In Response to FDA LDT Final rule, LISA Launches Crowdfunding Initiative for Clinical Laboratories
CAP/COLA Labs Invited to Join a Pioneering Initiative for Developing FDA-Compliant Assays
Carlsbad, CA- July 29, 2024 – The Laboratory Integration Strategic Association (LISA) proudly announces its official launch, ushering in a new era of collaboration and innovation in clinical testing. Designed to support CAP and COLA-accredited diagnostic laboratories, LISA’s objective is to empower labs to navigate the evolving FDA regulatory landscape for Laboratory Developed Tests (LDTs) while driving the development and FDA clearance of new, cutting-edge assays.
Why Join LISA?
LISA offers a unique platform for clinical laboratories to stay ahead of regulatory changes and remain at the forefront of diagnostic innovation. By joining LISA, labs can access:
- Collaborative Innovation: Participate in a pioneering crowdfunding model to develop and submit new assays for FDA clearance.
- Cost-Effective Solutions: Share the financial and technical burden of obtaining 510(k) clearance.
- Access High-Quality Reagents: Utilize state-of-the-art cGMP/ISO-grade reagents and protocols.
- FDA Compliance Assistance: Access expert guidance and resources to meet new FDA LDT requirements.
“LISA is designed to bring together CAP/COLA labs with key industry players to successfully address the new business challenges. Our goal is to ensure CAP/COLA labs continue to lead in delivering needed health care solutions by providing a new approach to diagnostic assay design and development. Instead of doing it alone, LISA’s CAP/COLA members have a community resource to draw on by sharing costs and contributing experience,” said James Gilmore, CEO of LISA. He concluded, “We believe with LISA resources and support, our members will be able to successfully navigate all phases of the Final FDA LDT rule.”
Key Players in LISA
LISA brings together industry leaders with specialized expertise:
- Argonaut Manufacturing Services: cGMP manufacturing, quality control testing, and supply chain management.
- Arete Biosciences: FDA communications, regulatory requirements, assay optimization, and clinical trials management.
- SeqOnce Biosciences: Assay development, assessment, documentation, and transfer to manufacturing.
- BlazedX: Lab recruitment, technical support, and association organization.
How LISA Works
LISA operates through a collaborative, crowdfunding model where labs can nominate new assays, pledge financial support, and share resources to develop, validate, and gain FDA clearance for new diagnostic tests.
Join Today
LISA invites CAP and COLA-accredited labs to join this transformative initiative. Develop innovative diagnostic tests, ensure regulatory compliance, and share costs and resources.
Contact Us
For more information about LISA and the crowdfunding initiative, and to join the association, visit www.lisabio.com or email us at [email protected].
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 crowd-funding 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.