Project Summary The state of knowledge regarding the human microbiome is advancing rapidly and a burgeoning new area of research and development is microbiome-based diagnostics. There is much that is not yet known about the implications of microbiome-based diagnostic or screening test results and it is possible that existing laws and regulations that did not contemplate these technological advancements are not adequate to address legal, regulatory, ethical and social concerns they raise. The overall goal of the project is to inform and support policy and regulatory approaches that stimulate scientific discovery, identify and address regulatory problems and gaps, and encourage innovation while ensuring that new microbiome-based products are safe and effective. Aim 1 of this project is to review the federal and state laws and regulations that govern diagnostic testing and results to determine if they are appropriate for microbiome-based diagnostic tests. We will conduct a comprehensive landscape analysis of laws and regulations governing diagnostic tests to determine how microbiome-based diagnostics are currently regulated,, assess the applicability of existing oversight mechanisms (e.g. CLIA, FDA), and evaluate what legal protections, if any, exist for individuals who may face discrimination or stigma based on their microbiome-based test results. Aim 2 is to better understand stakeholder perceptions of microbiome-based diagnostic tests including test utility and value to health care decision-making and concerns with regard to privacy and data security. We will conduct in-depth interviews and focus groups with three groups of stakeholders – microbiome researchers, providers and consumers/patients. This study will help inform clinicians, consumers and regulators by identifying patient and provider motivations to order these tests, assessing their understanding of test results, and highlighting issues raising the potential need for regulation. Aim 3 is to develop and propose an appropriate and comprehensive regulatory framework for microbiome-based diagnostic tests. Based on the analyses conducted in Aims 1 and 2, investigators, with the help of a multidisciplinary working group, will assess the current regulatory stance for microbiome-based diagnostics and evaluate the appropriateness and effectiveness of that stance considering the extent to which the regulations address risks associated with testing, contemplate the clinical validity and utility of the tests, ensure that consumers/patients receive accurate and adequate information about the benefits and risks of the tests and test results, and ensure appropriate patient access to these tests while also encouraging scientific innovation. The anticipated outcomes of our research are a comprehensive assessment of the current legal and regulatory landscape, evaluation of stakeholder perceptions of microbiome-based diagnostics and understanding of legal protections to inform an evaluation of the existing regulatory scheme and identification of a practicable, patient-centered approach to the regulation of microbiome-based diagnostics.

Project Narrative There is much that is not yet known about the implications of microbiome-based diagnostic or screening test results and, similar to the early days of genetic testing, it is possible that existing laws and regulations that did not contemplate these technological advancements are not adequate to address concerns they raise. The proposed project will evaluate the existing legal and regulatory frameworks regarding these new products and their use and assess patient and provider perspectives on their value, utility and potential for misuse in order to inform future regulatory approaches for these tools and ensure their appropriate use in patients. The overall goal of the project is to inform and support policy and regulatory approaches that stimulate scientific discovery, identify and address problems or gaps in the current regulatory and legal framework and encourage innovation while ensuring that new microbiome-based products are safe and effective.