Clinicians at Houston's Methodist Hospital have reported that using Bruker's MALDI Biotyper as part of the institution's antibiotic stewardship program significantly reduced average patient length of stay and overall costs.
Speaking at a Bruker symposium last week at the American Society for Microbiology general meeting, Patricia Cernoch, manager of the hospital's microbiology laboratory, noted that in a recent study conducted by the hospital, use of the Biotyper reduced average patient stays by 2.6 days and average hospitalization costs from $45,709 to $26,162 per patient.
The hospital now uses the Biotyper as its primary platform for identification of gram-positive bacteria, gram-negative bacteria, and yeast infections and is currently validating it for use in identifying asymptomatic bacteriuria and fungal infections, Cernoch told ProteoMonitor.
Detailed in a paper published in December in the online edition of Archives of Pathology & Laboratory Medicine, the study, which did not include Bruker as a participant, looked at Methodist patients with gram-negative bloodstream infections, comparing 100 patients whose treatment was guided using conventional microbiology platforms, including Becton Dickinson's Phoenix system, to 101 patients with treatment guided by the Biotyper.
The study found that the Biotyper allowed for significantly faster identification of the infecting organisms than conventional techniques, Cernoch said, leading to the observed reductions in patient stay and hospitalization costs.
The Biotyper cohort also saw a reduction in mortality with six of that group compared to 12 of the conventionally evaluated group dying within 30 days of treatment. However, Cernoch noted, larger sample sizes are required to determine if this difference is statistically significant.
"We're always looking for new technology to improve patient care," she said. "So when this new technology was available, and we saw its potential, we wanted to get it and see how we could put it into use for routine patient care."
Integrating the system into the hospital's antibiotic stewardship program required significant changes to the institution's workflows, Cernoch said. Specifically, the platform's speed made it possible for the hospital's microbiology lab to identify pathogens around the clock, as opposed to on the day shift only, as had been standard practice.
"The identification times of the bacteria on the Biotyper is basically less than a minute [per bacteria], whereas conventional systems for phenotypic identification can take anywhere from a couple of hours to 24 hours or longer," she said. "Normally in a microbiology lab the identification of the bacteria is only done on one shift. But with the [Biotyper], because it is so quick, you can train the people on the other shifts and it can be done continuously."
Such continuous identification work necessitates continuous communication between the lab, the pharmacy, and physicians, Cernoch added. While doctors might normally [make their rounds] once per day and make any changes to patient therapy then, integrating the Biotyper in this workflow allowed for "aggressive intervention based on immediate information from the microbiology laboratory," she said.
George Goedesky, executive director of marketing and business development at Bruker, told ProteoMonitor that while the company and outside researchers have conducted a number of studies investigating the Biotyper's ability to reduce costs within individual microbiology labs, the Methodist study is interesting in that it demonstrates the platform's potential on the scale of an entire hospital.
Microbiology laboratory expenses are typically less than 1 percent of a hospital's budget, he noted. However, the data produced by the microbiology lab can impact the pharmacy's budget, which can be greater than 15 percent of a hospital's overall budget.
"Antibiotics represent a significant proportion of that budget and, as discussed in the Houston Methodist article, significant savings can result from more rapid results as well as pharmacy intervention," he said.
Indeed, the hospital researchers projected that by moving to the Biotyper for management of gram-negative bloodstream infections, Methodist, which is a 1,000-bed quaternary care facility, could achieve an annual cost saving of roughly $18 million.
The bulk of these cost savings will be seen outside the hospital's microbiology lab, Cernoch said, noting that the lab has actually incurred increased costs due to the additional staff required to perform pathogen IDs around the clock.
She added, however, that the lab itself will likely see more cost savings as it moves to use the Biotyper for ASB and fungal infection identifications, assays that when done using conventional techniques have relatively high reagent costs and require large amounts of technician time.
Cernoch and her colleagues are now collecting similar data on use of the Biotyper for managing gram-positive infections. "We are seeing some savings, but it is too early to tell if it is as significant as what we saw with the gram-negative," she said.
In addition to cutting patients' stay lengths and costs, the rapid pathogen identification enabled by the Biotyper could also help reduce the development of antibiotic resistance," Cernoch said.
"The more you have patients on the wrong therapy, the more it can cause side effects ... can induce [antibiotic] resistance," she said. "Whenever you can get the right therapy [quickly] to a patient, it is going to reduce the possibility of using the wrong antibiotic for a prolonged period of time."
Launched by Bruker in 2006, the Biotyper identifies pathogens by matching their protein fingerprints against fingerprints contained in Bruker's proprietary database. The company has installed more than 800 of the devices worldwide. It is available in a research-use-only version, as well as in a CE-IVD version in various European countries, and as a Class 1 Medical Device for clinical microbiology sites in Canada. Bruker has also obtained clearance for clinical use of the instrument in Australia, New Zealand, Taiwan, and Japan.
Currently, Bruker is pursuing US Food and Drug Administration 510(k) approval for the device and, pending that approval, the instrument is available in the US for research purposes only.
This regulatory status doesn't, however, prevent hospitals like Methodist from using it in their laboratories, Cernoch said.
"If we are using a non-FDA approved test then we do have to make a comment on the chart that the test has been validated by us and has not been FDA approved," she said, noting that "there are many tests in a [hospital] laboratory that may not be FDA-approved and that are still used on a routine basis. So as long as we [include] the appropriate comments and do the appropriate validation, that fulfils our obligation."