Companion diagnostic devices play a crucial role in personalized medicine by helping healthcare professionals identify the most appropriate treatment for a patient based on their genetic, molecular, or other specific characteristics. Due to the unique nature of these devices, there are several regulatory considerations that must be taken into account to ensure their safety and effectiveness. These considerations include regulatory authorities, classification, clinical and analytical validation, and labeling.

The forces that have historically driven genomic testing in precision oncology are changing, and a new set of challenges and opportunities are presenting themselves. The healthcare and the industry ecosystem have been forced to evolve, with access and clinical quality in the balance. Technology is ever expanding with promise but needs to navigate both new and familiar challenges. This talk will approach these dynamics from a strategic perspective.

Despite the availability of many high-value precision oncology therapies, cancer patients who are eligible do not receive appropriate testing and/or targeted treatments due to clinical practice gaps related to diagnostic testing and the delivery of appropriate biomarker-indicated therapies. Modernized healthcare delivery policies and streamlined clinical practices are needed to address practice challenges and optimize precision oncology implementation.

Dr. Astion will share background and challenges associated with medical necessity policies for laboratory tests. These policies are foundational to the laboratory payment system in the United States. Problems with medical necessity policies affect patients, labs, physicians, and insurers. The talk emphasizes the importance of the following: 1) methods for achieving alignment and collaboration between patients, labs and payers, and 2) ideas for decreasing problems in policy that fall disproportionately on the most seriously ill patients, and which can affect both their finances and access to healthcare.

Traditional evidence review and value frameworks used by health plans and other stakeholders are derived from other areas of medicine and are often incomplete for precision medicine. When a single test encompasses more information than a single indication, this presents further challenges for assessing value and determining coverage. In this session, the results of a conceptual analysis and literature review inform a new Value Framework which can be easily applied to multi-cancer genetic testing in a tumor/somatic setting and hereditary cancer setting.

Physicians face many challenges in accurately and efficiently ordering genetic tests, leading to inappropriate ordering practices. A critical first step in ensuring successful laboratory utilization practices is appropriately identifying patients who meet guideline criteria for genetic testing. Digital health tools with point-of-care testing offer scalable approaches to hereditary risk assessment. This session will explore the usability, yield, and other implementation outcomes specific to deployment in a variety of clinical settings.