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Cambridge Healthtech Institute’s 11th Annual

At-Home & Point-of-Care Diagnostics

Innovation in Point-of-Care Testing: COVID-19 and Beyond

February 21-22, 2022

 

The point-of-care diagnostics market has been steadily growing, even before being fueled by the COVID-19 diagnostics wave. Cambridge Healthtech Institute’s 11th Annual At-Home & Point-of-Care Diagnostics meeting will review the latest technological advances, such as microfluidics, nanosensors, and miniaturized devices; as well as integration of POCT in hospitals, pharmacies, critical and home care, mobile settings, and resource-limited settings. Specialized applications, such as COVID-19 testing and antimicrobial resistance testing, will be included.

Monday, February 21

7:00 am Registration Open and Morning Coffee (Indigo West Foyer AB)

ROOM LOCATION: Indigo A

ADVANCES IN AT-HOME AND POINT-OF-USE TESTING

7:55 am

Chairperson's Remarks

James Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology and Immunology, Medical Director, Clinical Chemistry and POCT, Vanderbilt University School of Medicine
8:00 am

Personalized POCT: Opportunities and Risks of At-Home Diagnostics

James Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology and Immunology, Medical Director, Clinical Chemistry and POCT, Vanderbilt University School of Medicine

Patients are more engaged in their health. POCT allows patients access to laboratory testing in the privacy of their homes, but patients may not understand test limitations and misinterpret results. This presentation will review the advantages and limitations of home testing, explore the ways that patients are accessing POCT, and provide opportunities for new models of POCT delivery that can ensure quality of test results as well as professional interpretation.

8:30 am

At-Home Point-of-Care Testing: How Clinical Laboratory Professionals Can Assist

Hoi-Ying Elsie Yu, PhD, System and Core Laboratory Director, Chemistry, Toxicology and Point-of-Care Testing, Geisinger Health System

In recent years, there has been an expansion of at-home testing well beyond just pregnancy or glucose meter tests – for example, “23 and Me,” “Ancestry.com,” and COVID tests. Many of these tests are cheaper and more convenient than testing at a licensed clinical laboratory. In this presentation, the pros and cons of at-home testing will be discussed.  The roles of clinical laboratory professionals to promote the use of at-home tests for public health safety and patient care management will also be explored.

9:00 am

“That’s What I Want…”: Exploring Pandemic-Era Voice of the Customer (VoC) Trends in Community Pharmacy

Kenneth C. Hohmeier, PharmD, Associate Professor, Director of Community Affairs, PGY-1 Community-Based Pharmacy Residency Program, The University of Tennessee Health Science Center

The COVID-19 pandemic has accelerated the pace at which point-of-care (POC) testing is being adopted in the community pharmacy setting. Increasing numbers of community pharmacies are interested in developing their POC test and treat programs, including large pharmacy chains, as the US increasingly looks to this setting as a public health destination. After two years of the pandemic, the question is not if community pharmacy will adopt, but how. This session will describe lessons learned and share critical voice of the customer (VoC) community pharmacy data uncovered over the past few years.

9:30 am Session Break

INTERACTIVE DISCUSSIONS

9:45 am Interactive Discussions (In-person only)

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated to promote social distancing.  To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussion page on the conference website for a complete listing of topics and descriptions.

AT-HOME AND POINT-OF-USE TESTING: COVID-19 AND BEYOND

10:15 am

Home COVID-19 Testing: Strategies for Measurements that Are Fit for Purpose

Robert H. Christenson, PhD, Director, Clinical Chemistry Labs & Professor, Pathology & Medical & Research Technology, University of Maryland, Baltimore

Home COVID-19 testing is beneficial to public health by improving testing access, providing anonymity of results, easing overcrowding at healthcare venues, and reducing risk of disease transmission. Effective home testing devices must be fit for the intended purpose with straightforward use of diagrammatic instructions for use and interpretation, and documentation for comprehension and performance by non-technical individuals with limited literate skills. Coupling testing with smart devices allows access to care, epidemiological linkage, healthcare provider notification, and public health notification. This session will help specify and discuss characteristics for safe and successful home use in diverse communities. 


10:45 am

Development of a Home Testing System for Respiratory Pathogens Infections and Other Medical Conditions

Paul Yager, PhD, Professor, Department of Bioengineering, University of Washington

We have been developing two-dimensional porous networks for ultra-low-cost point-of-care disease detection and management; readout is by optical imaging. The COVID-19 pandemic and the restriction of people to their homes has opened up new markets for a full range of rapid home testing. We are now developing rapid multiplexed nucleic acid testing a home for a panel of respiratory pathogens under support of WRF and the Emergent Ventures fund.  

11:15 am

The Comprehensive COVID-19 Test

David T.W. Wong, DMD, DMSc, Associate Dean of Research, Felix & Mildred Yip Endowed Distinguished Professor, UCLA School of Dentistry

Non-invasive diagnostics are urgently needed to address supply-chain and logistical deficiencies in the current COVID-19 testing environment. We developed quantitative multiplex assays that can assess SARS-CoV-2 gRNA (N2 and NL) (LOD: 6.25 copy number per reaction), Antigen (N) (3.5 TCID50), and Antibody (IgG RBD) (LOD:  30pg/ml)  non-invasively in a sample of saliva with performance that surpasses current EUA assays, with TAT in 1.5 hours, deployable at the population level.

Bryan Bothwell, Senior Director of Strategy and Business Development, Qorvo Biotechnologies

COVID-19 has stressed worldwide demand for POC testing. Companies have had to innovate and develop at a rapid pace to meet pandemic demands. This presentation will discuss how Qorvo Biotechnologies has developed a breakthrough platform to address todays COVID-19 testing needs, and highlight what that differentiation means clinically. It will also show what investments have done to position for future success beyond COVID. 

12:15 pm Session Break
Dwight Egan, CEO, Co-Diagnostics, Inc.

Co-Diagnostics New Eikon Platform provides inexpensive, fast, and accurate PCR Results for At-Home and Point-of-Care Testing. 

12:50 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:20 pm Session Break

EMERGING TECHNOLOGIES FOR RAPID DETECTION AT THE POINT-OF-CARE

1:30 pm

Chairperson's Remarks

Hoi-Ying Elsie Yu, PhD, System and Core Laboratory Director, Chemistry, Toxicology and Point-of-Care Testing, Geisinger Health System
1:35 pm

Next-Generation CRISPR Products

Janice Chen, PhD, Co-Founder & CTO, Mammoth Biosciences

The programmable nature of sequence-specific targeting by CRISPR-Cas nucleases has revolutionized a wide range of genomic applications and is now emerging as a new method for nucleic acid detection. This talk will touch on the therapeutics capabilities of Mammoth's CRISPR platform, and then focus on current efforts and future potential for CRISPR-based detection and its impact across a continuum of diagnostic applications, particularly as it relates to the COVID-19 pandemic.

2:05 pm

LAMP & Isothermal Nucleic Acid Amplification: Ready for Prime Time?

Robert Meagher, PhD, Staff Scientist, Biotechnology & Bioengineering, Sandia National Labs

The COVID-19 pandemic brought new popularity and a new user base for isothermal nucleic acid amplifications, especially LAMP. We will survey recent developments in the field such as widespread adoption of closed-tube endpoint monitoring. We will identify knowledge gaps in the fundamental understanding of isothermal amplification methods, and we will discuss some of our own group’s research efforts toward making LAMP more robust and ready to adopt for future emergencies.

2:35 pm

Instrument-Free Molecular Diagnostic Test of SARS-CoV-2 at the Point-of-Care

Changchun Liu, PhD, Associate Professor, Biomedical Engineering, University of Connecticut, Farmington

Rapid and early detection of the novel coronavirus SARS-CoV-2, the causative agent of the COVID-19, plays a crucial role in reducing transmission of the virus and facilitating early intervention and treatment. In this talk, I will present our All-In-One Dual CRISPR-Cas12a (AIOD-CRISPR) technology for SARS-CoV-2 testing. I will introduce our low-cost diagnostic devices and detection platforms, enabling simple, affordable, instrument-free molecular diagnostics of SARS-CoV-2 at the point of care.

Ryan McGuinness, Global Head, In Vitro Technologies/Commercial GM, Triple Ring Technologies
3:20 pm Sponsored Presentation (Opportunity Available)
3:35 pm Session Break

KEYNOTE LOCATION: Indigo A

PLENARY KEYNOTE SESSION: PRECISION HEALTH: GENOMICS AND BEYOND

4:15 pm

Chairperson's Remarks

Robert C. Green, MD, MPH, Professor and Director of Genomes2People Research, Mass General Brigham, Broad Institute, Ariadne Labs and Harvard Medical School
Stephen Williams, MD, PhD, CMO, SomaLogic

Reliable outcomes prediction enables increased power in clinical trials and improved allocation of resources in clinical practice. The new discipline of using highly multiplexed measurements, machine learning and mixed study populations can lead to robust and generalized predictors of catastrophic and near-term risks. Key examples using SomaScan® proteomics for cardiovascular events, heart failure mortality and loss of kidney function will be shown.

4:30 pm

Universal Newborn Sequencing and the Path to Preventive Genomics

Robert C. Green, MD, MPH, Professor and Director of Genomes2People Research, Mass General Brigham, Broad Institute, Ariadne Labs and Harvard Medical School

Twenty years after the completion of the Human Genome Project, there is beginning to be broad acceptance for returning actionable genomic findings as an ethical imperative in large-scale genomic research, as secondary findings in indication-based sequencing, and as population-scale screening in forward-looking healthcare systems. While the evident data on patient-provider acceptability, clinical utility and cost-benefit are far from comprehensive, empirical research from many domains suggest that when unanticipated genomic information is delivered, patients are deeply interested and do not experience unusual distress, providers can manage disclosure and care with appropriate support, and downstream healthcare utilization is modest and appropriate. We recently completed the first randomized trial of comprehensive genome sequencing in healthy newborns and are beginning a multi-site second phase of this research (the NIH funded BabySeq Project). We present data from this and other studies to suggest that universal newborn sequencing may be well-tolerated and cost-effective, and may soon provide a platform for the lifelong use of genomics in risk stratification, disease mitigation and expanding longevity.

5:00 pm

Transforming Genomic Healthcare in the United Kingdom

Sir Mark Caulfield, PhD, Professor & Director, Clinical Pharmacology, The William Harvey Research Institute, Queen Mary University of London; CEO, Barts Life Sciences

The 100,000 Genomes Project focused on rare disease, cancer, and infection and demonstrated the potential of whole genomes to uplift diagnoses by 25% in rare disease, have a clinical utility for 25% of cancer patients, and discover 15 novel gene loci for severe COVID-19. Exploring of pharmacogenomics reveals many of us have genetic variants which if paired with a drug may cause harm. To do this we created a new National Test Directory where we evaluated 300,000 tests upgraded 25% to new technologies, and 500,000 whole genomes are available for rare disease and cancer care over the next 5 years. We have used this to transform the National Health Service with a new Genomic Medicine Service offering equitable access to 56 million people.

5:30 pm

Precision Health: Closing the Information and Decision Gaps

Jessica L. Mega, MD, MPH, Co-Founder and Chief Medical & Scientific Officer, Verily; Adjunct Professor, Stanford University School of Medicine

Genomic insights have proven to be powerful, from providing a better interpretation of the pathobiology of disease to tailoring medications based on pharmacogenetics. At the same time, there has been a growing appreciation that a multitude of inputs are needed to provide a comprehensive understanding of both the health of an individual and how it relates to the broader population. Accounting for (1) the highly complex interplay of biological, behavioral, environmental, and social systems, and (2) the changes in the cadence of data collection from episodic to continuous will be critical to improving clinical outcomes. The scale of data, from gigabytes to terabytes per individual, necessitates an updated framework to collect, organize, and activate this rich health information; recent advances in biomedical information systems and computation are making these activities possible. Additionally, tools to harness more comprehensive biological insights are being developed, and people are interacting more directly with their health data, along with the support of researchers and clinicians. All these efforts to close the information and decision gaps will ultimately advance precision health.

6:00 pm PANEL DISCUSSION:

Precision Health: Convergence of Genomics, Digital MedTech and Healthcare

Panel Moderator:
Robert C. Green, MD, MPH, Professor and Director of Genomes2People Research, Mass General Brigham, Broad Institute, Ariadne Labs and Harvard Medical School

Precision Health promises a much-needed shift from “sick-care” to “healthcare.” Driven by innovations in genomics, medtech, and AI, precision health strategies can focus on prediction, prevention, and early detection for individualized health and wellness. The panel will discuss how genomics and digital health technologies can advance community-wide genetic screening and early disease detection, patient monitoring and preventative health strategies, personalized lifestyle and wellness approaches, and precision health equity.

Panelists:
Sir Mark Caulfield, PhD, Professor & Director, Clinical Pharmacology, The William Harvey Research Institute, Queen Mary University of London; CEO, Barts Life Sciences
Jessica L. Mega, MD, MPH, Co-Founder and Chief Medical & Scientific Officer, Verily; Adjunct Professor, Stanford University School of Medicine
Lara Jehi, MD, Chief Research Information Officer, Professor, Neurology, Cleveland Clinic
Megan Mahoney, MD, Clinical Professor, Primary Care & Population Health, Stanford University
6:30 pm Welcome Reception in the Exhibit Hall with Poster Viewing (Indigo BFGCDH)
7:30 pm Close of Day

Tuesday, February 22

7:30 am Registration Open and Morning Coffee (Indigo West Foyer AB)

ROOM LOCATION: Indigo A

INFECTIOUS DISEASE POINT-OF-CARE TESTING: LESSONS FROM THE PANDEMIC

7:55 am

Chairperson's Remarks

Larissa May, MD, MSPH, MSHS, Professor, Emergency Medicine; Director, ED Antibiotic Stewardship; Medical Director, Learning Health System Hub, UC Davis Health
8:00 am

Point-of-Care Testing for COVID-19: Opportunities and Challenges

Julie Shaw, PhD, Clinical Biochemist & Director for POCT, EORLA, Ottawa Hospital

Point-of-care rapid molecular and antigen detection tests for COVID-19 were developed quickly during the second wave of the pandemic. Here, I will discuss our experiences with quickly verifying and validating the performance of these tests, while also developing and supporting quality assurance programs suitable for testing in non-traditional environments, performed by diverse groups of individuals. 

8:30 am

Point-of-Care Diagnostics in the Emergency Department: Current Use and Future Directions

Larissa May, MD, MSPH, MSHS, Professor, Emergency Medicine; Director, ED Antibiotic Stewardship; Medical Director, Learning Health System Hub, UC Davis Health

This presentation will highlight current and emerging trends in rapid and point-of-care diagnostic testing for infectious diseases. Gaps in current diagnostics for infectious diseases and future directions for research and development will be discussed using specific use cases. This presentation will cover diagnostics for respiratory infections, emerging diagnostics for sepsis, and diagnostic needs for urinary tract symptoms. Point-of-care testing for SARS-CoV-2 will be included. The presentation will emphasize workflow considerations, implementation, and the role of diagnostics in antimicrobial stewardship strategies.

Florent Chang-Pi-Hin, Ph.D., Vice President, Research and Development Life Science, Meridian Bioscience

Direct amplification in molecular assays is desired due to its speed, ease of use, and avoidance of extraction reagents.  However, clinical specimens contain a wide range of inhibitors that can hinder both the accuracy and sensitivity of an assay.  In this session, you will learn about Meridian’s latest technologies which are the newest solution for overcoming PCR inhibition and provide a fast-track method for developing room-temperature stable assays for POC applications.

9:30 am Coffee Break in the Exhibit Hall with Poster Viewing (Indigo BFGCDH)
10:10 am

Wows and Woes of Molecular Testing for COVID

Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and Virology, Children’s Hospital Los Angeles; Associate Professor, Pathology and Laboratory Medicine, Keck School of Medicine, University of Southern California

Laboratory detection of SARS-CoV-2 using nucleic acid amplification technologies is considered the gold standard with maximum sensitivity and specificity compared to other testing modalities. Innovation and development of SARS-CoV-2 molecular assays were high throughout the pandemic, offering much successes. Yet there are challenges that are important to recognize including inclusivity of testing and lingering detection. This session will explore these successes of molecular testing but also the challenges.

10:40 am

Community-Based Testing for Respiratory Pathogens

Michael E. Klepser, PharmD, FCCP, FIDP, Professor, Ferris State University College of Pharmacy

COVID-19 demonstrated the value of offering CLIA-waived point-of-care tests in non-traditional settings. Additionally, the need to promote frequent, sequential testing with rapid receipt of results opened the door for new models for home-based testing. As we move forward, the value of such testing strategies for pathogens other than SARS-CoV-2 have been recognized. This presentation will examine future of community/home-based testing for various respiratory pathogens.

James Downs, Global Business Development, Schott Minifab

If one thing is clear as we roll into 2022, it is that IVD point of care medical diagnostics have taken on new importance in global healthcare.  However, designing, developing and manufacturing these complex lab-on-a-chip systems in a rapid and commercially viable manner remains challenging. This presentation will examine these challenges and explore which key decision-making factors are important when considering an in-house effort vs outsourcing to a partner.

11:25 am Sponsored Presentation (Opportunity Available)
11:40 am Session Break
11:50 am Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
12:20 pm Refreshment Break in the Exhibit Hall with Poster Viewing (Indigo BFGCDH)
1:00 pm Close of At-Home & Point-of-Care Diagnostics Conference





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