Why does diagnosis for critical infections currently take days and sometimes weeks?
Current methods for diagnosing infectious diseases are based on the 150-year-old culture method, where physicians collect a sample of a patient’s tissue, such as blood, mucus or urine, and transfer it onto media bottle to allow the pathogens to grow. After a day or two, portions of the sample will multiply, which will help allow a lab technician to identify and correctly diagnose the source of infection.
The process takes time – days or even weeks – to receive a reliable diagnosis, which can delay a patient from receiving immediate care. Delays in treatment can be life-threatening for critically ill patients, which is why it is important to continue to improve methods of diagnosis.
Please can you give a brief overview of Abbott’s Polymerase chain reaction/Electrospray Ionization Mass Spectrometry (PCR/ESI-MS) technology and why it was developed?
We developed Polymerase chain reaction/Electrospray Ionization Mass Spectrometry (PCR/ESI-MS) under the stringent requirements of the Defense Advanced Research Projects Agency (DARPA) as a result of their heightened interest in rapidly identifying bioterrorism threats, such as MERS, Ebola or SARS.
However, in the process we discovered the technology can employ a combination of biological, physical and mathematical tools to quickly identify sources of critical infections. Abbott’s technology is able to detect hundreds of bacteria, virus and fungi more quickly than the current standard of care, which is culture.
In what way does the PCR/ESI-MS technology detect the source of the infection?
Abbott’s Polymerase chain reaction/Electrospray Ionization Mass Spectrometry (PCR/ESI-MS) technology is being designed to test for and rapidly identify hundreds of pathogens directly from a patient specimen through a four-step process:
- Step One: A lab technician collects a patient specimen. Genetic material from this specimen is removed and used for further testing. While most of the genetic material in the specimen is of human origin, some of it belongs to the pathogen that is making the person sick.
- Step Two: Multiple copies of the pathogen’s genetic material are generated using a process called polymerase chain reaction (PCR).
- Step Three: A device called a mass spectrometer is used to determine the molecular weight of the amplified genetic material.
- Step Four: Sophisticated mathematical algorithms are used to identify the pathogen.
Abbott’s technology is designed to complete testing within eight hours, giving clinicians the ability to obtain test results sooner than conventional methods to prescribe a more accurate anti-microbial drug or other therapy.
How does this compare to the current standard of care – blood cultures?
Doctors need better tools to diagnose their patients when facing unknown infections, and unfortunately, more than 50 percent of culture tests come back negative, even when infections are believed to exist.
Results from Abbott’s RApid Diagnosis of Infections in the CriticAlly IlL (RADICAL) study results suggest the technology can provide rapid much earlier than culture methods, allowing physicians to act quickly and effectively to make life-saving treatment decisions.
Why do many blood culture tests come back negative even when infections are believed to exist and how does the PCR/ESI-MS technology overcome this?
Many pathogens – for example, those that need special growth environments – can be tricky to culture. And sometimes it is impossible to culture bacteria from patients with critical infection because they may have already been treated with a broad spectrum antibiotic before a patient specimen is taken for culture, both of which could result in a negative result.
To identify pathogens that cause serious infections, the process requires an ability to distinguish the culprit’s DNA or RNA from the patient’s specimen being tests. Instead of having to wait until more microbes can be grown in culture, we use our PCR/ESI-MS technology to make copies – or amplify – the DNA or RNA present in a sample from a patient to help detect the source of infection within hours, even when blood cultures are negative.
Is the PCR/ESI-MS technology likely to reduce the time between testing and diagnosis of diseases?
Time is critical when diagnosing critically ill patients with unknown infections. For example, for patients with sepsis, the chance of survival decreases approximately eight percent with each hour appropriate treatment is delayed. Currently, the diagnosis of serious infections can take days or even weeks using current culture methods.
The RADICAL study results demonstrate that Abbott’s technology, known as IRIDICA (currently in development), may identify life-threatening infections within eight hours - faster and more accurately than existing diagnostic technologies.
Will this lead to more rapid treatment for patients?
Results from the RADICAL study suggest that Abbott’s technology will provide actionable information for physicians much earlier, helping them to improve patient outcomes.
For example, when a person enters the hospital with an unknown infection today, doctors try to determine the cause using procedures that may take days to weeks. This can lead to significant delays in appropriate treatment and extended lengths of hospital stays.
RADICAL results suggest Abbott’s technology may provide rapid results. This will help doctors get the information they need to prescribe the most effective treatment quickly, ultimately helping people recover in less time.
What impact could the reduction in diagnosis time have on hospital stays and health care costs?
The combination of quick turnaround and improved accuracy in diagnosis could translate into significant cost savings for health care systems across the world. By identifying the infectious pathogen early, physicians are able to initiate the appropriate treatment sooner, which translates into shorter hospital stays.
Based on a health economic model from results of the RADICAL study, data suggests that using the pioneering testing technology could reduce hospital stays by up to eight days and lower annual health care costs for people with serious infections by approximately £1.2 million.
Will this technology enable earlier discontinuation of broad-spectrum antibiotics?
The overuse of anti-bacterial drugs is contributing to the escalating issue of disease resistance. Infections caused by resistant microorganisms often fail to respond to standard treatments, which can lead to prolonged illness and greater risk of death.
Using Abbott’s technology to quickly identify the source of infection, a clinician can quickly prescribe the most effective anti-bacterial drug, preventing overuse of broad spectrum antibiotics.
What are Abbott’s plans for the future with regards to IRIDICA technology?
Abbott’s technology, known as IRIDICA, is expected to be available as a CE marked in vitro diagnostic device in European countries by year-end. We are simultaneously initiating clinical trials that will support FDA registration.
Where can readers find more information?
To learn more, please visit http://www.ibisbiosciences.com/home.html
About Dr. David J. Ecker
Ibis Biosciences, Abbott
Divisional Vice President and General Manager
Dr. David Ecker is the founder of Ibis Biosciences, now an Abbott business, and has more than 29 years of experience in the pharmaceutical and biotechnology industry in drug discovery and diagnostic platform technology development.
He is currently responsible for the Ibis site in Carlsbad, California, which has approximately 60 employees. Dr. Ecker oversees science, patents, business development, strategic direction and the management of corporate and government partnerships.
Dr. Ecker was a primary inventor of the Ibis technology. The technology was developed for infection control, infectious disease diagnostics, and biological weapons defense, and development was funded in part by DARPA, CDC, NIAID, FBI and DHS and other U.S. government agencies.
Prior to founding Ibis, he was a co-founder and executive officer of Isis Pharmaceuticals, where he and his colleagues created the scientific foundation of oligonucleotide therapeutics, a new sector of the pharmaceutical industry.
He has received numerous awards for his work at Ibis, including the Wall Street Journal Technology Innovation Award Gold Medal and The Scientist Top 10 Innovations in Life Science, both in 2009.
Dr. Ecker is a graduate of the College of New Jersey, received his Ph.D. in biochemistry from Utah State University, and completed post-doctoral studies in chemistry at the University of California, Berkley.