LISA CEO James Gilmore reveals why the crowdfunding effort for diagnostic assays is a game-changing strategy for managing the new regulatory costs associated with laboratory-developed tests (LDTs).
As the FDA’s final rule on Laboratory-Developed Tests (LDTs) reshapes the regulatory landscape, James Gilmore, CEO of the Laboratory Integration Strategic Association (LISA), is spearheading a revolutionary initiative to crowdfund diagnostic assays. Crowdfunding, which taps into the collective power of multiple contributors, is being positioned as a timely and critical solution to help CAP/COLA labs shoulder the financial and regulatory burdens imposed by the new guidelines.
LISA’s Crowdfunding Effort for Diagnostic Assays
LISA, short for “Laboratory Integration Strategic Association,” is a coalition of industry leaders and CAP/COLA lab partners united in their goal to support labs as they navigate the complexities of the FDA’s final rule on LDTs. The new regulations are far-reaching, demanding substantial investment in both money and expertise, which many smaller labs may struggle to provide on their own.
The crowdfunding effort for diagnostic assays is a game-changing strategy for managing the new regulatory costs associated with LDTs
The LISA initiative offers a collaborative approach to assay development by allowing labs to share the costs involved. “A relatively simple five-target assay can cost anywhere from $1.5 million to $4.2 million to develop,” says Gilmore. “A more complex assay with broader targets could easily exceed $14 million.” This substantial financial burden, along with the resource-intensive regulatory processes, makes it clear that many CAP/COLA labs could face overwhelming challenges if they attempt to go it alone.
Through LISA, labs can contribute to assay development by purchasing reagents they are likely to use anyway, making the crowdfunding effort for diagnostic assays both practical and efficient. “LISA is not your typical crowdfunding model,” Gilmore explains. “Labs aren’t just pledging money—they’re purchasing reagents that they’ll need for their work. This reward-based crowdfunding helps to spread the cost and ensure that only the assays labs are interested in developing receive backing.” Labs are also encouraged to nominate diagnostic projects they consider essential.
First Crowdfunding Projects Launched
LISA recently launched its first crowdfunding projects focused on diagnostic assays for urinary tract infections (UTI). The initiative offers CAP/COLA labs the opportunity to back the development of three multiplex PCR assays targeting four pathogens in each assay. Labs can choose to support one, two, or all three assays, with higher pledges leading to greater discounts on the associated reagents. Once each project reaches its funding target, LISA will begin the FDA clearance process.
One key advantage for backers is not only the potential discounts but also compliance with the FDA’s regulatory framework. LISA ensures that cGMP (current Good Manufacturing Practice) requirements are met, and labs participating in the crowdfunding for diagnostic assays initiative can opt to be included in the regulatory submission for the assay. This provides a clear and compliant path for labs to introduce new diagnostic tests to the market while navigating the FDA’s new guidelines.
The urgency of this initiative cannot be overstated. The final rule deadlines are fast approaching, and the lead time required to bring a new assay from concept to market is extensive. Labs that hesitate may find themselves unable to adapt in time. “Waiting for regulatory uncertainty to resolve is a risky strategy,” warns Gilmore. “Our goal is to secure FDA clearance for these assays, which will make reimbursement easier and potentially more profitable for CAP/COLA labs.”
“Momentum is key,” says Gilmore. “The more backers we have, the more we can accomplish together, and the greater the benefit to every lab involved.”
Partnered With Industry Leaders
LISA has partnered with industry leaders to ensure the success of this ambitious project. Argonaut Manufacturing Services, a leading FDA-inspected manufacturer with experience producing millions of diagnostic kits, handles production. Development and clinical trials are led by Arete Biosciences, a firm with a proven track record of helping assays gain regulatory approval. Legal guidance is provided by Epstein-Becker-Green, experts in both LDTs and FDA-regulated devices.
Crowdfunding effort for diagnostic assays is a bold and innovative solution to the challenges facing CAP/COLA labs, but it requires widespread participation to succeed. The more labs that join the effort, the more assays can be submitted for regulatory approval before the FDA deadlines. “Momentum is key,” says Gilmore. “The more backers we have, the more we can accomplish together, and the greater the benefit to every lab involved.”
As CAP/COLA labs face a rapidly changing regulatory environment, LISA’s crowdfunding for diagnostic assays initiative offers a path forward—one where labs can continue to innovate, stay compliant, and maintain their competitive edge.
Contact us with any questions you have about the crowdfunding effort for diagnostic assays.