By Monica Surfaro Spigelman –
Blood Test IDs Infectious Bacteria in Hours, not Days
We know bacteria. Our lives are intertwined with millions of these good and bad microorganisms that live in, on and around us. When the harmful ones take over, infection strikes.
Lately, methods that battle bloodstream infections with a barrage of antibiotics have proven hopelessly inadequate. Instead, a deadly rise of altered microbes impervious to antibiotics is sending science on a frantic search for approaches that steward the use of existing antimicrobials, to prevent development of further resistance to them.
Enter Tucson-based Accelerate Diagnostics, a game-changer in microbiology and medical diagnostics. President and CEO Larry Mehren moved his company to Tucson in 2012 from Colorado, setting up shop in first-class 15,000-square-foot labs and office spaces built out by Pima County in the Dr. Herbert K. Abrams Public Health Center at 3950 S. Country Club Road.
Four years after this move, the problem-solving hustle of Accelerate’s 200 microbiologists, engineers, computer scientists and other cross-functional professionals culminated in revolutionary high-tech diagnostics – the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit. This first direct-from-blood culture sample and completely automatic system identifies pathogens and assesses appropriate antimicrobial susceptibility – producing results up to 40 hours faster than conventional methods. By quickly applying antibiotics in targeted ways, said Mehren, the tool is helping medical professionals to cut antibiotic overuse and save lives.
“Others have taken swings at it and didn’t change the science at all,” he said. “We’re influencing antimicrobial therapy in a way that has never been done before. We can adjust therapy in very rapid fashion and practice precision medicine in a way that is quite curative and impactful – not just to one patient, but to society as a whole.”
The launch of Accelerate’s Pheno™ platform represents a new paradigm for a colossal problem, and has thrust a young company into the spotlight of medical diagnostics. Starting an entrepreneurial diagnostics company in microbiology required strength of technique coupled with something Mehren calls “out-of-this-world genius and social science.” It’s a process the hard-driving CEO has optimized over his multi-faceted career that’s included everything from book publishing to investment banking and global business leadership at Ventana Medical Systems and Roche Tissue Diagnostics.
“It’s all about being open to possibilities. And if failure rears its ugly head as it does for us all, it’s also about figuring out ways to turn that into opportunity,” Mehren said. “Usually the challenge with entrepreneurism is when the entrepreneur feels fear for the first time. It’s that moment that often defines the company – because almost every entrepreneur I find begins with hubris and then finds fear. That’s when they become smart enough to realize how little they know.”
That moment came for Mehren in 2016, when Accelerate had entered clinical trials and began its data analysis. It was when those social science skills of team-building and transparency came into play. “When we came up against data challenges, instead of just engaging the brains of three people to solve a problem, I had 200 people to express my fears to. And this company stepped to the fore with its collective intelligence and collective will. The collective faith of this group was brought to bear on the challenge. And that’s when problems were solved.”
After one of the largest clinical trials ever in clinical microbiology, the Accelerate Pheno™ system performance was validated. In February 2017, the FDA approved the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit to market in North America and Europe. To date, there are signed agreements for 191 instruments. Around the world – from Tucson Medical Center in Tucson to the Institute of Medical Microbiology and Hygiene in Tübingen, Germany – the Accelerate Pheno™ suite is rapidly identifying infectious bacteria in samples in a few hours in a test process that traditionally takes two to three days.
“When we talk about sepsis, time is life,” said John Allen, director of TMC Laboratory Services. “TMC has worked closely with Accelerate since the company was recruited to Tucson – from providing specimens to helping run testing prototypes. “We’re very excited by the promise of this test to help us find more targeted therapy as quickly as possible to improve patient outcomes and potentially save lives.”
Medicine’s most wanted
It only took a century to crack this dilemma. How did we get here?
Louis Pasteur’s germ research and Alexander Fleming’s discovery of penicillin were the first wave of the revolution. Prior to this work, even minor injuries could lead to infections that could result in death. The first antibiotics were wonder drugs of modern medicine. When they became widely available, they saved lives. Within a 10-year period around the 1950s, the medicine advanced further – introducing new antibiotics, like streptomycin, tetracycline, erythromycin and, later, ciprofloxacin.
But science didn’t anticipate the cunning quality of bacteria, Mehren said. “Remember that before invention of penicillin, the expectation was that you would die of infection. We forget that pre-antibiotic era was marked by the fact that if you got an earache you could die. Then along came sulfur and penicillin, and people started getting used to the idea that you could survive these infections. Expectations started to change.”
Bacteria then learned how to adapt and resist, Mehren said, forcing physicians to prescribe broad-spectrum cocktails of antibiotic therapies that began to decrease the long-term efficacy of the drugs.
“We failed to understand that the biome we were affecting started to evolve itself. When those bacteria began to change, what is now called antimicrobial resistance was bred.”
Bitter pills of history
Mehren said we’re passing through a golden age of antibiotic discovery, and on our way to a post-antibiotic era, when antibiotic resistance could raise a grim specter.
“That’s what the world is facing today – when bacteria continue to be virulent even in the face of antibiotics. That’s what everyone’s afraid of – a post-antibiotic era where antimicrobials fail to work and we go back to a time when you get an earache and you could die because it got into your bloodstream.”
In the face of this doomsday picture, Mehren’s belief in Accelerate’s exquisitely robust tool is farsighted and optimistic. “There’s a way to stop that – and that is by giving antibiotics only to people who need them in the quickest time frame possible.”
To deal with a post-antibiotic era, science now agrees that wanton use of broad-spectrum antibiotics contributed to the rise of superbugs. New strategies, like the holy grail of reliable rapid diagnostics that identify both the microbial cause of an infection and its drug resistance profile within hours, is the way to battle resistant incarnations of bacteria.
Accelerate’s inroads to solving pieces of the infection-control puzzle are now trailblazing the biosciences. Mehren has ramped up commercial activity for Accelerate’s testing system. Mehren’s mix of hubris and respect for fear continue to inform his business approach, upending medical diagnostics at Accelerate’s headquarters, where whiteboards detail complex team goals and messages that urge, “See it. Own it. Solve it. Do it.”
Each word is an omen of how Mehren plans to push Accelerate forward – and open the floodgates to more microbiological ingenuity and impact.