Published last month in The Pediatric Infectious Disease Journal, the study employed a decision analytic model to compare costs and outcomes of flu diagnosis using traditional PCR, direct-fluorescence antibody, rapid antigen tests, and the FilmArray RP.
Costs and benefits were found to hinge on the price and accuracy of the tests and the prevalence of flu, and were somewhat different for children younger than 3 compared to those between 3 and 18.
Ultimately, however, rapid multiplex PCR was determined to be the most effective strategy, the study concluded.
While it is associated with significant cost, the authors suggested that the cost is below a "willingness to pay" threshold for accepting new technologies that improve patient quality of life.
Health economics modeling for pediatrics is somewhat unique, Richard Nelson, a health economist and first author on the study, told GenomeWeb in an interview this week.
Typically a model will consider costs to three agents — the patient, the provider, and the payor.
In pediatrics, however, the group "patient" doesn't quite capture the dynamics, as the patient is sometimes non-verbal and is not usually the decision maker.
"There can be a burden or cost to caregivers that is separate to the cost to patients in this case," Nelson, who is affiliated with the Salt Lake City VA Medical Center and the University of Utah School of Medicine, explained.
This can be the case at the other end of the age spectrum as well, in geriatric patients. When a patient can't talk, she can't describe her symptoms, so molecular diagnostics may be particularly useful.
Wade Stevenson, vice president of sales and marketing at BioMérieux subsidiary BioFire Diagnostics, concurred.
"A lot of the patients that get tested with our technology are in the non-verbal stages of their lives, so doctors are much more comfortable using a syndromic approach," he said, noting that children's hospitals have been the early adopters of the firm's technology.
Nelson said the modeling study was initiated in response to requests for data from clinicians at Primary Children's Hospital in Salt Lake City, which is the pediatric teaching hospital for the University of Utah School of Medicine.
"We had recently introduced [the FilmArray] here … so we wanted to compare the potentially increased benefit with the potentially increased cost," he explained.
Among the many authors on the study were experts in diagnostics, pediatric infectious disease, emergency department providers, and pathologists, he said, so it was very much "team-based science."
A few had some connections with BioFire in the early days, with one holding intellectual property and receiving royalties from the company. Nelson said this helped the study because these authors had special insights into the technology, but he asserted the study was completely independent.
The analysis was limited to the potential costs and benefits of detecting influenza, since there is not a large amount of data yet available on other targets, Nelson said. Expanding the model to include those other targets may enhance the estimated cost-effectiveness.
The results can also perhaps be expanded to other rapid diagnostics that may have similar accuracy, he said, as well as ones that potentially have a lower cost. These could include influenza-specific rapid molecular diagnostics like Alere i or Roche Liat.
Psychological benefits
Both Nelson and Stevenson pointed out what appears to be a growing realization in the field — the synergy between disease identification and patient satisfaction.
And in pediatrics, this force may be particularly pronounced, Nelson noted.
"One of the benefits of more accurate information is that it has the potential to alleviate anxiety or fear," he said.
For example, if new parents bring a baby to the emergency room with a high fever and cough, knowing that the baby has respiratory syncytial virus versus parainfluenza may not change the treatment course, but a specific diagnosis could provide the parents more comfort than saying, "it's probably a virus."
BioFire's Stevenson pointed out that patient satisfaction metrics may soon become part of healthcare evaluations though the Affordable Care Act.
This zeitgeist was also alluded to by BioMérieux's Christine Ginnocchio during a recent conversation with GenomeWeb, but Stevenson said it is not officially part of the BioFire messaging.
However, given the assumption that "the psychological value of the test is huge," the firm is now sponsoring studies to measure how its products affect patient satisfaction.
Stevenson said he anticipates increasing that message in marketing efforts in the future. BioFire may also add bullet points to its core sales and marketing presentations citing the modeling study, and the study could end up in the hands of BioFire's sales force in the form of reprints, he said.
Other recent studies using BioFire's syndromic respiratory panel in pediatric populations have shown benefits in terms of length of stay and reduction in antibiotic usage as well as faster turnaround times.
However, a unique challenge of the pediatric population may be the incidence of viral and bacterial carriage among kids.
For example, kids under 3 are more likely to carry Clostridium difficile — one of the pathogens identified in the FilmArray gastrointestinal panel — but not have symptoms of active infection. While detecting carriage may activate costly hospital quarantine procedures, it could also potentially benefit the patient if it informed antibiotics prescribing, as antibiotics are known to cause microbiome imbalance and C. diff overgrowth.
BioFire's respiratory and gastrointestinal panels are cleared by the US Food and Drug Administration for use in patients of all ages suspected of having infections, Stevenson noted.
"Right now we do not offer a pediatric versus an adult panel," he said. "We just have one panel, because we feel like the syndromic approach … asks the question 'What's going on in this patient's GI tract from an infectious disease stand point?' and C. diff may or may not be part of the answer."
Stevenson also provided an update on BioFire's panel pipeline, noting that its meningitis/encephalitis assay is in the FDA's hands now and will likely launch this summer.
The firm is also on track for a 2017 launch of a "pneumonia panel" that will be the most ambitious yet. It will include "a lot of bacterial and antibiotic resistance targets, a good number of viral targets, and some fungal targets as well, and it will be our first panel that has quantitative results," Stevenson said.