Welcome to LISA: The Laboratory Integration Strategic Association

Advancing Clinical Laboratories

We empower diagnostic laboratories to grow and thrive in the evolving regulatory landscape.

Together we develop new assays

As the FDA enhances its oversight of Laboratory Developed Tests (LDTs), LISAbio provides its members with support and resources for CAP/COLA-accredited labs to be compliant, innovative, and competitive.

LISAbio uses crowdfunding from its members to drive the development of new assays. This process not only shares costs, it also shares rewards.

The LISA process:

LISA crowdfunding IVD assay development assay nomination

Any LISA member can nominate an assay.

LISA crowdfunding IVD assay development pledge

LISA members can pledge to sponsor the assay.

Sponsor labs are eligible for discounted reagents based on their pledges.

LISA crowdfunding IVD assay development

When the threshold level of pledge support  is reached, the assay development begins.

Sponsor labs will be referenced in the regulatory submission.

LISA crowdfunding IVD assay development trials submission

The assay is ISO/cGMP manufactured and undergoes analytical verification and clinical validation.

The LISA assay development process provides key benefits to your lab:

  • You can nominate & support assays you want to see introduced on the market.
  • Assay development costs are shared, so you don’t have to fund it alone.
  • You can participate in the development process.
  • Your lab can access cGMP/ISO reagents to support quality system requirements (required for Phase 3).
  • Your lab is referenced in assay 510(k)/PMA submissions (required for Phases 4/5).

Pledge a Project

By joining LISA, you become part of a forward-thinking community dedicated to advancing diagnostic testing and ensuring regulatory compliance.

Our collaborative approach and innovative funding model provides the support you need to navigate the complexities of the FDA landscape and continue to deliver critical diagnostic services.

Together, we can shape the future of diagnostic testing.

Welcome to LISA.