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Digital Diagnostics: Over-the-Counter (OTC) and Point-of-Care (POC)

Illustration of a swab, test tube, and test strip under the words OTC/POC, which stand for over-the-counter and point-of-care, respectively.

In vitro diagnostic (IVD) tests that have been traditionally performed in laboratories (labs) are becoming increasingly performed outside of labs, which leaves those tests untethered from their usual data collection and reporting systems. Over the past several years, we have seen a rapid increase in point-of-care (POC), at-home, and over-the-counter (OTC) tests ("non-lab-based") for SARS-CoV-2, and it is expected that these and other non-laboratory-based tests will continue to increase in the coming years.

Without capture and transmission of the increasing volumes of data from non-lab-based tests, federal and state public health leaders and physicians will have less information available to make evidence-based decisions for individual clinical care as well as population health using diagnostic data. It is also challenging to evaluate the performance of these tests without access to post-market real-world data. New and emerging technology and innovation in SARS-CoV-2 diagnostics is presenting both opportunities and challenges with regards to data capture, harmonization, transmission, and use for addressing the pandemic at both individual and population levels. Technologies developed and lessons learned from widely available tests during the COVID-19 pandemic will usher in both new expectations and new technological ways of accessing tests and using diagnostic data for years to come – and for conditions beyond infectious disease.

Data from Over-the-Counter (OTC) and Point-of-Care (POC) Tests

Barriers to capturing diagnostic data from OTC and POC tests are not technological – developers and innovators are rapidly rolling out solutions that will potentially enable far better data harmonization, capture, and reporting than traditional lab-based systems. Leveraging the combination of diagnostic technologies with digital health tools, apps, software, and wireless transmission facilitates use of diagnostic data for timely clinical decision-making and patient care. Further, the capture, transmission, aggregation, and analysis of the comprehensive, population-level diagnostic data may be used to guide evidence-based policy and public health decision-making, for example, in the case of an infectious disease outbreak.

As with other emerging medical technologies, developers need regulatory support and guidance that is timely and specialized to bring their innovations to market. As premarket submissions to market IVDs may combine components of different types, such as an assay with hardware (for example, an instrument), software, or digital applications, a dedicated interdisciplinary review team composed of FDA staff provides support to developers to manage and expedite the review processes when indicated. Interdisciplinary expertise and collaboration are critical to address the device review needs during a pandemic as well as to prepare for new, emerging technologies that will increasingly combine hardware and software systems with wireless connectivity and transmission of data. This collaboration between physicians and scientists at the FDA brings together essential expertise in IVDs, microbiology, virology, medicine, public health, software, digital health, cybersecurity, information technology, computing, and research and development.

The FDA is prepared to support developers who present the FDA with innovative, cross-cutting technological solutions and new types of tests – the volume of which will likely increase. The FDA also anticipates that a broad expansion of software integration with IVDs beyond COVID-19 will accelerate moving forward.

Lessons from Tests During the COVID-19 Public Health Emergency

The Coronavirus Aid, Relief, and Economic Security (CARES) Act specified that data elements be reported for COVID-19 diagnostic tests performed in laboratories. The Department of Health and Human Services (HHS) further defined these data elements through guidance and technical specifications for lab-based tests and non-lab-based tests. The reporting requirement and implementation strategies helped ensure critical diagnostic test data was collected and reported to state and federal public health officials to inform the pandemic response at every level across the U.S.

As the availability of "rapid tests" administered at POC and sold OTC dramatically increased between late 2020-2022, the volume of testing increased rapidly while the percentage of diagnostic data being collected and reported dropped dramatically. Over this period of time, many stakeholders raced to build integrated hardware-software solutions for diagnostic data capture and reporting, as well as the data collection and analytical systems to support the new diagnostic data ecosystem of widely available tests. However, the rapidly evolving landscape of testing options and surge in volume created challenges regarding diagnostic data that have been partly addressed in real-time but will require collaborative effort and investment by many stakeholders for years to come. Without the ability to capture, analyze, and utilize high quality data from non-lab-based tests, all stakeholders as well as patients and the general public will not be able to maximally benefit from more accessible testing. Ensuring the quality and performance of tests, as well as the ability to protect patient privacy and security, will be crucial features of the ecosystem as it expands.

To address these issues, the FDA's Diagnostic Data Program – including the Digital Diagnostics (OTC/POC) focus area – within CDRH is working to support the testing community to develop innovative methods for collection, harmonization, transmission, and analysis of diagnostic data originating from tests, including those performed outside laboratories. It will be critical that these non-lab-based data streams are harmonized and aggregated with lab-based data streams for similar diagnostic tests. This program is also working with stakeholders to inform regulatory review processes that will ensure safe and effective diagnostics arising from new, emerging, and convergent technologies are first to market in the U.S.

Another way CDRH is supporting innovation in diagnostics is through collaboration with other federal agencies, such as with NIH's Independent Test Assessment Program (ITAP) and Rapid Acceleration of Diagnostics (RADx) Program. ITAP has facilitated the authorization of at-home tests by developing standardized evaluation protocols and data reporting mechanisms along with targeted outreach to developers of rapid antigen tests that were authorized in other markets. RADx has worked with the IVD community to accelerate the volume and variety of SARS-CoV-2 testing technologies available in the U.S.

Digital Diagnostics: OTC/POC Funded Program Portfolio



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