Executive Summary

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FloodLAMP’s mission is to improve human health by enabling ultra low-cost, widely accessible molecular testing. In the near term, we are breaking down the barriers to scaling COVID-19 testing in the U.S. through 2 major initiatives: 1) obtaining FDA authorizations for several important open access tests, enabling unprecedented scale for all existing labs, and 2) building a highly efficient, end-to-end surveillance screening program to serve as a template for using our low-cost tests at scale. We are a Public Benefit Corporation deploying low-cost COVID-19 testing for large screening and surveillance programs, utilizing best-of-breed open access tests. In the near term, we will secure high-value contracts through public and private agencies to scale testing during this period of the pandemic. In the post-pandemic future, we will leverage the infrastructure built over the past year to enable low-cost molecular testing for infectious disease, but also any area of healthcare where molecular testing is limited due to cost and scale.

Molecular diagnostic and clinical testing have, until now, been characterized by proprietary technology, expensive equipment, and a trade secret regulatory process. We are developing open access, low-cost tests that are supply chain robust. Our strategy has similarities to open source software and generic pharmaceuticals. Inspired by the open access test SalivaDirect (developed by Nathan Grubaugh and FloodLAMP Scientific Advisor Anne Wyllie), FloodLAMP is actively engaged in filing multiple open EUAs for key tests. These can be thought of as generic molecular tests and will drop testing expense severalfold.

With the severity of the ongoing COVID crisis in the U.S., we need as many tests as possible, as fast as possible. Open EUAs can achieve this now, unlocking the direct supply of chemicals for tests. The implementation of our open access EUAs will dramatically decrease costs of testing and enable widespread screening, which has previously been limited due to cost and supply chain. This is not in the business interest of the currently established molecular diagnostics company or clinical labs, which is why we are leveraging the public benefit corporation framework and open access regulatory paradigm.

The tests we’ve selected have been chosen to be simple, effective, low-cost, and highly scalable. They cover a wide spectrum of lab needs and testing modalities, including LAMP and PCR, saliva and nasal swabs, automation-friendly, and completely instrument-free tests. FloodLAMP has recently received positive feedback for the open testing approach from the FDA’s Director of IVD Diagnostics, and we are currently engaged with a team of reviewers on our submission to the FDA.

FloodLAMP's instrument-free, colorimetric LAMP test
FloodLAMP’s Instrument-Free, Colorimetric LAMP Test

We are currently also securing the supply chain for LAMP tests generally. FloodLAMP will grant a blanket FDA Right of Reference to the LAMP primer sets, as the CDC did for PCR in March. These deliverables alone are a major contribution to scaling testing in the U.S.

FloodLAMP will apply our open access EUAs in building out highly efficient pooled screening programs, with a focus on surveillance testing at K-12 schools. We are beginning pilots based out of our state-of-the-art SF Bay Area lab (part of MBC Biolabs). We’ve developed a smartphone app that facilitates distributed on-site and at-home pooled collection, greatly streamlining sample accessioning and preparation. These steps can be done outside of the lab, which greatly increases efficiency and lowers costs, making frequent, repeated mass screening feasible.

Below are the near term milestones we are executing on and seeking further funding to quickly achieve:

  1. Obtain Open EUAs from the FDA,
  2. Secure supply chain for our tests,
  3. Implement pilots of screening program,
  4. Build our team.

FloodLAMP is a Public Benefit Corporation that is prioritizing positive impact during the COVID crisis. We’ve explicitly included commitments to open protocols and disease screening for the public good in our charter. We have taken the OpenCOVIDPledge and have lived this commitment throughout our six months of hard work on testing. Drawing on biotech startup and nonprofit experience, FloodLAMP has the scientific knowledge base and combined legal, business, and strategic expertise to lead this important effort. Scaling up COVID testing through the new open access paradigm will not only save lives and livelihoods in the near-term, it will also better prepare us for the next pandemic.

Open access, generic molecular testing is a public good, having far-reaching positive impacts in diagnostics and healthcare more broadly. We are seeking funding and support from a variety of sources to accelerate our initiatives and execute on this ambitious yet immediately actionable plan to massively increase COVID testing. We believe COVID-19 has permanently changed the public and private sectors views on public health. We are the only company building the low-cost, scalable infrastructure for a future where molecular testing will be much more broadly implemented.