NEW YORK — Todos Medical said on Tuesday that it has signed a letter of intent with Acumen Diagnostics of Singapore under which its Provista Diagnostics subsidiary will offer Acumen's AcuSept sepsis test in the US.
AcuSept is a PCR-based test designed to detect 19 mRNA biomarkers of infection, sepsis, and septic shock, according to Todos, and can be used to monitor patient responses to treatment.
Under the terms of the deal, Provista will have the right to commercialize the assay in the US as a laboratory-developed test. The company, which was acquired by Rehovat, Israel-based Todos in early 2021, will also conduct US clinical studies of AcuSept on behalf of Acumen to support a 510(k) submission to the US Food and Drug Administration.
Additional terms were not disclosed.
"As Provista expands its pipeline of proprietary tests, it intends to launch via the laboratory-developed test pathway in the United States; our growing sales force 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," Todos President and CEO Gerald Commissiong said in a statement.