Goal to Bring CAP/COLA Labs Together for Innovative FDA-Compliant Assays
CARLSBAD, Calif., Oct. 22, 2024 /PRNewswire/ — The Laboratory Integration Strategic Association (LISA) proudly announces the first crowdfund projects that empower labs to navigate the evolving 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 Final LDT 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 crowdfund projects get:
- Access to high-quality UTI reagents, including cGMP-grade (required for certain FDA Quality System Requirements).
- Validation and verification data.
- Opt-in to being listed on FDA submission (required before Stage 4 of the FDA Final LDT Rule).
- Discounts on reagents and cleared devices.
- A path to navigate the FDA Final LDT 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 crowdfund project is a multiplex PCR assay 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 of 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.”
About LISA
The Laboratory Integration Strategic Association (LISA) is dedicated to supporting CAP and COLA-accredited clinical laboratories in navigating the new FDA regulatory requirements for Laboratory Developed Tests (LDTs). Through a collaborative crowdfunding model, LISA drives the development and approval of new, cutting-edge assays, ensuring that labs can continue to innovate and provide high-quality diagnostic services.
Contact Us
For more information about LISA and to join the association, visit www.lisabio.com or email at [email protected].
Media Contact:
Marianne Woodard
Brainspores
[email protected]
408 313 8583
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SOURCE LISA Bio
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