The rapid movement of diagnostics out of traditional laboratories, and outside traditional provider ordering, is transforming how patients access and act on their own health information. In an increasingly hyperpersonalized world, the public is demanding greater convenience, but convenience alone is not enough. A new ecosystem is required to support safe, hyper-convenient testing. This talk discusses what’s happening and what’s needed for diagnostics to keep pace with our fast-changing, hyper-personalized ecosystems: from devices, logistics, and sampling to telehealth, algorithms, and regulatory adaptation.

While CRISPR-based diagnostics offer significant potential, the field remains limited by first-generation enzymes. To address this, Mammoth Biosciences has leveraged our diverse CRISPR protein portfolio and protein engineering expertise to develop MB-CasFire: a highly specific, sensitive, and thermostable enzyme optimized for compatibility with isothermal amplification reactions. By overcoming the limitations of current enzymes, MB-CasFire provides a robust, high-performance platform for CRISPR diagnostic assay development.

At-home access to laboratory quality diagnostic testing has taken two separate paths that don’t require patients to visit a clinic. The first is home collection and shipment of samples to a central lab, while the second is to collect samples and perform tests at the patient’s home. We will explore the pathways, types of testing involved, methods used, examples of technologies, benefits, issues, and trends.

Dr. William Hyun will explore how next-generation molecular diagnostic platforms are redefining accessibility, accuracy, and affordability in healthcare. Drawing from more than two decades of experience advancing cytometry, genomics, and clinical technologies, he will highlight the convergence of precision lab science with point-of-care and at-home testing. The talk will showcase pathways for translating complex molecular assays into deployable systems that deliver real-world impact.

This session will explore one of the key challenges facing developers of POC diagnostics—site of service restrictions that restrict coverage and reimbursement of some POC tests in certain sites of care (e.g., physician offices). While Payers may implement these policies for cost control, they can have unintended consequences for patient care. Attendees will gain actionable insights into the current state of site of service challenges, evidence-based support for ensuring POC diagnostic test access, and what industry can do to address these policies in a collaborative way.

This session will explore the diverse drivers of value for POC diagnostics. Using respiratory panels as an example, we will define how appropriate POC utilization—in the right place of service, for the right risk-stratified patients at the right time into the disease progression—can prevent care escalation and reduce health care resource utilization. Communicating to payers the criteria in which POC diagnostics generates value into the health care system, through rigorous health economic demonstration, can accelerate the coverage and access to POC for the population that benefits most. Attendees will gain actionable insights into the opportunity and challenges of demonstrating health care resource utilization impact of respiratory tests to convey POC value to payers.

Every company is now an AI company; leaders set themselves apart through velocity and the differentiated value of their data. Advanced diagnostics live at the intersection of unique biology, differentiated signal, and tailored intelligence. Clinical metagenomics, in particular, is only possible because of AI. Drawing on Karius's experience, this brief talk traces how AI transforms advanced diagnostics: from enterprise velocity to analytical precision, clinical relevance, and biomarker discovery.

Oncology transformed outcomes by learning to interpret molecular patterns—distinguishing disease from mimics, staging risk, and guiding therapy. Acute care faces comparable biological complexity but has never had this structure. Clinicians must make high-stakes decisions under uncertainty, often without a definitive diagnosis. This talk explores how AI applied to high-dimensional immune-expression data can guide management in acute illness. Key takeaways: 

• Acute care mirrors oncology’s complexity—but lacks staging tools 
• AI excels at interpreting multidimensional molecular patterns 
• Host-response data enables mimic differentiation and severity stratification 
• Decision support matters more than labels in high-acuity care 
• TriVerity illustrates a path to an integrated acute-care ecosystem
  

We will present our Virtual Geneticist platform with AI tools transforming genomic interpretation by automating variant prioritization, evidence aggregation, and phenotype matching. Machine learning models integrate literature, population databases, functional annotations, and patient phenotypes to rank pathogenicity at scale. In addition, we use natural-language processing which accelerates curation from reports. Deployed in clinical pipelines, AI significantly reduces turnaround time, supports reanalysis, and can raise diagnostic yield.

Combining metagenomic next-generation sequencing (mNGS) with host response profiling can improve diagnostic accuracy in complex clinical cases. RNA host response data collected over a decade of cerebrospinal fluid mNGS testing has been leveraged to generate machine-learning based classifiers for infectious—bacterial, fungal, viral, and parasitic—and non-infectious syndromes. The talk will discuss leveraging these classifiers to enhance diagnosis and treatment for critically ill patients with neurologic illness.

With the rapid emergence of anti-microbial resistance and the clear utility of syndromic testing, high multiplex diagnostics are becoming more valued. However, the reimbursement and willingness to pay issues are not changing to match the advancements in technology. Q-POC has been designed to address the cost issues in multiplexing, without compromising on speed, portability, ease of use, and quality.

What does innovation in Market Access activities look like? There has always been a bit of a roadmap on how labs approach payers for coverage and reimbursement. The question is if that historical roadmap offers the most efficient approach today. The market is primed for collaboration to address issues that are preventing the value of precision diagnostics from being realized. Collaboration, to be most impactful, should encompass as many actors as possible. It is within this model of collaboration that we rise the tide for everyone, patients, providers, and payers.

Cardiovascular genomics offers opportunities to improve risk identification, prevention, and treatment selection for patients, but raises questions for payers and providers. This session reviews a recent study supporting genomic applications in the key subspecialities of cardiovascular medicine, focusing on clinical utility, cost-effectiveness, and coverage considerations. The talk will explore how genomics can support value-based care, population health, and sustainable reimbursement strategies – while driving pharmaceutical development and health system strategies.