Sepset Biosciences Inc.
Sepset Biosciences is a diagnostic company in advanced development of a blood test (Sepset-ER) for hospitals to identify patients in the emergency room (ER) who will acquire severe sepsis and have high risk for organ failure. Sepset’s test will provide much earlier (~1-2 hours) and more reliable data to help physicians select the right treatment for the right patients at the right time. This is critical since every hour’s delay in starting appropriate treatment leads to a 7.6% increased risk of death (Kumar, 2006). At the same time the Sepset-ER test will inform physicians who will not acquire sepsis, sparing the need to use potent antibiotics and increase the risk of antimicrobial resistance. Our vision is to increase patient survival and improve quality of care, while at the same time improving efficiency in hospital spending.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Clinical Services
- Market Focus:
- Nationally (across the country)
Welcome
Sepset Biosciences Inc. is a molecular diagnostics company developing a first-in-class diagnostic assay for the very early and rapid diagnosis of severe sepsis. This novel diagnostic is based on the detection of a unique signature of severe sepsis based on the dysfunctional immune response rather than the presence of a pathogen.
This technology has tremendous commercial potential since sepsis is one of the most expensive conditions for hospitals to treat and current methods of diagnosis (including blood cultures) can take more than 24 hours and are not very accurate in predicting early sepsis. Sepsis causes the hospitalization of more than 49 million people around the world every year, including ~170,000 Canadians (Farrah, 2021). It has a staggering 23-30% mortality rate (leading to 19.7% of all deaths) while leaving most survivors suffering from long-term, physical and physiological effects (post-sepsis syndrome). The total cost of treating sepsis in the USA amounts to $24 billion per year.
History
Sepset Biosciences was launched in 2016 as a spinout company, as a collaboration between Dr. R.E.W (Bob) Hancock and the Centre for Drug Research and Development/adMare. It was based on the discovery by Drs. Hancock and Olga Pena of a novel gene signature that was able to distinguish between septic and non-septic patients and predict organ failure (Pena, 2014). This signature was filed for patent protection and patents have been granted in Europe, China and Hong Kong and are pending in other jurisdictions. Sepset has an exclusive license to these patents and the background intellectual property. Sepset was seed funded through a loan from CDRD who also provided management support. Recently ASEP Medical acquired majority ownership of Sepset in exchange for $2.5 million of investment. Dr. Hancock and his collaborators have performed a large multi-center international clinical study (4 countries, 4 continents NCT04118179) and have statistically validated the gene signature demonstrating its high accuracy, sensitivity and specialty.
What is Sepsis?
Sepsis is a serious condition where the immune system becomes unbalanced due to underlying infection(s) that lead to multiple organ failure and in 23% of cases, death, especially if not diagnosed early and treated promptly (Vincent, 2016). It is one of the most prevalent and deadly, yet misdiagnosed (Vincent, 2016), medical conditions. It was recently described that Sepsis in 2017 caused 49 million cases annually and was responsible for 11 million deaths (nearly 20% of all deaths). It is also the cause of the most deaths from severe COVID-19 disease. (Rudd, 2020)
What causes Sepsis?
A simple infection in the lungs, urinary tract, pelvis or abdomen can lead to sepsis (Cawcutt, 2014). An infection typically results in inflammation or tissue swelling which prevents it from spreading to the rest of the body. In some patients the response is dysregulated and actually acts against the body. In this case the infection can spread quickly resulting in widespread inflammation and immune suppression, one type of which is called cellular reprogramming, in which the body’s immune cells literally “forget” how to respond to infection. It is this type of cellular amnesia that the Sepset-ER test detects. As a result, the blood flow is affected and thereby the oxygen reaching the lungs and tissues.
Current Burden of Sepsis Diagnoses
Current methods to diagnose sepsis take more than 24 hours by which time patients are often well on their way towards tissue damage, organ failure, and death.
In 2017, 1 in 5 deaths worldwide involved sepsis (Rudd, 2020). Early recognition and management of sepsis saves lives. With every hour in delay of antimicrobial treatment during sepsis, there is an increase in mortality rate by 8% (Kumar, 2006). To err on the side of caution, patients recognized as “possible sepsis” receive sepsis treatment (~50% of patients actually go on to severe sepsis). However, the early clinical signs and symptoms examined to recognize possible sepsis can be seen in a variety of other conditions. Blood culture results to diagnose sepsis can also take days and their sensitivity is low. Inaccurate diagnosis can lead to worse outcomes, including death, for patients who are discharged with unrecognized sepsis or severely septic and not admitted directly to the ICU. Triage is important, as physicians need to decide who can go home, be managed in the ER, or be sent to the Intensive Care Unit (ICU) immediately. Physicians need more accurate data to help guide decision-making about when treatment is urgently required.