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

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Provista now has 7 Thermo Fisher PCR systems and 1 Biorad system providing an ability to run over 2,400 patient samples at a time. (Credit: Gerd Altmann from Pixabay)

Todos Medical, 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).

Source: Company Press Release