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Todos Medical is a commercial in vitro diagnostics company focused on developing novel, convenient tests for the early detection of COVID-19, cancer and neurodegenerative disorders. We offer the following COVID-19 products and services in support of healthcare professionals, testing labs, policy-makers and the communities they serve:

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PCR Kits for Molecular Testing

Does an individual have an active COVID-19 infection?

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Point of Care (POC) Antibody Tests

Does an individual have antibodies from a past COVID-19 infection?

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Personal Protective Equipment (PPE)

Can an individual prevent a potential COVID-19 infection?

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Ventilators & Medical Supplies

Can an individual recover from a severe COVID-19 infection?

Todos Medical’s robust paradigm is designed for pairing PCR and antibody testing to determine COVID status of individuals and communities –
The path to reopening the economy.

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PCR Kits for Molecular Testing

Does an individual have an active COVID-19 infection?

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Point of Care Antibody Tests

Does an individual have antibodies from a past COVID-19 infection?

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360° View of COVID Status

Todos Medical Covid-19:
The path to reopening the economy

HOW DOES IT WORK?
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PCR Kits for Molecular Testing

Does an individual have an active COVID-19 infection?

PRODUCT OVERVIEW

Todos’ RT-PCR technologies are sourced from multiple vetted manufacturers.

• Primary technology is available through a US-based manufacturer with FDA-EUA approval
• Chinese manufacturer contracted Todos to be their OEM partner, and to submit for FDA EUA status
• Todos designated as exclusive distributor in US and Israel for a second Chinese manufacturer

The test kits are intended for the qualitative detection of nucleic acid from SAR-CoV-2 virus in upper respiratory specimens collected from individuals who meet criteria for SAR-CoV-2 testing.

PCR SAR-CoV-2 detection kits include:

• Swabs and viral transport medium
• Oligonucleotide primers and fluorescent dye-labeled probes and control material

FEATURES & BENEFITS

Todos using ‘Digital PCR’ with significantly improved sensitivity and consistency.

Todos using efficient, high-throughput processes in its partner CLIA lab (Alpharetta, GA) and will offer multiple sample collection methods and sample types such as:

• Oral/nasal
• Stool
• Saliva

Distributing high-throughput equipment to other clinical labs in US and Israel.

Distributing Digital PCR test kits in the US and Internationally.

SAMPLE HANDLING & INSTRUCTIONS FOR USE

Sample Collection: By HCP (with appropriate PPE) based on person’s symptomatology and/or who meet CDC guidelines for testing.

Sample Collection Venues: Typically at drive-throughs, physician offices, or other designated sites.

Sample Processing: CLIA-accredited labs, medium-high complexity environment.

Instructions for Use
Factsheet for Patients
Factsheet for Healthcare Providers
CLIA LAB REQUIREMENTS

CLIA Accreditation: Medium to High-Complexity Lab Environments

PCR Technology Platform(s): Our PCR tests can be run on an array of standard instruments such as Quantstudio; Thermofisher; etc.

Access to Reagents & Swabs: Todos offers these essential reagents and components that often are in limited supply

Ability to Run High-Throughput COVID-19 Testing: (defined as 200 or greater tests per day)

• Taps advantages of higher reimbursement rates – $100 vs. $51.33 per test (non-high throughput)

ADDITIONAL OFFERINGS

Todos supports its offering with 3 categories of product enhancements:

1. Detection kit that, in addition to COVID-19, detects influenza A/B in the event that the specimen is negative for SAR-CoV-2;

2. A small footprint, automated RNA extraction instrument to significantly boost turnaround time and throughput, bringing testing closer to the professional/patient interface;

3. RNA extraction reagents to support the PCR-based processes.

CONQUERING THE SAMPLE EXTRACTION BOTTLENECK:
ANDIS 350 3DMED AUTOMATED RNA EXTRACTION SYSTEM

  • 30min/run = 32 samples/set X 3 sets = 96 samples/run
  • 70min/run; 94 samples with NC / PC X 2 sets
  • 6 hours (5 runs) = 470 tests

3 ANDiS®350 for RNA Extraction
+ 1 qPCR System
+ 3-4 Operators =

450+

Tests every 6 hours

Todos’ 360° approach reduces risk of premature re-entry to work and communities.

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PCR Kits for Molecular Testing

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Point of Care Antibody Tests

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360° View of COVID Status

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Point of Care (POC) Antibody Tests

Indicates whether there has been prior exposure to, and recovery from, COVID-19

OVERVIEW

Todos’ serology kits vetted in US and offer significantly improved sensitivity and specificity.

Useful for:

Rapid testing and screening of populations to understand prior infection rates
Can be produced as mass scale (1M – 5M tests/day/manufacturer)

Not recommended as a sole test to diagnose COVID-19 but rather as a highly recommended adjunct to PCR testing.

FEATURES & BENEFITS

Colloidal Gold-based immunochromatography tests.

Sourced from multiple vetted Chinese manufacturers with NMDA approval, and FDA notification pathway.

Administered at point of care for detection of antibodies by collecting whole blood, plasma, serum via finger prick or venipuncture and dropping sample plus diluent into a cassette.

Results read in less than 15 minutes.

SAMPLING & PROCESSING

Antibody Testing Process:

  • 1

    Venipuncture or finger prick
  • 2

    Collect whole blood, serum or plasma
  • 3

    Drop specimen into cassette well
  • 4

    Add 2 drops of diluent and wait for results
REQUIREMENTS & QUALIFICATIONS

There are currently 2 paths for use:

• FDA notification
• EUS submission and approval

As per current FDA guidelines, these tests can be used in:

Medium-high-complexity lab settings,
• hospitals,
• urgent care facilities,
• Independent CLIA labs, etc.
• pharmacies with a Medicare lab

ADDITIONAL DETAILS

Our tests (with the exception of Gensure) have approval to sell in US based on FDA notification pathway. As per FDA guidelines, these tests are designated for use by health care providers in a high-complexity lab environment.

Todos has completed the validation of Shanghai Liangrun and will submit for FDA Emergency Use Authorization (EUA).

Todos is evaluating additional immunoglobulin markers to improve testing accuracy as well as other point of care innovations.

Todos’ comprehensive testing paradigm offers important opportunities for laboratories and supply chain professionals to regain volume and capacity in support of the Return-to-Work and Community Re-entry demands.

WHO CAN BENEFIT FROM TODOS’ COVID-19 TESTING SOLUTIONS?

Distributors

U.S. Distribution of COVID-19 Testing Supplies to CLIA/CAP Labs & Governments

Labs

U.S. CLIA/CAP Lab Operations Running COVID-19 Testing

Employers

International Import / Export of COVID-19 Testing & Medical Supplies

Todos’ testing paradigm enables qualified healthcare industry professionals and organizations to assess the COVID status of our workforce and communities for re-entry.

Regain Volume by processing COVID-19 tests

and alleviate the challenging business environment facing most labs today.

WHY CHOOSE TODOS’ COVID-19 TESTING?
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% decline in lab testing volume as a result of COVID-19

Laboratory Volume Index

Total Lab Tests as % of Baseline Average

Laboratory Testing Volume

% of Baseline Average as of 4/26/20

Our Partners
LEARN MORE

Todos Medical has partnered with Meridian HSN to provide a turnkey solution for on-site COVID testing. This collaboration enables us to set up testing sites anywhere in the US for any length of service. Meridian provides every step needed surrounding safe and secure PCR and Rapid testing, including telemedicine with medical personnel to write scripts, in addition to CLIA high complexity labs, testing sites, CLIA certified staff and full documentation. The key elements are not just testing, but data collection, telemedicine, and results delivered within 24 to 48 hours.

LEARN MORE

Todos and Meridian have also partnered alongside Moto-Para, a non-profit organization providing well trained retired service veterans from all branches of the military including Navy Seals, Force Recon Marines, Army Rangers, Green Beret encompassing site operations, physicians, paramedics and nurses.

LEARN MORE

Todos has recently expanded its agreement with 3D Medicines Corporation for COVID-19 testing products, whereby Todos has been granted the exclusive right to seek out FDA Emergency Use Authorization (EUA) for 3D Med’s SARS-CoV-19 and SARS-CoV-19 + influenza A/B qPCR test kits, as well as exclusive branding and distribution rights to 3D Med’s qPCR test kits in the United States. The full deployment of 3D Med’s additional extraction capacity would allow for an increase of approximately 25% in total US testing capacity per day. Todos has completed validation of 3D Med’s qPCR kits and extraction reagents and machines at its partner CLIA/CAP certified lab Provista Diagnostics, Inc. in Alpharetta, GA.

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