An innovative new diagnostic platform that is capable of detecting more than 1,000 disease-causing organisms in just six hours has just been approved for use in Europe, potentially paving the way for a transformation in the manner in which diseases are diagnosed. The revolutionary new system is now being put through its paces in the US in the hope that it will be given the FDA’s seal of approval within the next few years.
Identifying the agent responsible for an infection or disease is not always easy, especially when the symptoms could indicate a number of different pathogens. This means that sometimes a variety of different specimens need to be taken, such as tubes of blood, swabs or urine samples, all of which then need to be subjected to different tests. But if the microbe, such as a virus or bacterium, is not on the list of suspects, doctors are unlikely to identify it because many tests are very specific. This means that the diagnostic process can be slow, causing delays in targeted treatment and consequently doctors are often forced to use blanket therapies, such as broad spectrum antibiotics, when time is limited.
But this could be set to change with the advent of IRIDICA, the brainchild of four researchers based at Isis Pharmaceuticals. After spending several years working on developing new antimicrobial compounds, they wondered whether they could apply the concepts they had come up with for drug discovery to the field of 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,” Dave Ecker, one of the scientists behind IRIDICA, explains to Fast Co.Exist. “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?’”
More than a decade of hard work and dedication later, the IRIDICA platform was born. It works by first isolating the genetic material from pathogens within a patient's sample, such as a vial of blood or a tissue biopsy, and then amplifying it so there is more to work with.
Next, this material is put into an instrument called a mass spectrometer, which measures both the masses and concentrations of atoms and molecules in a sample. Because the basic building blocks of genetic material (the nitrogenous bases), all weigh different amounts, it is possible to work out the number of pairs of bases that the pathogen has based on the total molecular weight. This can then be compared to a database containing the base pair counts for known pathogens, allowing rapid identification of the microbes present in the sample.
Impressively, the platform is capable of picking up more than 780 species of bacteria, over 200 species of fungi and yeast, and more than 130 different viruses, all in just six hours. The team believes it would be particularly useful for identifying the causative agent of sepsis, a serious complication of an infection that can kill within just 15 hours.
The machine has already received the CE-Mark approval in Europe, and is now undergoing clinical trials in the US.