Cambridge Healthtech Institute’s 17th Annual

Advanced Diagnostics for Infectious Disease

Improving Clinical Outcomes through Novel Technologies and Molecular Testing

August 19 - 20, 2025 ALL TIMES EDT

At the 17th Annual Advanced Diagnostics for Infectious Disease, thought leaders in the industry will showcase the latest diagnostic developments, approaches, and solutions for the biggest challenges facing the clinical lab, including managing workflow, incorporating NGS and molecular testing, community surveillance, advancing multiplex options, variant detection, gaining reimbursement and regulatory approval, market access, and more.

Tuesday, August 19

PLENARY SESSION

11:30 am

Introduction to GINA

Jessica Lynn Roberts, JD, Professor of Law, Artificial Intelligence, Machine Learning and Data Science, Emory Law

This session will provide a brief introduction to the federal Genetic Information Nondiscrimination Act (GINA) and its protections.

11:40 am PLENARY PANEL DISCUSSION:

Genetic Discrimination: Impact of Genetic Test Results on Access to Life, Long-Term Care, and Disability Insurance

PANEL MODERATOR:

Laura Geller, National Investigative Producer, CBS

Genetic testing has become progressively more important in predicting disease risk and has facilitated the development of targeted therapies. Passed in 2008, the Genetic Information Nondiscrimination Act (GINA) prohibits genetic discrimination by health plans and employers. However, this federal law does not apply to life, long-term care, or disability insurers so it is legal to use genetic test results in these coverage or premium decisions.

This panel brings together stakeholders from the patient, genetic counselor, lab, and research communities to explore:

  • How fear of genetic discrimination impacts the uptake of genetic testing
  • Experiences of patients with pathogenic mutations in securing life, long-term care, and disability insurance policies
  • Informed consent and delivering genetic test results to research participants
  • Legislative efforts to ban the use of genetic information in insurance policy coverage and rate decisions
PANELISTS:

Jennifer R. Leib, Founder, Innovation Policy Solutions LLC

John William Musick, Patient Advocate, End the Legacy

Jessica Lynn Roberts, JD, Professor of Law, Artificial Intelligence, Machine Learning and Data Science, Emory Law

Lisa Schlager, Vice President, Public Policy, FORCE Facing Our Risk of Cancer Empowered

12:20 pm PLENARY PANEL DISCUSSION:

From AI to LDTs: Top Lab Advocacy Topics

PANEL MODERATOR:

Joyce Gresko, Partner, Alston & Bird LLP

  • Over the last few years, policy makers' awareness of the role of clinical laboratory testing services as foundational to preventing and predicting disease and core to informed clinical decision making has increased, with many new voices calling for increased focus on prevention
  • Building upon this increasing awareness to affect positive policy change in reimbursement and regulation is critical to laboratories' advancement of patient access to innovative technologies that are positively changing the way care is delivered
  • Reimbursement issues to be covered will include improving coding policy for new and existing codes, bringing rationality to Medicare payment through PAMA reform, and cutting through aggressive payer prior authorization practices and other barriers to care and payment
  • Regulatory issues will delve into the latest for LDTs from the Administration, Courts, and Congress
PANELISTS:

Jonathan R. Genzen, PhD, CMO, ARUP Labs

Lauren R. Silvis, PhD, Senior Vice President, External Affairs, Tempus, Inc.

Rachel Stauffer, Principal, McDermottPlus Consulting LLC

INTERACTIVE DISCUSSIONS

1:05 pmLuncheon 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. 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 Discussions page on the conference website for a complete listing of topics and descriptions.

TABLE 1:

CMS CLIA Interpretation Changes to Technical Consultant and Impact on POCT Training and Competency

Jeanne Mumford, MLS(ASCP), Manager, Point-of-Care Testing, Johns Hopkins Hospital

  • What current workflow is in place in your program, and are there aspects in place that will help you meet the new regulations?
  • How do I review a transcript to determine if my 4-year RN meets the requirements to fill the TC role?
  • Are you already seeing an impact on your Training and Competency workflow in your program?
  • Will these new regulations help us hire more full-time employees in our POCT programs?​
TABLE 2:

Integrating AI and Machine Learning into IVD Products

Daniel Gare, PhD, Head Global Business Development, Diagnostics, TTP plc

Lawrence Worden, Founder, Principal, IVD Logix

Even beyond the hype, we are seeing a technological shift enabled by AI and ML disrupting professions and whole industries. In vitro diagnostics will also see changes from the broader upheavals that AI will bring. This open breakout discussion looks to consider how AI may impact us in POCDX in the future. Areas we may touch on include:

  • Where AI may be applied in the diagnostic development pathway
  • How AI-enabled tools may enable better diagnostics
  • How multianalyte and longitudinal data could be applied for personalization of diagnostic approaches
  • Regulatory and other hurdles to overcome

2:25 pmOrganizer's Welcome Remarks

RAPID BACTERIAL DETECTION AND RESISTANCE/SUSCEPTIBILITY TESTING

2:30 pm

Chairperson's Remarks

Robin Patel, MD, D(ABMM), FIDSA, FACP, F(AAM), Elizabeth P. and Robert E. Allen Professor of Individualized Medicine; Director, Infectious Diseases Research Laboratory; Professor of Medicine and Microbiology, Co-Director, Bacteriology Laboratory; Vice Chair of Education, Department of Laboratory Medicine and Pathology, Mayo Clinic

2:35 pm

Impact and Outcomes of Rapid Molecular Detection and Resistance Testing

Michael J. Loeffelholz, PhD, D(ABMM), Vice President, Scientific Affairs, Cepheid

The fight against emerging antimicrobial resistance relies in large part on the use of rapid and accurate detection methods. Molecular methods are inherently able to provide fast and accurate results but may come at greater cost-per-test compared to traditional methods. It is therefore incumbent upon those who promote the use of molecular methods to demonstrate their ability to improve patient outcomes and provide downstream economic savings.

3:05 pm

Walking Pneumonia: The Silent Stride of Mycoplasma pneumoniae and Antibiotic Resistance

Tanner Rothstein, MS, Senior Developer, Department of Laboratory Medicine and Pathology, Clinical Microbiology, Translation Research, Innovation, and Test Development, Mayo Clinic

Mycoplasma pneumoniae is a significant respiratory pathogen, and emerging macrolide (azithromycin) resistance poses a clinical challenge. This presentation will discuss the epidemiology of M. pneumoniae and the mechanisms of macrolide resistance. Current diagnostic methods will be reviewed, including use of real-time PCR for genotypic prediction of macrolide resistance and its role in directing antimicrobial therapy.

3:35 pm

Addressing a Super Threat: Untreatable Gonorrhea

Jeffrey D. Klausner, MD, Clinical Professor, Preventive Medicine, University of Southern California

Gonorrhea is becoming increasingly resistant to antibiotic therapy. Novel diagnostics that include markers for resistance can help guide therapy and facilitate treatment diversification. We will discuss the state-of-the art in resistance-guided therapy including FDA trials and assays in development.

4:05 pmRefreshment Break in the Exhibit Hall with Poster Viewing

4:45 pm

POINT-COUNTERPOINT DEBATE: Will AI Replace Most Conventional Microbiology Testing in 10 Years?

PANEL MODERATOR:

Susan Butler-Wu, PhD, D(ABMM), SM(ASCP), Associate Professor of Clinical Pathology, Keck School of Medicine of USC; Director, Clinical Microbiology Laboratory, LAC+USC Medical Center

Will artificial intelligence revolutionize infectious disease diagnostics—or are traditional microbiology methods here to stay? Join us for the lively Point-Counterpoint Debate: Will AI Replace Most Conventional Microbiology Testing in 10 Years? at the Advanced Diagnostics for Infectious Disease track at the Next Generation Dx Summit. This timely session brings together leading experts to argue both sides of the question, challenging assumptions and highlighting the promise, pitfalls, and practical realities of integrating AI into diagnostic workflows. Don’t miss this engaging discussion that’s sure to spark new ideas and perspectives.

PANELISTS:

Steven D. Dallas, PhD, D(ABMM), Department of Pathology and Laboratory Medicine, UT Health San Antonio

Khosrow R. Shotorbani, MBA, MT (ASCP), President and CEO, Project Santa Fe Foundation; Founder, CEO, Lab 2.0 Strategic Services, LLC

5:45 pmAttend Concurrent Track

6:15 pmClose of Day

Wednesday, August 20

7:15 amRegistration Open

7:30 amInteractive Discussions with Continental Breakfast (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. 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 Discussions page on the conference website for a complete listing of topics and descriptions.

TABLE 1:

The Role of CRISPR Technology in the Future of Clinical Diagnostics

Gregory Brett Robb, PhD, Senior Scientific Director & Head, CRISPR Science, VedaBio, Inc.

  • Sample preparation—is it needed?
  • Selection of amplification versus amplification-free CRISPR methods
  • Selection of the optimal Cas enzymes 
  • Selection and evaluation of guide sequences​
TABLE 2:

What Future Syndromic Panels Are Needed in the Clinical Laboratory?

Niaz Banaei, MD, Professor, Pathology and Medicine; Medical Director, Stanford Health Care Clinical Microbiology Laboratory; Director, Stanford Clinical Microbiology Fellowship; Associate Program Director, Stanford Clinical Pathology Residency Training, Stanford University School of Medicine

  • Met needs for syndromic panels
  • Unmet needs for syndromic panels
  • Challenges for industry to develop future syndromic panels
  • Regulatory changes for future syndromic panels​

FUTURE CLINICAL MICROBIOLOGY DIAGNOSTICS

8:25 am

Chairperson's Remarks

Susan Butler-Wu, PhD, D(ABMM), SM(ASCP), Associate Professor of Clinical Pathology, Keck School of Medicine of USC; Director, Clinical Microbiology Laboratory, LAC+USC Medical Center

8:30 am

What Future Syndromic Panels Are Needed in the Clinical Laboratory?

Niaz Banaei, MD, Professor, Pathology and Medicine; Medical Director, Stanford Health Care Clinical Microbiology Laboratory; Director, Stanford Clinical Microbiology Fellowship; Associate Program Director, Stanford Clinical Pathology Residency Training, Stanford University School of Medicine

Syndromic panels have advanced healthcare delivery and efficiency. However, there is a need for novel syndromic panels to further advance medicine. This presentation will discuss novel syndromic panels including the role of fungal panels used to non-invasively diagnose patients with invasive fungal disease.

9:00 am

The Role of CRISPR Technology in the Future of Clinical Diagnostics

Gregory Brett Robb, PhD, Senior Scientific Director & Head, CRISPR Science, VedaBio, Inc.

Nucleic acid-based testing offers high sensitivity and specificity for the diagnosis of a variety of diseases by Laboratories and now efficiently in Point-of Care settings. Innovative technologies continue to emerge including the use of CRISPR-based diagnostics. The developing power of CRISPR/Cas systems for these applications will be reviewed.

9:30 amAttend Concurrent Track

10:00 amNetworking Coffee Break

10:30 am

Artificial Intelligence Applications in Clinical Microbiology

Thomas Durant, MD, Resident, Pathology & Lab Medicine, Yale University

As digitization and automation continue to advance in microbiology, opportunities for the integration of artificial intelligence (AI) and machine learning (ML) are expanding. This session will provide an overview of machine learning concepts and commonly used terminology, equipping attendees with the foundational technological literacy needed to navigate this evolving field. Additionally, it will explore both established and emerging AI/ML-enabled technologies and devices relevant to clinical microbiology, along with future considerations for laboratory professionals.

11:00 am

From Disk to Desktop: Novel Approaches to Improve Antimicrobial Susceptibility Testing

Lucas J. Osborn, PhD, D(ABMM), Director of Microbiology, Keck Medical Center of USC; Assistant Professor, Clinical Pathology, Keck School of Medicine, USC

Antimicrobial susceptibility testing (AST) remains a cornerstone of infectious disease management, yet prolonged turnaround times of conventional AST methods can delay optimal treatment. This talk will explore novel strategies to accelerate AST, from low-cost enhancements that integrate into existing workflows within the laboratory, to cutting-edge next-generation sequencing-based methods. By adopting these innovations, laboratories may enhance diagnostic efficiency, which could help reduce time to optimal treatment and potentially improve patient outcomes.

11:30 am

Utility of AI in PCR QC Monitoring

Meghan W. Starolis, MS, PhD, HCLD(ABB), Senior Science Director, Infectious Disease, Quest Diagnostics

In this session,  artificial intelligence (AI) will be defined, and current applications in the routine and molecular microbiology laboratory will be identifed. The use of AI and Machine Learning (ML) algorithms are now being considered for PCR data analysis. Emerging applications such as PCR.ai, a software-as-a-service (SaaS) AI tool, to analyze PCR data to improve quality and reduce hands-on-time will be demonstrated. Lastly, future applications of AI in areas such as prediction of antimicrobial resistance, diagnostic stewardship, and in clinical decision support, will be discussed.

12:00 pmEnjoy Lunch on Your Own

MULTIMODAL TESTING

1:10 pm

Chairperson's Remarks

Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology; Medical Director, Medical College of Wisconsin

1:15 pm

Testing Needs from the Point-of-Care, Can Multimodal Testing Move the Needle in the ED?

Chadd Kraus, DO, DrPH, CPE, FACEP, Vice Chair, Research, Department of Emergency and Hospital Medicine, Lehigh Valley Health Network

Emergency departments (EDs) are the central diagnostic hub in providing acute, unscheduled, and emergency care. Diagnostic testing in the ED requires considerations for timeliness, sensitivity, workflow optimization, efficiency, cost-effectiveness, and value. Multimodal diagnostic testing can improve the efficient use of resources in EDs and acute care settings, including integration into existing workflows, allowing the clinical and laboratory teams to optimize result turnaround times for a range of test results that inform and positively impact patient care. Multimodal testing with high-sensitivity results can help guide decisions for initiating time-sensitive interventions and for clinical disposition such as hospitalization and care linkages.

1:45 pm

Multimodal Detection System to Streamline Healthcare Delivery

Vasu Nadella, CEO, Vital Biosciences

Timely and accurate diagnostics are vital for receiving effective care, yet traditional lab testing often introduces delays in the process. This session will delve into how breakthroughs in biochemistry, robotics, and microfluidics are revolutionizing diagnostics, enabling faster, decentralized testing without sacrificing accuracy. This talk will share new insights on how rapid blood analysis is transforming clinical decision-making, improving patient outcomes, and streamlining healthcare delivery.

2:15 pm

How Multimodal Technology Reduces Healthcare Costs

Tej Patel, CEO, Fluxergy LLC

With rising healthcare costs and limited access to diagnostic testing, Fluxergy offers a novel solution. By leveraging multimodal technology with advanced manufacturing, we dramatically reduce point-of-care testing costs, making lab-quality diagnostics more accessible, especially in rural and underserved communities.This talk will explore how Fluxergy’s innovative manufacturing and platform lowers cost and enables affordable, decentralized testing in urgent cares, community health centers, free-standing emergency departments, and community hospitals. The result? Lower costs, better access, and improved patient outcomes.

2:45 pm

Expanding beyond Molecular Syndromic Testing: Catalyzing the Shift to Multifunctional Syndromic Testing with Digital Microfluidics

Vamsee K. Pamula, PhD, Founder & President, Baebies, Inc.

Patients requiring rapid diagnosis often need a combination of molecular, chemistry, immunoassays, and coagulation testing, yet current diagnostic platforms rely on multiple single-function instruments. Digital microfluidics (DMF) enables multifunctional syndromic testing, integrating all major diagnostic modalities on a single system. We demonstrate example applications in sepsis (all modalities), trauma (chemistry, coagulation, and immunoassays), and hepatitis (molecular and chemistry), among others. Multifunctional testing eliminates delays, reduces sample burden, and lowers costs while improving clinical efficiency and maximizing diagnostic yield. Data demonstrating assays on DMF across modalities will be presented, highlighting its potential as the most adaptable platform for comprehensive, near-patient diagnostics.

3:15 pmClose of Summit





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