Breath-based Diagnostic Test Technology

Wisconsin Company Developing Breath-based Diagnostic Test Technology that Can Detect Early-Stage Infections within Two Hours of Onset

Hospital-based pathologists may soon gain a new diagnostic assay that could prove effective in detecting hospital-acquired infections more quickly and more accurately than with existing rapid molecular diagnostic tests

Isomark CEO Joe Kremer
Isomark CEO Joe Kremer
Source: http://www.darkdaily.com

Imagine a diagnostic assay designed for hospital settings that uses a specimen of the patient’s breath, can be performed at the bedside, and can detect early-stage infections within two hours of onset. Pathologists and clinical laboratory managers will recognize that a diagnostic test such as this could play a big role in helping hospitals reduce hospital-acquired infections (HAI).

That’s just one application that Madison, Wisconsin-based Isomark has for the new breath analyzer test it is developing. The company says that its diagnostic test is capable of detecting early metabolism and immune system changes based on reading carbon dioxide (CO2) in a patient’s breath.

Canary Could Affect Volume of Clinical Laboratory Specimens
The Isomark Canary Breath Analyzer test (Canary) was specifically designed to identify infections before they have a chance to overwhelm the patient’s immune system. Canary has so many potential uses for identifying infection early that, if the technology were cleared for clinical use, medical laboratories could eventually see a significant reduction in the volume of patient specimens coming into the microbiology department.

Identifying Infections Prior to Admission Could Reduce HAI Fines
The Canary breath-based test can detect early-stage infections within two hours of onset. That capability could save many lives by preventing the introduction of infections into critical care hospitals and other healthcare environments. The hospital-administered test also could help reduce fines leveled by Medicare for HIAs, or healthcare-associated infections as the Centers for Disease Control and Prevention (CDC) calls them.

In 2014, Medicare cut payments to 721 hospitals for having high rates of infections and other patient injuries. Some of these infections, hospital officials claim, were already present when the patients were admitted. Until now, however, there was no way to detect the infections until the later stages.

“Everything that’s being used right now [for detection] uses either vital signs, or testing blood serum, or trying to do a culture. But all that is predicated on having enough of this pathogen in you that it’s causing significant changes,” explained Isomark CEO Joe Kremer in an interview with Health IT Outcomes.

The Canary Breath Delta Value Analyzer would change all that. “If you can stop an infection before it develops too far, you’re going to keep people from developing sepsis,” Kremer said.

How the Canary Breath Analyzer Works
The non-invasive Canary breath Analyzer consists of a plastic bag connected by tubing to a device called a cavity ring-down spectrometer (CRDS), according to an April 2014 article in the Wisconsin State Journal. A patient breathes into the bag and the spectrometer finds changes in the patient’s metabolism by examining the carbon isotopes. Isomark’s technology interprets the results.

Unlike current clinical laboratory tests that use blood, urine, and other body fluids to detect infection, the Canary breath analyzer test does not depend on physical symptoms or immune response factors. Instead, according to the Health IT Outcomes article, “it uses metabolism-based technology, and searches for acute-phase response with which the body counters an initial attack by a pathogen.”

“When you measure the breath delta value over time, changes in the value indicate the onset of infection at the earliest possible stage of the process,” explained Dan Bütz, Ph.D., Isomark’s Chief Science Officer in an article for the 2014 BIO International Convention. “Isomark is specifically targeting the critically ill patient at this stage who is at a high risk of developing infections,” he added. “Right now we’re using it to detect hospital acquired infections, which is a huge problem in the industry.”

The High Cost of Hospital-Acquired Infections
Isomark’s initial focus for this patented, non-invasive breath technology was the intensive care patient on a ventilator. An estimated 49,900 incidences of ventilator-associated pneumonia (VAP) occur annually in intensive care patients in the United States. Persons with VAP have longer hospital stays and up to a 20% to 30% death rate.

A 2011 study of HAIs in the United States, published in the March 2014 edition of the New England Journal of Medicine (NEJM), illustrates the extent of the overall HAI problem.

Researchers found that 4% of the 11,282 hospitalized patients included in the study had one or more infections. The most common types of infections are pneumonia, gastrointestinal infections, and surgical site infections. The most commonly reported pathogen is Clostridium difficile.

According to the Centers for Disease Control and Prevention (CDC), each day about one in every 25 inpatients in U.S. acute-care hospitals has at least one HAI. The National Institutes of Health (NIH) estimates:

• The death rate from all types of HAIs in the 750,000 intensive care patients who develop infections annually is between 28% and 50% (This does not include infants in neonatal intensive care units).

• The dollar cost of HAIs is somewhere between $35 billion and $88 billion annually, according to the CDC.

Not only do these numbers show the market potential that Isomark is eyeing for its Canary Breath Analyzer test, but hospital and health system administrators have great motivation to reduce HAIs for the reasons mentioned above. Thus, Isomark is optimistic that there will be strong demand for this diagnostic assay once clinical studies have demonstrated its effectiveness for these clinical applications.

NIH Grant Is a Sign of Interest in Developing Breath-based Tests
In October 2014, In Business magazine reported that Isomark received a 2-year, $1.7 million “Fast Track” Small Business Innovation Research grant from the NIH to speed development of its Canary breathalyzer.

Dark Daily has long predicted that breath-based testing would have a promising future in pathology and clinical laboratory testing. (See Dark Daily, “Researchers Want to Introduce Breath Analysis into Clinical Pathology Laboratory Testing” September 9, 2011.) Now that the CDC and NIH are fast tracking breath-based testing technologies, and handing out multi-million dollar research grants, maybe pathologists and medical laboratory technologists should pay closer attention to the multiple companies developing diagnostic assays that utilize breath specimens.

 

 

24.04.2015

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