There is a diagnostic platform sitting in a hospital in Paris that can identify over 1,000 disease-causing pathogens in just six hours and could potentially save hundreds of thousands of lives each year. This platform, called IRIDICA, is more than 15 years in the making. It was created by a group of men who believed that they could overturn the status quo of infectious disease diagnostics, which has been largely the same since the 1800s. They may have been right.
The origins of IRIDICA, which just received CE-Mark approval (the European equivalent of FDA approval) can be traced back to the mid-1990s, when four researchers–Dave Ecker, Rangarajan Sampath, Lawrence Blyn and Steve Hofstadler–were working at a company called Isis Pharmaceuticals. The group, which refers to itself as the “Band of Brothers,” became interested in developing new antimicrobial drugs. For three years, they worked on the project, buoyed by cash from the Department of Defense and other government agencies.
When they learned that the government was interested in funding revolutionary ideas for diagnostics to be used in everything from biosecurity to pandemic detection, the group had an idea: Why not take the same concepts they were working with for drug discovery and use it for diagnostics?
“Everyone was asking the wrong questions, taking existing technology and making individual tests for diseases. But with over 1,000 organisms causing disease in humans, you can’t make 1,000 tests,” says Ecker, who is now the divisional vice president of R&D for Abbott’s Ibis Biosciences business. “So we asked: Can we use our technology to say ‘Give me a specimen and I’m going to tell you what infectious organisms are in it no matter what they are?'”
In the year 2000, they came up with the concept that would ultimately become IRIDICA: a universal pathogen detector that could detect disease directly from specimens, like blood or tissue. That same year, Ecker went to an industry meeting on diagnostics, where people were discussing the Gram stain–a limited method for identifying the cause of bacterial infection that’s over 100 years old. “I was appalled that things had not advanced any further than that. In 2014, people are still using the Gram stain,” says Ecker.
For over a decade, Ecker and his colleagues worked on their skunkworks project, which was helped along with funding from numerous government agencies. Naturally, there was plenty of resistance from people who didn’t believe that could overcome the now-ancient gold standards of disease detection. The group’s first challenge was convincing agencies that they could take on their particular pet project, whether it be food-borne pathogens or potential pandemics. Viruses, the fly, anthrax, plague–the platform had no trouble diagnosing any of these pathogens. “It’s always an extra burden to prove yourself as a game-changing technology,” says Blyn, director of science and technology at Ibis Bioscience.
Now, after overcoming doubters, Abbott–which bought the technology–is rolling out IRIDICA.
Here’s how it works: doctors provice a specimen (blood or a biopsy, say). Genetic material (some it belonging to the sick human, some belonging to the pathogen) is extracted. Copies of the pathogen’s genetic material are created. Then, that material goes into a device called a mass spectrometer to figure out the molecular weight of the pathogen (each letter of the DNA–AGCT–weighs a different amount). Once the molecular weight has been determined, that information is scanned against a database that has the AGCT counts of all the pathogens that cause disease in humans. The whole process takes about six hours.
The platform can diagnose all sorts of bacterial, fungal, and viral infections, but Ecker believes that its ability to quickly figure out the specific organism causing a patient’s sepsis–an infection that can kill within 15 hours–is “the bright shining tool, the flagship.” Up to 300,000 people die of sepsis each year in the U.S. largely because doctors don’t know what drug to put people on. “The most important thing you can do for someone with the infection is to find out what microbe is causing it,” explains Ecker.
IRIDICA’s ability to quickly diagnose fungal infections is also a big deal; today, it can take months to identify a fungal pathogen while a sample slowly grows in a lab.
Unfortunately, Hofstadler–one of the platform’s creators–hasn’t been able to reap the rewards of his work. He passed away suddenly this past January. “He wasn’t sick. Something went wrong with his heart. We carried on, and had a whole brutal year of hard work to get to where we are at this moment,” says Ecker.
Abbott is now initiating clinical trials for IRIDICA in the U.S. It will most likely take a couple years before FDA approval. If that’s achieved, diagnosing mysterious pathogens might suddenly seem a lot less intimidating.