The laboratory-developed test (LDT), dubbed AcuSept, is a host immune response test, designed to identify 19 mRNA biomarkers related to infection, sepsis and septic shock, and can also be used to monitor patient response to treatment


AcuSept is a host immune response test. (Credit: Louis Reed on Unsplash)

Israel-based medical diagnostics firm Todos Medical has signed a letter of intent with Singapore-based medical diagnostics technology company Acumen Diagnostics for the US rights to its PCR-based sepsis diagnostic test.

The Israeli company would license the laboratory-developed test (LDT), dubbed AcuSept, for its clinical testing lab Provista Diagnostics.

AcuSept is a host immune response test, designed to identify 19 mRNA biomarkers related to infection, sepsis and septic shock.

The PCR-based test can also be used to monitor patient response to treatment.

As per the agreement, Provista will also conduct clinical validation studies on AcuSept to support Acumen Diagnostics’ US Food & Drug Administration (FDA) submission.

Todos Medical president and CEO Gerald Commissiong said: “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.

“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 the potential to contribute in an impactful way to fulfil this important unmet need of improved sepsis diagnosis.”

AcuSept is designed to provide a sepsis result within five hours after patient sample collection.

According to clinical studies conducted by Acumen Diagnostics, AcuSept detected sepsis with superior sensitivity when compared with other single-biomarker tests.

Also, the test is highly effective in diagnosing culture-negative sepsis.

In the studies, AcuSept detected infection in patients with superior positive and negative predictive values, to provide complementary data to pathogen identification tests.

The test provides physicians with a comprehensive view of a patient’s condition and enables better-targeted, faster treatment decisions, said the Israeli medical device maker.

Acumen Diagnostics CEO Ong Hwa Siew said: “We are very excited to partner with Provista to bring our AcuSept test to the United States.

“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 centres 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.”