(Total Views: 361)
Posted On: 06/11/2020 5:20:30 AM
Post# of 1418
From the presentation slides and Gerald's presentation
• Todos offers the following COVID-19 products and services:
-PCR kits for molecular testing
Small footprint automated RNA extraction equipment
-Extraction reagents
-Point of Care (POC) rapid IgA/igM/IgG and IgM/igG fingerprick antibody tests
-High throughput CLIA/CAP accredited laboratory services in Alpharetta, GA (acquisition in progress) for processing molecular and antibody tests (US only)
-Access to Personal Protective Equipment (PPE) and ventilators through a network of brokers and suppliers
Todos Medical LTD. Israel
International import/export of COVID-19 testing & medical supplies
Todos Medical USA Inc.
Distribution of of COVID-19 testing
Supplies to CLIA/ CAP Labs, Gov't & Hospitals
CORONA Diagnostics LLC
US CLIA/CAP Lab
Operations Running
COVID-19 Testing
Todos Int'l COVID-19 Distribution Strategy
- Geographies of interest: North America, Latin America, Europe, Southeast Asia
- Clients: Federal, State and Local Governments & Sub-Distributors with local market access
- Israel strong hub for import/export given strong international connections
- Distribution Offering
- COVID Molecular Testing Solutions: Polymerase Chain Reaction (PCR) Test kits
-Automated Extraction Machines
-Highly sensitive (<10 copy/reaction) qPCR reagents, extraction reagents and swabs/VTL
-Digital PCR reagents
-COVID Antibody Testing Solutions: Rapid Point-of-care (POC) Antibody test Kits
- Todos has access to significant volume from multiple manufacturers (up to 5M kits per week)
- Todos establishing OEM operations outside of China (Singapore or US) and will clinically validate tests in the US
- Personal Protective Equipment (PPE) • Masks, Gloves, Face Shields, Etc.
PPE Products Available Through our Network
Israel strong hub for import/export given strong international connections
• Geographies of interest: North America, Latin America, Europe, Southeast Asia
- Clients: Federal, State and Local Governments & Sub-Distributors with local market access
- Distribution Offering: Complements Testing Offering
- Ventilators: LifeCan from Elbit Systems
- Agreement via L1 Systems, Ltd
- Manufactured in Israel • Non-Contact Thermometers Gloves
• Surgical Gowns
• Hand Sanitizer
• Masks
• N95s, KN95S, 3-ply
Labs have seen 50% decline
Via COVID-19 testing we can helping labs regain revenue
Serology Testing Menu
Shanghai Liangrun - Validated
IGm, IGg - China
Max cap. 5 million p/w
US, EU, Latin America & Southeast Asia
10 - 14 day from PO
Nanjing Vazyme - FDA EUA submitted
IGm, IGg - China
Max cap. 3 million p/w
US, EU, Latin America & Southeast Asia
10 - 14 day from PO
Gensure - FDA EUA in progress
Global
US Guidelines For Antibody Testing
- Antibody POC Testing available Today
-Current FDA guidelines allows manufacturers that have notified FDA under Part D of the FDA EUA diagnostic testing guidelines to have their tests administered in high complexity lab settings such as independent CLIA labs, hospital, urgent care facilities, and other health care facilities with a high complexity lab.
- Once a test has EUA approval and is designated for use at POC, it can be used as a CLIA-waived test and be administered in any patient care setting that operates under a CLIA Certificate of Waiver or Certificate of Compliance/Certificate of Accreditation (this includes many physician offices, pharmacies and other healthcare settings)
- No manufacturer has received POC package insert labeling
- Small number of manufacturers have received FDA EUA Authorization
-A few have been authorized to allow testing to be conducted in Medium Complexity Labs, in addition to High Complexity Labs
Own Lab willstart with 1000 test p/d and ramp up to 7000+
-Own Lab will handle the billing
- handle parking lot testing
There are waiting for 2nd orders before they announce
Same with pilot programs that are going in now, they anticipate those programs to turn into repeat clients.
And as those clients pave the way, other companies, Gov't agencies and businesses will most likely jump in on bundling rather than trying to start from scratch and do theiown pilot programs.
Brazil is crazy right now but things will most likely move ahead open up and quickly
More testing deta will be released soon
They have tests that are down to 2 - 5 minutes
The relationships and testing machines are going to be aimed at turning into othe Diagnostic testing, ALZ / Cancer down the riad.
First is to help Labs get up and running with COVID-19 testing
Mentioned more than a few times
Telemedicine
Heath networks
And how they will help.
I believe that's where the relationship with EMOR , Bonsa & Carie will be coming into play.
Gerald continues to speak about UPLIST for Todos as priority. "Soon"
Things seem to be moving quickly behind the scenes and ducks are getting lined up.
Not sure when the switch will be flipping to full go, but it sounds like there are well on their way, not just in the US either.
Aloha
• Todos offers the following COVID-19 products and services:
-PCR kits for molecular testing
Small footprint automated RNA extraction equipment
-Extraction reagents
-Point of Care (POC) rapid IgA/igM/IgG and IgM/igG fingerprick antibody tests
-High throughput CLIA/CAP accredited laboratory services in Alpharetta, GA (acquisition in progress) for processing molecular and antibody tests (US only)
-Access to Personal Protective Equipment (PPE) and ventilators through a network of brokers and suppliers
Todos Medical LTD. Israel
International import/export of COVID-19 testing & medical supplies
Todos Medical USA Inc.
Distribution of of COVID-19 testing
Supplies to CLIA/ CAP Labs, Gov't & Hospitals
CORONA Diagnostics LLC
US CLIA/CAP Lab
Operations Running
COVID-19 Testing
Todos Int'l COVID-19 Distribution Strategy
- Geographies of interest: North America, Latin America, Europe, Southeast Asia
- Clients: Federal, State and Local Governments & Sub-Distributors with local market access
- Israel strong hub for import/export given strong international connections
- Distribution Offering
- COVID Molecular Testing Solutions: Polymerase Chain Reaction (PCR) Test kits
-Automated Extraction Machines
-Highly sensitive (<10 copy/reaction) qPCR reagents, extraction reagents and swabs/VTL
-Digital PCR reagents
-COVID Antibody Testing Solutions: Rapid Point-of-care (POC) Antibody test Kits
- Todos has access to significant volume from multiple manufacturers (up to 5M kits per week)
- Todos establishing OEM operations outside of China (Singapore or US) and will clinically validate tests in the US
- Personal Protective Equipment (PPE) • Masks, Gloves, Face Shields, Etc.
PPE Products Available Through our Network
Israel strong hub for import/export given strong international connections
• Geographies of interest: North America, Latin America, Europe, Southeast Asia
- Clients: Federal, State and Local Governments & Sub-Distributors with local market access
- Distribution Offering: Complements Testing Offering
- Ventilators: LifeCan from Elbit Systems
- Agreement via L1 Systems, Ltd
- Manufactured in Israel • Non-Contact Thermometers Gloves
• Surgical Gowns
• Hand Sanitizer
• Masks
• N95s, KN95S, 3-ply
Labs have seen 50% decline
Via COVID-19 testing we can helping labs regain revenue
Serology Testing Menu
Shanghai Liangrun - Validated
IGm, IGg - China
Max cap. 5 million p/w
US, EU, Latin America & Southeast Asia
10 - 14 day from PO
Nanjing Vazyme - FDA EUA submitted
IGm, IGg - China
Max cap. 3 million p/w
US, EU, Latin America & Southeast Asia
10 - 14 day from PO
Gensure - FDA EUA in progress
Global
US Guidelines For Antibody Testing
- Antibody POC Testing available Today
-Current FDA guidelines allows manufacturers that have notified FDA under Part D of the FDA EUA diagnostic testing guidelines to have their tests administered in high complexity lab settings such as independent CLIA labs, hospital, urgent care facilities, and other health care facilities with a high complexity lab.
- Once a test has EUA approval and is designated for use at POC, it can be used as a CLIA-waived test and be administered in any patient care setting that operates under a CLIA Certificate of Waiver or Certificate of Compliance/Certificate of Accreditation (this includes many physician offices, pharmacies and other healthcare settings)
- No manufacturer has received POC package insert labeling
- Small number of manufacturers have received FDA EUA Authorization
-A few have been authorized to allow testing to be conducted in Medium Complexity Labs, in addition to High Complexity Labs
Own Lab willstart with 1000 test p/d and ramp up to 7000+
-Own Lab will handle the billing
- handle parking lot testing
There are waiting for 2nd orders before they announce
Same with pilot programs that are going in now, they anticipate those programs to turn into repeat clients.
And as those clients pave the way, other companies, Gov't agencies and businesses will most likely jump in on bundling rather than trying to start from scratch and do theiown pilot programs.
Brazil is crazy right now but things will most likely move ahead open up and quickly
More testing deta will be released soon
They have tests that are down to 2 - 5 minutes
The relationships and testing machines are going to be aimed at turning into othe Diagnostic testing, ALZ / Cancer down the riad.
First is to help Labs get up and running with COVID-19 testing
Mentioned more than a few times
Telemedicine
Heath networks
And how they will help.
I believe that's where the relationship with EMOR , Bonsa & Carie will be coming into play.
Gerald continues to speak about UPLIST for Todos as priority. "Soon"
Things seem to be moving quickly behind the scenes and ducks are getting lined up.
Not sure when the switch will be flipping to full go, but it sounds like there are well on their way, not just in the US either.
Aloha
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