At the top of the CDC’s urgent threat category is the pathogen, Clostridium difficile (C. difficile). the pathogen causes 29,000 deaths per year, more than Leukemia and Parkinson Disease and nearly half a million life-threatening infections. This devastating gastrointestinal infection degrades the wall of the colon and can lead to organ failure and death.
What is it?
C. difficile is a common environmental bacterium, especially in healthcare institutions and nursing homes. It exists and two forms, a benign “spore” form, and an active, vegetative form that secretes a protein toxin causing the degradation of the colon. Many people carry the benign form of the bacteria in their gut without carrying the disease. The bacteria can also be found in the food chain and soil and is often transferred by people without illness.
What causes C. diff to become virulent?
The gut is the home of a large constellation of microbes, the gastrointestinal microbiome, some of which create substances that suppress the transformation of the benign C. difficile spores into the toxin-producing and disease-causing vegetative form. When those protective microbes are eliminated by antibiotics, C. difficile can go from the dormant spore form to the toxin-producing, disease-causing vegetative form, causing C. difficile infection and degradation of the colon.
Who’s at Risk?
Patients taking antibiotics are at a higher risk for C. difficile infection because the antibiotics can kill germination suppressing bacteria. Patients who have compromised immune systems are also a high-risk group.
How is C. difficile diagnosed?
Today there are two rapid technologies used to detect C. difficile. Unfortunately, neither one is both highly sensitive and highly specific. Tests must be highly sensitive to detect all the patients that have this life-threatening infection, and highly specific to ensure that patients who don’t have the infection aren’t misdiagnosed and unnecessarily treated with antibiotics, creating negative outcomes.
Enzyme immunoassays, one of the current technologies that detect the C. difficile toxins, is specific but lacks the sensitivity to detect low toxin levels in some infected patients. Another test is the nucleic acid amplification test. It is very sensitive but lacks clinical specificity because the test detects the C. difficile organism itself and not the disease-causing toxin. Thus, these tests detect as positives, not only the patients who have C. difficile infection but also those who do not have the infection but who are instead colonized with the benign spore form of C. difficile. Mis-identifying these patients as positive can lead to overtreatment which can lead to poor medical outcomes.
What is needed to properly diagnose and treat C. difficile?
There is a need for is a rapid test for the C. difficile toxin that is both sensitive enough to detect all patients with C. difficile infection and specific enough to distinguish infected patients from uninfected, colonized patients with negligible amounts of the toxin in their samples. First Light’s C. difficile test is both highly sensitive and highly specific.
How First Light is filling the current gap in C. difficile diagnostics
The MultiPath™ C. difficile test is the first rapid, ultrasensitive, and specific test for C. difficile infection. The MultiPath Platform is a fully automated benchtop analyzer that consists of a menu of application specific test cartridges. The products are easy-to-use and require no sample preparation, allowing testing to be performed closer to the point-of-care. The proprietary MultiPath immunoassay technology achieves high sensitivity and quantification by using digital, non-magnified imaging to count fluorescently labeled cellular and molecular targets.
In clinical studies, the MultiPath C. difficile test demonstrated high clinical accuracy in the detection of the C. difficile infection in 30 minutes directly from patient samples.
C. difficile is the most common cause of life-threatening infections. Current methods for diagnosing C. difficile are either insensitive or non-specific, which results in negative medical outcomes or poor therapeutic choices. First Light’s MultiPath Platform aims to be the first that accurately distinguishes patients with C. difficile for treatment from patients without the infection. This will not only improve medical outcomes but can help prevent the spread of the infection.