Dr. Courtney Lias, PhD, who now officially serves as the Director for the Office of In Vitro Diagnostics (OIVD) at the FDA, recently delivered a keynote speech at the Next Generation Diagnostic Summit, highlighting key trends and challenges in FDA diagnostics policy. Her address provided a comprehensive overview of the evolving landscape, focusing on the increased emphasis on home testing, the impact of the pandemic on diagnostic access, and the integration of AI and cybersecurity in medical devices.
Expanding Access to Diagnostics
A major theme of Dr. Lias's speech was the ongoing shift towards expanding access to diagnostic testing beyond traditional healthcare settings. She emphasized how the COVID-19 pandemic accelerated the demand for home testing and point-of-care diagnostics, particularly in the infectious disease arena. The pandemic underscored the importance of making tests more accessible to under-screened populations, such as through home specimen collection for HPV screening and at-home testing for sexually transmitted infections.
Dr. Lias pointed out that while the concept of home testing is not new, with the FDA authorizing over 400 over-the-counter products in the past decade, there is a growing interest in diversifying the types of tests available for home use. The Cancer Moonshot Initiative, for example, is pushing for increased home-based screening to reach individuals who might otherwise avoid testing due to privacy concerns.
Public-Private Partnerships and Innovation
The collaboration between public and private sectors was another highlight of Dr. Lias's speech. She praised the Independent Test Assessment Program (ITAP), born out of the RADx initiative during the pandemic, as a model for efficient development and validation of diagnostic tests. This program enabled the rapid authorization of numerous COVID-19 tests, including point-of-care and over-the-counter options, and has since expanded to address other unmet needs, such as Hepatitis C testing in underserved populations.
Dr. Lias suggested that expanding programs like ITAP could streamline the development of diagnostic tests for other diseases, illustrating the potential of public-private partnerships to drive innovation and meet public health challenges.
The Role of AI and Cybersecurity
Artificial intelligence (AI) and machine learning (ML) in diagnostics are areas of significant interest for the FDA, and Dr. Lias addressed the complexities of regulating these technologies. While many AI-enabled devices are now common in areas like digital pathology and image analysis, the FDA is working closely with international counterparts, such as Health Canada and the UK, to establish best practices for AI in medical devices.
Dr. Lias introduced the concept of Predetermined Change Control Plans (PCCPs), which allow for more flexible updates to AI algorithms post-market authorization. This approach aims to balance innovation with safety, enabling manufacturers to update AI models without needing to submit new applications to the FDA, provided they adhere to the pre-approved PCCP.
Cybersecurity was another critical issue addressed by Dr. Lias, particularly in light of new regulations requiring medical devices to meet stringent cybersecurity standards. She stressed the importance of building cybersecurity into devices from the outset and choosing instruments that meet these requirements, even if they are not directly developed by the test manufacturers. The FDA's focus on cybersecurity reflects the growing recognition of the risks posed by cyber vulnerabilities in healthcare settings, where outdated or insecure devices can lead to significant patient safety issues.
Moving Forward
Dr. Lias concluded her speech with a call to action for the diagnostics industry, emphasizing the need for continued innovation, collaboration, and adherence to regulatory standards. As the FDA navigates the challenges of modernizing diagnostics policy, Dr. Lias's leadership will be crucial in guiding the industry toward a future where diagnostic testing is more accessible, reliable, and secure.
Her insights underscore the FDA's commitment to fostering innovation while ensuring that safety and efficacy remain paramount in the development and deployment of diagnostic technologies.
