Initial Crowdfunding Assays Are Now Available in Response to LDT Final Rule
LISA heads up new effort with UTI assays designed to comply with the FDA’s regulations for lab-developed tests
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CARLSBAD, CA, OCTOBER 22, 2024—The Laboratory Integration Strategic Association (LISA) announced the first crowdfunding assays that empower labs to navigate the evolving Food and Drug Administration (FDA) regulatory landscape for laboratory-developed tests (LDTs), focusing on urinary tract infection (UTI) assays.
These UTI projects mark a new era where accredited clinical labs cooperate with industry to develop cutting-edge assays that comply with FDA’s LDT final rule.
Under LISA, the UTI projects will undergo analytic validation and clinical verification geared toward FDA submission, a pathway that LISA makes more cost-effective for labs. Labs joining the LISA UTI crowdfunding assays project get:
- Access to high-quality UTI reagents, including cGMP-grade (required for certain FDA Quality System Requirements).
- Validation and verification data.
- Opt-in option to being listed on the FDA submission (required before Stage 4 of the FDA’s LDT final rule).
- Discounts on reagents and cleared devices.
- A path to navigate the final rule.
Unlike other crowdfunding mechanisms, labs joining the UTI initiatives back projects by purchasing reagents. There is no investment requirement, and backers can choose levels that make sense—from labs just entering the UTI space to those comprising larger regional labs.
Each UTI crowdfunding assay is a multiplex PCR test with four pathogen targets and a control. The initial three UTI projects are designed towards common UTI pathogens.
“We are excited to get these first UTI crowdfund projects into the clinical lab and encourage labs to consider this approach as an important tool for navigating the FDA final LDT rule,” said James Gilmore, CEO at LISA. “Upon funding, these assays will undergo more extensive verification and validation than your typical LDT. Labs should note that crowdfunding is useful regardless of litigation outcome, as upon clearance these types of assays would likely not only be easier to reimburse, but they may also provide higher revenue.”
Read more about LISA’s efforts here.