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

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 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.

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)

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.

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.

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.

Antibody Testing Process:

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

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 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.

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.