Idaho Technology has been awarded a one-year, $262,000 grant from the National Institutes of Health to develop a molecular diagnostic panel for its FilmArray platform to detect pathogens causing pneumonia or other lower respiratory tract infections.
Under the grant, administered by the National Institute of Allergy and Infectious Diseases, Idaho Tech plans to test two existing FilmArray panels — one for upper respiratory tract infectious agents and one for sepsis-causing agents — on different clinical sample types collected from children and adults with suspected pneumonia.
The ultimate goal of the project is to develop a consolidated assay panel to help physicians diagnose the cause of pneumonia faster and more accurately; and to determine the optimal clinical sample type for performing such an assay, Richard Ajioka, a senior research scientist at the company and principal investigator on the grant, told PCR Insider this week.
"When considering the pathogens that are most commonly associated with lower respiratory tract infection, these are fairly well-covered between the [FilmArray] respiratory panel and the [sepsis] panel," Ajioka said.
"The essence of the grant is to compare sampling sites in pediatric patients and adult patients with suspected pneumonia to see what, if any, correlation there is between sampling from an upper respiratory site and a theoretically sterile lower respiratory site," he added.
This means comparing FilmArray tests run from a nasopharyngeal swab — which is what the current commercial FilmArray UTI panel uses — and either plural aspirate, in the case of children, or endotracheal tube aspirate prior to bronchial alveolar lavage, in the case of adults.
"The hope is that we'll either find some correlation or not between the less-invasive procedures compared to the more invasive procedures to see if there is any diagnostic value in samples from those other sites … [and] gain information from the combined two panels to develop a single, abbreviated panel that will pick up what we need to reasonably diagnose lower respiratory tract infections," Ajioka said.
Pneumonia can be caused by a wide array of pathogens, but identifying these pathogens is complex and difficult using current culture-based methods, according to the grant's abstract. This can lead to incorrect and over-prolonged use of broad-spectrum antibiotics or other inappropriate therapy choices.
Further, pneumonia can often result in severe bloodstream infections, or sepsis, usually caused by bacteria, particularly Streptococcus pneumonia. Such infections are often life-threatening, making the need for early and accurate molecular diagnosis even more acute.
According to Idaho Tech, the FilmArray's "ease of use, short time to result, and highly multiplexed pathogen panel is uniquely suited to the evaluation of both viral and bacterial agents of pneumonia."
The FilmArray platform integrates sample preparation, amplification, detection, and analysis, and is designed to provide results in about an hour with about two minutes of hands-on time, according to the company. The instrument performs PCR to initially amplify nucleic acids from target pathogens, and uses high-resolution melt curve analysis for multiplexed detection.
The company's first FilmArray test, a panel that detects and differentiates between 20 different pathogens that cause upper respiratory infections, has 510(k) clearance from the US Food and Drug Administration (PCR Insider, 5/17/2012).
Meantime, the company is also developing a panel called FilmArray Blood Culture Identification, which is designed to identify more than two dozen sepsis-causing organisms and the presence of certain antibiotic resistance genes. That assay is not yet commercially available, and Idaho Tech said last week that it has begun clinical trials for the panel (PCR Insider, 7/192012).
Combining the two panels into a single panel for diagnosing LRTIs and pneumonia "would save the clinic and the physician from having to run two different panels," Ajioka said. "Some of the pathogens that are covered in the two individual panels would not be suspected as being involved in lower respiratory disease, and those would be eliminated. Hopefully as a result we would have a significantly smaller panel that is directed specifically at pneumonia."
Further, the researchers will investigate whether there is an appreciable difference between using less-invasive specimen types such as nasopharyngeal swabs and the more invasive sampling types that are commonly employed in pneumonia patients.
"It's significantly more traumatic to take a pleural fluid sample [from kids]; and bronchial alveolar lavage in adults," Ajioka said. "That's OK, as far as we're concerned, that we may be dependent on those sampling sites. But the idea is that the ability to make an early diagnosis before waiting for culture results from the hospital lab would potentially enable the physician to make a better and earlier informed decision about whether to administer antibiotics and which ones to administer."
Salt Lake City-based Idaho Tech will be testing pediatric samples collected at Primary Children's Medical Center, also in Salt Lake City; and adult samples from the University of Utah School of Medicine's pulmonary medicine division.
Idaho Tech's award, a Phase I Small Business Innovation Research Grant, began on July 15 and is set to expire next June. At the end of the project, Idaho Tech will "choose the most informative site and sample type to move forward toward development of a comprehensive diagnostic test with the potential to significantly improve the care of patients with pneumonia," according to the grant's abstract.