Todos Medical Initiates Validation Plan for PCR-based MonkeyPox Test

 Todos Medical Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP-certified laboratory Provista Diagnostics has initiated a validation plan for PCR-based MonkeyPox testing. Under the plan, the Company is validating multiple PCR assays for MonkeyPox and will launch the most sensitive for lesion-based and saliva-based sample collections. While lesion-based testing is the current standard of care according to CDC guidelines, saliva-based sample collection is currently undergoing intense research that could open up the potential for testing of asymptomatic or very early-stage patients at high risk of severe disease (such as immunocompromised patients) that could result in earlier diagnosis and early intervention with therapeutic drugs such as Tecovirimat (TPOXX). TPOXX is an investigational drug candidate, and currently only available under an expanded access Investigational New Drug (EA-IND) protocol. The 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

“The significant investment we made to automate PCR testing at Provista to maximize COVID testing capacity can now be partially redeployed towards MonkeyPox as we prepare to help the nation scale-up MonkeyPox testing capacity to meet the emerging public health crisis,” said Gerald E. Commissiong, President & CEO of Todos Medical.

https://www.biospace.com/article/releases/todos-medical-initiates-validation-plan-for-pcr-based-monkeypox-test-at-clia-cap-clinical-testing-laboratory-provista-diagnostics/