In Response to FDA LDT Final Rule, LISA Launches Crowdfunding Initiative for Clinical Laboratories
29 Julio 2024 - 5:00AM
Business Wire
CAP/COLA Labs Invited to Join a Pioneering
Initiative for Developing FDA-Compliant Assays
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 to join the association,
visit www.lisabio.com or email us at info@lisabio.com.
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.
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Contact: marianne.woodard@brainspores.com Website:
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