FDA’s Final LDT Rule – Stricter Regulatory Requirements
In his recently published white paper on Today’s Clinical Lab, James Gilmore, CEO of The Laboratory Integration Strategic Association (LISA), emphasizes increasing urgency for CAP/COLA laboratories as FDA’s Final Rule on Laboratory-Developed Tests (LDTs) takes hold. With the rule introducing stricter regulatory requirements, many labs will face significant financial and operational challenges with new assays. Gilmore proposes crowdfunding as an urgent and practical solution to help labs navigate these hurdles.
For those willing to innovate, the opportunity to stay competitive and continue developing new diagnostics is clear.
FDA’s Final LDT Rule – Short Timeline and Significant Costs
While FDA’s final LDT rule has allowed a four-year phase-in period and included some “grandfather” clauses, the long-term effects of the rule are profound for many labs. The clock is ticking for launching new tests after May 6, 2024. These labs will need to comply with costly regulatory pathways, such as 510(k) or 513(f)(2), which involve expensive clinical data and validation. For many smaller labs or those looking to expand their testing portfolios, this timeline represents a formidable barrier. Without swift action, they risk being priced out of the market or missing the opportunity to develop new assays entirely. Meanwhile, larger labs with the financial means to absorb these costs will continue to expand, leaving smaller players behind.
Crowdfunding – an Urgent Solution
Gilmore underscores that smaller labs cannot afford to delay. Crowdfunding could be a lifeline—allowing multiple labs to pool resources and share the burdens FDA’s final LDT rule compliance. By participating in a consortium, labs can collectively finance new assay development, reducing individual costs and accelerating the regulatory submission process. This shared approach not only alleviates financial pressure, it also allows labs to tap into regulatory expertise without having to develop it in-house, thereby streamlining efforts to meet good manufacturing practice (cGMP) requirements and other regulatory standards.
Increasing urgency for CAP/COLA laboratories as FDA’s Final LDT Rule takes hold.
Gilmore acknowledges that crowdfunding isn’t without its challenges. There are inherent risks in developing new assays, as clinical validation can yield unpredictable outcomes, and future regulatory changes could add further complexity. Additionally, there may be reluctance among labs to collaborate with perceived competitors. But for those willing to innovate, the opportunity to stay competitive and continue developing new diagnostics is clear.
Act Now – Stringent Deadlines
With the increasingly stringent FDA deadlines approaching, Gilmore urges labs to act now as developing and submitting an assay to the FDA requires substantial time and effort. Crowdfunding offers a transformative way forward, enabling labs to overcome financial and regulatory barriers while keeping pace with industry changes.
Download the white paper here: Today’s Clinical Lab.
Read more about LISA’s crowdfunding initiative in this post.
Contact us if you have any questions, or click here if you want to join LISA.