Sepsis, a complication of an infection caused by foreign cells infiltrating a person’s bloodstream, affects nearly two million people each year in the U.S. If not addressed quickly, the infection triggers the body’s immune system to begin attacking its own organs, resulting in a slow, weeks-long death.

The challenge for clinicians is identifying the source of the infection, according to T2 Biosystems (NSDQ:TTOO) CEO John McDonough.

“Is it bacterial? Is it fungal? If so, what species is it? Because the really good news is if you could know that information fast enough and get patients on the right drugs you could cut mortality rates in half,” McDonough told MassDevice.com.

For decades, healthcare practitioners have relied on blood cultures to diagnose infections. But that can mean several days going by before the patient is linked to the proper therapy. And most diagnostic systems aren’t sensitive enough to detect the small levels of intruder cells in a patient’s blood.

Often, doctors will immediately prescribe broad-spectrum antibiotics to sepsis patients, in the hopes of killing off the infection with a lucky shot. But McDonough points out that this type of empiric therapy is not ideal, especially in an environment where doctors are working to use antibiotics less frequently.

That’s where McDonough hopes that T2 and its diagnostic technology can meet an unmet need.

‘One challenge after another’

Lexington, Mass.-based T2 was founded in 2006 by a group of serial entrepreneurs, including MIT’s Bob Langer. McDonough came on board in 2007 as chief executive, bringing with him a bundle of experience in leading startups.

“I’ve been doing start-ups for way too long,” he joked. “I love the challenge of trying to do something new and different and innovative. In the case of T2, it’s truly all about saving the lives of patients who are dying of sepsis.”

The company’s technology uses super-paramagnetic nanoparticles with species-specific probes to detect pathogens directly in a patient’s blood sample. Thanks to years of work, T2 has managed to develop a system that can identify tiny levels of sepsis-causing pathogens in a matter of hours.

But it didn’t happen overnight.

“There was every reason at the beginning why this was going to fail. I mean, it was just one challenge after another,” McDonough said.

“We could hardly detect anything at first,” added chief scientific officer Tom Lowery. “When we were trying to figure out how to solve a problem, there was no, ‘That’s not a good idea.’ We would try five, six, seven very different approaches and try not to be dissuaded by all of the times we ended up realizing it didn’t work.”

“At a big company, you would allocate your resources away from the risk. But in a small company, you don’t even know there’s risk,” McDonough told us. “You just take picks and shovels and you keep digging until you find a way to get there. It’s crazy how it happens but you’re often just in a dark space and the only thing that’s getting you through it is you really believe. You believe in the people around you. You believe in the opportunity and you just keep going.”

Changing the paradigm

The 175-person company now has the only FDA-approved diagnostic for detecting sepsis-causing pathogens at a sensitivity once thought impossible. While traditional methods detect pathogens at between 100-10,000 colony-forming units per mL, T2’s system can make a positive ID down to 1 CFU/mL.

Not only is the T2Bacteria product highly sensitive, but in a pivotal trial, it demonstrated 98% specificity.

Importantly, while a traditional blood culture can take days to produce a result, T2’s system cranks out an answer in just three hours.

Now that the T2Bacteria panel has FDA clearance, the next step is convincing hospitals to adopt the technology directly into their sepsis protocols. McDonough thinks that beyond the diagnostic’s sensitivity and specificity features, the technology has a convincing cost-savings angle.

“Sepsis is the most expensive hospital-treated condition in the U.S., at more than $27 billion dollars per year. There are two million patients and more than $27 billion dollars being spent. If you get patients on the right drug within the first 24 hours, you can cut that cost by 20% to 30%,” he explained.

McDonough and Lowery both noted that their conversations with potential customers are always interesting, as many can’t believe that the system doesn’t require a blood culture.

“Blood cultures have been in use for 80, 90 years and it’s so ingrained in laboratorians’ minds that this is the way you handle things,” Lowery said.

“When you’re changing a paradigm, it often doesn’t change easily,” McDonough added. “But driving mass adoption is priority number one.”