What are the most exciting advancements of Karius over the past few years?
Karius is growing quickly – the company has expanded from around 50 people in October 2020 to nearly 200 today. We have improved our Karius Test offerings, and whereas we used to have a few dozen hospitals ordering from us, we now have hundreds of hospitals that have used the test. These hospitals are primarily leading oncology, solid organ, and stem cell transplant institutions. Moreover, we are uniquely used in children's hospitals around the country.
In 2022, we will probably achieve one of the most important milestones in Karius’ history, which will be the readout of a prospective study called PICKUP —an observational trial designed to examine the efficacy of the Karius Test in immunocompromised patients with pneumonia. To put this in context, there are over 600,000 cancer-related deaths in the US each year. Up to half of those are from infection, with pneumonia being the main infection. People get very excited about new therapeutics and diagnostics to screen for cancer, but one of the top threats to a cancer patient today is not a malignancy, but an infection. The application of the Karius Test in this way has monumental implications.
Can you speak to the range of therapeutic applications of the Karius Test?
Our test helps clinicians non-invasively and rapidly diagnose infections in patients, particularly those enduring arduous forms of cancer treatment, most of whom will experience some degree of immunosuppression. Our core focus is on cancer and immunocompromised patients, solid organ transplantation, stem cell transplantation, and pediatrics.
We also have another trial in immunocompromised patients with invasive fungal infections, which have some of the highest mortality rates and are very difficult to diagnose and treat. Finally, we have another data set coming out in 2022 relative to both adult and pediatric patients undergoing stem cell transplantation and diagnosing critical infections.
What are the advantages of having a diagnostics test based on microbial cell-free DNA?
The unique advantage of our liquid biopsy test is that it does not require an invasive sample collection of infected tissue or fluid. Instead, it detects small fragments of DNA from the pathogen causing the infection within the bloodstream. In this way, we can find over 1,000 different pathogens from the site of the infection, irrespective of where the infection is in the body. Our internal analysis of data from a recent third party study showed that roughly 60% of invasive diagnostic procedures could have been avoided had the Karius Test been used instead. This is critical, as 30% of people who have one of those procedures could have an adverse event, and the average cost of that adverse event is US$15,000 per patient to the healthcare system.
A second advantage of our test, as evidenced by the clinical validation data, is its ability to often identify the underlying causes of more infections compared to standard of care. We can identify the likely pathogen causing infection typically within 24 hours of receiving the sample.
How has the medical community responded to the Karius Test?
Our test is performed in a CLIA certified and CAP accredited laboratory. Last year, we received approval from the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP). The decision by CLEP is a first-in-class approval of a clinical metagenomics test for the detection of infectious diseases and will expand patient access to critical testing in New York. Additionally, we have been featured in over 100 publications that provide clinical evidence for our product. We were published in Nature Microbiology in 2019 for a study that illustrated the validation of the Karius Test, examining its ability to identify the likely pathogens causing sepsis in hundreds of patients.
What potential does the power of genomics hold for the future of diagnostics?
Advanced genomics is still a relatively young industry, which had its origins in oncology and prenatal treatment and diagnosis. The industry focus has traditionally been therapeutic-centric, but the pandemic raised public awareness around the importance of rapidly and accurately diagnosing infections. We are excited to help advance the field of diagnostics with a liquid biopsy for infectious diseases.