LISA (Laboratory Integration Strategic Association) is a consortium designed to support CAP and COLA-accredited diagnostic laboratories in navigating the new FDA regulatory requirements for Laboratory Developed Tests (LDTs). We provide resources, expertise, and a unique crowd-funding model to drive the development and approval of new diagnostic assays.
LISA offers comprehensive support to help ensure your lab meets FDA requirements through each phase of compliance. This includes expert guidance on regulatory submissions, access to cGMP/ISO reagents, and technical support to help you maintain compliance during the transition period.
Our crowdfunding model allows LISA members to collectively fund the development of new assays. Members can nominate assays, and once the Assay Committee approves, a pledge threshold is set. When the threshold is met, the assay moves into development. Members who pledge receive discounts on reagents and are named in the regulatory submission.
As a LISA member, your lab will receive:
Regulatory Compliance Support: Expert guidance on meeting FDA requirements.
Technical Assistance: Access to state-of-the-art reagents and protocols.
Cost Savings: Shared financial and technical burden of obtaining 510(k) clearance.
Collaborative Network: Membership in a community of like-minded laboratories and industry experts.
To join LISA and take advantage of our resources and support, contact us at [email protected].
LISA’s key players and their roles include:
Argonaut Manufacturing Services: Quality control testing, cGMP manufacturing, and supply chain management.
Arete Biosciences: FDA communications, regulatory requirements, and clinical trials management.
SeqOnce Biosciences: Assay assessment, documentation, and transfer to manufacturing.
BlazedX: Lab recruitment, technical support, and consortium organization.
Epstein, Becker, and Green, P.C.: CLIA and FDA counsel for LISA.
Any LISA member can nominate an assay. The Assay Committee reviews and approves nominations. Once approved, a pledge threshold is set, and members can pledge to sponsor the assay. When the threshold is met, the assay is activated, and development begins.
LISA offers three pledge levels:
Bronze: Lowest initiation fee and lowest minimum purchase of assay reagents per year make this the easiest pledge level. It has the lowest discount on reagents and any approved device.
Silver: Mid-level initiation fee and mid-level minimum purchase of assay reagents per year. You get very good discounts on reagents and any approved device.
Gold: Highest initiation fee and a higher minimum purchase of assay reagents per year. This level offers the highest discount on reagents and any approved device.
Yes! Please reach out to us and we can work towards getting you more rewards.
To nominate an assay, submit a proposal to the Assay Committee, including the concept, protocol, materials, data, and any supporting information. The committee will review the nomination and decide if it meets the criteria for approval.
If the estimated costs exceed the initial pledge threshold, the Assay Committee may vote to return the assay for re-sponsorship with new cost estimates. If a sponsored project is discontinued, any unused initiation fees are returned to the sponsors.
The Assay Committee is comprised of one nominated CAP/COLA lab and one representative of each team: viability, manufacturing, clinical.
LISA currently focuses on qPCR assays due to their widespread use in diagnostic laboratories. Depending on member interest and demand, LISA may expand to include other technologies such as Next Generation Sequencing (NGS), microarrays, lateral flow, or flow cytometry.
Yes!
LISA provides ongoing support to its members. If additional resources or assistance are required, our team is ready to help with technical support, regulatory guidance, and access to high-quality reagents and protocols. Reach out to us via email on [email protected] or via the web contact form.
We hope these FAQs help address your questions about LISA. For more detailed information or specific inquiries, please feel free to contact us.