Experimental Design: A total of 45 men underwent transrectal ultrasound-guided biopsy of the prostate for suspected malignancy. Clean-catch voided urine specimens were prospectively collected from each patient immediately after biopsy. Genomic DNA was isolated from urine specimens and subjected to sodium bisulfite modification. Methylation of the GSTP1 promoter was examined in a blinded manner by methylation-specific PCR analysis and correlated with pathology results, and clinical information was obtained from the patient record.
Results: Methylation of GSTP1 in the urine was detected in a total of 18 of 36 (50%) informative cases. A total of 7 of 18 (39%) patients with prostate adenocarcinoma identified on their initial biopsy had detectable urinary GSTP1 methylation (58% sensitivity among informative cases). Abnormal urinary GSTP1 methylation was also detected in 7 of 21 (33%) patients without evidence of cancer on biopsy and in 4 of 6 (67%) patients diagnosed with atypia or high-grade prostatic intraepithelial neoplasia.
Conclusions: We have demonstrated the feasibility of a novel, noninvasive molecular approach for the detection of epigenetic changes associated with prostate cancer. A screening test based on GSTP1 methylation in the urine specimens of patients with suspected prostate malignancy may be a useful adjunct to serum screening tests and digital rectal examination findings for identification of men at increased risk of harboring cancer despite a negative biopsy. This molecular assay has potential application for stratification of patients into low- and high-risk groups for surveillance versus repeat biopsy.
Besides this we have the following to look forward too.
HDC's key license partners to date include Abbott Laboratories (ABT, Trade ), Quest Diagnostics (DGX, Trade ), Clarient Inc. (CLRT, Trade ) and Pfizer Inc. (PFE, Trade ).
HDC recently entered into royalty-bearing licenses for its new urine-based prostate cancer test with Quest Diagnostics Incorporated and Abbott Laboratories for development and commercialization. These licenses are solely for the use of HDC's prostate cancer biomarkers in urine.
HDC also entered into royalty-bearing licenses for its tissue biopsy-based prostate cancer test with Abbott Laboratories and Clarient Inc. for development and commercialization. This license is solely for the use of HDC's prostate cancer biomarkers in tissue biopsy specimens.
HDC has also partnered with Pfizer Inc. for use of HDC's SVM and SVM-RFE pattern recognition technology in Pfizer's global research and development.
HDC has also entered into a license with Smart Personalized Medicine, LLC ("SPM"), a privately-held company, founded by Dr. Richard Caruso, Chairman and founder of Integra Life Sciences (NasdaqGS: IART) to develop a superior breast cancer prognostic test using HDC's SVM technology in cooperation with MD Anderson Cancer Center. HDC has a fifteen percent equity position in SPM and HDC will receive royalties from this new breast cancer prognostic test.
HDC has entered into a development and license agreement with DCL Medical Laboratories, LLC, for the collaborative development and commercialization of SVM-based computer assisted diagnostic tests for the independent detection of ovarian, cervical and endometrial cancers.
HDC's Patents Cover Non-Medical Applications
There are a large number of non-medical applications protected by HDC's patents, including but not limited to, fraud detection, investment and commodities price predictions, bankruptcy prediction, image and object analysis, face recognition, text and document classification, speech recognition, personalized consumer purchasing patterns, decryption, vehicle control and monitoring, weather forecasting and database marketing
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