Clinical Research

Developing next-gen solutions for diagnosing complicated infections

Rapid and accurate detection of complex infections
Sensitive detection of biofilm-associated infections
Realtime Antimicrobial Susceptibility Testing (AST)

We have a bold vision to transform in-vitro diagnostics of infections, developing a one-stop-solution for detection, species ID and antimicrobial susceptibility testing (AST) – all using our biocalorimetry metabolic measurements matched with machine learning.

We are in early development but have come far with our first proof-of-concept solution in PJI. This builds upon internal development, our H2020 multicenter study on rapid AST in sepsis of over 600 clinical isolates as well as collaborations in orthopedics with data from over 1000 clinical samples. We are starting in orthopedics and PJI, but will target all implant and tissue related infections including blood for the future.

We’re changing the game

Speed and detection

Up to 20% of patients’ PJIs are undiagnosed with the current methods. The calScreener™ detects infections with an improved sensitivity and specificity compared to gold standard methods and in a fraction of the time directly on the patient sample. The median detection time according to study with the calScreener™ was shown to be reduced to just 2 hours, compared to an average of 51 hours using conventional microbial culture methods for PJI.

Microbial identification

Peer-reviewed research (refer to the study) shows that the calScreener™ can accurately identify microbial pathogens directly on the patient sample . The calScreener™ translates metabolic readouts into time-trace diagrams, effectively capturing a unique “fingerprint” of the metabolic activity to the different microbial species. This metabolic profile can then be used in research studies to precisely identify what organisms are present in a clinical sample..

Fast Antimicrobial Susceptibility Testing (AST)

In infection diagnostics, one of the most significant challenges lies not only in identifying the pathogen responsible but also in determining which antibiotics will effectively combat it. The conventional approach is often slow and can be labor-intensive.

The calScreener™ identifies the presence of a pathogen and can assess which antibiotics will be most effective in a fraction of the time required by traditional methods – in as few as two hours (reference to publication or is this referring to in house data?) . It can also distinguish between antibiotics that kill (bactericidal) the bacteria and those that merely suppress (bacteriostatic) its growth. This changes the game, and is crucial for tailoring the most effective.

fast-antimicrobial-susceptibility-testing

Beyond diagnosis

Beyond diagnosis, identifying bacteria within biofilms opens new possibilities for addressing one of the most challenging aspects of PJI management. While further research and clinical validation are necessary, the calScreener’s™ performance in early studies suggests that it could play a crucial role in the future of infection diagnostics, particularly in the complex and growing field of implant-related infections.