This talk will summarize the current state of approved companion diagnostics from a technology perspective, and provide critical insights into emerging diagnostic technologies. It will highlight some emerging technologies such as AI-assisted digital pathology, focusing on how these technologies help address limitations of standard approaches, balanced with challenges and barriers that limit the adoption of such technologies.

Amivantamab (Ami) is a bispecific antibody against EGFR and MET that has been developed to address unmet needs in non-small cell lung cancer (NSCLC). The efficacy of Ami has been demonstrated in pivotal studies for NSCLC with EGFR Exon 20 insertion mutations and NSCLC with common EGFR mutations (Exon 19 deletion and L858R). This talk will describe precision medicine enabling clinical development success for Ami, highlighting various companion diagnostics (CDx).

As precision medicine evolves, the need for effective implementation strategies becomes paramount to translate research findings into clinical practice. In this talk, we will explore the integration of implementation science within precision medicine, focusing on frameworks, methodologies, and real-world applications. Key topics will include the assessment of barriers to adoption, strategies for stakeholder engagement, and the evaluation of outcomes. By fostering interdisciplinary collaboration, we aim to enhance the scalability and sustainability of precision medicine initiatives, ultimately improving patient outcomes and health equity.

This session will review a case study involving implementation across several health care ecosystem stakeholders (payer, provider, industry) aimed at addressing various issues associated with the commercial clinical adoption of exome and genome sequencing in pediatric rare disease. It will underscore the complexity of improving access to genomic testing and the importance of a multifaceted approach.

Reimbursement systems traditionally are designed around conventional healthcare delivery workflows such as patient visits, laboratory testing, and follow-up care, which are codified into billable services. While early health technology, like EMRs primarily functioned in a supportive role, health technologies today increasingly enable doctors to do more. Reimbursement models and processes aren't designed for many healthcare innovations, and they are slowly evolving in reaction to the emergence of these newer technologies.

Direct-access testing (DAT), also known as patient-authorized or direct-to-consumer testing, allows individuals to order laboratory tests without a physician's order. This approach empowers patients autonomy, expands healthcare access, and improves health outcomes. This abstract explores the utility of DAT by examining its benefits and drawbacks, considering its impact on patient care, and discussing its role in the evolving healthcare landscape. When implemented responsibly and ethically, can serve as a valuable tool for enhancing accessibility and promoting individual health management. However, there is still an unmet need for ongoing research and collaboration in the field to optimize the benefits of DAT.

Precision Medicine has rapidly evolved over the last decade; as a part of the dynamic future of healthcare, where do we stand with payer coverage and reimbursement?   What steps can we take to better understand how coverage decisions are going to be made and what steps can be taken "pre" and "post" market entrance to help support coverage?