Few novel POCT technologies reach patients who need them. This presentation will look beyond well known capital markets, into supply chain & human resource constraints and provide a "Good, Bad & Ugly" overview.

This talk will include a review of the current situation regarding access to POC diagnostics in LMIC and the main global initiatives aimed at addressing important shortcomings. It will also take a brief look at how trends in access to POC testing in the developed world are finding traction in LMIC and will conclude with a look at challenges and future prospects for POC testing in LMIC.

Throughout the history of medicine, the default preference has been to do what you can at home, before you seek care or intervention. Diagnostic tests and their results are fundamental to medical decision-making in this very first healthcare pathway. General practitioners (GPs) and other primary care professionals have traditionally had a limited ability to access diagnostic tests directly. Instead, a common model is for GPs to refer patients for laboratory testing. Offering more diagnostic tests in the community could enable faster and earlier diagnosis of common conditions and avoid unnecessary referrals. Additionally, as remote healthcare gathers traction, patients with chronic diseases could get easier access to diagnostic data than ever before. Greater availability of diagnostic testing in primary care is supported by technological, economical, and policy drivers. This talk will present evidence for models of diagnostic service that focus on answering healthcare needs. An attempt will be made to show what’s within reach to reshape care pathways with winning innovative technologies and shift care closer to home.

Mobile health is revolutionizing healthcare, providing patients with more direct access to critical services, personal data tracking, and their own doctors. As the number of applications for smartphones and wearables grows, more people will use them to personalize their own healthcare. This session will explore mobile health technologies and how e-health is transforming the future of laboratory medicine. Data interconnectivity and concerns for privacy, security, and confidentiality will be discussed.

Direct access testing (DAT) is becoming mainstream and will certainly be a crucial part of our healthcare system within this decade. This talk will explore how DAT can provide high quality laboratory testing, while being cost effective, accessible, and comfortable for patients.

The digital transformation of healthcare can be disruptive. Cutting-edge technologies and accelerating change present both challenges and opportunities. The digital health ecosystem encompasses a variety of technologies and concepts. and will revolutionize the way we deliver healthcare in the coming years. Strong legal and regulatory frameworks are needed to protect the privacy, confidentiality, integrity, and availability of data and the processing of secure personal health data, and to address cybersecurity, trust, accountability and governance, ethics, equity, capacity building, and digital health literacy. Digital technologies will only be effective if they are accessible and useful to as many people as possible.

The transition of standard of care testing away from the lab toward greater POC and at-home offerings is improving patient access and efficiency in our healthcare systems. The trend in new testing environments, however, presents new regulatory requirements and demonstrating performance of the tests with non-laboratory trained users is paramount to making these tests available to the broader population. This talk will present the regulatory requirements and discuss study design insights for CLIA-waived and at-home (prescription use/over-the-counter) tests.

This session will serve to educate on the reimbursement of tests outlined in L38988, MolDX: Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing. Included will be a specific discussion of POCTs that may fall within scope of this policy.

Home-based diagnostics enable patients or consumers to conduct different types of tests directly at home. Often these test kits are for known health conditions, can they ALSO be effectively used for diagnosing a previously undiagnosed medical issue?​

- What tests/parameters or syndromes are best suited for at-home diagnostics?   

- As home testing grows from a nascent trend to an emerging trend – will reimbursement impede patient access? 

- How do we ensure that technologies are fool-proof to allow for optimal “do it yourself” testing? 

- What are some key success factors for self-testing?

- Successfully managing the retail aspects of “at-home diagnostics”​

- Evidence in the literature supporting saliva as a reliable sample type for the detection of respiratory pathogens

- Key considerations for working with this non-traditional sample type 

- Insights gained from the COVID-19 response: self-collection, sample stability, simplified testing methods

- Reasons to incorporate saliva into your laboratory or surveillance systems, particularly in low-resource settings​​​

Diagnostic testing in the point-of-care and at-home settings creates several regulatory and reimbursement challenges. In this session, we will explore key challenges in market access for these products and walk through strategies for addressing the same.