In just a few months, members of the diagnostic community will converge in Washington, DC for the 10th annual Next Generation Dx Summit. During the conference, experts in their respective fields will be sharing their unparalleled insights into the most timely and important issues facing the industry. We can’t wait to hear the latest on cell- and cell-free biopsies, biomarkers and companion diagnostics for immunotherapy, point-of-care testing, infectious disease, microfluidics and precision medicine, and more. With six programs within the conference, there’s sure to be something for everyone. Here are just a few of the sessions we have highlighted as we prepare for another great summit. – The Editors and the Next-Gen Diagnostics Summit Team.
For the featured presentation of the Precision Medicine track, Ron Kamienchick from Teva Pharmaceuticals will discuss how mutation-based companion diagnostics, to date, address just part of personalized and precision medicine, and mainly in oncology. Just as we use biological markers to identify responder populations, Kamienchick will argue, we should leverage digital markers collected from connected devices to help us further tailor therapy, in oncology and beyond. This talk will present technologies and ongoing efforts aimed at exactly this.
At Memorial Sloan Kettering Cancer Center, Michael Berger and his team have performed comprehensive genomic profiling of tumor and matched normal DNA in more than 20,000 active cancer patients to guide diagnosis and treatment selection. Berger will describe informatics systems and algorithmic tools we have developed to harness these data for improved clinical use.
The bioengineering lab at the University of Washington is pursuing development of low-cost rapid diagnostics to identify the agents of infectious diseases; these tools must be appropriate for use in low-resource settings. Paul Yager (who will be giving several talks during the conference) will discuss how, under support of NIH and DTRA, the lab has been developing single-use, disposable, inexpensive sensitive lateral flow tests for use with human samples.
Artificial intelligence (AI) is driving a paradigm shift in healthcare, powered by increasing availability of healthcare data and rapid progress of analytics techniques. AI can be applied to various types of Clinical Diagnostic data (structured and unstructured). Major disease areas that use clinical diagnostic results and AI tools include Oncology and Rare Diseases. Jason Bhan from Prognos will review in more details how we can predict diagnosis and major disease events earlier in these areas. The specific applications are in early detection, intervention, and outcome prediction.
In his keynote presentation, healthcare consultant Harry Glorikian will tackle the important questions facing the new data-driven healthcare market. What are the goals of this data-driven revolution and how far are we from starting to achieve them? Will a completely new business paradigm emerges for next-generation health systems to optimize operations and patient care? Is there room for disruptive entrepreneurs alongside existing companies to succeed in data-driven drug discovery and development? Roll up your sleeves and get ready to discuss what is working and what is getting in the way of flourishing in the world of MoneyBall Medicine.
Medimmune’s Associate Director of Translational Medicine, Katie Streicher, will present on single-cell RNAseq and its ability to characterize the molecular effects of IO therapy. Numerous IO combinations are currently in clinical trials across multiple tumor types; however, how each combination modifies the tumor microenvironment is not well understood. Using single cell RNA sequencing and ex vivo tumor models, it is possible to systematically characterize the downstream cellular and molecular effects of different treatment modalities, potentially leading to the identification of novel biomarkers that could increase treatment response.
According to Esther Babady, director of Clinical Microbiology Operations at Memorial Sloan Kettering Cancer Center, sepsis remains a significant cause of morbidity and mortality in hospitalized patients. The current gold standard, blood culture, is limited by a slow turn-around time to results. Molecular methods for rapid diagnosis directly from blood samples are emerging. Additionally, several options for rapid diagnosis from positive blood cultures are now available. Her presentation will review current and future options for rapid diagnosis of sepsis and discuss utility in patient care.
Karen W. Dyer from the Centers for Medicare & Medicaid Services will provide background on the CLIA law and corresponding regulations with focus on requirements for waived, moderate, and high complexity testing. Updated CLIA laboratory statistics will be presented as well as findings from Certificate of Waiver educational surveys.
Peter Tobin from the FDA will also discuss CLIA law, providing an update on recent developments, regulatory pathways, and study design recommendations for CLIA waiver, including how the Dual 510(k) and CLIA Waiver by Application pathway can help speed the process of bringing simple and accurate tests to CLIA-waived settings through valuable time and study efficiencies. Study design recommendations for over-the-counter tests and non-waived point-of-care tests will also be discussed.
