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

CURRENT PROJECTS

Digital Health and Connected Diagnostics

Awardee: SAFE Health Systems

Safe Health Systems (SAFE) has been contracted by the FDA to lead the "Open Connected Diagnostics" initiative, which is designed to accelerate implementation and adoption of connected diagnostics capabilities for use with digital health platforms as part of clinical workflows. Working in collaboration with the FDA, SAFE seeks to achieve three initial objectives:

Define methods and provide standards-based technologies required for robust diagnostic data capture with a focus on overcoming the challenges unique to OTC/POC diagnostics in non-traditional and non-clinical settings. Overcoming issues in these settings such as accurate data collection and timely reporting to public health authorities demonstrates a practical approach to improving healthcare.
Implement a standards-based Interoperability Specification and developer toolset to enable developers to embed interoperable Connected Diagnostics capabilities into their applications and securely interact with other applications in the Open Connected Diagnostics ecosystem. Interoperability is crucial in the healthcare sector, as it promotes collaboration, enhances patient care, and accelerates innovation.
Launch a reference implementation of the Open Connected Diagnostics ecosystem and carry out a series of pilot programs aimed at demonstrating the value of connected diagnostics capabilities in enhancing healthcare delivery. These pilots will demonstrate how established standards and technologies can advance predictive health data analytic models by standardizing the collection and sharing of patient data captured at the Point of Need (PoN) as well as help to reduce costs, improve clinical outcomes, improve public health surveillance, and improve diagnosis and treatment.

Ultimately, the Open Connected Diagnostics initiative aims to establish interoperable connections between PoN diagnostic test data silos, enabling near real-time data processing that enhances the efficiency and effectiveness of our health care system and minimizes operational burdens.

Nanobiosym Digital Diagnostics Platform for Precision Diagnosis and Personalized Medicine: Next-Gen Tools for Pandemic Surveillance and Management

Awardee: Nanobiosym

Nanobiosym has been contracted by the FDA to demonstrate the feasibility of high precision molecular data collection using the Nanobiosym Digital Diagnostics Platform. Using Real World Data and Real World Evidence (RWD/RWE) collected by this platform, Nanobiosym aims to provide new insights to better manage ongoing COVID-19 infections, enabling smarter patient triage, personalized precision medicine, and data-driven public policies.

Nanobiosym seeks to demonstrate the feasibility of the Nanobiosym Digital Diagnostics Platform for: i) high precision molecular data collection, and ii) the ability to seamlessly integrate with connected mobile IVD devices. Working in collaboration with the FDA, Nanobiosym will conduct a prospective, observational study to achieve three goals:

Collect standardized, harmonized diagnostic data via investigational measurement of quantitative viral loads in enrolled patients at different stages of SARS-CoV-2 infection and COVID-19 disease, and analysis of this new type of data alongside available observational RWD from conventional qualitative diagnostic testing.
Collect patient demographic data, clinical and symptomatic data, and contextual and metadata to analyze this RWD/RWE alongside quantitative viral load data to support the evaluation of real-world IVD test performance in different settings and across different patient populations.
Demonstrate feasibility for secure and effective methods for the capture, harmonization, transmission, and flow of clinical and diagnostic data in compliance with the FDA's proposed standards and pathways.

More broadly, this project aims to provide insights to providers, patients, and the FDA regarding the performance of various medical countermeasures and approaches, which will enable more personalized precision care at the individual level and better insights for managing COVID-19 at a population level.

Real World Digital Diagnostic Data Collection, Aggregation, and Analysis

Awardee: ImageMover

ImageMover has been contracted by the FDA to capture and harmonize real-world, point-of-care COVID-19 diagnostic test result data and other relevant clinical data from multiple nontraditional testing locations, and to securely transmit this anonymized data to the FDA in a HIPAA compliant manner. ImageMover will share this data to help the FDA accomplish the following objectives:

Evaluate the data for quality, completeness, interoperability, harmonization, standardization, and regulatory utility.
Inform approaches and expectations of real-world data and its fitness-for-purpose with regards to IVD test performance.
Inform an analytics tool that provides aggregate data trends and actionable insights for the purpose of informing public health decisions at both individual and population levels.

The overall aim of this project is to provide the FDA with a robust, large-scale dataset that can be used to demonstrate how high-quality data can support better regulatory decision-making.

Large-Scale Interactive Lab Test Driven Insight Discovery Engine

Awardee: Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center (BIDMC) has been contracted by the FDA to make accessible the rich, HIPAA-compliant clinical information encoded by billions of real-world laboratory test results for the advancement of regulatory science and clinical care. Working in collaboration with the FDA, BIDMC seeks to achieve three initial objectives:

Develop a web-based discovery engine in which users can select one or more laboratory tests, define one or more cohorts by demographics, clinical presentations, comorbidities, medications, procedures, outcomes, and clinical impressions, and view and compare the resulting distributions of laboratory values.
Support regulatory decision-making with regards to the use of Real-World-Data (RWD).
Expand applicability and demonstrate utility beyond SARS-CoV-2 diagnostics, which could open the door for applications across other medical device and product spaces of interest to the FDA.

Ultimately, this project aims to make the clinical information encoded in real-world laboratory tests—ideal for discovery, trial design, product development, and clinical advancement—safely and securely available to regulators, manufacturers, clinicians, scientists, and the public. This aligns with the FDA's objectives of advancing regulatory science, specifically its goal of stimulating innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes and harnessing diverse data through information sciences to improve outcomes.

Diagnostic Data Evidence and Ecosystem Platform

Awardee: Palantir Foundry

Palantir Foundry has been contracted by the FDA to develop the Diagnostic Data Evidence and Ecosystem (DEEP) Platform, a robust, technical infrastructure that integrates Real-World-Data (RWD) and Real-World-Evidence (RWE) to support the FDA's regulatory review process. Working in collaboration with the FDA, Palantir Foundry seeks to achieve the following objectives:

Develop a technical infrastructure for handling RWD/RWE to support the conversion from emergency use authorizations (EUAs) to 510(k) clearances for COVID-related IVDs (e.g., rapid tests, PCR tests) so these tests can continue to be available after the EUA declaration is terminated.
Provide the FDA with an EUA Conversion Model that can support the 510(k) submission and review process.
Support an interoperable ontology, backed by the underlying core data of federal government agencies as well as other data sources, such as external diagnostic tests.
Provide data and analytical tools that ensure all diagnostic data is cleaned and harmonized, and that FDA has access to granular insights across all data at scale.

Most importantly, DEEP features extensible front-end data pipeline assets that can be used to build reusable solutions for analogous pathways. In the long term, DEEP aims to provide the FDA with an agile, scalable solution beyond COVID-related IVDs to handle changing business needs, new IVDs, or a future pandemic.

COMPLETED PROJECTS

Project Title: Advanced Capability Development for Digital Diagnostic Data

Awardee: Johns Hopkins Applied Physics Laboratory

The Johns Hopkins Applied Physics Laboratory (APL) was previously contracted by the FDA to build a prototype Smartphone mobile app to reliably interpret the results of at-home and OTC antigen COVID-19 diagnostic tests along with standardized diagnostic data elements. This project aimed to advance the digital diagnostics field by creating a framework to assess emerging technologies using Software as a Medical Device (SaMD) to interpret and capture results digitally.

APL developed an easy-to-use, manufacturer-agnostic mobile app to take an image of an at-home COVID-19 test and interpret and convey the results to users easily and accurately, as well as in a standardized data format. The APL team leveraged its multidisciplinary expertise in Artificial Intelligence and Machine Learning techniques, Optics, Software Engineering, Biology, and Systems Engineering to build the proof-of-concept Android mobile app which, based on initial testing, may be able to read and interpret test results better than a human eye. As a result, this work is positioned to advance regulatory science for at-home testing of diseases beyond COVID-19.

COVID-19 Digital Diagnostics TOPx Sprint: Diagnostic Data Exchange

USG Partner: U.S. Census Bureau

In 2023, the U.S. Census Bureau was contracted by the FDA to leverage The Opportunity Project (TOP) model for collaborative problem-solving around issues of health data standardization, harmonization, interoperability, capture, and reporting from OTC/POC tests.

Using the Census Bureau's innovation sprint framework, called TOPx, the FDA aimed to explore new possibilities for seamless, secure diagnostic data exchange from diagnostic testing devices. This sprint brought together various stakeholders – including technologists, public health officials, manufacturers, software developers, regulatory reviewers and community leaders – to accomplish the following objectives around the 2023 problem statements:

Identify gaps in diagnostic data harmonization, capture, and reporting.
Educate upstream stakeholders about adopting diagnostic data standards, harmonization, and interoperability.
Explore new possibilities for seamless, secure data ingestion from OTC/POC diagnostic devices.
Understand new strategies for quickly disseminating high-quality data that could provide actionable insights to stakeholders.
Gain insights to inform regulatory review processes, policies, and guidance for new, digitally-integrated and diagnostic tests performed beyond laboratories.

The TOPx Sprint convened seventeen teams of innovators who developed solutions to address these objectives. With more than 30 user advocates and data stewards involved and SMEs from multiple agencies (FDA, ONC, NIH, CDC etc.), eighteen innovative approaches and solutions were brought forward and highlighted at the concluding TOP FDA Diagnostic Data Solutions Showcase hosted live on YouTube. The FDA 2023 TOPx Sprint was the largest sprint in the Census Bureau's 8-year history of hosting innovation sprints.

Additional Resources

Contact Us

DiagnosticDataProgram@fda.hhs.gov