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Can you tell us about your journey to leading Karius and some of the challenges along the way?
Sure, it’s been an interesting ride. I started at Pfizer when it was very much this scrappy, entrepreneurial company in the late ’80s. Back then, Pfizer and other companies were launching new antibiotics and antifungals often. Today is a different story. If you look today, the number of companies developing new anti-infectives has dropped dramatically. Meanwhile, antimicrobial resistance is becoming a global crisis, responsible for millions of deaths annually.
Unlike the first 11 years, the last 15 years of my career have been focused on genomics. So when I came across Karius, it felt like a perfect fit—we’re at the intersection between infectious disease and genomics. I’m really proud of the work we’ve done so far. When you look back at infectious disease diagnostics, honestly, there hasn’t been much change in the past 80 to 100 years. We still grab the organism from a person, we put it on a plate, we try to get it to grow. We’re still using cultures, PCR, and serology tests that have been around forever. With genomics, we’re bringing something new to the table, something that can actually make a difference in the patients most at risk of significant morbidity and mortality.
Can you explain how the Karius Test works?
Sure, let’s start with the biology. When any of us get an infection—whether it’s bacteria, fungi, or a virus—two things can happen: you get an immune response and an inflammatory response. These biological processes attack the invading organism, break it down, and release those degraded fragments of DNA into the bloodstream, even if you’re immunocompromised.
What we do at Karius is find the debris left behind in the bloodstream after the body starts breaking down the infection. These little DNA fragments end up in the blood no matter where the infection is in the body. So whether it's in the brain, lungs, liver, or anywhere else, those fragments are floating around in the blood.
With the Karius Test, we can detect over 1,000 pathogens within a day of sample receipt. We start with a plasma sample sent to us from a hospital, and we have proprietary techniques to remove the human DNA and amplify the microbial DNA signal. Then we sequence it using Illumina technology. The final piece is our bioinformatics pipeline, powered by AI, which helps us pinpoint exactly what’s causing the infection. That’s making it simple, but a lot of work goes into decoding those signals.
Our test has also been getting better and better over the past eight years, and our machine learning approach has allowed us to constantly improve. That’s something you don’t see with traditional diagnostics like PCR or serology, which have static efficacy over time and almost never get better.
What progress have you made with the FDA?
We received our FDA Breakthrough Designation earlier this year for immunocompromised patients with suspected pneumonia. It’s a big focus for us because the unmet patient need is massive. According to the American Thoracic Society, this patient population is defined as people with cancer, HIV, and autoimmune diseases who are receiving immunosuppressants. These patients are at such a high risk - in the U.S. alone, 900 cancer patients die every day from infection.
Few people know that over 50% of all cancer deaths are related to infections. For those with blood cancers, that number jumps to 65%. Our goal with the FDA is to demonstrate that our test can significantly improve outcomes for these patients by providing faster, more accurate diagnostics.
The mortality rate for immunocompromised pneumonia can be as high as 65% over 30 days. So, right now, we’re focused on this population because it’s where the stakes are highest. Immunocompromised patients can become infected by a diverse array of pathogens that might not cause infection in healthy people, and determining the cause of their infection is a critical unmet need to ultimately improve patient outcomes.
How has the Karius Test performed in clinical trials?
The results have been remarkable. We published a trial in pneumonia last year comparing the Karius Test to the standard microbiological tests used in hospitals. On average, immunocompromised patients go through about 40 tests during a two-week hospital stay, costing anywhere from $13,000 to $15,000, and 70% of those tests fail to identify the cause of the infection.
With the Karius Test, we identified as many causes of disease in 24 hours as hospitals found in seven days of testing, and we detected 40% more infections when added to the standard workup.
Here’s the fascinating part: many of these patients were admitted for pneumonia, but our test found that some didn’t actually have pneumonia. I’ll repeat that - they were admitted for pneumonia, but the Karius Test showed they didn’t have it. Almost 40% of these patients had infections, not pneumonia, and standard testing missed it. These patients were enrolled in pneumonia trial, given bronchoscopy, and treated for pneumonia when the real issue for many patients was elsewhere. That’s the power of genomics—we’re not limited by what’s suspect; we can identify infections well beyond the suspected infectious syndrome, like pneumonia.
Is cost a barrier for hospitals adopting the test?
It’s a question that comes up, but you have to look at the bigger picture. The Karius Test costs about $2,200, which might seem high compared to a single PCR test or a blood culture. But hospitals are spending much more than that over the course of an admission trying to diagnose infections—$15,000 to $20,000 by day seven in our trial for pneumonia.
In the U.S., many hospitals get paid a fixed amount to treat a patient, so if they can diagnose more patients, faster, they can impact spending, outcomes and risk of readmission. So hospitals that adopt the Karius Test are doing it because it not only makes clinical sense but also economic sense. Last year, we had 24,000 tests ordered across hundreds of hospitals, and that’s growing.
Looking ahead to 2025, what are your priorities for Karius?
Our top priority is getting the test into more hospitals. There are about 500 to 1,000 hospitals in the U.S. that treat most of the immunocompromised patients, and we’re focused on expanding access there. We’re also looking at partnerships with large reference labs and hospital organizations, which would allow us to scale the test to even more hospitals.
Any plans for international expansion?
Definitely. As part of our FDA approval process, we’re looking at developing a kit that hospitals worldwide could use locally. Many hospitals already have the equipment - DNA sequencers and liquid handling machines. With the right kit, they could run the Karius Test locally, and then send the data to our cloud-based bioinformatics platform for analysis. That could deliver results to their physicians in as little as 15 hours for over 1,000 causes of disease.
What do you think is the most important quality for a leader in life sciences?
For me, it’s empathy. People who work for Karius are making a huge trade—they’re giving up time with their families to work here, to work on the mission we have chosen. As a leader, I recognize the magnitude of that trade and treat it with respect. If you don’t have empathy for what your employees are going through and an empathetic lens both inside and outside of work, you can fail as a leader.
The other key is focus. In a fast-paced, ambitious environment, it’s easy to get distracted by opportunities. But Karius leadership is also about knowing when to say no. Everyone wants to change the world right now, but by focusing on fewer things, you give your team the ability to succeed and do their best work. Our mission is clear: we want to reduce the number of immunocompromised patients dying from infections—right now, that’s 900 people a day. If we can bring that number down, we’ll have made a real impact. We cannot take our eye off that goal.
