NEW YORK (GenomeWeb) – Accelerate Diagnostics is a step closer to selling an automated system and test kit in the US as a clinical diagnostic that can be used for identification and antimicrobial susceptibility testing of pathogens.
The firm this week submitted a de novo request for evaluation of Automatic Class III Designation to the US Food and Drug Administration for its Accelerate Pheno system and Accelerate PhenoTest BC kit for positive blood culture samples.
If the results of the FDA review are favorable, the company may be able to launch its tests in the US towards the end of the third quarter.
Accelerate has requested that the FDA review be expedited and has worked closely with the agency to prepare it for a sizeable submission, the firm said. In June 2015, Accelerate achieved CE-IVD status. Both the system and initial kit for positive blood cultures are available in Europe and commercial activities are already underway.
Accelerate expects to benefit from an uptake in tests for hospital-acquired infections and antimicrobial resistance. When clinicians suspect patients have bacteremia or fungemia, which are life-threatening conditions with high morbidity and mortality risk, they will be able to use the firm's molecular and phenotypic detection technologies to identify pathogens from blood samples and test them for antimicrobial susceptibility.
"We conduct very fast identification using molecular probes, but the next step in which we test the susceptibility of the organism to a variety of antibiotics is what provides differentiation," Joen Johansen, head of strategic marketing for Accelerate Diagnostics, told GenomeWeb. "The system gives you a measure of the minimum inhibitory concentration (MIC), which is the minimum concentration level that will kill bacteria. We enable you to challenge the bacteria with a specific antibiotic and then provide an MIC that determines whether the bacteria are susceptible or resistant to that antibiotic."
To identify microbiological agents, the Accelerate system combines gel electro-filtration, fluorescent in situ hybridization, high-speed microscopy, and advanced algorithms.
In preliminary clinical trial results, according to the firm, the total time to identification from presentation of a patient sample averaged 1 hour and 23 minutes, while the total time to an antimicrobial susceptibility result averaged 6 hours and 41 minutes. Additionally, in recent marketing studies, the system and kit saved more than 40 hours compared to the standard of care, according to Accelerate Diagnostics. The Accelerate system workflow involves four main steps—patient blood draw, blood bottle incubation and screening, ID and susceptibility measurement, and the provision of an optimized therapy. The current standard-of-care workflow is far more complex, according to the firm, involving 11 distinct steps from blood draw to provision of an optimal therapy.
"Today in the laboratory, you have to obtain a pure isolate of the bacteria, and the result can take an additional one to three days," Johansen said. "We speed up the process significantly and report out the susceptibility profiles for a range of different antibiotics to the clinician. The clinician can therefore decide which antibiotic is resistant to the organism. More important, the system also can report out which antibiotic is susceptible, so clinicians can prescribe that for the patient."
There were 648,000 patients with 721,800 health care-associated infections in US acute care hospitals in 2011, according to a survey published in 2014 in the New England Journal of Medicine. The group conducted a prevalence survey in 10 geographically diverse states to determine the prevalence of healthcare-associated infections in acute care hospitals and generate updated estimates of the national burden of such infections.
According to Accelerate estimates, the total available market for the sample types targeted by the company's planned menu of tests is worth approximately $2.5 billion for tests and $2 billion for instruments. The firm includes in this estimate opportunities for its pipeline of tests, including those that are in clinical trials (blood culture-based infections), development (respiratory, and skin and soft tissue-based infections), and discovery (urine infections).
With the initial kit for positive blood culture samples, the potential exists to tap into a market comprising some 20,000 global ID/AST opportunities, the firm said.
"The system has capabilities that have yet to be unleashed," Johansen said. "There's potential to provide new insights into susceptibility or the types of interaction that bacteria have with antibiotics that could lead to better use of antibiotics beyond what we can achieve today."
Accelerate said that it anticipates launching the Accelerate PhenoTest BC kit with 140 individual assays. The final number of assays included in the kit distributed in the US will depend on the review of each individual assay for marketing authorization by the FDA.
The de novo request, sent last Friday to the FDA, is supported by a recently completed clinical study including more than 1,800 samples across 13 study sites, the company noted. Overall results across all assays from the study showed 97.4 percent sensitivity and 99.3 percent specificity for pathogen identification results, and 95.1 percent essential agreement and 96.0 percent categorical agreement for antimicrobial susceptibility testing.
"Because of the clinical utility the system will offer and this unique commercial approach, we expect the Pheno system will gain significant market share quite quickly after it is introduced," wrote Brian Weinstein, an analyst with William Blair Equity Research in a research note earlier this week. "We expect the company's positive blood culture kit for the Pheno instrument, and for the instrument itself (which should eventually run multiple panels), to be FDA approved in the next several months and believe that if this occurs it would allow for arguably the biggest innovation in microbiology in the last several decades."