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Delivering the testing our world needs

For COVID-19 and beyond

FloodLAMP

Biotechnologies, PBC

Randy True, Founder and CEO | randy@floodlamp.bio

FloodLAMP.bio

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Addressing Current Vulnerabilities

Antigen Tests are at Risk of Failure with New Variants

Preliminary observational reports of antigen test failures in multiple outbreaks (BinaxNOW)
Even if current antigen tests prove to detect Omicron, we're at risk of that not being the case with the next VOC

Multi-Gene Molecular Tests are Resilient to New Variants

Our test combines primer sets for 3 genes: ORF1ab, N2 and E1
LAMP uses 6 primers and is highly tolerant to mismatches ( see recent NEB preprint analyzing our primers)

Reagent Based Molecular Tests are Adaptable

Primers can be swapped out quickly and cheaply, with all other test components remaining the same
Primers can be produced in large volumes and distributed quickly (10's of M of reactions per production run)

FloodLAMP can deliver Prepositioned Assets

For distributed, rapid response surge capability
Our systems comprise ordinary low cost lab equipment and offer best-in-class capacity per cost
We deliver custom-designed wraparound components (digital tools, QA, training) that enable rapid scaling

FloodLAMP.bio

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Bypassing Typical Limitations

Not limited by CLIA labs

Non-Dx "surveillance" screening permitted by FDA and CMS but potential has not yet been realized at scale.
Huge advantage in flexibility for deployment to widely distributed bare-bones test processing sites, which minimizes turnaround time and give highly valued local control and resiliency.

Not limited by need for certified clinical lab techs

Staffing shortages in the testing field are stifling. We can bring on and train new test operators very quickly while simultaneously ensuring test safety, reliably, and traceability.

Not limited by upfront capital equipment

$2K of standard, non-proprietary equipment gives 20K/day screening capacity.
Sites can typically operate far under max capacity, and then quickly surge with addition of extra labor.

Not limited by centralized manufacturing and sole sources

Our test use standard consumables and has reagent supplier redundancy.

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Filling a Gap in the Testing Landscape

CLIA Labs

At Home

OTC

Point of Care

Point of Need

Scaling a single test up to very high levels offers opportunities for innovation in sampling, test chemistry, and program configuration.
A "Point of Need" modality of testing is needed that combines the scalability and low cost of liquid reagent processing with the ease, flexibility and decentralized nature of POC/At-Home.
Public Health processing sites can fill the gap between CLIA labs and DIY at home tests.
Want this new capability to be additive and not cannibalize the clinical diagnostic infrastructure.

Current testing paradigms cannot stem a pandemic caused by an asymptomatically transmitted, aerosolized pathogen.

FloodLAMP.bio

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Performance in All Dimensions

FloodLAMP QuickColor^TM

Low Cost

< $5 per person

Good Sensitivity

Detects Pre-Infectious Asymptomatics

Rapid Turnaround Time

< 2 hrs sample to answer

Antigen Test Strips

Rapid Molecular Cartridges

SalivaDirect^TM & FloodLAMP Pooled Swab PCR

High upfront capital cost for PCR instruments limit replicability. These 2 tests have potential to drive down PCR costs.

Clinical Lab Purified PCR

Long turnaround renders it unsuitable for large scale screening - schools and workplaces need to know quickly if someone is infected.

People want higher confidence for both positive and negative results.

Will help usher in era of at-home concierge diagnostics but simply too constrained by manufacturing and too expensive for public health screening.

Local
Fast
Cheap
Molecular
Flexible
Resilient

FloodLAMP.bio

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FLOODLAMP PLATFORM

Admin Portal

Collection Kits

Reagent

Test Kits

Sample Processing Sites (Labs)

Service, Support,

Consulting

App

Standard Equipment

Standard Consumables

Training Program

Quality Management System

PHYSICAL

DIGITAL

Core

Modules

COVID Response

EMS & Municipalities

Applications

Network

Zikka

Influenza

STD's

Cancer

Emerging Threats

(Pandemic Prep)

Testing Program Management

Products

All-in

Test Kits

Schools and Businesses

U.S. Federal Agencies (BARDA, ASPR, CDC, DoD, FEMA)

International Governments

FloodLAMP.bio

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FloodLAMP QuickColor^TM Test

Molecular Performance

RT-LAMP "PCR-like" molecular amplification
No instruments to run test or analyze results
Low cost and easy to run
Results in 45 minutes with only 15 min hands-on

FloodLAMP Mobile App

Decentralized Accessioning

Supports both self and sponsored collection
Results can be reported directly to participants and administrators
Lab staff and program admin interfaces

Our Unique Solution

Pooled Swab Collection

At-home Family Pooling

Up to 4 nasal swabs per sample tube
Upfront at-home and on-site pooling makes lab processing far more efficient

Standalone Components and Fully Integrated Program

Training Program

Remote certification

In development with top learning experience consulting group
Assessment for understanding and compliance
Enables rapid growth while maintaining quality

Quality System

Streamlined traceability

In development with top QMS consulting group
Covers suppliers, manufacturing, and test processing

Turnkey Complete Packages

1000's Samples/Day Anywhere

Everything needed to bringup program from empty room with 3 tables
Comprises calibrated standard equipment, supplies, consumables, and test reagent kits (50+ SKUs, many pre-prepped for ease of use)

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FloodLAMP has fully validated 2 complementary tests that are best-of-breed with EUAs submitted to the FDA. Pooled home collection kit was also submitted for interactive review. The test workflow and collection kit has been designed to expand to other disease targets in the future.

QuickColor^TM LAMP Test*

High sensitivity (90%)
Ultra-high throughput
Ideal for serial screening
Uniquely scales without capital intensive instruments

*Licensed from Harvard Medical School (Rabe Cepko - "SARS-CoV-2 detection using isothermal amplification and a rapid, inexpensive protocol for sample inactivation and purification" PNAS 09-29-2020, MGH Clinical Validation Preprint)

EasyPCR^TM Test

Very high sensitivity (98%)
Medium throughput (1.5 hrs/94)
Ideal for diagnostics and confirmatory reflex

Visual Readout

Streamlined Sample Prep

Upfront swab pooling
Highly scalable, integrated processing
Same sample for both tests

Standard RT-qPCR instrument

Core Assay Technology

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Clinical Evaluation Data

Clinical evaluation performed by the Stanford CLIA Lab, with excellent results and praise on the "really straightforward" protocol.

QuickColor^TM LAMP Test

12 copies/µl LoD
90% Sensitivity (PPA 36/40)
Missed positives only high Ct (>36 with direct PCR)
100% Specificity (40/40)
No false positives

EasyPCR^TM Test

3 copies/µl LoD
98% sensitivity (PPA 39/40)
100% Specificity (40/40)
No false positives

Source of Specimens: Stanford COVID-19 Clinical Testing Program

Specimen Type: Anterior Nares Swab in PBS, previously tested and frozen

Comparator Test: Hologic Panther Fusion SARS-CoV-2 Assay and Hologic Panther Aptima SARS-CoV-2 Assay

Gamma inactivated cell lysate from BEI spiked into raw clinical negative sample

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Program mechanics

EMS/Employer program

On-site employee pooled collection
Multiple collection points
Courier service to lab (10-30 minutes)
On-site lab
Case study of hundreds of employees screened daily by one tester in 2 hrs
Cost $2 per person
Flexibility for follow up testing of families and contacts
Case study of asymptomatic town manager testing positive, and using FloodLAMP to immediately test his family, picking up 2 asymptomatic positive kids and stopping exposure in their schools

Collection site

On-site FloodLAMP lab

10-30 minute courier

Collection site

FloodLAMP.bio