The misuse of antibiotics has become a huge problem evidenced by the uptick in methicillin-resistant staphylococcus aureus (MRSA). A recent survey of 218 hospital staff found that nine out of 10 infection control and laboratory personnel across the United States agreed on the severity of the misuse of broad-spectrum antibiotics. The personnel also cited the need for quick bacterial identification and antibiotic susceptibility/resistance testing. Of particular concern among hospital personnel is the potential for S. aureus bloodstream infections, which have a mortality rate ranging from 23 to 36%.
|Results from an online survey of 218 hospital infection control and laboratory personnel found widespread optimism for the prospects of improved antibiotic susceptibility testing.|
MicroPhage (Longmont, CO) is targeting this problem using bacteriophage technology, which is based on bacteria-specific viruses. Safe to humans, the bacteriophages, replicate efficiently on specific bacteria, enabling fast bacterial identification and antibiotic susceptibility testing. By contrast, standard diagnostic methods require three days to deliver results.
To learn more about the technology and the problem it addresses, MPMN reached out to Don Mooney, CEO of MicroPhage and Jack Brown, PharmD, a professor at The State University of New York (Buffalo), who was the investigator in the aforementioned study.
“About six years ago, MicroPhage really settled in on applying phage technology to clinical outcomes for hospitals and patients,” Mooney says. “That is when the work really started to come up with a bloodstream infection test. The platform can be utilized in other specimen types and other tests but that was the first test that they decided to move forward on.”
The FDA cleared the test in May of 2011. “It became the first and only test in its category,” Mooney explains.
The test enables simultaneous detection of both MRSA and MSSA (methicillin-sensitive staphylococcus aureus) within 5.5 hours of a blood culture draw. By contrast, other tests on the market require a number of days for results to return. Jack Brown explains: “The process of the blood culture in terms of a patient showing up in the [emergency room is that the hospital staff] takes a culture, puts it in a bottle and the bottle alarms. They then do a gram stain,” he says. Culturing the bacteria to determine which antibiotics it is susceptible to typically takes between three and five days, he explains.
“Honestly, I think it one of those interesting areas in medicine where there is a clear advantage for the patient and there is a clear economic benefit for the hospital,” Brown explains. The challenge is getting the message out to physicians who are often trained in a dogmatic way.
In terms of how the technology will play globally, Brown explains that it depends on the geographical prevalence of MRSA. “There are places in Europe that only have 5% MRSA. And there are places like Hawaii that have roughly 95% of their staph. aureus species being MRSA,” he explains. “Clearly, in the lower populations such as in the Netherlands, which has 5%, I think the value of the test is limited. The vast majority of institutions—especially large academic institutions where you see the sickest of the sick patients, it is really going to be valuable because their MRSA rate is, on average, at least 60%.”
The company is now working with strategic partners to move the product outside of the United States who have done demographic work and research on MRSA. “In the top EU countries, the prevalence is there and the market is there for the test to be distributed,” Mooney says. “The other place that a lot of the companies that we are talking to are looking to move this is both Japan and China. There is a lot of overuse of antibiotics—especially in China these days.”
Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.
- Changing a Colorant in an Approved Medical Device, What Should I Know? - Webcast
- Reduce Risk! Control Costs! Get to Market Faster! The Customer Solution Centre is Your Pathway to Successful Device Development. - Webcast
- Innovating within Cost Constraints to Get More Bang for Your Buck - Webcast
- Conformal Coatings for Tomorrow’s Medical Technologies - Webcast
- ISO80369 Standards Bring Changes to Medical Device Companies - Webcast
- Automation in Machining - Webcast