Description:
Overview
Severe infections cause sepsis, which kills one in five people in the world. Prompt identification of infections leads to appropriate antibiotic treatment that improves outcomes. We have developed methods to identify RNA produced by infectious agents in critical illness and use these targets on a PCR platform to diagnose pathogens more rapidly along with their antibiotic resistance.
Market Opportunity
In addition to being a leading cause of death, in the US, sepsis is one of the costliest hospital diagnoses. Sepsis care is improved with appropriate antibiotics within hours, but this requires fast diagnosis of the pathogen and potential antimicrobial resistance. Current diagnostic tests, including molecular assays, require culturing of the pathogen from the patient’s sample (blood, urine, lung, etc) and this can take hours to days. A direct from blood test, without the need for culture, is needed to identify the pathogen and resistance to guide antimicrobial treatment. Faster diagnosis of infection will lead to better treatment, and better treatment will save lives.
Innovation and Meaningful Advantages
We have developed a methodology using RNA sequencing data to identify RNA targets produced by pathogens during human infections. These RNA targets are only present in the blood of patients who are infected with that distinct pathogen. The targets have then been used to design PCR primers capable of quickly identifying pathogen in hours. This work has been done to diagnosis COVID-19 from the blood, and blood infections due to other bacteria and subsequent resistance genes.
It is important to emphasize that since RNA is used as the target, there is no need to culture the blood. One pathogen can make many copies of the RNA target, allowing for direct-from-blood diagnosis. In addition, RNA allows for a better diagnosis of resistance. Previous efforts look at DNA, and just the presence of DNA does not mean that the protein is made; but if the RNA from that resistance gene is present, it is likely the bacteria is producing it in the stressful conditions of an ill host. Messenger RNA from a pathogen only lasts minutes, allowing confirmation that the pathogen that is causing the infection is present. In contrast, DNA is longer-lived and can linger from a previous infection, leading to erroneous results. Even though RNA is more labile than DNA, our methodology uses RNA stabilized at the time of blood draw to allow for this work to be completed.
Work is currently ongoing on the following projects. We are moving the PCR test to a digital PCR platform utilizing all FDA cleared instruments so that the test can quickly translate from research to clinical practice. We are expanding the number of pathogens and resistance mechanisms to identify more bloodstream infections causing sepsis, as well as a direct from blood test for lower respiratory tract infections. Ultimately a panel of targets that diagnose infection locations (blood, lung, urine) will be added to the standard workflow identifying the pathogen and resistance, all within 4 hours to guide selection of the appropriate antimicrobial agent.
Collaboration Opportunity
We are interested in exploring 1) startup opportunities with investors; 2) collaborations with leading medical research companies; and 3) licensing opportunities with companies.
Principal Investigator
Sean Monaghan M.D.
IP Information
US utility application 17/723,271 Filed 4/18/2022