Ultrasensitive PCR-based Sepsis Diagnostics

Sepsis is one of the major killers worldwide with millions of dead every year. The persisting issue in sepsis-causing pathogen diagnostics is the lack of fast and reliable solutions. The standard use of blood culture takes days and often leads to false negative results , which can end in wrong medication. Several PCR-based solutions are available on the market, however, neither managed to capture the market, often due to their insufficient sensitivity.


We managed to address the issues of PCR-based sepsis diagnostics and came with a new approach offering superfast solution with ultra sensitive testing!

Scientist working with samples in a laboratory
Scientist working with samples in a laboratory

Ultrasensitive Sepsis Diagnostics

Sepsis: The Major Global Killer

Sepsis is a life-threatening condition caused by body's immune system extreme response to an infection, causing organ dysfunction. Early diagnostics is the key to successful treatment.

49 million sepsis cases worldwide
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Sepsis Diagnostics

49 million cases

Sepsis remains a major global health challenge, with an estimated 49 million cases each year and approximately 11 million sepsis-related deaths accounting for nearly 20% of all global mortality. Beyond its staggering impact on survival, sepsis often leads to severe long-term consequences for those who recover. Many patients face prolonged hospital stays, a high risk of organ dysfunction, and lasting complications such as impaired immune function, chronic pain, cognitive decline, and reduced quality of life.

15 in 1000 hospitalized patients develop sepsis
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Sepsis Diagnostics

15 out of every 1,000 patients

Sepsis is also a serious complication of medical care, affecting about 15 out of every 1,000 hospitalized patients only as a result of receiving healthcare. These cases often occur in vulnerable individuals and are frequently linked to multidrug-resistant pathogens. The outcomes are severe, such as longer hospital stays, higher costs, organ failure, and increased mortality, making prevention and early detection essential priorities in healthcare.

32K USD per case is the hospital cost of sepsis
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Sepsis Diagnostics

32,000 USD

Sepsis is not only a life-threatening condition but also an immense economic burden. The average hospital cost per case is estimated at around 32,000 USD. Beyond the direct costs of intensive care and prolonged hospitalization, sepsis often leads to readmissions, rehabilitation needs, and long-term health problems, further straining patients, families, and healthcare systems.

Pie charts: of 319 tested samples, 101 were positive; of 138 pathogens found, 43 were detected by both methods, 83 by DIANA only and 12 by the reference only
Diagnostics icon: test result and sample tube

Sepsis Diagnostics

Unreliable diagnostics

Gold standard in sepsis diagnostics is slow and limited in sensitivity, often leading to false-negative results, which delays and misleads critical decision-making. Yet, early recognition is vital, because every hour of delayed treatment increases the risk of death by about 8% in severe cases. Rapid and reliable diagnostics are therefore essential to improve survival and reduce the devastating impact of sepsis.

What are the main problems of sepsis diagnostics?

The diagnostics of sepsis is problematic because of lack of sensitivity and slow testing. Current techniques do not offer a market winning solution yet.

Donut chart of pathogens leading to sepsis: Gram-negative bacteria 42.5%, Gram-positive bacteria 32.8%, polymicrobial 21.6%, fungal and other 3.2%

Sepsis is caused mainly by bacterial infection

Common signs of sepsis include fever, fast heart rate, rapid breathing, confusion and body pain. It can lead to septic shock, multiple organ failure and death.​


Sepsis is usually caused by bacterial infections but may be the result of other infections such as fungi and in rare cases by viruses or parasites.​


Healthcare associated infections are caused by pathogens that are often resistant to drugs and can rapidly lead to deteriorating clinical conditions.​ Precise diagnostics and targeted antibiotic treatment are vital in such cases.

Donut chart of pathogens leading to sepsis: Gram-negative bacteria 42.5%, Gram-positive bacteria 32.8%, polymicrobial 21.6%, fungal and other 3.2%

Four pathogens cause majority of sepsis

Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae and Pseudomonas aeruginosa are the most prevalent BSI (bloodstream infection) pathogens globally.


These four agents cause 55–68 % of all sepsis cases, depending on the geographical location.​

The DIANA technology: Ultrasensitive and fast solution

Our proprietary qPCR-based technology offers an ultimate solution for ultrasensitive and fast sepsis diagnostics

We are aware of the ongoing issues with sepsis diagnostics and insufficient solutions on the market. Thanks to our strong RnD diagnostic team with experiences of developing our unique DIANA COVID-19 PCR kits, we were able to start developing a completely new solution how to diagnose sepsis faster with unmatched sensitivity.

We have established strong partnerships, which can help us to develop the complete diagnostic kit. We collaborate on the whole project with two major hospitals, FN Motol and FN Olomouc in the Czech Republic (TACR TREND PROJECT FW10010005).​ Collaborators collect clinical samples and test our approach directly on site​.

Key Parameters

DIANA ultrasensitive qPCR solves sepsis diagnostics problems

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Ultrasensitive


DIANA platform vastly increased sensitivity and signal-to-noise ratio without compromising specificity. All of this thanks to our assay design and proprietary PCR chemistry and enzymes.

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Semi-automated


Our semi-automated protocol is easily integrated with standard laboratory instruments. No need for large investments for implementation.

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Ultimate effectivity


We can detect high number of targets from a single NA isolation. The initial proof-of-concept solution detects the top 4 pathogens. Additional pathogens are under development.

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No market-winning alternative available


Available solutions are often too slow or have no information of specific pathogen. Other PCR solutions on the market suffer from low-sensitivity and need high additional investments.

„We addressed the shortcomings of current PCR-based sepsis diagnostics and, building on our experience with DIANA COVID-19 PCR kits, developed an ultrasensitive solution.“

Radim Svačina, PhD

Lead Scientist in Sepsis Diagnostics

INTERESTED IN COLLABORATION?

Do you have an interesting project we could collaborate on? Looking for an OEM partner?

Co-CEO

Martin Dienstbier

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Happy to get in touch

[email protected]