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Todos Medical Announces PCR Validation of Wound and Respiratory Pathogen Panels at CLIA/CAP Lab Provista Diagnostics

Thursday, August 11, 2022

Todos Medical, Ltd., a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP-certified laboratory Provista Diagnostics has completed validation of its PCR-based Wound and Respiratory Pathogen panels. The Wound Panel (WP) is a 31-pathogen multiplexed PCR panel, including antibiotic resistance, taken from swab samples of a wound or lesion that will assist physicians in determining which combinations of drug therapies prescribed to the patient will result in the best patient outcomes. The Respiratory Pathogen Panel (RPP) is 24-pathogen multiplexed PCR panel taken from nasal or saliva samples that will assist physicians in making better treatment decisions for patients presenting with respiratory illnesses. Both the WP and RPP tests can be run on Provista’s state-of-the-art Tecan and 3D Med liquid handling automation systems that improve efficiency, safety and capacity, allowing Provista to currently perform up to 25,000 PCR tests per day. With nine (9) liquid handling systems currently onsite at Provista from former Todos PCR testing lab clients, the Company expects Provista to soon be able to run up to 50,000 PCR tests per day. Provista now has 7 Thermo Fisher PCR systems (2 QuantStudio 12k Flex, 2 QuantStudio 7 Flex, 3 QuantStudio 5) and 1 Biorad (CFX) system providing an ability to run over 2,400 patient samples at a time. The Company will continue to redeploy automation and equipment assets towards Provista as 3rd party lab testing contracts wind down.

Additionally, the Company provided an update on the validation of its MonkeyPox lesion and saliva-based assays that validation is on track to be completed in the second half of August. The Company intends to wait until the MonkeyPox validation is complete in order to commercially launch its WP and RPP tests, as it is the Company’s intention to also make MonkeyPox testing available on those samples. Given that MonkeyPox is spread primarily through skin-to-skin contact, contact with open wounds (lesions), as well as through respiratory droplets and aerosols, both with WP and RPP assays will have important clinical value for differential diagnosis.

While lesion-based testing is the current standard of care according to CDC guidelines, prospective clients have expressed eagerness to gain access to saliva-based sample collection as a means of improving the safety of frontline healthcare workers screening suspected MonkeyPox cases. Flow Health in Los Angeles, CA, a leader in MonkeyPox testing, has already reported successfully assisting in the diagnosis of asymptomatic MonkeyPox patients using saliva samples, proving saliva testing’s clinical usefulness in the current MonkeyPox outbreak. Provista MonkeyPox tests are being developed as Laboratory Developed Tests (LDTs). A recent peer-reviewed article describing strong correlation of the sensitivity of lesion and saliva-based PCR testing was recently published in the journal Eurosurveillance: https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2022.27.28.2200503

“It has become clear to us that waiting an additional couple of weeks for the MonkeyPox validations to be complete in order to move forward with the previously planned commercial launch of our wound and respiratory panels makes a lot of sense given that, just in the last couple of days, we have started to get a number of unsolicited healthcare practices enrolling as ordering physicians for Provista lab services after reading about our plans for saliva-based MonkeyPox testing,” said Gerald E. Commissiong, President & CEO of Todos Medical. “While we do have the ability to reference suspected MonkeyPox samples collected through lesion-based swabs right now to partner labs doing swab-based testing, it is clear that the most effective way to increase healthcare providers’ willingness to more broadly screen for MonkeyPox is to improve the safety of its assessment through self-administered saliva sample collection. We believe that saliva-based MonkeyPox testing will be a game-changer in our ability to track and trace infections.”

In 2021, U.S. wound and tissue management market size was valued at $10.7 billion and is expected to grow to $13.8 billion by 2028. The primary drivers of market growth were previously anticipated to be the over 65 population that has a 3-6% likelihood of venous leg ulcers. The Company believes MonkeyPox will add substantially to this market size for the second half of 2022, and potentially beyond if the United States is unable to adequately contain MonkeyPox. The Respiratory Diagnostics market in the U.S. was estimated at US$3.5 Billion in the United States in 2022 and is expected to grow to $5 Billion by 2027. This market is primarily driven by COVID-19 and COPD testing. The Company believes MonkeyPox will add substantially to this market size for the second half of 2022, and potentially beyond if the United States is unable to adequately contain MonkeyPox.

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