Point-of-Care Diagnostics & Global Health World Congress Agenda

Badge and Conference Materials Pick-Up

Regulatory Briefing: Overcoming Regulatory Challenges in Bringing Point-of-Care Tests to Market
James Boiani, Partner, Epstein Becker & Green, P.C., United States of America

Point-of-Care Testing has had a profound impact on patient care, and the public health benefits of expanding access to more novel POCTs is
unquestionable.  However, going through the FDA review process to get the marketing clearances and approvals you need to take tests from the bench
top to the bedside is no easy task.  In this presentation, we'll explore strategies to prevent and solve obstacles arising during FDA pre-market and CLIA Waiver reviews.

Phenotypic Personalized Medicine: Merging Nanomedicine with Engineering Optimization Platforms to Transform Combination Therapy
Dean Ho, Professor and Co-Director, University of California-Los Angeles, United States of America
Dong-Keun Lee, Research Scientist, University Of California Los Angeles, United States of America

Nanodiamonds have emerged as promising agents for drug delivery and imaging due to their unique surface properties. Nanodiamond-anthracycline compounds have mediated major improvements to drug delivery efficacy and safety. Most recently, NDX, a nanodiamond-doxorubicin agent, markedly enhanced the pre-clinical treatment efficacy of multiple drug-resistant tumor models with no apparent myelosuppression, demonstrating potent drug binding and the absence of early drug release. The combination of these pre-clinical advancements in diamond-based nanomedicine and nanodiamond surface properties serves as a foundation for a promising developmental roadmap that will be discussed. More recently, or team has focused on the integration of nano-modified and unmodified drug administration towards improved combination therapy via engineering optimization platforms. More specifically, we have developed a Phenotypic Personalized Medicine (PPM)-based platform for the mechanism-independent optimization of combination therapy towards a broad spectrum of diseases. The translational progress of the PPM platform will be highlighted.

On-Site, Rapid, Molecular Detection of Pathogens and Cancer Markers
Haim Bau, Professor, University Of Pennsylvania, United States of America

Our group at Penn is developing a system for on-site, rapid (<30 min), molecular detection of pathogens and specific nucleic acids in body fluids, food, and water.  The system isolates, concentrates, and purifies nucleic acids with membrane capture. The isolated nucleic acids are subjected to isothermal enzymatic amplification.  An array of amplification reactors operate in parallel to enable detection of multiple markers.  Reverse transcription and amplification are carried out in a single process.  The amplicons are detected either by eye or with a smartphone camera.  All necessary reagents for the assay are dry-stored on chip and released just in time.  We will also describe the determination of HIV viral load and the detection of parasitic helminths in blood.

Enabling Platforms for Multiplex Diagnostics
Claude Dufresne, President, SCIENION US INC, United States of America

A number of technologies have evolved that are very well suited for the creation and manufacturing of multiplex diagnostics tests.  This presentation will illustrate how biological content can be used to create high quality diagnostics devices.  Examples covering different platforms will include R&D and production aspects on lateral flow strips, microarrays in microtiterplates, and on custom biochips. While Lateral Flow test strips have been around for a long time, their multiplex version, based on spot arrays, is just now emerging in the next wave of low cost diagnostics.  In central diagnostic labs, the use of microarrays in microtiter plates allows for a high degree of multiplexing together with a very high sample throughput. Finally, a number of companies have developed unique diagnostic format platforms. Often based on custom fabricated biosensors, electrodes or other CMOS structures need to be loaded with biological substances in a way that does not damage surface features.

Rapid and Absolute Quantification of Rare Antibiotic-resistant Bacteria Using Droplet-based Microfluidics
Dong-Ku Kang, Assistant Research Scientist, University of California-Irvine, United States of America

Antimicrobial resistance is a growing health problem in the United States and worldwide. According to the Centers for Disease Control and Prevention (CDC), more than two million people are infected annually with antibiotic-resistant infections, with >23,000 deaths. Especially, extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae is commonly found in K. pneumoniae and Escherichia coli are among the most prevalent antimicrobial resistant pathogens. Rapid diagnostics are particularly needed for pathogens such as E. coli, which are common, virulent, and have acquired ESBLs. Furthermore, diagnostic tests that can confirm the presence of ESBLs regardless of the species would be exceedingly valuable in directing early therapy and enabling better antimicrobial stewardship for those not infected with antibiotic resistant pathogens. Unfortunately, existing bacterial detection methods are limited in their inability to rapidly detect and identify pathogens that typically occur at low concentrations in blood (1 to 100 colony-forming unit (CFU)/mL) as is commonly found in adult BSIs. Here, we will discuss about our strategy for monitoring beta-lactamase producing bacteria at single-cell sensitivity within a few hours by miniaturized droplet-based microfluidic system.

In Vitro Nanocytology Test for Highly Accurate Early Cancer Screening and Prognostication in Primary Care Setting
Hariharan Subramanian, Chief Technology Officer, NanoCytomics LLC, United States of America

NanoCytomics, LLC in collaboration with Northwestern University and Boston Medical Center is developing a new in vitro technology platform termed nanocytology for highly sensitive, cost-effective and non-invasive cancer screening and prognostication in a primary care setting. The optical assay measures the nanoscale alterations in chromatin structure as a highly robust and accurate marker of field carcinogenesis in lung, colon, and prostate cancers. A significant application of nanocytology is in cancer screening enabled by the detection of field carcinogenesis via the analysis of the nanoarchitecture of cells obtained from easily accessible surrogate tissue sites with the objective to increase the detection rate of significant pre-neoplastic or neoplastic lesions while reducing overdiagnosis. Examples include the analysis of rectal cells for colon neoplasia and buccal (cheek) cells for lung cancer identification. Data from multi-institutional clinical trials has demonstrated that nanocytology has the potential to become a new platform for cancer screening broadly applicable to a number of organ sites from which cellular specimen can be obtained.

Close of Session.

Conference Registration and Continental Breakfast in the Exhibit Hall. Exhibit Hall Opens.

Coffee Break, Networking, Visit the Exhibitors and Poster Viewing

Point of Care Technologies in the Diagnosis of Breast Cancer in Both Resource-Rich and Poor Settings
Jane Brock, Chief of Breast Pathology, Brigham and Women’s Hospital, Harvard Medical School, United States of America

Breast Cancer care includes prevention, early detection, diagnostics and therapeutics. Therapeutic decisions are made based on traditional prognostic factors including tumor size, lymph node status, and factors obtained from pathological assessment including tumor grade, immunohistochemical profile of Estrogen and Progesterone Receptor (ER and PR) and Her2/neu gene amplification status. Point of care technology is not currently used in this routine pathological assessment, but there are opportunities to both expedite diagnosis and reduce costs in both resource-rich and poor settings. This presentation will discuss alternative methods of tissue biopsy handling and imaging, that can obviate the need for expensive processing equipment (that is rarely available in resource-poor settings), and can allow for rapid diagnosis, compared with traditional tissue processing (within fifteen minutes rather than > 24 hours). Tissue diagnosis by a pathologist remote from the point of care technology is also possible (pathologists are rarely available in resource-poor settings). The utility of providing a more rapid diagnosis in resource-rich settings will be increasingly apparent, as pre-treatment tumor samples are now routinely obtained to assess molecular signatures of targeted therapeutic susceptibility or resistance in the research setting. Rapid prognostic marker diagnosis, using either fresh or fixed tumor mRNA PCR, could easily replace the traditional histological evaluation for tumor grade, and ER, PR and HER2 status evaluation by immunohistochemistry on formalin-fixed, processed tissue specimens.  Such simple PCR amplification technology can provide the prognostic marker results within just a couple of hours, and can be a cheaper viable alternative for providing prognostic marker information, as it requires less skilled labor, both for the testing procedure and reading the test results, along with fewer reagents and fewer pieces of equipment overall. As such, it is

Networking Lunch in the Exhibit Hall, Visit the Exhibitors, and Poster Viewing

Technology Spotlight:
Isothermal Amplification Detection
Roberto Spricigo, OEM Manager, Point-of-Need, QIAGEN Lake Constance

The need for a thermal cycling instrument or a skilled technician to perform a PCR assay can sometimes be prohibitive for resource-poor settings. The presentation gives an overview on isothermal amplification technologies and the new dedicated solutions provided by QIAGEN Lake Constance GmbH. Sensing nucleic acid sequences is crucial for modern biology and medicine. This sector has grown exponentially since the 1990s and it is likely to continue to increase in its importance over the next few decades.

Non-Invasive Methods of Diagnostics for Women’s Health
Barbara Smith, Assistant Professor, School of Biological and Health Systems Engineering, Arizona State University, United States of America

Development of translational diagnostics tools, including: (i) molecular diagnostics on paper, and (ii) olfactory sensing for early cancer detection.  The goal of this work is to develop useful point-of-care devices that are translated from the bench-top into the hands of the user.

• Molecular diagnostics on paper.  We are developing a completely on-board assay - from sample to results.  In this work, paper is used as a microfluidic platform, where reagents are stored and the device provides a basis for multiplexed detection of nucleic acids.  The detection is made to be low-cost, simple-to-use and easy-to-read, non-invasive, fieldable, and fully disposable. 

• Olfactory sensing.  We are detecting volatile organic compounds (VOC’s), specific to cancer cells.  Through the determination of these biomarkers, we aim to develop an external sensor for the point-of-care, non-invasive detection of cancer.

Design for Point-of-Need Testing in the Developing World
Marya Lieberman, Professor, University of Notre Dame, United States of America

This talk will focus on design of paper millifluidic devices for chemical analysis outside a laboratory setting.  The main  analytical applications that our group has pursued are detection of low quality or fake pharmaceuticals and quantitative analysis of the iodine content of iodized salt.   Paper test cards for analysis of five antibiotics (ampicillin, amoxicillin, amoxicillin/clavulanate, azithromycin, and ciprofloxacin) are being implemented in the pharmacovigilance system of the second largest hospital in Kenya, and a titration-on-paper card is undergoing external validation studies and technology comparison studies at labs in South Africa and Burkina Faso.  Because academic researchers in the developed world are sometimes frustrated when they attempt to translate laboratory prototypes to field studies in the developing world, this talk will focus on design features that made the test cards more acceptable for users in the developing world. Key design elements included bringing researchers to the field setting to better understand user constraints , maintaining connections to users; selection of analytical targets that our users think are most important; using cell phones to read card results, which makes the devices easier to use; and a life-cycle approach that maximizes ease of manufacture and minimizes the hazard and environmental impact of the cards.  The resulting point-of-need devices balance sensitivity, selectivity, and robustness in order to meet the user's analytical goals in a field setting where instruments, electricity, reagents, and laboratory equipment are often not available.

Coffee Break, Networking, and Visit the Exhibitors

Creating Point-of-Care Diagnostics for Use in Resource-Limited Settings: Lessons Learned from South Africa
Paul Drain, Instructor of Medicine, Harvard Medical School, United States of America

Point-of-care diagnostics have improved dramatically in accuracy, rapidity, accessibility, and cost during the last several decades. While rapid diagnostic tests for HIV have been widely adopted worldwide, newer molecular tests for tuberculosis are facing operational challenges and programmatic resistance. The Xpert MTB/RIF assay–a rapid molecular diagnostic test for tuberculosis–was endorsed by the World Health Organization in 2010. By June 2014, 3,269 GeneXpert instruments and over 7.5 million Xpert MTB/RIF tests had been procured in developing countries. South Africa has a very high burden of tuberculosis, and started implementing the Xpert MTB/RIF assay throughout national laboratories in 2011. Although the test has been called a “game changer,” nearly every study in South Africa has shown that Xpert MTB/RIF has not had a significant clinical impact or been cost-effective. I will present our study data demonstrating that centralized use of Xpert MTB/RIF was slower than conventional tuberculosis tests (e.g. culture and smear microscopy), and summarize additional studies on the application and clinical impact of the test’s rollout in South Africa. By reviewing the experience of South Africa’s real-world experiment in introducing a rapid molecular diagnostic test, I will highlight the critical lessons learned for the future design and implementation of advanced diagnostics for infectious diseases. I will present our revised criteria for an ideal diagnostic point-of-care test, which were recently published in The Lancet. Finally, I will summarize the appropriate clinical evaluations of these tests and conclude with common benchmark criteria that novel point-of-care diagnostics should achieve in order to gain widespread global use.

One Size Fits All – A Microfluidics-enabled Platform for a Broad Range of POC Diagnostic Assays
Holger Becker, Chief Scientific Officer, Microfluidic ChipShop GmbH, Germany

Microfluidics has emerged as one of the crucial enabling technologies for POC diagnostics. The ability to integrated complex diagnostic assays, especially molecular diagnostic assays onto a single consumable has led to a dramatic growth of academic and commercial activities in this field. The big challenge however remains that such solutions in the past have typically been disease-specific, leading to the necessity to have a variety of different systems in a diagnostic lab. We present here a universal microfluidic-enabled POC platform which is capable of performing molecular diagnostic, immunodiagnostic and clinical assays with a single system. As demonstrator cases, a molecular assay for TB, an immunoassay for HIV and a clinical assay for ALT will be presented which all run on this single benchtop instrument platform.

Non-Invasive Biomarker Sensing Through Sweat
Jason Heikenfeld, Professor and VP Operations, UC Office of Innovation, University of Cincinnati, United States of America

Using sweat for non-invasive access to biomarkers has shown promising clinical results for decades. A compelling commercial scenario is now upon us, enabled by advances in wearable electronics, low-cost electronic mM to pM sensing techniques, and a deeper understanding of how biomarkers partition into sweat.  We present the latest results from a large consortium of researchers lead by the University of Cincinnati, in creation of sweat patches for continuous physiological monitoring.

Microfluidic Blood Cell Counters for Biomedical Diagnostics
Rashid Bashir, Professor And Head, University Of Illinois, United States of America

Integration of biology, medicine, and fabrication methods at the micro and nano scale offers tremendous opportunities for solving important problems in biology and medicine and to enable a wide range of applications in diagnostics, therapeutics, and tissue engineering. Microfluidics and Lab-on-Chip can be very beneficial to realize practical applications in detection of disease markers, counting of specific cells from whole blood, and for identification of pathogens, at point-of-care. The use of small sample size and electrical methods for sensitive analysis of target entities can result in easy to use, one-time-use assays that can be used at point-of-care. In this talk, we will present our work on detection of T cells for diagnostics of HIV AIDs for global health, development of a CBC (Complete Blood Cell) analysis on a chip, electrical detection of multiplexed nucleic acid amplification reactions, and detection of epigenetic markers on DNA at the single molecule level. While the above mentioned devices are built with PDMS or silicon, bio-printing with stereolithography can be a very powerful technology to produce bio-hybrid devices made of polymers and cells such as biological machines and soft robotics. These devices could have potential applications in drug delivery, power generation, and other biomimetic systems.

Portable Platform Technologies for Detecting Pathogens and Cells at the Point-of-Care
Utkan Demirci, Professor, Stanford University School of Medicine, United States of America
Fatih Inci, Postdoctoral Research Fellow, Stanford University School Of Medicine, United States of America

Micro/nano-scale technologies can have a significant impact on medicine and biology in the areas of cell manipulation, diagnostics and monitoring. At the convergence of these new technologies and biology, we research for enabling solutions to the real world problems at the clinic. Emerging nano-scale and microfluidic technologies integrated with biology offer innovative possibilities for creating intelligent, mobile medical lab-chip devices that could transform diagnostics and monitoring, tissue engineering and regenerative medicine. In this talk, we will present an overview of our laboratory's work in these areas focused on applications in point-of-care and primary care settings including applications for ovarian cancer detection from urine, rapid CD4 counts for global health, multiple pathogen detection with a focus on viral load from unprocessed whole blood and bedside peritonitis detection for end-stage kidney disease patients going through peritoneal dialysis therapy. These emerging technologies could shape our future creating broadly applicable platforms for scientific discovery, providing clinical solutions for resource-constrained settings in the developing world as well as for primary care settings in the developed world.

Networking Reception: Enjoy an Awesome Evening and Network with your Fellow Delegates, Visit Exhibitors, and View Posters. Beer, Wine, and Appetizers will be Served

Close of Day 2 of the Main Conference

Morning Coffee, Breakfast Pastries, and Networking in the Exhibit Hall

Breakfast Briefing: A Disposable, Visual, Color-Based, Patient-Operated Anemia Diagnostic
Wilbur Lam, Assistant Professor, Georgia Institute Of Technology, United States of America

Our laboratory has recently developed a rapid, stand-alone, and disposable anemia test that, via a single drop of capillary blood, outputs color-based results that correlate with hemoglobin (Hgb) levels and can be assessed with the naked eye or an optional smartphone app. We have recently published a clinical assessment demonstrating that results from our system correlated with gold standard hematology analyzer Hgb levels (r = 0.864 and r = 0.856 for visual interpretation and smartphone app, respectively), and both test methods yielded comparable sensitivity and specificity for detecting any anemia (n = 178) (<11 g/dl) (sensitivity: 90.2% and 91.1%, specificity: 83.7% and 79.2%, respectively) and severe anemia (n = 10) (<7 g/dl) (sensitivity: 90.0% and 100%, specificity: 94.6% and 93.9%, respectively). These results demonstrate the feasibility of this color-based diagnostic test for anemia self-screening in the general population, self-monitoring for chronic anemia patients, and most importantly, as an inexpensive anemia diagnostic in low resource settings. Work on all of these fronts is currently ongoing.

Point-of-Care Detection of Bacterial DNA for Diagnosis of Infectious Disease
Yu-Hwa Lo, Professor, University of California San Diego, United States of America

The talk will be focused on a lab-on-a-chip platform for detection of nucleic acid biomarkers from bacteria.  The technique uses no amplification or any enzymatic reactions to lower the cost and to avoid bias.  Instead it uses on-chip sample enrichment and op-chip detection methods to achieve high sensitivity, high specificity, and fast process time.  In addition to POC detection of infectious diseases such as sexually transmitted infectious diseases, the technology is also attractive to quantitative detection such as miRNA analysis.  Besides the device technology, we will also discuss the physical model for a quantitative analysis of the device performance.

Fabrication and Integration of Polymer-based Sample-to-Answer Microfluidic Systems for Rapid Molecular-based Diagnostic Applications
Teodor Veres, Section Head, Bioanalytical Micro-Nano Devices, Life Sciences Division, National Research Council of Canada & McGill University, Canada

The development of disposable microfluidic devices for rapid point-of-care applications has become central to progress in medical diagnostics and a variety of other fields. The use of these systems is attractive because they promote reduced sample consumption and analysis time without being restricted to standard laboratory settings. To this end, lab-on-a-chip (LOC) systems have mostly been shown to function in conceptual ways, yet their commercialization and widespread in clinical use has been hindered by a number of challenges, which include materials and low-cost fabrication technologies as primary concerns. We will present specific examples of designs and fabrication processes using thermoplastics polymers able to produce microfluidic systems for rapid diagnostics applications.  Examples of all-thermoplastic integrated sample-to-answer centrifugal microfluidic systems for nucleic acid analysis performing less than one hour cellular lysis, polymerase chain reaction (PCR) amplification, amplicon digestion, and microarray hybridization on a plastic support will be presented.  In addition, this talk will also demonstrate the possibility to use new materials and fabrication processes to bridge the gap between the laboratory proof-of-concept Lab-On-Chip demonstrations and the industrial like fabrication production based on the use of low-cost thermoplastic elastomers.

Coffee Break, Networking, Visit the Exhibitors and Poster Viewing

A Robust Point-of-Care Diagnostics Platform for Laboratory-Quality Testing in Global Health Settings
James Herron, Associate Professor, University Of Utah, United States of America

Q-SENS is an innovative point-of-care (POC) diagnostics testing technology that integrates waveguide optics, semiconductor chip manufacturing and solid-phase bio-sensing for rapid, inexpensive, multiplex immunoassays. Q-SENS offers advantages of short assay time (<10 minutes), small sample volume (single drop of blood), high density multiplexing (up to 32 tests), high analytical sensitivity (sub-picomolar), and lower instrument cost compared to conventional POC diagnostics platforms.  Desktop and hand-held readers equipped with cloud-based communications provide instant worldwide connectivity for telemedicine applications.

Inexpensive, Point-of-Care, Molecular Assay for HIV Viral Load Testing
Changchun Liu, Research Associate Professor, University of Pennsylvania, United States of America

Over two-thirds of the estimated 34 million people living with HIV/AIDS worldwide reside in developing countries, and nearly three-fourths of the 2.5 million new HIV infections in 2011 occurred in these countries. HIV viral load testing plays a critical role in monitoring antiretroviral treatment and in diagnosing HIV infection in babies under 18 months of age. There is a clear need for inexpensive, point-of-care systems for HIV viral load testing in low and middle-income countries because of technical constraints, lack of testing facilities, lack of trained personnel, and cost. In this talk, I will present our work towards the development of an inexpensive, point-of-care molecular diagnostics system for HIV viral load testing, including: 1) disposable plasma separator for relative large-volume plasma separation; 2) HIV virion meter for visual detection and 3) smartphone-based quantitative detection.

cobas® Liat System: Providing Lab-quality PCR Testing to the Point-of-Care
Lingjun Chen, Vice President, Roche Molecular Systems Inc, United States of America

The cobas® Liat System is a compact, innovative real-time PCR platform designed for on-demand STAT testing at the point of care or in the laboratory to support time-sensitive diagnoses and treatment decisions. Utilizing Nobel prize winning polymerase chain reaction (PCR) technology, the cobas® Liat System fully automates the testing process, simplifies workflow and enables healthcare professionals to perform molecular testing in a variety of settings with speed, reliability and minimal training. Definitive results are generated in 20 minutes or less to aid a treatment decision.

Networking Lunch in the Exhibit Hall, Visit the Exhibitors, and Poster Viewing

Printable Diagnostic Systems for Biomedical and Environmental Monitoring
John Brennan, Professor and Director, Biointerfaces Institute, McMaster University, Canada

The talk will focus on the development of printable components to produce bioactive paper sensors with a range of capabilities, including integrated sample preparation, biorecognition, amplification and readout technologies that can allow multi-step reactions on paper with ultra-sensitive detection capabilities.

Ultra-sensitive On-chip Isolation of Rare Cells and In-situ RNA Analysis for Cancer and TB Diagnostics
David Issadore, Professor, University of Pennsylvania, United States of America

We combine microelectronics, microfluidics, and nanomaterials to create ultrasensitive disease diagnostics. Here, we combine nano-magnetic sorting with on-chip RNA analysis, and apply it to the early detection of pancreatic cancer and the detection of Tuberculosis in under-served populations.

Coffee Break, Networking, and Visit the Exhibitors

The Cellphone Future of Precision Medicine: Enhanced TIRF Microarrays for Accurate and Rapid iDiagnostics
Alexander Asanov, Chief Scientific Officer, TIRF Labs, Inc., United States of America

There are over 7 billion cellphone users in the world. Most of the cellphones are equipped with numerous sensors, powerful computers, and high resolution CCD cameras. Cellphones have changed the landscape of many technological areas. Their capabilities can be employed for home-use precision diagnostics, as well as point-of-care applications. Cellphone-based diagnostics offers numerous opportunities for improving the health care. In this talk, I will present a novel cellphone-based platform technology, termed iDiagnostics, which is capable of detecting protein, nucleic acid, and metabolite biomarkers simultaneously, in real-time mode, using a droplet of blood, saliva, urine, or other biofluids. The technology is based on Total Internal Reflection Fluorescence (TIRF) and is rapid, supersensitive, and multiplexed, which allows for precision diagnosing and accurate prognosing. Yet, iDiagnostics is inexpensive. The cradle will cost $200-$300, and disposable cartridges $1-5, if manufactured massively.  iDiagnostics microarray employs a silk fibroin self-assembled nanometer-scale structure, which implements several functions. Firstly, silk fibroin film captures the excitation light from the TIRF lightguide and allows for much greater immobilization of affinity reagents at the surface of TIRF sensor chip. Since the resulting signal is a thousand-fold greater than that with classical TIRF, sensitivity of cellphone CCD cameras is sufficient for detection. Secondly, silk fibroin scaffold provides biologically-friendly environment for bioassay immobilization, preserving their activity after immobilization. Thirdly, silk-encapsulation prolongs shelf life of antibodies and other biological compounds, a feature which is important for diagnostics in low resources settings. High sensitivity and broad dynamic range of iDiagnostics allows for detecting the entire range of clinically significant biomarkers.

From Bench to Bedside: Building the Pipeline for Point-of-Care Diagnostics Product Realization in China
Xianqiang Mi, Professor, Shanghai Advanced Research Institute Chinese Academy of Sciences, China

Rapid progress has been made about technologies and approaches in POCT field. How to stride over “the Dead valley” of POC product realization is still a big challenge. We are now building the pipeline for POC product realization in China. The pipeline mainly consists of 3 milestones: engineering product phase, performance evaluation phase and clinical evaluation phase. Academic network for product concept and design specification, preclinical study network for product verification and clinical study network for product validation are being built. Cooperating with incubator and investor, we aim to accelerate transformation of enabling POCT technology in China. Product realization of an electrochemical POCT device for HbA1C will be discussed as a case study.

Close of Day 3 of the Main Conference