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LISA provides IVD assay development to help CAP/COLA-accredited labs continue innovation while giving a path through the FDA Final LDT Rule.
LISA uses a unique crowdfunding mechanism to drive down costs of gaining regulatory approval.
As a CAP or COLA-accredited lab, participating in LISA’s pledging process allows you to directly contribute to and benefit from the IVD assay development. Once an assay is nominated and approved by the LISA Assay Committee, the next step is to gather financial support for its development. LISA announces the approved assays and sets a pledge threshold. This threshold represents the total amount of funding required to develop, validate, and seek regulatory approval for the assay.
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.
Mid-level initiation fee and mid-level minimum purchase of assay reagents per year. You get very good discounts on reagent and any approved device.
Highest initiation fee and higher minimum purchase of assay reagents per year. This level offers the highest discount on reagents and any approved device.
Your lab selects a pledge level based on your anticipated reagent usage, budget, and desire to see the IVD assay development reach its goal. On the Crowdfund Project page, you select your level. By pledging, you commit to funding the development of the assay and purchasing the necessary reagents at a discounted rate.
As labs across the LISA network pledge their support, the total amount pledged is tracked. Once the combined pledges meet or exceed the threshold, The assay initiation pledge is collected, the assay is activated and it moves into the development phase.
After the assay meets the pledge threshold, the pledge benefits will decrease. This is to incentivize all of us to get the assay started.
Pledging early secures eligibility for greater discounts on reagents and final approved assay that you pledge to sponsor.
Your lab can be actively involved in the IVD assay development process you sponsor, including receipt of updates and relevant aggregated data as the assay progresses. You can use the provided information to develop internal protocols regarding use of the assay once approved or cleared.
When the assay enters the manufacturing stage, labs assisting in the development will have access to cGMP-grade reagents available for purchase at reasonable cost. cGMP reagents can be essential for maintaining compliance with FDA quality system regulations described under Phase 3 of the phaseout period in the Final LDT Rule and beyond.
Sponsoring labs can opt in to be named in the regulatory submission for the assay(s) sponsored as contributors, enhancing your lab’s reputation and demonstrating your commitment to advancing innovation in diagnostic testing.
By participating in the pledging process, your lab not only helps bring vital new assays to market, but also benefits from reduced costs, early access to cutting-edge technology, and a strong collaborative network within LISA.
