New developments in point-of-care diagnostics include trends in biosensors, microfluidics technology, and connectivity. Biosensors and microfluidics have enabled highly sensitive molecular diagnostics and immunoassays in compact portable formats suitable for point-of-care testing. Connectivity between point-of-care devices and laboratory and health information systems is also growing to integrate test results into electronic health records.
New technologies in point-of-care nucleic acid testsPaolo Dametto
An adapted version of my technical Journal club on a new technology that detects DNA amplification using a pH-sensing system. The implications for point-of-care nucleic acid tests are significant.
Point of care testing market and forecast to 2016 global analysisRenub Research
Renub Research (http://www.renub.com/report/point-of-care-testing-market-and-forecast-to-2016-global-analysis-88) has announced the addition of the "Point of Care Testing Market and Forecast to 2016: Global Analysis" report to its offering
Point of Care Testing Market and Forecast to 2016: Global Analysis - Market Overview
The concept of Point of Care Testing (POCT), also known as bedside, near-patient testing and decentralized testing, relates to tests that are conducted by clinical operators at the site of patient care where immediate medical action is taken on the results. The fact that point of care (POCT) represents a departure from conventional laboratory medicine has created new opportunities in the field of diagnostics industry. Technical advancements over recent years have helped point of care testing (POCT) to grow with double digit CAGR from 2009 to 2011 and evolve into a vital diagnostic tool. It is predicted that point of care testing market will be approximately US$ 25 Billion by 2016.
Blood glucose test controls a lion’s market share of around 70% for the year 2011 and it is expected to continue its dominance till 2016. Rest of all the others point of care tests market share covered in this report are in single digit. Infectious disease testing market is expected to double by 2016 from its market of 2011. As countries are making the healthcare more and more accessible to people, the demand for various point of care testing is keep on rising. The point of care testing market has become an established sector worldwide and will continue to provide vital contribution in in-vitro diagnostics industry.
This 83 page report contains 26 Figures and 12 Tables provides a comprehensive analysis of the emerging point of care tests market segments, including their dynamics, size, growth, regulatory requirements, technological trends, competitive landscape, and emerging opportunities for instrument and consumable suppliers. Renub Research report entitled “Point of Care Testing Market and Forecast to 2016: Global Analysis” report also provides market landscape and market share information in the point of care testing market. The report brings together major merger & acquisition, distribution agreement, licensing deals information in point of care testing market. The report also entails major drivers and challenges of point of care testing market.
10 Point of Care Test Segments Covered in this Report
Blood Glucose Testing, Cardiac Marker Testing, Lipid Panel/Cholesterol Testing, Blood Coagulation Testing, Infectious Disease Testing, Urinalysis Testing, Drug of Abuse Testing, Fecal Occult Blood Testing, Pregnancy & Fertility Testing and Tumor Marker Testing
Point of Care Testing for Enhancing Patient Centered Planned Care DeliveryPAFP
PAFP 2013 Regional Lecture Series
Session 1 - Northeast
Presenter: Linda Thomas-Hemak, MD
The Wright Center for Primary Care
Broadcast live through the PAFP Community.
October 2nd, 2013 12pm - 1pm
Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
Our experts will dive into case studies explaining the issues that arose with past projects, and how these studies got back on track. The knowledge gained from these experiences accelerate CGT development by avoiding potential pitfalls and getting ahead of regulatory and operational issues. Our team will walk you through the delays associated with these pitfalls and how to avoid them.
Cancer Diagnostics Reference Laboratory / NeoGenomics April 2014 investors company overview presentation. This presentation highlights the following:
--Fast growing cancer genetics lab servicing Oncologists, Pathologists and Hostpitals
--Strategic client partnerships created by "Tech-Only" model
--Dynamic, rapidly-growing and consolidating industry
Industry-leading revenue & test volume growth
--Strong productivity and operating leverage leading to accelerating cash flow and net income
--Strong Management Team with large cap lab experience
New technologies in point-of-care nucleic acid testsPaolo Dametto
An adapted version of my technical Journal club on a new technology that detects DNA amplification using a pH-sensing system. The implications for point-of-care nucleic acid tests are significant.
Point of care testing market and forecast to 2016 global analysisRenub Research
Renub Research (http://www.renub.com/report/point-of-care-testing-market-and-forecast-to-2016-global-analysis-88) has announced the addition of the "Point of Care Testing Market and Forecast to 2016: Global Analysis" report to its offering
Point of Care Testing Market and Forecast to 2016: Global Analysis - Market Overview
The concept of Point of Care Testing (POCT), also known as bedside, near-patient testing and decentralized testing, relates to tests that are conducted by clinical operators at the site of patient care where immediate medical action is taken on the results. The fact that point of care (POCT) represents a departure from conventional laboratory medicine has created new opportunities in the field of diagnostics industry. Technical advancements over recent years have helped point of care testing (POCT) to grow with double digit CAGR from 2009 to 2011 and evolve into a vital diagnostic tool. It is predicted that point of care testing market will be approximately US$ 25 Billion by 2016.
Blood glucose test controls a lion’s market share of around 70% for the year 2011 and it is expected to continue its dominance till 2016. Rest of all the others point of care tests market share covered in this report are in single digit. Infectious disease testing market is expected to double by 2016 from its market of 2011. As countries are making the healthcare more and more accessible to people, the demand for various point of care testing is keep on rising. The point of care testing market has become an established sector worldwide and will continue to provide vital contribution in in-vitro diagnostics industry.
This 83 page report contains 26 Figures and 12 Tables provides a comprehensive analysis of the emerging point of care tests market segments, including their dynamics, size, growth, regulatory requirements, technological trends, competitive landscape, and emerging opportunities for instrument and consumable suppliers. Renub Research report entitled “Point of Care Testing Market and Forecast to 2016: Global Analysis” report also provides market landscape and market share information in the point of care testing market. The report brings together major merger & acquisition, distribution agreement, licensing deals information in point of care testing market. The report also entails major drivers and challenges of point of care testing market.
10 Point of Care Test Segments Covered in this Report
Blood Glucose Testing, Cardiac Marker Testing, Lipid Panel/Cholesterol Testing, Blood Coagulation Testing, Infectious Disease Testing, Urinalysis Testing, Drug of Abuse Testing, Fecal Occult Blood Testing, Pregnancy & Fertility Testing and Tumor Marker Testing
Point of Care Testing for Enhancing Patient Centered Planned Care DeliveryPAFP
PAFP 2013 Regional Lecture Series
Session 1 - Northeast
Presenter: Linda Thomas-Hemak, MD
The Wright Center for Primary Care
Broadcast live through the PAFP Community.
October 2nd, 2013 12pm - 1pm
Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
Our experts will dive into case studies explaining the issues that arose with past projects, and how these studies got back on track. The knowledge gained from these experiences accelerate CGT development by avoiding potential pitfalls and getting ahead of regulatory and operational issues. Our team will walk you through the delays associated with these pitfalls and how to avoid them.
Cancer Diagnostics Reference Laboratory / NeoGenomics April 2014 investors company overview presentation. This presentation highlights the following:
--Fast growing cancer genetics lab servicing Oncologists, Pathologists and Hostpitals
--Strategic client partnerships created by "Tech-Only" model
--Dynamic, rapidly-growing and consolidating industry
Industry-leading revenue & test volume growth
--Strong productivity and operating leverage leading to accelerating cash flow and net income
--Strong Management Team with large cap lab experience
Cellgen Diagnostics is an early stage venture that is developing a break through Companion Diagnostic platform that will enable Precision Medicine by determining whether a patients genetic profile is a match for the prescribed cancer therapeutic.
Globalization of Clinical Trials: Mutual acceptance of Medical Device dataAnnet Visscher
Technologies and regulatory standards facilitate clinical trial globalization and mutual acceptance of clinical trial data. Changes in trial execution, however, are not 1:1 reflected in foreign data acceptance. Factors such as ethnic and local requirements seem to outweigh the benefits.
The RACE for Children Act Will Change the Landscape for Pediatric Cancer Rese...Medpace
In this webinar, we explore the regulatory implications of the RACE for Children Act and what this law means for your development program, particularly with navigating the change in requirements for pediatric oncology trials. Furthermore, we explore the challenges of executing oncology trials in pediatric populations and offer insight into design and operational aspects to seamlessly execute these studies as part of your clinical development plan
2016 11-15 Lygature partnership meetup, Utrecht, Alain van GoolAlain van Gool
Contribution to the opening of the Joint Innovation Mile in the Beatrix building in Utrecht, home of the offices of Lygature, HealthRI, BBMRI-NL and others to follow.
Survival guide to stem cell research and therapiesArete-Zoe, LLC
Survival guide to stem cell research and therapies provides comprehensive guidance to publicly available resource materials, libraries and registries for people who are interested in understanding currently available treatment options involving human stem cells.
Potential: The first section explains how stem cells are currently used in research, drug testing, and therapy, and how they have to be manipulated before transfer to make any treatments possible.
Classification: Origin and ability of stem cells to differentiate into different cell types determine how different types of stem cells are typically used.
Clinical Research: In this section, we will introduce the two most important registries of clinical trials: NIH registry ClinicalTrials gov and WHO International Clinical Trials Registry Platform. A project is part of this section to give students the opportunity to get hands-on experience with collecting and collating relevant information from registries and libraries, and interpretation of the findings. Real-time interactive sessions are included to allow students to ask questions and offer additional guidance.
Patient Demand: In this section, we briefly introduce challenges relating to marketing claims, objective outcome measures, advertising strategies, and patient autonomy.
Regulatory and Legal Framework: Stem cell therapies are regulated differently in various countries around the world. In this section, we will focus on regulations that govern stem cell research and therapies in the U.S. and in the European Union. Policies on stem cell research are driven by ethical concerns relating to research that utilizes human embryos. China recently announced new ethical guidelines and new rules for its stem cell clinics, regulating both trials and treatments.
Professional Societies: The last section explains the role of professional societies in stem cell research and therapies.
As medical understanding of the genotype/phenotype correlation of a disease becomes clearer, genetic testing can be expected to become a mainstay in the clinical setting. While the application of genetic testing to the clinical setting is very much in line with the larger medical goals of preventative and personalized medicine, there are many unanswered questions with regard to genetic testing.
Speakers: Dr. Mansoor Mohammed, Genomics Portraits Inc., Dr. Brian Underdown, Managing Director, MDS Capital, Dr. June Carroll, Sydney G. Frankfort Chair in Family Medicine Mt.Sinai Hospital, Dr. Peter N. Ray, Head, Molecular Genetics Department of Paediatric Laboratory Medicine. HSC Professor, Molecular and Medical Genetics, University of Toronto
Blueprints to blue sky – analyzing the challenges and solutions for IHC compa...Candy Smellie
Manual assessment of biomarker expression is associated with significant inter- and intra reader variability. In some cases there are also limitations when it comes to sensitivity and specificity of manual biomarker assessment.
In one example to the left, the “pure” contribution of inter-reader variability associated with Ki67 assessment was quantified across 20 tumors and 126 participating labs. In that study, it was demonstrated how image analysis can be used to significantly reduce inter-reader variability.
In a another study, the National Danish Validation study of Her2, it was demonstrated how improved sensitivity/specificity of quantitative HER2 protein expression wrt gene amplification lead to significant cost savings in reflex testing.
By automating aspects of stain quality control, it will become scalable to he point where EQA organizations may be able and willing to offer more frequent – perhaps even on-demand – proficiency testing and calibration services.
It is possible that objective and quantitative standards will contribute to improve compliance with protocol recommendations.
In clinical multi-center trials it will be easier to standardize and monitor data from each center.
And it is our hope tha larger diagnostic pathology labs will be able to benefit from such a method by closely monitoring drift in staining quality for biomarkers.
Nw biotech fundamentals day 2 session 4 medical devices and diagnosticsNicholas Weston Lawyers
In this presentation:
• Definition of Medical devices and Diagnostics
• The stages of an R&D project
• The state of the art
• Regulatory nuances
• Future trends
• Challenges and opportunities
• Case studies and examples
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
The American Association of Clinical Chemistry was held this year in Atlanta, GA. Kalorama was at the meeting and notes several developments, with a particular focus on point-of-care.
What You May Have Missed at AACC 2018 White Paper - Kalorama InformationBruce Carlson
Each year the American Association for Clinical Chemistry draws tens of thousands of lab professionals and in vitro diagnostic vendors to one place. Kalorama Information was there and noted major developments at the meeting in this White Paper. Major themes of scientific sessions, new products from lab and IVD vendors are included.
Cellgen Diagnostics is an early stage venture that is developing a break through Companion Diagnostic platform that will enable Precision Medicine by determining whether a patients genetic profile is a match for the prescribed cancer therapeutic.
Globalization of Clinical Trials: Mutual acceptance of Medical Device dataAnnet Visscher
Technologies and regulatory standards facilitate clinical trial globalization and mutual acceptance of clinical trial data. Changes in trial execution, however, are not 1:1 reflected in foreign data acceptance. Factors such as ethnic and local requirements seem to outweigh the benefits.
The RACE for Children Act Will Change the Landscape for Pediatric Cancer Rese...Medpace
In this webinar, we explore the regulatory implications of the RACE for Children Act and what this law means for your development program, particularly with navigating the change in requirements for pediatric oncology trials. Furthermore, we explore the challenges of executing oncology trials in pediatric populations and offer insight into design and operational aspects to seamlessly execute these studies as part of your clinical development plan
2016 11-15 Lygature partnership meetup, Utrecht, Alain van GoolAlain van Gool
Contribution to the opening of the Joint Innovation Mile in the Beatrix building in Utrecht, home of the offices of Lygature, HealthRI, BBMRI-NL and others to follow.
Survival guide to stem cell research and therapiesArete-Zoe, LLC
Survival guide to stem cell research and therapies provides comprehensive guidance to publicly available resource materials, libraries and registries for people who are interested in understanding currently available treatment options involving human stem cells.
Potential: The first section explains how stem cells are currently used in research, drug testing, and therapy, and how they have to be manipulated before transfer to make any treatments possible.
Classification: Origin and ability of stem cells to differentiate into different cell types determine how different types of stem cells are typically used.
Clinical Research: In this section, we will introduce the two most important registries of clinical trials: NIH registry ClinicalTrials gov and WHO International Clinical Trials Registry Platform. A project is part of this section to give students the opportunity to get hands-on experience with collecting and collating relevant information from registries and libraries, and interpretation of the findings. Real-time interactive sessions are included to allow students to ask questions and offer additional guidance.
Patient Demand: In this section, we briefly introduce challenges relating to marketing claims, objective outcome measures, advertising strategies, and patient autonomy.
Regulatory and Legal Framework: Stem cell therapies are regulated differently in various countries around the world. In this section, we will focus on regulations that govern stem cell research and therapies in the U.S. and in the European Union. Policies on stem cell research are driven by ethical concerns relating to research that utilizes human embryos. China recently announced new ethical guidelines and new rules for its stem cell clinics, regulating both trials and treatments.
Professional Societies: The last section explains the role of professional societies in stem cell research and therapies.
As medical understanding of the genotype/phenotype correlation of a disease becomes clearer, genetic testing can be expected to become a mainstay in the clinical setting. While the application of genetic testing to the clinical setting is very much in line with the larger medical goals of preventative and personalized medicine, there are many unanswered questions with regard to genetic testing.
Speakers: Dr. Mansoor Mohammed, Genomics Portraits Inc., Dr. Brian Underdown, Managing Director, MDS Capital, Dr. June Carroll, Sydney G. Frankfort Chair in Family Medicine Mt.Sinai Hospital, Dr. Peter N. Ray, Head, Molecular Genetics Department of Paediatric Laboratory Medicine. HSC Professor, Molecular and Medical Genetics, University of Toronto
Blueprints to blue sky – analyzing the challenges and solutions for IHC compa...Candy Smellie
Manual assessment of biomarker expression is associated with significant inter- and intra reader variability. In some cases there are also limitations when it comes to sensitivity and specificity of manual biomarker assessment.
In one example to the left, the “pure” contribution of inter-reader variability associated with Ki67 assessment was quantified across 20 tumors and 126 participating labs. In that study, it was demonstrated how image analysis can be used to significantly reduce inter-reader variability.
In a another study, the National Danish Validation study of Her2, it was demonstrated how improved sensitivity/specificity of quantitative HER2 protein expression wrt gene amplification lead to significant cost savings in reflex testing.
By automating aspects of stain quality control, it will become scalable to he point where EQA organizations may be able and willing to offer more frequent – perhaps even on-demand – proficiency testing and calibration services.
It is possible that objective and quantitative standards will contribute to improve compliance with protocol recommendations.
In clinical multi-center trials it will be easier to standardize and monitor data from each center.
And it is our hope tha larger diagnostic pathology labs will be able to benefit from such a method by closely monitoring drift in staining quality for biomarkers.
Nw biotech fundamentals day 2 session 4 medical devices and diagnosticsNicholas Weston Lawyers
In this presentation:
• Definition of Medical devices and Diagnostics
• The stages of an R&D project
• The state of the art
• Regulatory nuances
• Future trends
• Challenges and opportunities
• Case studies and examples
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
The American Association of Clinical Chemistry was held this year in Atlanta, GA. Kalorama was at the meeting and notes several developments, with a particular focus on point-of-care.
What You May Have Missed at AACC 2018 White Paper - Kalorama InformationBruce Carlson
Each year the American Association for Clinical Chemistry draws tens of thousands of lab professionals and in vitro diagnostic vendors to one place. Kalorama Information was there and noted major developments at the meeting in this White Paper. Major themes of scientific sessions, new products from lab and IVD vendors are included.
Real world clinical medical data. Corporate presentation of Ad Scientiam which is a startup specialized in real life data acquisition during clinical trials.
Learn more at : www.adscientiam.com
PharmaLedger Press Release #2 June 2020 PharmaLedger
PharmaLedgers June 2020 press release covers the strong foundations in the project’s first year and how it set the stage for accelerated development and ecosystem engagement.
The press release also announces the establishment of PharmaLedger’s Advisory Board and the outlook for 2021.
—
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
Early diagnosis of infectious diseases and monitoring of community health are essential
for delivering cost-effective healthcare solutions. Healthcare delivery in developing coun-
tries have many challenges because they do not have enough resources for meeting the
healthcare needs, and they lack testing lab infrastructures in communities. It is necessary that a solution must be developed to safeguard the impacted communities. It has
been proven that Point-Of-Care (POC) testing can be considered as one of the ways to
resolve the crisis in healthcare delivery in these communities. The term 'POC testing'
has been used in many contexts. Use case, where a passenger in an autonomous vehicle
is driven to the nearest hospital for an emergency treatment due to an alert received by
the health monitoring system in the car. The POC that the research exploring is for
the use for a remote patient who does not have access to lab testing facilities because of
the social and economic conditions in that community.
The POC testing is a mission critical processes in which the patient conduct tests in a
home environment, as opposed to the tests undertaken otherwise in a laboratory facility
and it needs a communication system of architecture support which the research refers
as POCT system. The research looked at the requirements and made recommendations concerning critical aspects: requirements gathering for POCT system, design and
development methods of secure communication architecture, finding a suitable strategy
for testing the system and project managing the end-2-end process.
Data security is another critical factor in healthcare data. The research came up with
secure data communication architecture and processes for the system. A secure data
storage for the test results are needed, and the research came up with an architecture
for cloud storage. Deployment and expansion of the secure communication system are
essential for practical use cases based on community needs, and a scalable communication
architecture was developed to support the objective.
March 5, 2015 PoCDx Seminar - Wallace White, Stratos - Development of the Pan...BerkeleyPoCDx
Development of the PanDx Integrated Diagnostic Platform
Wallace White
Director, Point-of-Care Diagnostics
Stratos Product Development
UC Berkeley, March 5, 2015
After a decade developing point-of-care diagnostics for commercial clients, Stratos Product Development was approached by the Bill and Melinda Gates Foundation for a bigger challenge: creating a single system capable of all the diagnostics needed at primary health clinics in developing countries. In this—the first public talk on the project—Wallace White will describe the development of the PanDx system and share observations from the health-clinic visits on three continents that have informed it.
Video of the talk is available on YouTube: https://www.youtube.com/watch?v=9oewE5NH4mI
HospitalSoftwareShop provides exhaustive LIS Software - Laboratory Information System -for Pathology Labs. Being web-based makes lab software globally accessible. Software for labs offers widest range of pathology tests, direct integration with lab equipment without manual intervention reduces errors and time
ApolloDx is developing a Mobile Diagnostic Platform comprised of a smart device attached to an analyzer. This system provides and transmits laboratory-quality, GPS-tagged results in 10 minutes or less. It is capable of multiplexing a broad range of analytes from ions to cells and discerning viable versus non-viable pathogens. The bidirectional data transmission with real-time analytics enables medical professionals to practice evidence-based medicine.
Point-of-Need Testing: Application of Microfluidic Technologies - 2018 Report...Yole Developpement
Decentralized testing is now widespread, thanks to the endless possibilities enabled by microfluidic technologies.
More information on that report at https://www.i-micronews.com/report/product/point-of-need-testing-application-of-microfluidic-technologies.html
LIMS in Modern Molecular Pathology by Dr. Perry MaxwellCirdan
This presentation was delivered by Dr Perry Maxwell, Queen's University Belfast at Pathology Horizons 2017 in Cairns, Australia.
Pathology Horizons is an annual CPD conference organised by Cirdan on the future of pathology. You can access more information on the event at www.pathologyhorizons.com
Similar to New Developments in Point of Care Diagnostics (20)
The American Association of Clinical Chemistry is the largest gathering of lab professionals. It's also a time and place for IVD suppliers to show off new products. This year in Philadelphia, there were new products on display and new trends in evident.
The United States might out-perform the IVD markets of many other nations in growth as well as size. Yet there are challenges. Will ACA-based changes be shortlived? This White Paper discusses them. Based on information from our United States IVD Market.
5 Cutting-Edge Trends in Molecular DiagnosticsBruce Carlson
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The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
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This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
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Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
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ACCORDING TO apic.org,
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ACCORDING TO pewtrusts.org,
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VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
Struggling with intense fears that disrupt your life? At Renew Life Hypnosis, we offer specialized hypnosis to overcome fear. Phobias are exaggerated fears, often stemming from past traumas or learned behaviors. Hypnotherapy addresses these deep-seated fears by accessing the subconscious mind, helping you change your reactions to phobic triggers. Our expert therapists guide you into a state of deep relaxation, allowing you to transform your responses and reduce anxiety. Experience increased confidence and freedom from phobias with our personalized approach. Ready to live a fear-free life? Visit us at Renew Life Hypnosis..
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CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
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Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
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1. New Developments in
Point-of-Care (POC)
Diagnostics
POC Biochips and device connectivity are among the new trends in point of care
Diagnostics covered in this white paper, based on information from Kalorama
Information’s latest report on the testing market, The World Market for Point of
Care Testing.
POC Biosensors
Molecular diagnostics and extremely sensitive next-generation immunoassays are
now available for POC testing and physician office laboratories through the
development of microfluidics and biosensors. Biosensor technology use substrates, nanomaterials and
advanced spectroscopic or electromagnetic wavelength analysis methods to perform extremely sensitive
testing on a small platform that signals results through an electronic digital system. Industry leveraging of
biosensor and microfluidics technologies has been diverse with manifold products available on the market
and in development.
These unique test formats are very applicable to POC testing as they eliminate the requirement for
multi-step assay preparation and extensive or complex reagent and or wet chemistry handling.
Microfluidics technology has made the transition from research into the commercialized IVD space
through the use of multichannel and multiplex cartridges, cassettes and
cards. These self-contained, largely disposable, assays can be run alone or in
conjunction with an analyzer that determines results through a luminescent,
fluorescent or chromatographic result that is digitized. A common feature of
such prototypes and products is the miniaturization of clinical lab
capabilities onto new assay forms.
Products enabled by biosensors or microfluidics are intended to produce
lab quality results outside of the laboratory and to be used by relatively
untrained operators. Competition between numerous molecular POC platform providers and developers
may factor significantly into future POC markets. Currently, molecular POC systems are targeted
primarily for hospital markets and POC markets in developing regions.
Based on Information from
Kalorama Information's
The World Market for
Point of Care Diagnostics
http://www.kaloramainform
ation.com/Point-Care-POC-
9030928/
2. Selected Biochip and Biosensor Players
Company/ Organization Location Target Details
Acrongenomics Inc. Switzerland creatinine BioLED Lab on a Chip; urine creatinine
Ativa Medical U.S. various Analyzer and microfluidics test card systems
Biocartis Switzerland various Molecular Diagnostics Platform and Multiplex
Detection Platforms (immunodiagnostic)
Biomagnetics Diagnostics U.S. / China inf dis Integrity Optical Biosensor (IOBS); infectious
diseases
Biosensia Ltd. Ireland various RapiPlex microfluidics immunoassay instrument
and test card system with multiplexing capability
Diagnostics for All U.S. inf dis Paper-based microfluidics card; infectious diseases
in developing world
EKF Diagnostics GmbH Germany glucose / lactate BIOSEN instrument chips for enzymatic detection
and quantification of glucose and lactate
Gentag Inc. U.S. various Printable biosensors on adhesive battery-less RFID
skin patch for glucose monitoring, other patient
monitoring parameters, pathogen and cancer
marker detection
Great Basin Corporation U.S. inf dis Company platform combines isothermal
amplification with chip-based detection
Hai Kang Life Corp. Hong Kong multiplex
molecular
EFADchip using electric field-assisted
hybridization
Innovative Biosensors U.S. inf dis Immunodiagnostic technologies and biosensor
components for infectious disease testing,
including HAIs
Micronics (Sony
Corporation)
U.S. blood type / inf
dis
Laminar flow diffusion cards for rapid blood
typing products and analyzer system for rapid
molecular detection of infectious pathogens
Philips Handheld
Immunoassays
Netherlands cardiac /
emergency
Magnotech technology uses magnetic fields to
wash away analyte-unbound magnetic
nanoparticles and quantify remaining analytes;
cardiac markers
Q-linea Sweden inf dis Amplified Single Molecule Detection (ASMD)
recognition and microfluidics analysis system for
targeting nucleic acids and proteins
QuantuMDx Group U.K. inf dis
cancer markers
Diagnostic and sequencing bio-chips; developing a
microfluidic solution for nucleic acid extraction,
nanowire-based biosensor, genomic sequencing
biosensor, and thermal reactor (amplification)
based on microfluidic channels; Q-POC cartridge-
based POC analyzer
Rhenoix U.S. inf dis
companion
POC molecular analyzer and self-contained,
microfluidics all-in-one molecular cartridges
Sentinel Bioactive
Paper Network
Canada inf dis Paper-based immunochromatographic sensors
Veredus Laboratories Singapore influenza VereID Biosystem, PCR lab-on-a-chip
VeriTeQ Corporation U.S. glucose Implantable RFID glucose monitoring biochip
acquired from PositiveID Corporation
Source: Kalorama Information
3. Microfluidics technology has been widely implemented in molecular multiplex assays and in many
nascent alternative format immunoassays. Biosensors generally have failed to live up to previous
expectations of a +$1 billion clinical and applied diagnostics market (with the exception of the common
glucose meter), but continue to draw interest in the form of academic research and start-ups.
Commercialized and cleared biosensors would find ready application in the POC setting due to small
system footprint, the elimination of user interpretation (biosensor design implies a digitized result), and
flexible throughput (disposable assay through small benchtop systems).
Beyond molecular POC systems (primarily for infectious diseases), biosensor- and microfluidics-
enabled systems and assays will represent nascent or niche markets for POC testing.
POC Connectivity
Connectivity in POC testing has transcended the interface between device and user or computer to
support the integration of POC and POL testing results in greater laboratory information and health
information systems (LIS/HIS). Healthcare consolidation has intensified demand for data and results
availability from POC testing on organization systems that can be shared among clinics, hospitals, and
affiliated laboratories. Suppliers of POC testing products and third-party vendors have appropriately
standardized POC instrument-desktop/laptop computer connectivity, complete with data management
software or features, and have developed solutions for data conversion and availability on same-party and
third-party information systems. Continued consolidation in healthcare systems and mounting pressure to
coordinate care and eliminate unnecessary repeat services will encourage greater penetration of
connectivity solutions among POC instruments and devices.
Device connectivity with office, practice or clinic computers is easily accomplished with device
manufacturer data management software. Device data and test results can be downloaded or uploaded to a
POC device through wireless connection, USB port, docking station, or ancillary device. Data
compatibility and standards are more easily achieved in device-computer interfaces and closed systems,
allowing a specialty clinic or practice to streamline test volumes from one
device – whether hematology analyzer, coagulation analyzer, or
immunoanalyzer.
The true challenge and increasingly evident imperative for POC
suppliers is the interconnection of POC test devices through an interface
with laboratory information systems (LIS). Largely absent standards for
POC test data run afoul of quality assurance (QA)/quality control (QC)
requirements and efficient user or operator data management. In a study by
Kalorama Information, only 4 out of 17 major LIS vendors offered systems with POC interface
capabilities. The POC-LIS interface will be the chief focus of development as POC test data integration
with organization LISs will in turn ensure the inclusion of POC test results in patient electronic records on
Based on Information from
Kalorama Information's
The World Market for
Point of Care Diagnostics
http://www.kaloramainform
ation.com/Point-Care-POC-
9030928/
4. HISs and electronic medical records (EMRs). While physician offices and practices have not seen EMR
penetration on the scale of hospitals and inpatient care facilities, the associated market is expected to see
the highest growth in the short term as EMR vendors seek out growth by downscaling products or remote
hosting systems to make investment more amenable to smaller clients. With the penetration of EMR into
the physician office market, POC tests will also require POC test device interfaces – whether direct or
indirect – with electronic patient records.
Middleware has also emerged as a solution to the development of POCT-LIS/EMR interfaces.
Middleware vendor TELCOR’s QML system architecture uses its population of device-specific drivers to
reformat data for upload and download between POC test devices and health systems. TELCOR
middleware for POC connectivity is available for the following POC devices:
• Abaxis Piccolo Xpress
• Abbott Diagnostics CELL-DYN Emerald and 1800; Abbott Point of Care i-STAT; Abbott
Diabetes Care glucose meters
• Accriva Diagnostics VerifyNow, Hemocron Signature, and Hemocron Response
• Alere Afinion and Triage
• Beckman Coulter Ac·T
• Bio-Rad Laboratories in2it (II)
• Helena Laboratories Cascade POC and ICHOR II
• HemoCue (Radiometer) 201DM, B-Hg, and Glucose
• Horiba ABX Micros 60 and Pentra 60C+
• Instrumentation Laboratory GEM PCL Plus
• Quidel Sofia
• Roche Diagnostics CoaguChek XS Plus, CoaguChek XS Pro, and Urisys 1100
• Sysmex pocH-100i
Additional connectivity solutions are available through manufacturers such as Abbott (i-STAT
instrument dock for download and POC data manager software; integration possible through Abbott,
Alere, RALS and TELCOR architectures), Alere (Afinion optional data connectivity converter
component; Triage Census ATM system for upload/download capability); Roche Diagnostics
(CoaguChek ancillary device for wireless transmission of device data and upload onto connected
computer); and Abaxis (data manager software able to connect to up to 8 Piccolo Xpress instruments).
Many benchtop analyzers feature connectivity features as product extensions of core lab instruments.
Additionally, a subset of lab instruments and analyzers are able to connect HL7 data transfer directly
to an EMR system, eliminating the requirement for interfaces or additional systems.
5. The World Market for Point of
Care (POC) Diagnostics
The World Market for Point of Care (POC) Diagnostics presents
the most current and authoritative analysis of the POC diagnostics
industry and the role it plays in medical practice. This report takes
an in-depth look at the POC diagnostic testing market, both
professional and self-testing. The report provides exclusive market
sizing and growth projections for the following POC market
segments:
• Blood Glucose Tests
• Blood and Electrolytes Testing Market
• Rapid Coagulation
• Rapid Cardiac Markers
• Substance Abuse Testing
• Pregnancy and Fertility Testing
• Colon Cancer Screening/Fecal Occult Blood Testing
• Infectious Disease Testing
• Cholesterol Testing
• Cancer Testing
• Urine Strip Testing
• Miscellaneous POC Testing
Who are the top companies in the market? What types of point of care testing is selling fastest? What
disease areas will drive near-patient forward? Is POC earning its place in clinical practice? How is home
testing progressing? These questions and more are addressed in Kalorama
Information’s report. Past editions of the report have long been used by top
point of care test makers to conduct business planning.
The report’s geographic scope is worldwide with information for specific
geographical regions, world demographics, and other general issues
affecting the market. All market data pertain to the world market at the
manufacturers’ level. The market includes manufacturer tests excluding
services. The base year for data is 2014.
Historical data is provided for the years 2012 and 2014, with forecast data
provided for 2014 through 2019. Compound annual growth rates (CAGRs)
are provided for 2014-2019 periods for each segment covered. Competitive
analysis is provided for the year 2014.
6. Market analysis of the global POC testing market includes:
• Market Overview
• Market Analysis by Product Categories
• Market Analysis by Subcategory: POC Professional Testing, POC Self-Testing
• Market Analysis by Country: United States, Germany, France, UK, Switzerland, Japan,
China, India
• Market Conclusions
• Competitive Analysis
• Trend-Reimbursement Challenges
• Trend-Competition
• Trend-POC and Biosensors
• Trend-POC Connectivity
• Trend-The Emergence of Non-invasive Technologies
Among the top and/or innovative competitors discussed within the report's
Corporate Profiles:
• Abaxis
• Abbott Labs
• Accriva
• ACON
• Alere
• Arkray
• Beckman Coulter
• bioMerieux
• Church & Dwight
• Eiken Chemical
• EKF Diagnostics
• Enterix
• Helena Labs
• Insight Pharmaceutical
• Instrumentation Laboratories
• LifeScan
• Macherey-Nagel
• Meridian BioScience
• Nova Biomedical
• OPKO Health
• OraSure
• Ortho Clinical Diagnostics
• Polymed Therapeutics
• Polymer Technologies
• Quidel
• Radiometer Medical
• Response Biomedical
• Roche Diagnostics
• Siemens Healthcare
• Sysmex
• Trinity Biotech
FOR MORE INFORMATION OR TO ORDER
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