Todos Medical Enters Into Letter of Intent for Pro
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Posted On: 03/28/2023 11:59:53 AM
Todos Medical Enters Into Letter of Intent for Provista Diagnostics to License PCR-based Sepsis Diagnostic Test AcuSept LDT Rights From Acumen Diagnostics
New York, NY, Alpharetta, GA, Tel Aviv, ISRAEL and SINGAPORE, March 28, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced it has entered into a letter of intent with Acumen Diagnostics Pte Ltd of Singapore for its CLIA/CAP-certified clinical testing lab Provista Diagnostics to license the laboratory developed test (LDT) rights to commercialize the sepsis PCR-based diagnostic test AcuSept® in the United States. AcuSept is a host (patient) immune response test that identifies 19 mRNA biomarkers of infection, sepsis and septic shock, and can be used to monitor patient response to treatment. Under the terms of the agreement, Provista will also conduct clinical validation studies on AcuSept® to generate the data in the United States to support Acumen Diagnostics’ 510(k) submission to the US Food & Drug Administration.
According to the Sepsis Alliance, sepsis is the #1 leading cause of death in hospitals in the United States, has an economic cost to the US healthcare system of at least $62 billion annually and is the leading cause of US hospital readmission. Hospitalized COVID-19 patients are 300% more likely to develop septic shock as compared with hospitalized influenza patients. The risk of developing septic shock increases 4-9% per undiagnostic hour of sepsis.
AcuSept can provide a sepsis result within 5h of patient sample collection; clinical studies conducted by Acumen Diagnostics had shown that AcuSept detected sepsis with superior sensitivity when compared with other single-biomarker tests, and proved to be exceedingly effective in diagnosing culture-negative sepsis. AcuSept detected infection in patients with superior positive and negative predictive values, providing complementary data to pathogen identification tests, including PCR-based tests Provista currently offers, that will allow physicians to have a more comprehensive view of a patient’s condition that will enable for better targeted, faster treatment decisions.
“Sepsis presents a huge human and economic toll on the healthcare system as the #1 cause of death in hospitals,” said Gerald Commissiong, President & CEO of Todos Medical. “As Provista expands its pipeline of proprietary tests it intends to launch via the Laboratory Developed Test (LDT) pathway in the United States, our growing salesforce is very excited to work with hospitals and long-term care facilities to improve the screening and diagnosis of sepsis, thereby allowing for earlier therapeutic interventions that have greater benefit at the earliest stages of sepsis that reduce the likelihood of a patient undergoing septic shock. In this era of COVID-19 and widespread antibiotics resistance, we believe that sepsis has become an even more urgent medical challenge, and that it may also play a role in the worst outcomes of Long COVID. After an extensive evaluation of technologies to diagnose sepsis, we came to the conclusion that AcuSept has potential to contribute in an impactful way to fulfill this important unmet need of improved sepsis diagnosis.”
“We are very excited to partner with Provista to bring our AcuSept test to the United States,” said Dr. Ong Hwa Siew, CEO of Acumen Diagnostics. “We spent several days with the Provista team, evaluating their lab capabilities and meeting with physicians in Atlanta regarding the deployment of AcuSept® to assist with the screening and diagnosis of sepsis in long-term care facilities, urgent care centers and hospitals. It was clear that the Provista team is well-integrated into the Atlanta healthcare community and has the necessary relationships to execute a successful launch of AcuSept in the United States.”
https://investor.todosmedical.com/news-events...r-provista
New York, NY, Alpharetta, GA, Tel Aviv, ISRAEL and SINGAPORE, March 28, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced it has entered into a letter of intent with Acumen Diagnostics Pte Ltd of Singapore for its CLIA/CAP-certified clinical testing lab Provista Diagnostics to license the laboratory developed test (LDT) rights to commercialize the sepsis PCR-based diagnostic test AcuSept® in the United States. AcuSept is a host (patient) immune response test that identifies 19 mRNA biomarkers of infection, sepsis and septic shock, and can be used to monitor patient response to treatment. Under the terms of the agreement, Provista will also conduct clinical validation studies on AcuSept® to generate the data in the United States to support Acumen Diagnostics’ 510(k) submission to the US Food & Drug Administration.
According to the Sepsis Alliance, sepsis is the #1 leading cause of death in hospitals in the United States, has an economic cost to the US healthcare system of at least $62 billion annually and is the leading cause of US hospital readmission. Hospitalized COVID-19 patients are 300% more likely to develop septic shock as compared with hospitalized influenza patients. The risk of developing septic shock increases 4-9% per undiagnostic hour of sepsis.
AcuSept can provide a sepsis result within 5h of patient sample collection; clinical studies conducted by Acumen Diagnostics had shown that AcuSept detected sepsis with superior sensitivity when compared with other single-biomarker tests, and proved to be exceedingly effective in diagnosing culture-negative sepsis. AcuSept detected infection in patients with superior positive and negative predictive values, providing complementary data to pathogen identification tests, including PCR-based tests Provista currently offers, that will allow physicians to have a more comprehensive view of a patient’s condition that will enable for better targeted, faster treatment decisions.
“Sepsis presents a huge human and economic toll on the healthcare system as the #1 cause of death in hospitals,” said Gerald Commissiong, President & CEO of Todos Medical. “As Provista expands its pipeline of proprietary tests it intends to launch via the Laboratory Developed Test (LDT) pathway in the United States, our growing salesforce is very excited to work with hospitals and long-term care facilities to improve the screening and diagnosis of sepsis, thereby allowing for earlier therapeutic interventions that have greater benefit at the earliest stages of sepsis that reduce the likelihood of a patient undergoing septic shock. In this era of COVID-19 and widespread antibiotics resistance, we believe that sepsis has become an even more urgent medical challenge, and that it may also play a role in the worst outcomes of Long COVID. After an extensive evaluation of technologies to diagnose sepsis, we came to the conclusion that AcuSept has potential to contribute in an impactful way to fulfill this important unmet need of improved sepsis diagnosis.”
“We are very excited to partner with Provista to bring our AcuSept test to the United States,” said Dr. Ong Hwa Siew, CEO of Acumen Diagnostics. “We spent several days with the Provista team, evaluating their lab capabilities and meeting with physicians in Atlanta regarding the deployment of AcuSept® to assist with the screening and diagnosis of sepsis in long-term care facilities, urgent care centers and hospitals. It was clear that the Provista team is well-integrated into the Atlanta healthcare community and has the necessary relationships to execute a successful launch of AcuSept in the United States.”
https://investor.todosmedical.com/news-events...r-provista
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