Animal-Based Medical Diagnostics: A Regulatory Problem
Matthew Avery and Makenzi Galvan
Fears of global pandemics due to outbreaks of highly virulent diseases like the novel Coronavirus disease of 2019 (COVID-19) have boosted interest in rapid and non-invasive diagnostics. One solution is to use animal-based diagnostics, which have the potential to be more accurate and efficient than conventional diagnostics. For example, researchers have shown that trained detection dogs have been able to identify C. difficile infections in patients with 97% accuracy—higher than the 92.7% reported accuracy for real-time PCR diagnostic methods. While these animal-based diagnostics clearly fall within the scope of FDA’s regulatory authority, innovations in diagnostic technologies, specifically animal-based diagnostics, have outpaced the Agency’s ability to update its requirements for receiving marketing approval. Consequently, researchers in this area face a regulatory regime that does not address the challenges or risks inherent in using animals to detect diseases.
This Article predicts how the Agency will regulate animal-based diagnostics and shows how the current regulatory regime is inadequate. The Article then proposes modifying the current regulatory regime to encourage development of animal-based diagnostics by (1) creating guidelines for demonstrating analytical and clinical validity in animal-based diagnostics and (2) adopting the technology certification pathway provisions of the proposed VALID Act of 2020, a reform bill that would streamline how FDA regulates medical diagnostics.
Food and Drug Law Journal
Volume 75, Number 3