A recent federal executive order and $20 million prize bringing antibacterial-resistance into the spotlight is lifting a Tucson company’s hopes of changing the future of diagnostic testing.
Tucson-based Accelerate Diagnostics Inc. has developed a patented system that allows for quick identification of antibiotic-resistant bacteria and the drugs that will be most effective for treatment.
In September, President Obama issued a call to action for federal groups and agencies to step up their efforts and prevent further increase of antibiotic-resistant bacterial infections.
In conjunction with the order, the White House also released a National Strategy for Combating Antibiotic-Resistant Bacteria and announced the prize, co-sponsored by the National Institutes of Health (NIH,) for the development of rapid diagnostic testing.
“One of the most pressing public health problems today is the development and spread of antibiotic-resistant bacterial infections,” NIH Director Dr. Francis S. Collins said.
Antibiotic resistance is a microorganism’s ability to survive after it’s exposed to an antibiotic. In many cases, bacteria can become resistant to an antibiotic because of overuse of commonly prescribed antibiotics
Antibiotic-resistant infections cause 23,000 deaths and 2 million illnesses each year, according to the Centers for Disease Control and Prevention, with an estimated $20 billion impact to the national economy in excess health-care costs.
For Accelerate, which moved its headquarters from Denver to Tucson in 2013, the national call to action has some exciting implications.
“There’s a $20 million prize, but they’re also putting a lot more money behind both antibiotic and diagnostic development and are looking to spend upwards of $400 million per year over 10 years to fund those kind of initiatives,” said Joen Johansen, Accelerate’s head of marketing.
“There’s a whole range of different initiatives that they’re putting together to combat antibiotic resistance, and antibiotic use in health-care settings is something we’re going to be very much involved in,” he said.
Diagnostic testing has long relied on the culture method, in which a patient’s sample is applied separately to multiple culture mediums, such as agar, and left to grow overnight. After the bacteria is identified, further culturing needs to be done to determine the bacteria’s susceptibility to different antibiotics, and the whole process takes anywhere from two to three days.
Accelerate’s method is culture-free, substantially decreasing the diagnostic time to only one to five hours. The Accelerate system tracks colony growth using time-lapse microscopy and identifies the bacteria. The system then measures the bacterial colonies’ responses to different antibiotics and determines which will be most effective.
The patient’s sample is inserted into a single cassette that is used for all the necessary testing, as opposed to the traditional culture method, which utilizes multiple dishes and slides.
“It’s all in one location and it makes it much simpler for the laboratory in helping them streamline their workflow,” Johansen said. “Doing it this way also minimizes any errors that you can have in the process.”
While the decreased margin of error is certainly a benefit, the drastic reduction in time from days to hours also has lifesaving potential.
According to a 2006 study in the journal Critical Care Medicine, for patients with critical infections, every hour of delay in treatment resulted in a 7 percent increase in mortality.
“This is why it’s so important for patients to get antibiotics as quickly as possible, and that it’s the right antibiotic,” Johansen said
Accelerate, which has about 70 employees, is finishing its clinical trials before submitting a premarket notification to the FDA, which will then decide if the device can be cleared for use in laboratory diagnostics.
The company, which is publicly traded on the Nasdaq Stock Market under the ticket symbol AXDX, raised $45 million in a stock rights offering earlier this year.
Accelerate isn’t the only company that’s excited about the national fight against antibiotic resistance, as some well-funded companies around the world are also in the process of developing and manufacturing their own rapid diagnostics.
Among them are BD Diagnostics, a New Jersey-based division of diagnostic instruments giant Becton, Dickinson and Co. has developed its own widely used system for rapid testing.
As opposed to the colony growth technique that Accelerate’s system utilizes, the BD MAX analyzes biological markers on a genetic level. This system also provides results in hours instead of days, but the specific time is dependent on which tests are being run, the company says.
“BD is excited to see the National Institute of Health’s commitment to accelerate and bring focus to this critical health-care need,” said Mike Nugent, director of global partnerships for BD Molecular Diagnostics division.
In May, BD received FDA clearance on a product that detects common causes of bacterial gastroenteritis. The company already has products on the market that test for other common hospital-acquired infections, such as Methicillin-resistant Staphylococcus aureus (MRSA) and clostridium difficile.
Hospital and university research programs, including the University of Arizona College of Medicine, also welcomed the new strategy and prize.
“It’s unfortunate that we have to resort to an incentive to do what’s needed in treating infections, said Dr. John Po, director of the UA’s Infectious Diseases Fellowship Program. “But they will spur on research in the area of rapid diagnostics and antibiotic development, rather than using broad spectrums and waiting.”
Po is also hopeful that this will give drug companies an incentive to develop new antibiotics, as the current arsenal of effective medications to treat infections has run out.
“Antibiotics aren’t necessarily as profitable for these companies and those to treat chronic diseases because there’s not the potential for long-term use,” he said. “Once the infection is diagnosed, it’s treated and the patient gets better.”
Po believes the national attention will help create momentum for the creation of new diagnostics and treatments for antibiotic-resistant bacteria.
“This gives companies the incentive to be rewarded for something that’s not as glamorous and serve the greater good.”