Time is of the essence for reducing morbidity and mortality associated with sepsis, a potentially life-threatening state of immune hyper-activation with enormous social and economic consequences. The rapid diagnosis and treatment of the disease could prevent up to 80% of associated deaths and contribute to alleviating the $23 billion impact that sepsis has in the United States each year.
San Francisco-based medical technology company Cytovale is developing a novel platform to aid in the early detection of sepsis, founded upon research demonstrating that the mechanical properties of immune cells are altered during the disease and could be used as a diagnostic biomarker. Their technology assesses the mechanical state of circulating immune cells with speed and costs that could permit its translation into the clinic.
Here is a closer look into the theory and features of Cytovale’s Rapid Sepsis Diagnostic System. This is an exclusive ImmunoFrontiers interview with the CEO and co-founder of Cytovale, Ajay Shah, Ph.D.
Which problem or problems does your technology address, and why is your approach unique?
Sepsis is the number one cause of death in hospitals, taking the lives of 270,000 people every year in the United States, which is more than opioid overdoses, prostate cancer and breast cancer combined. Sepsis-related healthcare costs in the U.S. are astronomical – in excess of $27 billion every year. Consistent and accurate early sepsis detection can help triage patients appropriately and reduce this cost.
With current approaches, sepsis remains challenging to diagnose early and accurately, often consuming valuable resources and delaying care to those who need it most. The two biggest advantages of the Cytovale System are the ease of use – a simple blood test – and the speed of results – in less than 10 minutes – that can help triage seriously ill patients and direct vital hospital resources (i.e., ICU beds, PPE, clinical staff, additional testing) where they are needed most.
Cytovale technology is focused on the patient, namely host immune response, rather than the pathogen. Evaluating the mechanical state of cells allows the system to provide accurate information independent of the pathogen. For example, we recently launched a study for suspected COVID-19 patients. We were able to do so because the Cytovale System didn’t require any modifications to be able to provide sepsis risk information based on the specifics of this novel pathogen. The system may be able to help clinicians understand which of these patients are at highest risk for viral sepsis, allowing more effective triage.
What is the underlying theory of your technology?
After years of methodical research and testing, we’ve pioneered a system that integrates microfluidics, machine learning, high-speed imaging and cell mechanics to rapidly provide reliable information to aid in the early detection of fast-moving diseases like sepsis.
The Cytovale Rapid Sepsis Diagnostic System is a simple blood test. With just two user steps, a small blood sample is prepped and loaded on a single-use microfluidic cartridge, with proprietary features for assessing the biomechanical properties of individual cells. In less than 10 minutes, each patient’s unique signature is compared to established profiles of robustly constructed multidimensional disease signatures, reduced by machine learning techniques, to determine a diagnostic score.
How will your technology transform patient care?
Mortality from sepsis increases as much as 8% for every hour that treatment is delayed. As many as 80% of sepsis deaths could be prevented with rapid diagnosis and treatment – making early detection essential.
While not specifically designed to address COVID-19, the near-term applications for patient care were immediately clear. The pandemic has helped raise awareness among the general public about how serious infectious diseases, and the immune response to them, can be. Sepsis is a potential outcome of this infection, and Cytovale is actively engaged in research to assess rapid sepsis diagnosis in the COVID-19 population.
COVID-19 has also brought the issue of resource preservation to the forefront. While it never made sense to put someone in an ICU bed who doesn’t need it, for the first time, perhaps, it’s really hitting home with the general public why it’s important to save that space for someone who does need it. We are optimistic that our technology can be a part of the solution by helping providers make informed decisions quickly to treat sepsis patients who need it, spare those who don’t, and ultimately help save lives.
In your opinion, what is the most interesting or novel feature of your technology and why?
Cytovale is unlocking the ability to identify the mechanical signatures of disease at the cellular level. Until now, biophysical datasets have had limited clinical utility due to low throughput, with most techniques measuring only tens of cells per hour. Such approaches are characterized by low reproducibility, extended time-to-results and complex operations. While we are initially focusing our efforts on rapid sepsis diagnosis, our innovative technology has the potential to change the way that certain cancers are diagnosed, which is very exciting. With both sepsis and cancer, we know that early diagnosis can lead to early intervention that saves lives. This is the driving force behind our technology and research.
What is your take-home message for readers?
Providing critical keys to unlock a sepsis diagnosis in under 10 minutes, the Cytovale System is fast, straightforward to perform and consistently reliable. The diagnostic information provided can inform appropriate treatment paths, saving valuable time for patients in life-threatening situations and saving valuable resources for healthcare systems faced with ballooning costs and inappropriate treatment.