in drug development strategies necessitated by companion diagnostics are discussed along with commercial challenges such as available resources and mismatched market sizes.

Chapter 3 summarizes the observations of representatives from three different end user groups: patients, health care providers, and clinical laboratories. Challenges for clinical labs, the regulation of NGS, and patient-centered efforts are addressed. Chapter 4 offers the views of representatives of pharmaceutical companies. Several workshop participants pointed to what they called “the problem of the generic”—that is, once an IVD has been approved, little prevents clinical laboratories from offering a test for the same analyte at a reduced cost. This undercuts the economic incentives to develop IVDs and the performance characteristics of LDTs compared with FDA-approved IVD.

Chapter 5 focuses on the regulatory environment for the marketing of co-developed companion diagnostics, the regulatory scrutiny that should be given to IVDs and LDTs, demonstrating the safety and effectiveness of devices, and reimbursement decisions based on clinical utility.

Finally, Chapter 6 outlines observations made by individual speakers and workshop participants about the possible solutions in Box 1-2 for addressing the current co-development landscape. Regulatory considerations are discussed, including a role for FDA to regulate tests based on risk, making CLIA more robust for LDTs, and choosing one regulatory pathway for all co-developed companion diagnostic tests to ensure their safety and effectiveness. The chapter reviews how standards of evidence for clinical utility are defined, as well as the pricing of tests. The role of NGS in the context of test regulation and reimbursement for more comprehensive diagnostics was not a focus of the workshop, but several speakers addressed these issues as they may be important in the future.



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