Dr. Hassan's lab has developed a 3D-printed, portable, smartphone enabled fluorescence microscopy setup for point-of-care diagnostic applications. This hand-held setup can be easily used to image cells of interest or other micro-nano particles used in different biological assays.The validation of the device with clinical samples will be shown in the talk. The setup is user-friendly and can be easily adaptable to different diagnostic applications.

Nostics is developing a point-of-care diagnostics platform integrating photonics, nanotechnology, and machine learning, to detect and identify pathogens at species-level within minutes. With our first application DUTI, we target the identification of bacteria causing urinary tract infections from urine samples during the first patient visit, enabling more effective antibiotic treatments. The platform can be expanded to other pathogens (e.g., fungi) and sample types (e.g., blood cultures), revolutionizing infectious disease testing.

Snakebite envenoming, one of the world's most neglected diseases, causes significant morbidity and mortality annually. Diagnosis largely relies on patient history and symptomatic assessment, with the availability of diagnostic tests varying globally. Timely diagnosis and treatment are warranted, emphasizing the need for novel, rapid, and affordable diagnostics to improve outcomes in both established and decentralized healthcare settings. This could enhance patient outcomes and reduce costs in resource-scarce healthcare institutions worldwide.

Decentralized diagnostics have proven value as critical medical and public health tools, from self pregnancy tests, to HIV self testing, to the international COVID-19 response and much more. However, truly decentralized POC testing is too often seen as antithetical to public health for lack of robust test monitoring, reporting and connectivity to EHRs. In 2022, the Biden Administration and the NIH launched the Home Test to Treat Program to leverage home diagnostics to support fast treatment and public health reporting. That program leveraged eMed's Test-to-Treat platform, developed in conjunction with the CDC, and enabled millions of Americans to return to the US during the early days of the pandemic, based on a self test. With appropriate innovations, distributed diagnostics can overcome traditional barriers and accelerate medicine, trials and responses to public health emergencies.

• Preliminary inquiries and interactions
• Funding mechanisms
• BAA solicitation process (Stage I – III)
• Key questions before starting a submission/advice for submitters​
  

With recent legislative changes, many regulatory barriers to providing point-of-care testing services in pharmacies and other non-traditional settings have been removed. Reimbursement for services in these settings remains as the largest barrier to wide-scale adoption and sustainability. While a barrier, models exist to reimburse providers for their services. In this session, current and potential reimbursement models for non-traditional settings will be presented along with the role diagnostic manufacturers can play in supporting reimbursement efforts.

Explore the success story of our innovative collaboration, where Recuro Health's virtual care delivery seamlessly integrates with Exact Sciences, bringing large-scale colorectal cancer screening and care to patients nationwide within the comfort of their homes. Our talk will highlight the program's practical value, the rich data generated, and its notable success so far for Exact Sciences.

Join me on a journey of developing an IVD medical device from scratch to obtaining CLIA Waiver. The challenges of creating a non-conventional Point-of-Care IVD are unique and varied. I will take you through the development process during the pandemic (non-COVID), from concept to regulatory clearance. I’ll describe our innovation, share the challenges we encountered, explore the lessons we learned, and outline the principles we believe enable success. The goal is to inform, encourage, share, and inspire others on this journey and suggest ways to collaborate in bringing safe and effective products to market as soon as possible.

As patient needs evolved throughout the pandemic, Walgreens stepped up to uncover and address the challenges and root issues that continue to impact community health. From parking lot testing sites to over 7000 testing locations, learn how Walgreens operationalized testing, assessment, and treatment services to not only offer alternatives to traditional channels but also allow our pharmacists to provide services to and help bridge care gaps.

Community pharmacists remain one of the most accessible healthcare providers in the U.S., with 9 in 10 Americans living within five miles of a pharmacy. Post-pandemic, there continues a shift in the perception of the role of the pharmacist as it relates to acute infectious disease treatment. However, there is sparse literature on pharmacist POCT service impact. This session will shed light on the topic with insights from a nationwide study.

Integrating CLIA-waived POCT into the workflow of a pharmacy is critical to the success of a testing service. Means to track scheduling, clinical notes, and other data are essential for such programs. Additionally, understanding and tracking compliance with state-level legislative requirements for disease reporting, record keeping, and training of personnel is vital.

This presentation aims to empower pharmacists and technicians in point-of-care testing (POCT) for improved patient care. Attendees will gain insights into the pivotal role pharmacists and technicians can play in POCT, explore the process and workflow of pharmacy-conducted POCT, and discover how these practices can elevate value-based care.

Point-of-care testing (POCT) provides unprecedented amounts information to outpatient healthcare practitioners. If used correctly, these tests can help reduce inappropriate antibiotic use by a substantial amount. In this talk, we will discuss how the appropriate use of POCTs can fuel antimicrobial stewardship efforts. We will also discuss the Collaboration to Harmonize AntiMicrobial Registry Measures (CHARM) project and how tracking antibiotic use is essentially to monitoring antimicrobial stewardship efforts.