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Accelerate Diagnostics Ramps Up Commercial Activities on the Back of FDA Clearance


NEW YORK (360Dx) – A half hour after the US Food and Drug Administration cleared Accelerate Diagnostics’ test kit and instrument for sale in the US last week, the firm closed its first deal, selling four automated system and test kit modules.

To Accelerate President and CEO Lawrence Mehren, the quick turnaround is a sign of things to come for the Tuscon, Arizona-based IVD company, reflecting the test’s value proposition — in addition to identifying bacteria and yeast from a positive blood culture, it provides a measurement of antimicrobial susceptibility within eight hours.

For a firm that was once teetering on the brink of collapse, the FDA's clearance of the PhenoTest BC Kit and Pheno System was a major milestone, and could provide the impetus to the firm's revival. On a conference call on Monday to discuss the FDA clearance and the firm's preliminary fourth quarter financial results, Mehren said the company began work on the test in 2012, when "we realized that to address the challenges of serious infectious diseases, we needed a truly disruptive instrument."

According to one analyst, Accelerate may have, indeed, achieved that. William Blair analyst Brian Weinstein said in a research note today that the investment bank is "not aware of anyone else who can do what Accelerate can at this time." He added in a separate note last week, that it's the first time a definitive claim has been granted from the FDA and should "provide a nice marketing advantage to the product."

The Accelerate Pheno system uses genotypic technology to identify infectious pathogens and phenotypic technology to conduct antibiotic susceptibility testing, which determines whether live bacterial or fungal cells are resistant or susceptible to an antibiotic, Accelerate said.

Its Accelerate PhenoTest BC Kit is a highly-multiplexed panel that targets more than 80 percent of the "routine and significant pathogens" that cause blood stream infections, and more than 90 percent of the antibiotics useful in treating those pathogens, the firm said. The kit provides ID and AST results for patients suspected of bacteremia or fungemia, which are life-threatening conditions with high morbidity and mortality risk.

The test can identify 14 different bacterial species and two yeast species that cause bloodstream infections and provides antibiotic sensitivity information on 18 selected antibiotics for a subset of identified organisms as appropriate.

The cleared product has 140 assays of which 116 are FDA cleared, and 24 are available to be run in a research-use-only mode, the firm said.

Accelerate said that it also received FDA clearance for a “definitive monomicrobial test.” When interpreted with a gram stain, the test achieved a 99.7 percent positive predictive value on fresh samples in a clinical trial, confirming that additional testing is highly unlikely to identify additional bacteria or yeasts and accordingly is not required, Mehren said. “This puts us in a unique position, as we believe [that] all other rapid systems require this additional testing,” he added.

In the antimicrobial testing space, Accelerate's competitors include Abbott, Danaher, BioMérieux, and Becton Dickinson, among others. In an interview Accelerate spokesperson Andrew Chasteen said that some companies may provide separate pathogen identification and antimicrobial susceptibility testing systems, while others, including emerging IVD players, are developing systems that may provide both ID and AST together, but none provides results as quickly as the Pheno system.

He added that several nonclinical trial sites have compared Accelerate's test to other tests using standard-of-care processes, and on average, clinicians said they can get test results 40 hours earlier than is possible with current systems and current standard of care testing in large hospitals. Journal articles reporting specific results will be published soon, he said.

“We are not aware of an all-in, single solution that provides quantitative antimicrobial susceptibility testing,” he said, adding that Accelerate’s internal research shows that most hospitals are conducting patient susceptibility testing in a lab, "though it may not be automated."

Accelerate recently leveraged the clinical data collected for the FDA clinical trials submission to expand its claims in the European Union, and received a new CE mark to include all of its tests.

As a result, the firm now has approval to market the Accelerate Pheno system and blood culture test kits in its target markets of North America and Europe.

While Accelerate believes it has clear advantages for identification and antimicrobial susceptibility testing over potential competitors, it does not expect to immediately replace existing equipment, Chasteen said. Some instruments have been on the market and in clinical use for years and include menus and sample sets that are broader than just blood culture.

So, Accelerate is looking primarily for new placements. “Hospitals may begin by purchasing ID/ACT testing equipment from Accelerate and continue to use the existing systems for other types of testing,” he said. Over time, as Accelerate expands its menu, the firm expects that customers may migrate to more of its systems and tests.    

Chasteen further noted that while Accelerate’s solution can aid clinicians in making decisions to effectively treat sepsis, the firm's testing scope is far broader than that, and should in many cases aid a clinician in “getting ahead of sepsis” — before it causes major damage to patients, such as irreparable organ damage.  "Certainly, our first test has application there," Chasteen said. "It has the attention of the ICU team and hospital administration, so that’s helpful from a marketing viewpoint."

Chasteen said that the path to achieve commercialization, even with a system that may have a clear value proposition, is filled with challenges. Navigating through regulatory compliance, convincing customers of clinical utility, and sometimes modifying systems based on early customer feedback are all challenges that emerging companies will encounter.

Mehren said that the firm’s vision was to create “the first direct-from-sample, completely automated system that would identify a pathogen and perform antimicrobial susceptibility testing, all in under eight hours. Not only did it need to be fast, it needed to be highly multiplexed [and] able to conduct any one of more than 100 different assays,” he said.

He noted that the company’s goal to build such a test was initially met with a “high degree of skepticism.” To achieve this goal, the firm assembled an internal team and engaged with “forward thinking external scientists and clinicians,” he said.

The Accelerate team built three generations of instruments, each more capable and reliable than the previous generation, “until we believed we had it right,” Mehren said.

The firm ran “tens of thousands of tests internally” to optimize what became 140 different assays, and engaged in extensive clinical studies to develop what he said may be “one of the largest trials and submissions ever in clinical microbiology.”

The trial included more than 39,000 tests on around 1800 samples and across 13 sites, he said, and added that the final submission to the FDA was more than 10,000 pages long and included clinical study data for individual assays, multiple analytic studies, and “other important validations” of the Pheno system’s performance.

In anticipation of FDA clearance and the launch of its products, Accelerate completed building its North America sales team in 2016 by hiring 25 “seasoned professionals” covering the US and the major metropolitan areas of Canada. Mehren said that early work of the team yielded “a number of signed contracts” prior to the firm receiving FDA clearance, which were designed to allow customers “to do a systematic evaluation against pre-determined endpoints.”

“If those endpoints are met, the contracts proceed to acquisitions,” Mehren said. One of the endpoints was achieving FDA clearance, and another was passing internal customer test validation.

“Now with FDA approval we expect to begin seeing conversions of many of these contracts into revenue producing acquisitions,” Mehren said, noting the four sales captured almost immediately after the FDA clearance.

Accelerate has also been developing its go-to-market plan in Europe. In 2016, the firm built a sales team there with the experience needed to “match the challenges of selling to 15 different countries each with different clinical and laboratory needs, healthcare systems, acquisition processes, and reimbursement policies,” Mehren said. “We ended 2016 with numerous contracts and installed a number of modules,” he said. He added that two contracts began producing revenue in the final days of 2016, and the firm expects solid performance for the remainder of this year and beyond.   

In 2016, the firm ramped up its manufacturing capabilities and built more than 390 instruments and more than 100,000 kits that it believes will allow it to meet demand, Mehren said.

Mehren noted that in 2017, the firm will need to match the R&D success it has achieved in the past with commercial success in the marketplace. Most important, he said, is a successful launch of its Pheno test system and positive blood culture test kit. Success, he said, will be measured by placements and revenue. Additionally, the firm will work to increase demand for its test system and kit by adding assays, capabilities, features, and improvements, he said.

Accelerate said it expects to receive CE marking for a respiratory kit in 2017, followed by FDA clearance in 2018.

The respiratory panel is significantly differentiated from other respiratory panels and it will “be the first test to provide ID and antibiotic susceptibility testing, reducing time-to-result and improving clinical outcomes,” for patients with lower respiratory bacterial infections, Mehren said.

In the future, Accelerate has plans to provide pharmacokinetic and pharmacodynamic information and analysis that "gives clinicians information that they can’t currently obtain," Chasteen said. This type of analysis can reveal populations of cells that are dying, as well as being inhibited. Tracking and analyzing cells according to their behavior could lead to therapies and care that's far more precise than is currently possible, he added.