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CLEVELAND--(BUSINESS WIRE)--Cleveland Diagnostics, Inc., a biotechnology company focused on developing next-generation diagnostics for the detection of cancers, today announced the online publication of interim results for an ongoing multi-center trial of the IsoPSA™ prostate cancer test in European Urology. The findings illustrate a significantly improved diagnostic accuracy over the current gold standard, prostate-specific antigen (PSA), for both detection of any prostate cancer as well as high-grade prostate cancer. The study, led by Eric Klein, M.D., Chairman of Cleveland Clinic’s Glickman Urological & Kidney Institute, involved researchers from Cleveland Clinic, Kaiser Permanente Northwest, Michigan Institute of Urology, and other clinical sites. “ PSA has been the mainstay test in screening and diagnosing of prostate cancer for over two decades, but its sensitivity to cancer is negated by its lack of specificity for the same, resulting in millions of unnecessary biopsies and billions of precious healthcare dollars wasted annually,” said Arnon Chait, Ph.D., CEO of Cleveland Diagnostics. “ We are very pleased with the results obtained by some of the key opinion leaders in the field, and we hope to use data from this and follow-on studies to complete the validation for clinical use.” The multicenter study compared the diagnostic accuracy of Cleveland Diagnostics’ IsoPSA™ technology to PSA, the current standard in prostate cancer, in men scheduled for prostate biopsy. The results demonstrated that IsoPSA™ is significantly better than PSA in both determining whether a patient has prostate cancer and identifying patients at risk for high-grade disease, a critical distinction given the slow progression of many prostate cancers and the shift to active surveillance in properly selected patients. “ The technology underlying IsoPSA™ represents a transformational departure in how cancer biomarkers are defined. Instead of asking the non-specific question of how much of a biomarker, such as PSA, is circulating in blood, our test essentially identifies the type of PSA that originates only from cancer cells,” said Chait. The results of the study show that the non-invasive, blood-based IsoPSA™ could, if adopted clinically, reduce unnecessary biopsies by as much as 50 percent. While the United States Preventative Services Task Force (USPSTF) recently updated its assessment of PSA as a screening tool for prostate cancer from a “D” to a “C” grade, questions regarding the diagnostic accuracy of PSA in prostate cancer screening and early detection paradigms remain. “ The clinical utility of PSA to primary care providers and urologists is limited by the relatively poor diagnostic accuracy and predictive value of the test,” said Mark Stovsky, M.D., co-author and urologist at Cleveland Clinic. “ Clinicians today are using an array of diagnostic tests and procedures to inform decisions about a patient’s prostate health and the risk of prostate cancer. We believe that IsoPSA™ has the potential to fill a major void in this space.” Dr. Klein has no personal financial interest in the company. Dr. Stovsky has a leadership position (Chief Medical Officer) and investment interest in Cleveland Diagnostics, Inc. Cleveland Diagnostics, Inc., is a clinical-stage biotechnology company developing technology to improve cancer diagnostics. Its Solvent Interaction Analysis (SIA) technology investigates biomarkers at the structural level as opposed to overall concentration, giving better insights as to its cellular origin. Its pipeline of high performance, non-invasive cancer diagnostics include tests for prostate cancer, breast cancer, and Alzheimer’s disease. Visit us at For more information, please email

News Article | May 15, 2017

A team of researchers from Cleveland Clinic, Louis Stokes Cleveland VA Medical Center, Kaiser Permanente Northwest, and other clinical sites have demonstrated that a new blood test known as IsoPSA detects prostate cancer more precisely than current tests in two crucial measures - distinguishing cancer from benign conditions, and identifying patients with high-risk disease. By identifying molecular changes in the prostate specific antigen (PSA) protein, the findings, published online last month by European Urology, suggest that once validated, use of IsoPSA may substantially reduce the need for biopsy, and may thus lower the likelihood of overdetection and overtreatment of nonlethal prostate cancer. The research team, led by Cleveland Clinic's Eric Klein, M.D., conducted a multicenter prospective study of 261 men scheduled for prostate biopsy at five academic and community centers in the U.S. enrolled between August 2015 and December 2016. "Despite criticism, PSA has transformed the landscape of early detection, screening, and management of prostate cancer in the last few decades," said Dr. Klein, chair of Cleveland Clinic's Glickman Urological & Kidney Institute. "Unfortunately, PSA is tissue-specific but not cancer-specific, leading to overdiagnosis and overtreatment of biologically insignificant cancers, which is widely recognized as a key limitation in its clinical utility." The study directly compared the clinical performance of a new test based on PSA, called IsoPSA, to PSA itself with patients already scheduled for prostate biopsy. IsoPSA proved significantly superior to PSA in two key indications: discriminating between prostate cancer and benign conditions; and identifying patients with high-grade disease. The former indication is potentially useful for using IsoPSA for screening by primary care physicians, while the second is helpful for urologists in identifying patients who would benefit from curative intent therapy and other applications. The results show that if validated and adopted clinically, IsoPSA could significantly reduce the rate of unnecessary biopsies by almost 50 percent. "The methodology used in the IsoPSA assay represents a significant departure from conventional ways to define biomarkers in blood, and may be applicable to improving other cancer biomarkers," said Dr. Klein. "Due to its inherent simplicity, requiring only a blood draw and presenting information to the physician in familiar context using a single number - just like PSA itself - we are quite hopeful in IsoPSA's future utility after further validation studies," said Mark Stovsky, M.D., co-author and staff member, Cleveland Clinic Glickman Urological & Kidney Institute. The IsoPSA test was developed by Cleveland Diagnostics, a company co-founded by Cleveland Clinic, in which it has financial interest. Dr. Klein has no personal financial interest in the company. Dr. Stovsky has a leadership position (Chief Medical Officer) and investment interest in Cleveland Diagnostics, Inc. Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Among Cleveland Clinic's 51,000 employees are more than 3,500 full-time salaried physicians and researchers and 14,000 nurses, representing 140 medical specialties and subspecialties. Cleveland Clinic's health system includes a 165-acre main campus near downtown Cleveland, 10 regional hospitals, more than 150 northern Ohio outpatient locations - including 18 full-service family health centers and three health and wellness centers - and locations in Weston, Fla.; Las Vegas, Nev.; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2016, there were 7.1 million outpatient visits, 161,674 hospital admissions and 207,610 surgical cases throughout Cleveland Clinic's health system. Patients came for treatment from every state and 185 countries. Visit us at Follow us at News and resources available at

Ferreira L.A.,Cleveland Diagnostics | Uversky V.N.,University of South Florida | Zaslavsky B.Y.,Cleveland Diagnostics
Physical Chemistry Chemical Physics | Year: 2017

The solvent features of water (solvent dipolarity/polarizability, π∗, hydrogen bond donor acidity, α, and hydrogen bond acceptor basicity, β) were examined in aqueous solutions of Na2SO4, NaF, CH3COONa, NaCl, NaBr, NaI, and NaClO4 at concentrations of each salt from 0 to 1.0 M (up to 2.0 M for NaClO4). The solvent features of water in solutions of different concentrations for each salt were found to be linearly related as π∗j i = zj o + aj oαj i + bj oβj i. The coefficients of this relationship were suggested to represent the signature of the salt effect on the solvent features of water. The normalized distances for each salt were calculated using glucose as a reference compound. These distances may be used as the relative measures of the salt-water interactions. It is demonstrated that the distances for all salts examined are interrelated with structural water entropies and static polarizabilities of anions. It is shown that the distance may be used as a measure of the relative effects of salts on precipitation of ferric oxide, excessive chemical potential of propanol in salt solutions, surface tension, and viscosity. The distance represents the relative measure of the salt effect on the solvent features of water in a salt solution. The examples presented confirm that the approach used does enable us to characterize the differences between the effects of salts in the Hofmeister series on the properties of water. © 2017 the Owner Societies.

— Pancreatic Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, report provides an overview of Pancreatic Cancer Diagnostic Tests currently in pipeline stage. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Pancreatic Cancer Diagnostic Tests pipeline products Complete report on Pancreatic Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2016 spread across 175 pages is available at The report reviews the major players involved in the development of Pancreatic Cancer Diagnostic Tests and list all their pipeline projects. The report provides key clinical trial data of ongoing trials specific to pipeline products List of Tables: • Pancreatic Cancer Diagnostic Tests Products under Development • Pancreatic Cancer Diagnostic Tests - Pipeline Products under Development by Companies • Pancreatic Cancer Diagnostic Tests Companies and Product Overview • Pancreatic Cancer Diagnostic Tests - Recent Developments • Pancreatic Cancer Diagnostic Tests - Ongoing Clinical Trials • Pancreatic Cancer Companies - Pipeline Products by Stage of Development • Pancreatic Cancer Diagnostic Tests - Pipeline Products by Stage of Development • ImmunoCellular Therapeutics Announces Third Quarter 2016 Financial Results and Provides Research and Development Update • 2016: VolitionRx Announces Third Quarter 2016 Financial Results and Business Update • 2016: Merrimack Reports Third Quarter 2016 Financial Results • 2016: Exact Sciences Appoints Jeff Elliott Chief Financial Officer • 2016: OPKO Health Reports Third Quarter Financial and Operating Results • 2016: Halozyme Reports Third Quarter 2016 Financial Results • 2016: Clovis Oncology Announces Q3 2016 Operating Results and Corporate Update Company Discussed In Report: A&G Pharmaceutical Inc, Abcodia Ltd Company, BioMarker Strategies, Matrix-Bio, US Biomarkers Inc, , PeriRx LLC, Oxford Gene Technology Ltd, Asuragen, Inc, BioMarker Strategies, Cleveland Diagnostics, CompanDX Ltd, German Cancer Research Center, IV Diagnostics Scope Extensive coverage of the Pancreatic Cancer Diagnostic Tests under development. The report reviews details of major pipeline products which include, product description, licensing and collaboration details and other developmental activities. The report reviews the major players involved in the development of Pancreatic Cancer Diagnostic Tests and list all their pipeline projects. The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage. The report provides key clinical trial data of ongoing trials specific to pipeline products. Recent developments in the segment / industry Reasons to Buy Formulate significant competitor information, analysis, and insights to improve R&D strategies Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage. Identify and understand important and diverse types of Pancreatic Cancer Diagnostic Tests under development Develop market-entry and market expansion strategies. Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline. In-depth analysis of the product's current stage of development, territory and estimated launch date About Us: is an online database of market research reports offer in-depth analysis of over 5000 market segments. The library has syndicated reports by leading market research publishers across the globe and also offer customized market research reports for multiple industries. For more information, please visit

Ferreira L.A.,Cleveland Diagnostics | Breydo L.,University of South Florida | Reichardt C.,University of Marburg | Uversky V.N.,Russian Academy of Sciences | Zaslavsky B.Y.,Cleveland Diagnostics
Journal of Biomolecular Structure and Dynamics | Year: 2016

The solvatochromic solvent features of water (dipolarity/polarizability, π*, hydrogen bond donor acidity, α, and hydrogen bond acceptor basicity, β) of water have been determined in aqueous solutions of erythritol, glucose, inositol, sarcosine, xylitol and urea with concentrations from 0 to ~3 M and higher. The concentration effects of the osmolytes on the solvent features of water were characterized and compared with those reported previously for sorbitol, sucrose, trimethylamine N-oxide (TMAO), and trehalose. The solvent features of water in solutions of all osmolytes except TMAO and sarcosine were established to be linearly interrelated. It is shown that the concentration effects of essentially all nonionic osmolytes depend on osmolytes’ lipophilicity, molecular polarizability, and polar surface area. It is demonstrated that solubility of various compounds in aqueous solutions of glucose, sucrose, sorbitol, and urea of varied concentrations may be described in terms of solvent dipolarity/polarizability of water in these solutions. Surface tension of aqueous solutions of sucrose and sorbitol may also be described in the same terms. The relative permittivity of aqueous solutions of glucose and sucrose may be described in terms of the solvent hydrogen bond donor acidity of water. It is suggested that the effects of nonionic osmolytes on behavior of proteins and nucleic acids in aqueous media may be considered in terms of the altered solvent features of water instead of “nano-molecular crowding” effect. © 2016 Informa UK Limited, trading as Taylor & Francis Group

Ferreira L.A.,Cleveland Diagnostics | Madeira P.P.,University of Porto | Breydo L.,University of South Florida | Reichardt C.,University of Marburg | And 3 more authors.
Journal of Biomolecular Structure and Dynamics | Year: 2016

Analysis of the macromolecular crowding effects in polymer solutions show that the excluded volume effect is not the only factor affecting the behavior of biomolecules in a crowded environment. The observed inconsistencies are commonly explained by the so-called soft interactions, such as electrostatic, hydrophobic, and van der Waals interactions, between the crowding agent and the protein, in addition to the hard nonspecific steric interactions. We suggest that the changes in the solvent properties of aqueous media induced by the crowding agents may be the root of these "soft" interactions. To check this hypothesis, the solvatochromic comparison method was used to determine the solvent dipolarity/polarizability, hydrogen-bond donor acidity, and hydrogen-bond acceptor basicity of aqueous solutions of different polymers (dextran, poly(ethylene glycol), Ficoll, Ucon, and polyvinylpyrrolidone) with the polymer concentration up to 40% typically used as crowding agents. Polymer-induced changes in these features were found to be polymer type and concentration specific, and, in case of polyethylene glycol (PEG), molecular mass specific. Similarly sized polymers PEG and Ucon producing different changes in the solvent properties of water in their solutions induced morphologically different α-synuclein aggregates. It is shown that the crowding effects of some polymers on protein refolding and stability reported in the literature can be quantitatively described in terms of the established solvent features of the media in these polymers solutions. These results indicate that the crowding agents do induce changes in solvent properties of aqueous media in crowded environment. Therefore, these changes should be taken into account for crowding effect analysis. © 2015 Taylor and Francis.

Zaslavsky B.Y.,Cleveland Diagnostics | Uversky V.N.,University of South Florida | Chait A.,Cleveland Diagnostics
Expert Review of Proteomics | Year: 2015

Proteins have several measurable features in biological fluids that may change under pathological conditions. The current disease biomarker discovery is mostly based on protein concentration in the sample as the measurable feature. Changes in protein structures, such as post-translational modifications and in protein–partner interactions are known to accompany pathological processes. Changes in glycosylation profiles are well-established for many plasma proteins in various types of cancer and other diseases. The solvent interaction analysis method is based on protein partitioning in aqueous two-phase systems and is highly sensitive to changes in protein structure and protein–protein- and protein–partner interactions while independent of the protein concentration in the biological sample. It provides quantitative index: partition coefficient representing changes in protein structure and interactions with partners. The fundamentals of the method are presented with multiple examples of applications of the method to discover and monitor structural protein biomarkers as disease-specific diagnostic indicators. © 2015 Taylor & Francis

Myers T.R.,Cleveland Diagnostics | Tomasio L.,Cleveland Diagnostics
Respiratory Care | Year: 2011

Asthma is a multifactorial, chronic inflammatory disease of the airways. The knowledge that asthma is an inflammatory disorder has become a core fundamental in the definition of asthma. Asthma's chief features include a variable degree of air-flow obstruction and bronchial hyper-responsiveness, in addition to the underlying chronic airways inflammation. This underlying chronic airway inflammation substantially contributes to airway hyper-responsiveness, air-flow limitation, respiratory symptoms, and disease chronicity. However, this underlying chronic airway inflammation has implications for the diagnosis, management, and potential prevention of the disease. This review for the respiratory therapy community summarizes these developments as well as providing an update on asthma epidemiology, natural history, cause, and pathogenesis. This paper also provides an overview on appropriate diagnostic and monitoring strategies for asthma, pharmacology, and newer therapies for the future as well as relevant management of acute and ambulatory asthma, and a brief review of educational approaches. © 2011 Daedalus Enterprises.

Zaslavsky B.Y.,Cleveland Diagnostics | Uversky V.N.,University of South Florida | Chait A.,Cleveland Diagnostics
Biochimica et Biophysica Acta - Proteins and Proteomics | Year: 2016

This review covers the fundamentals of protein partitioning in aqueous two-phase systems (ATPS). Included is a review of advancements in the analytical application of solute partitioning in ATPS over the last two decades, with multiple examples of experimental data providing evidence that phase-forming polymers do not interact with solutes partitioned in ATPS. The partitioning of solutes is governed by the differences in solute interactions with aqueous media in the two phases. Solvent properties of the aqueous media in these two phases may be characterized and manipulated. The solvent interaction analysis (SIA) method, based on the solute partitioning in ATPS, may be used for characterization and analysis of individual proteins and their interactions with different partners. The current state of clinical proteomics regarding the discovery and monitoring of new protein biomarkers is discussed, and it is argued that the protein expression level in a biological fluid may be not the optimal focus of clinical proteomic research. Multiple examples of application of the SIA method for discovery of changes in protein structure and protein-partner interactions in biological fluids are described. The SIA method reveals new opportunities for discovery and monitoring structure-based protein biomarkers. © 2016 Elsevier B.V. All rights reserved.

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