S2X Blog

With 11 million annual deaths attributed to sepsis, this condition remains one of the greatest challenges in modern medicine. In this critical landscape, Loop Diagnostics has emerged as a disruptive leader with a revolutionary solution: SeptiLoop. This innovative diagnostic test promises to transform early sepsis detection, saving lives and redefining healthcare standards.

But what makes SeptiLoop so groundbreaking? How does it compare to traditional diagnostic methods? And beyond its medical impact, how can hospitals and corporations leverage this innovation to drive better healthcare outcomes?

You will find in this article: ⬇️

🔹 How SeptiLoop works – a test 10x faster and 3x more effective than current methods
🔹 Clinical validation – why hospitals are adopting this high-sensitivity diagnostic
🔹 Sepsis treatment evolution – how early detection reduces mortality and hospital stays
🔹 The power of collaboration – why corporate and healthcare partnerships drive impact

The problem: Slow diagnosis with fatal consequences

Today, sepsis detection relies mainly on blood cultures, a process that can take 18 to 72 hours and offers only 30% sensitivity. This delay is deadly: every hour without treatment increases the risk of death by 7.6%.

In this context, Loop Diagnostics identified the urgent need to accelerate this process and improve diagnostic precision, developing an innovative solution to minimize this critical issue.

The Solution: SeptiLoop and Its Transformative Impact

SeptiLoop, as Eduard Guerrero, COO and Co-Founder of the company explains: “Is an IVD test that uses the lack of TNF-α production as a biomarker to detect bacterial infections before progressing to sepsis. It is 10 times faster and 3 times more effective than the current gold standard, achieving 91% sensitivity and delivering results in less than 3 hours”.

This cutting-edge technology not only improves accuracy but also enables physicians to act faster, saving lives when every second counts. A key element of this cutting-edge approach is its immune response release assay, which measures the ex vivo immune response—specifically, the lack of TNF-α production—an early and highly sensitive indicator in the progression of bacterial infections to sepsis. By enabling physicians to act faster, the assay significantly increases diagnostic accuracy and improves patient outcomes when every second counts.

The process is as efficient as it is innovative:

1. A whole blood sample is mixed with specific reagents.
2. The mixture is incubated for 2.5 hours.
3. The results are ready and can be read through visual inspection or automatically through a specialized reader.

This methodology measures the ex vivo immune response, specifically the lack of TNF-α production, a key indicator in the progression of bacterial infections to sepsis, enabling highly accurate early detection.

Clinical results that speak for themselves

SeptiLoop has been validated through clinical trials in international hospitals, yielding impressive results: “Prospective clinical trials on sepsis-suspected patients demonstrated three times the sensitivity of current clinical practices. These trials involved confirmed sepsis patients meeting Sepsis-3 criteria, showcasing superior diagnostic accuracy compared to traditional biomarkers like CRP and PCT“, states Guerrero.

These findings position SeptiLoop as an essential tool for emergency and critical care units.

The challenge: Innovating while meeting global standards

Developing SeptiLoop was not without obstacles. Loop Diagnostics faced the challenge of designing a test that was fast, affordable, and easy to use, while also complying with strict regulations such as UKCA (They are in the last phase to obtain the CE Mark).

How did they overcome these hurdles? Through:

• Collaboration with immunology experts
• Rigorous clinical trials
• Strategic guidance from key advisors in the field​

This collaborative approach allowed them to overcome barriers and bring SeptiLoop to market with confidence.

Global impact: Transforming sepsis treatment

SeptiLoop is more than just a diagnostic tool; it represents a paradigm shift. Its ability to provide rapid and precise results has the potential to: “Significantly reduce hospital mortality by enabling earlier and more targeted treatments, decreasing hospital stays, and reducing associated costs. It could revolutionize sepsis management in emergency departments,” explains Enrique Hernández, Founder & CEO.

In short, SeptiLoop is poised to revolutionize sepsis management worldwide.

The Future of Loop Diagnostics

Loop DX’s journey does not end here. The next steps include:

• Expanding into the UK and European markets
• Obtaining FDA certification to enter the U.S. market
• Launching commercial activities in the U.S. to become a global leader in early sepsis diagnosis

But this growth will not happen alone. Loop Diagnostics is actively seeking strategic partnerships with hospitals, large IVD corporations, and distribution platforms to scale commercialization and drive global adoption of SeptiLoop.

The Role of Corporations: Joining Forces to Save Lives

Large corporations can play a crucial role in the scalability and industrialization of SeptiLoop, providing key resources and ensuring regulatory compliance across different markets. In return, technologies like SeptiLoop offer innovative solutions that address unmet medical needs, significantly improving healthcare outcomes.

Loop Diagnostics has already collaborated with international hospitals through clinical trials and has received support from strategic investors and advisors, facilitating the validation and commercialization of its product.

“These collaborations have accelerated technological validation, provided access to key markets, and established relationships with decision-makers in hospitals and healthcare systems. Both parties benefit through innovation and technology adoption. Corporate venturing is crucial for providing access to resources, expertise, and international markets, shortening development cycles, and maximizing the impact of innovations like SeptiLoop,” states Hernández.

With SeptiLoop, Loop Diagnostics is not only tackling one of the greatest challenges in modern medicine but also ushering in a new era in sepsis diagnosis and treatment. Their technology is not just about saving lives—it is about setting a new standard for healthcare innovation.

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