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32 results on '"Okrongly, David"'

1. Role of the 4Kscore test as a predictor of reclassification in prostate cancer active surveillance

Author

Borque-Fernando, Ángel, Rubio-Briones, José, Esteban, Luis M., Dong, Yan, Calatrava, Ana, Gómez-Ferrer, Álvaro, Gómez-Gómez, Enrique, Gil Fabra, Jesús M., Rodríguez-García, Nuria, López González, Pedro Á., García-Rodríguez, Jorge, Rodrigo-Aliaga, Miguel, Herrera-Imbroda, Bernardo, Soto-Villalba, Juan, Martínez-Breijo, Sara, Hernández-Cañas, Virginia, Soto-Poveda, Ana M., Sánchez-Rodríguez, Carlos, Carrillo-George, Carlos, Hernández-Martínez, Yumaira E., and Okrongly, David

Published
2019
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6. Clinical performance of the 4Kscore Test to predict high-grade prostate cancer at biopsy: A meta-analysis of us and European clinical validation study results

Author

Zappala, Stephen M., Scardino, Peter T., Okrongly, David, Linder, Vincent, and Dong, Yan

Subjects
Predictive Performance Evaluation
Abstract

The 4Kscore® Test (OPKO Diagnostics, Woburn, MA) is a blood test utilized prior to a prostate biopsy to determine a patient’s risk of high-grade prostate cancer (PCa) should the biopsy be performed, thus providing critical information in the clinical management of men with a suspicious prostate-specific antigen value or digital rectal examination result. Multiple US and European clinical studies confirmed that a prebiopsy 4Kscore Test has a high degree of discrimination for a subsequent discovery of high-grade (Gleason score ≥7) PCa. The aim of this study was to evaluate the predictive accuracy of the 4Kscore Test to discriminate between patients with and without high-grade PCa based on published clinical validation studies. A systematic review and meta-analysis of the eligible 4Kscore Test clinical validation studies was conducted. The pooled area under the curve (AUC) of the 4Kscore Test as reported from all the studies, and the heterogeneity among these studies were analyzed and repeated for subgroups of the studies. Twelve clinical validation studies were included in the meta-analysis, comprising a total of 11,134 patients. The pooled AUC to discriminate for high-grade PCa for all 12 studies was 0.81 (fixed effects 95% CI, 0.80-0.83). Restricting the analysis to the six publications that used the contemporary 4Kscore Test algorithm led to very similar results (AUC 0.81; 95% CI, 0.79-0.83). Heterogeneity was high among all of the 12 studies, as well as among the six publications that used the contemporary 4Kscore Test (Cochrane’s Q test, p = 0.001 for both); however, in both cases, after exclusion of a single outlying study with a much lower AUC, heterogeneity was no longer significant (p = 0.08 and p = 0.21). The pooled estimate of 4Kscore Test discrimination (AUC) for high-grade PCa is >0.80, and is consistent across multiple US and European clinical validation studies.

Published
2017

7. Role of the 4Kscore test as a predictor of reclassification in prostate cancer active surveillance

Author

Borque-Fernando, Ángel, primary, Rubio-Briones, José, additional, Esteban, Luis M., additional, Dong, Yan, additional, Calatrava, Ana, additional, Gómez-Ferrer, Álvaro, additional, Gómez-Gómez, Enrique, additional, Gil Fabra, Jesús M., additional, Rodríguez-García, Nuria, additional, López González, Pedro Á., additional, García-Rodríguez, Jorge, additional, Rodrigo-Aliaga, Miguel, additional, Herrera-Imbroda, Bernardo, additional, Soto-Villalba, Juan, additional, Martínez-Breijo, Sara, additional, Hernández-Cañas, Virginia, additional, Soto-Poveda, Ana M., additional, Sánchez-Rodríguez, Carlos, additional, Carrillo-George, Carlos, additional, Hernández-Martínez, Yumaira E., additional, and Okrongly, David, additional

Published
2018
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8. Integrated diagnostics and the future of health care: corporate innovation as an engine for change

Author

Okrongly, David

Subjects
Company acquisition/merger, Market trend/market analysis, Bayer Diagnostics Corp. -- Mergers, acquisitions and divestments, Dade Behring Inc. -- Mergers, acquisitions and divestments, Medical equipment and supplies industry -- Mergers, acquisitions and divestments, Medical test kit industry -- Mergers, acquisitions and divestments, Medical innovations -- Economic aspects, Medical innovations -- Forecasts and trends, Scientific equipment and supplies industry -- Mergers, acquisitions and divestments, Diagnostic services -- Innovations, Diagnostic services -- Mergers, acquisitions and divestments, Diagnostic services -- Economic aspects
Abstract

In this discussion, I will be covering molecular diagnostics and how it fits into an integrated diagnostics company. Integrated diagnostics for Siemens Healthcare Diagnostics (Tarrytown, New York) was a dream [...]

Published
2009

9. Cover Image

Author

Zappala, Stephen M., primary, Dong, Yan, additional, Linder, Vincent, additional, Reeve, Michael, additional, Sjoberg, Daniel D., additional, Mathur, Vinita, additional, Roberts, Richard, additional, Okrongly, David, additional, Newmark, Jay, additional, Sant, Garnnum, additional, and Steiner, Mitchell, additional

Published
2017
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10. The 4Kscore blood test accurately identifies men with aggressive prostate cancer prior to prostate biopsy with or without DRE information

Author

Zappala, Stephen M., primary, Dong, Yan, additional, Linder, Vincent, additional, Reeve, Michael, additional, Sjoberg, Daniel D., additional, Mathur, Vinita, additional, Roberts, Richard, additional, Okrongly, David, additional, Newmark, Jay, additional, Sant, Garnnum, additional, and Steiner, Mitchell, additional

Published
2017
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15. 2053 URINARY EXOSOMES/MICROVESICLES AS A NON-INVASIVE PLATFORM FOR PROSTATE CANCER ANALYSIS

Author

McKiernan, James, primary, Saltzstein, Daniel, additional, Cochran, James, additional, Badani, Ketan, additional, Concepcion, Raoul, additional, Shore, Neal, additional, Patel, Vipul, additional, Brown, Gordon, additional, Shapiro, Edan, additional, Ahn, Jennifer, additional, Noerholm, Mikkel, additional, Comper, Wayne, additional, Belzer, Susan, additional, Bentink, Stefan, additional, Donovan, Michael, additional, Okrongly, David, additional, and Russo, Leileata, additional

Published
2013
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30. The ADVIA Centaur® imunoassay system—designed for infectious disease testing

Author

Okrongly, David

Subjects
*PATHOLOGICAL laboratories, *AUTOMATION, *COMMUNICABLE diseases, *ROBUST control, *ESTERS
Abstract

The ability to automate immunodiagnostics testing is critical for the efficiency of clinical laboratories. For automation of Infectious Disease testing, special design considerations must be made to ensure the integrity of the testing result while at the same time delivering productivity. The ADVIA Centaur® was designed with the intent of performing a complete Infectious Disease panel including HBV, HCV, and HIV markers. Features such as disposable sample tips, sample and reagent delivery verification, and clog and clog detection have been incorporated in the design for assay robustness. Productivity features deliver best in class throughput performance for the Infectious Disease assays. Moreover, the underlying technology incorporating flexible assay protocols, universal solid phases and proprietary acridinium ester technology contribute to the assay design flexibility and analytical performance of the ADVIA Centaur® immunoassay system. [Copyright &y& Elsevier]

Published
2004
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31. Clinical performance of the 4Kscore Test to predict high-grade prostate cancer at biopsy: A meta-analysis of us and European clinical validation study results.

Author

Zappala SM, Scardino PT, Okrongly D, Linder V, and Dong Y

Abstract

The 4Kscore ® Test (OPKO Diagnostics, Woburn, MA) is a blood test utilized prior to a prostate biopsy to determine a patient's risk of high-grade prostate cancer (PCa) should the biopsy be performed, thus providing critical information in the clinical management of men with a suspicious prostate-specific antigen value or digital rectal examination result. Multiple US and European clinical studies confirmed that a prebiopsy 4Kscore Test has a high degree of discrimination for a subsequent discovery of high-grade (Gleason score ≥7) PCa. The aim of this study was to evaluate the predictive accuracy of the 4Kscore Test to discriminate between patients with and without high-grade PCa based on published clinical validation studies. A systematic review and meta-analysis of the eligible 4Kscore Test clinical validation studies was conducted. The pooled area under the curve (AUC) of the 4Kscore Test as reported from all the studies, and the heterogeneity among these studies were analyzed and repeated for subgroups of the studies. Twelve clinical validation studies were included in the meta-analysis, comprising a total of 11,134 patients. The pooled AUC to discriminate for high-grade PCa for all 12 studies was 0.81 (fixed effects 95% CI, 0.80-0.83). Restricting the analysis to the six publications that used the contemporary 4Kscore Test algorithm led to very similar results (AUC 0.81; 95% CI, 0.79-0.83). Heterogeneity was high among all of the 12 studies, as well as among the six publications that used the contemporary 4Kscore Test (Cochrane's Q test, p = 0.001 for both); however, in both cases, after exclusion of a single outlying study with a much lower AUC, heterogeneity was no longer significant ( p = 0.08 and p = 0.21). The pooled estimate of 4Kscore Test discrimination (AUC) for high-grade PCa is >0.80, and is consistent across multiple US and European clinical validation studies.

Published
2017
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32. Corporate innovation as an engine for change: panel discussion.

Author

Friedman BA, Cartwright G, Okrongly D, Soenksen D, and Newburger M

Subjects
Diagnosis, Computer-Assisted methods, Diagnostic Imaging economics, Diagnostic Imaging methods, Humans, Interdisciplinary Communication, Organizational Innovation, Pathology methods, Diagnosis, Computer-Assisted trends, Diagnostic Imaging trends, Pathology trends
Published
2009
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