With the FDA’s Final LDT (Laboratory Developed Test) Rule introducing stringent regulations, CAP/COLA labs are facing increasing costs to develop new diagnostic assays. For many clinical laboratories, navigating the FDA’s regulatory framework can be a major financial barrier, especially with the high costs of 510(k) submissions and compliance. These regulatory shifts have created challenges for smaller labs looking to expand their diagnostic testing capabilities.
Crowdfunding provides a powerful solution for clinical labs by enabling them to share the financial burden of assay development and compliance. By joining a crowdfunding consortium, labs can collectively lower the costs of developing new tests while staying compliant with FDA regulations. This approach allows laboratories to maintain competitive advantage, without needing to invest millions independently in regulatory submissions.
Download this whitepaper to discover how the FDA Final LDT Rule impacts diagnostic assay development, the financial challenges labs face with 510(k) and regulatory compliance, and how crowdfunding can help reduce assay development costs. Learn a different way to stay competitive in the evolving diagnostics landscape.
