This story originally appeared in Biocommerce Week, a newsletter that has been discontinued.
As a growing number of firms line up to challenge Cepheid’s and Becton Dickinson’s molecular tests for hospital-acquired infections, Accelr8 is developing a single-cell test system that could potentially supply a physician with more critical information within a few hours.
The firm, which is known primarily for its surface chemistry used on certain microarrays, said last week that it has received a notice of allowance from the US Patent and Trademark Office covering its BACcel system and the methods it employs to rapidly identify infectious agents, such as methicillin-resistant Staphylococcus aureus.
Though the system and accompanying tests are probably more than a year away from reaching the market, company officials believe the technology will rapidly provide crucial information that will help guide physicians’ therapy decisions — a task that cannot be accomplished with currently marketed molecular diagnostics for MRSA testing.
“There’s a lot of activity on screening carriers, but no one in the world seems to be addressing the problem of what to do about rapid identification of multiply resistant organisms in patients that do have an infection,” said David Howson, president of Accelr8.
The market for HAI tests has been estimated at upwards of $3 billion, and several genomics tools and molecular diagnostics players either have already entered the field or are working on getting there quickly. Cepheid and Becton Dickinson are the only two firms that currently have molecular tests for MRSA cleared for marketing by the US Food and Drug Administration.
In that market they are likely to face competition within the next few years from several firms that have expressed an interest in developing and selling an FDA-cleared MRSA test. Among those firms are BCW Index participants Qiagen, Third Wave, and Beckman Coulter, as well as other molecular diagnostic players, such as Roche and Gen-Probe.
But Howson pointed out that Cepheid’s and Becton Dickinson’s tests, as well as others in development, only screen patients that present with symptoms of MRSA infection. Accelr8’s target is to aid the physician in making a rapid decision on what therapy to give the patients, he told BioCommerce Week.
The current crop of MRSA tests “can’t do antibiotic-susceptibility testing using genetic methods,” said Howson. “The bottom line is it’s not one gene, one kind of resistance that you can predict. We take old-fashioned test principles … but we do it in a way that you don’t have to have a day or two of culturing first to get the answer.”
The firm’s technology enables the extraction of live bacteria from a specimen, which is then immobilized on the slide’s surface, so “you can find the same organism time after time for over a period of hours. That’s the magic, and that’s what the patent is concerned with,” said Howson.
He said the patent — application number 20070037225 — covers not just the instrumentation, but the method or principle of uniquely identifying single cells over time. “If you got bugs to a surface in a way that you can individually identify them and keep coming back to them over time, Accelr8 owns that,” said Howson. “Even when they’re growing or dividing, we can follow that clone in place and identify its heritage.”
He said the technology enables a physician to know within two hours what the bacteria is and whether there are enough of them to be considered diagnostic — “in other words, that’s not a contaminant, but very likely causing the disease.”
It also provides the physician with actionable information on which drugs to use and which are guaranteed to fail. “The lab can’t tell the doctor what to use,” said Howson. “The doc needs to know what’s almost certain to fail. That’s what we do in a total of four to six hours after receiving a specimen.”
Targeting the ICU
Initially, the instrument will be placed in hospital labs. The prototypes are “pretty big,” he said, but the initial finished product will be about the size of “a hefty desktop computer — a mini-tower. But we’re about to start placing some research ones out in the field in the next month, and those are pretty big because they’re based around a commercial microscope,” said Howson.
“We’ll probably sell it for research first, because there is no FDA requirement” there, he said. “But it [will be] targeted directly at the ICU.”
“There’s a lot of activity on screening carriers, but no one in the world seems to be addressing the problem of what to do about rapid identification of multiply resistant organisms in patients that do have an infection.”
Initial empiric therapy fails 20 percent to 40 percent of the time in treating MRSA, said Howson, but the situation is “even worse because if you switch from an inadequate to adequate therapy even in a day’s time it’s too late and does not improve outcome.”
Accelr8 currently buys the microscope incorporated in the BACcel system from Olympus, but Howson said the firm will need custom optics to bring down the size and cost. Accelr8 is currently discussing those options with an undisclosed partner.
He also noted that the system is highly automated, with an initial manual specimen clean-up step. The technician uses a pipette to put the sample in a cartridge that goes into the machine, which is fully automated after that point, Howson explained.
He said Accelr8 also is currently looking for commercial partners, which will shape the direction the firm takes in addressing the clinical diagnostics and research markets. Accelr8 is targeting late 2008 to have a non-FDA approved machine on the market, but the firm is not providing a timeline for possible FDA clearance yet.
“Our end game for the BACcel is not to become a vertical diagnostics company,” said Howson. “There are already too many of them. We want to find a commercial partner that is well established, has a franchise in the hospital — preferably in the ICU or the clinical microbiology lab — and make money for our shareholders through that deal structure, however that rolls out,” he said.
Howson said the firm hopes the new platform will bring in “nominal” revenues in 2008 and build after that.
In addition to the MRSA test cartridges, Accelr8 plans to develop a test for multiple strains of Acinetobacter extracted from lung fluids.
Accelr8 was initially founded in the late 1980s as a software company and went public in 1996. The firm exited that business earlier this decade and bought some “distressed R&D assets” and became a bioscience company, said Howson.
“Our grand strategy is, along the way to the BACcel platform, we’re spinning off pieces of the technology for different applications as a way to validate it, but also generate a little bit of revenue,” he said.