Siemens Healthcare Diagnostics, Inc. - IMMULITE/IMMULITE 2000 PSA Assay - Class 2 Recall

IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts

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Abstract Polymorphic variants in the PTEN (rs2735343), PI3K (rs2699887), AKT1 (rs2494750), AR (rs17302090), and AMACR (rs3195676) genes were evaluated as possible molecular markers of susceptibility, prognosis, and progression of prostate cancer (PCa), in a case-control study. Samples consisted of 277 patients with PCa and 277 controls from Londrina, PR, Brazil. SNPs were analyzed by real-time PCR. A family history of cancer, including PCa, as well as level of schooling were risk factors for PCa. The data were obtained via logistic regression, using odds ratios with a CI 95%. The genotypes of AKT1 and AKT1+AR demonstrated ...
Source: Genetics and Molecular Biology - Category: Genetics & Stem Cells Source Type: research
ABSTRACT Objective To assess the association between prostate volume index (PVI), and prostatic chronic inflammation (PCI) as predictors of prostate cancer (PCA). PVI is the ratio between the central transition zone volume (CTZV) and the peripheral zone volume (PZV). Materials and methods Parameters evaluated included age, prostate specific antigen (PSA), total prostate volume (TPV), PSA density (PSAD), digital rectal exam (DRE), PVI, PCI and number of positive cores (NPC). All patients underwent baseline 14-core, trans-perineal random biopsies. Associations of parameters with the NPC were investigated by univariate and mu...
Source: International Braz J Urol - Category: Urology & Nephrology Source Type: research
ABSTRACT Objectives Fusion prostate biopsy (FPB) has recently emerged as a popular and successful biopsy technique on diagnosis of prostate cancer. The aim of this study was to compare the pain levels in TRUS-guided standard 12-core prostate biopsy (SPB) and MpMRI-guided FPB. Materials and Methods Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥ 3 lesion on MpMRI underwent MpMRI-guided FPB (Group I) and the patients who had no suspected lesions or had a PI-RADS
Source: International Braz J Urol - Category: Urology & Nephrology Source Type: research
ABSTRACT Objectives Fusion prostate biopsy (FPB) has recently emerged as a popular and successful biopsy technique on diagnosis of prostate cancer. The aim of this study was to compare the pain levels in TRUS-guided standard 12-core prostate biopsy (SPB) and MpMRI-guided FPB. Materials and Methods Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥ 3 lesion on MpMRI underwent MpMRI-guided FPB (Group I) and the patients who had no suspected lesions or had a PI-RADS
Source: International Braz J Urol - Category: Urology & Nephrology Source Type: research
Conclusions 223Ra therapy require an adequate selection of patients to obtain the greatest clinical benefit. Low basal Hb, hight basal ALP, bone marrow involvement and an altered ECOG were the main factors that decreased OS in our patients. 223Ra should be considered relatively early in the course of treatment.
Source: International Braz J Urol - Category: Urology & Nephrology Source Type: research
Conclusions 223Ra therapy require an adequate selection of patients to obtain the greatest clinical benefit. Low basal Hb, hight basal ALP, bone marrow involvement and an altered ECOG were the main factors that decreased OS in our patients. 223Ra should be considered relatively early in the course of treatment.
Source: International Braz J Urol - Category: Urology & Nephrology Source Type: research
This study investigated the expression of miRNA-182 and miRNA-187 in prostate cancer patients and established a correlation between miRNA expression and staging of prostate cancer. Materials and Methods This prospective observational study involved patients undergoing transrectal ultrasound-guided biopsy for suspicion of prostate cancer. Pre-biopsy urine samples and prostatic core tissue samples of the patients were preserved and the miRNA-182 and miRNA-187 were studied. Results Sixty-three patients were included in this study, thirty-three patients were diagnosed with prostate cancer and thirty patients having benign hist...
Source: International Braz J Urol - Category: Urology & Nephrology Source Type: research
Condition:   Prostate Cancer Interventions:   Drug: Apalutamide;   Drug: Enzalutamide Sponsors:   Chinese University of Hong Kong;   Janssen, LP Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
CONCLUSIONS: Based on the results of these clinical trials, the application of gene therapy in prostate cancer therapeutics can be satisfactorily established. PMID: 32473623 [PubMed - as supplied by publisher]
Source: Endocrine, Metabolic and Immune Disorders Drug Targets - Category: Drugs & Pharmacology Tags: Endocr Metab Immune Disord Drug Targets Source Type: research
PROSTATE cancer can be detected in otherwise healthy men in a major breakthrough by British scientists. They made the discovery by "barcoding" patients for their genetic risk and testing them for DNA changes.
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
More News: Cancer | Cancer & Oncology | Medical Devices | Prostate Cancer