NEW YORK – Qvella expects to commercially launch an automated cartridge-based system to speed up detection of pathogens from positive blood cultures, called FAST-Prep PBC, later this year. The firm will also begin clinical trials this summer for its rapid PCR-based diagnostic test system and an assay, called FAST-ID BSI, to detect bloodstream infections.
Qvella highlighted its research-use-only FAST-Prep PBC last week during an Industry Day presentation at the World Microbe Forum — a joint conference held virtually by the American Society for Microbiology and the Federation of European Biochemical Societies — touting the system as a new paradigm in positive blood culture processing.
In an interview, Qvella CEO Tino Alavie said that FAST-Prep is essentially a processing tool to isolate and concentrate bacteria from a culture bottle, clean it, and create a so-called liquid colony.
In cases of suspected bacterial sepsis, a patient's blood sample is typically incubated in special media in a microbiology lab. The process can take about one day, and a positive blood culture is then typically plated out on agar and incubated for a second day in a technique known as subculturing. This allows the lab to grow enough isolated bacterial colonies to perform identification and antimicrobial susceptibility testing.
Because it concentrates the bacteria directly from the blood culture, Qvella's system can save time compared to standard methods. "We take that second day out," Alavie said.
Independent beta testing by researchers from the University of California, San Diego of the FAST-ID BSI was presented at the WMF conference. The UCSD team showed in a poster that FAST-ID BSI had 100 percent agreement with standard of care culture-based methods and suggested a potential time savings of 24 to 48 hours compared to traditional techniques.
Qvella's core technology is called field activated sample treatment, or FAST. The firm uses fluidics, a proprietary lysis reagent, and centrifugation to isolate and concentrate microorganisms from biological specimens.
For the FAST-ID system, the firm uses an electric field to lyse cells, while for concentrating pathogens in FAST-Prep, it applies a centrifugal field, Alavie said.
Launching FAST-Prep as a separate instrument had always been in the firm's pipeline, he said, but Qvella accelerated the project last year when the COVID-19 pandemic led to substantial challenges in performing clinical trials for its FAST-ID system.
"Some of the sites that we want to run the FAST-ID trial at are still closed to an outside clinical trial," Alavie said. "We're still waiting for things to normalize so we can start that program."
In the meantime, Toronto-based Qvella pivoted to launching the sample preparation component in advance of the full FAST-ID system.
"There is a great market opportunity, because laboratories want to get results faster and save lives, but they also want to address ever-increasing antimicrobial resistance and the associated escalating costs of sepsis," Alavie said.
The addressable market for FAST-Prep PBC is essentially "all positive blood cultures," Alavie said, which are the gold-standard test in cases of suspected sepsis. Worldwide, an estimated 11 million cases of sepsis in 2017 accounted for 20 percent of all deaths, according to one recent study, and there are approximately 1.7 million cases of sepsis in the US each year that lead to 270,000 deaths.
"FAST-Prep enables labs to shorten the second day in a three-day cycle down to roughly half an hour," Alavie said. This can increase the efficiency of an existing workflow, and because it is an automated solution, it requires less technical skill, so it can help labs short on skilled microbiologists, he also said.
Labs would need to validate their downstream workflows using the FAST-Prep liquid colony approach.
At WMF, Qvella's VP of medical affairs, Susan Novak Weekley, said that guidelines around the world suggest a patient should be put on appropriate antibiotic therapy within one hour of a sepsis diagnosis. As many as 45 percent of patients end up on inappropriate antimicrobials, at least initially, in part due to the turnaround times for lab results.
And, while clinicians wait for lab results, patients will remain on empiric therapies, which "can induce the spread of resistance within the hospital, or the community," Weekley said.
The FAST-Prep PBC system uses a cartridge that can accept 2 milliliter aliquots of a positive blood culture, requiring two minutes of hands-on time, according to Weekley's WMF presentation. Lysis buffer in the cartridge selectively lyses blood cells and removes debris, and a pellet of viable microorganisms is then repeatedly washed and resuspended in the firm's trademarked "liquid colony" format.
"The liquid colony is designed to have comparable biomass to a solid colony on an agar plate," Weekley said in the presentation. Once the processing is finished, "this liquid colony is ready to be used for downstream applications, such as identification and antimicrobial susceptibility testing," she added.
The system takes 30 minutes to process two samples, or 20 minutes for a single sample, and cartridges can be stored at room temperature until needed, Weekley said.
The UCSD team evaluated liquid colonies from 181 patient samples using standard subculture followed by Bruker's Biotyper MALDI-ToF MS for identification and Becton Dickinson's Phoenix system for antimicrobial susceptibility testing. The researchers saw complete agreement between the results from samples processed using subculture and FAST-ID PBC for the 148 patient samples in which ID was obtained.
Qvella plans to make FAST-Prep fully commercially available early in the fall and has already started shipping research-use-only systems for evaluations.
Accelerate Diagnostics has also pursued a strategy of spinning off components of its overall ID/AST system, intending to launch an AST-only system, PhenoAST, this year, and a sample preparation component, PhenoPrep, in late 2023.
Alavie said that at the moment he does not see any competition for FAST-Prep that is currently commercially available. "There is nothing that we see that is as automated and easy to use," he said.
Qvella is not disclosing pricing for FAST-Prep PBC prior to commercial launch.
Overall, FAST-Prep PBC has the potential to bring legacy ID/AST workflows and systems on par with newer rapid ID/AST systems in terms of time-to-results, he also said.
"We see this as a tool to help laboratories decide for themselves and their own workflows what makes sense for them."
On the horizon
Qvella expects to begin clinical trials at six trial sites for its FAST-ID system this summer, Alavie said, and the study will take one year.
The firm's bloodstream infection pathogen ID test, called FAST-ID BSI, boasts PCR-based detection of common sepsis-causing organisms as well as resistance profiling directly from a whole blood sample in one hour using a single cartridge and requiring approximately two minutes of hands-on time.
The system specifically detects bacterial ribosomal RNA, which the firm has previously claimed is a sensitive method that can be used to detect up to 84 sepsis-causing species covering more than 90 percent of the pathogens known to cause bloodstream infections.
In addition to FAST-Prep PBC and FAST-ID BSI, Alavie said there are other products in the pipeline but declined to disclose them.
Earlier this year, Qvella was awarded $692,236 from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority's Division of Research, Innovation, and Ventures, or DRIVe, Solving Sepsis initiative.
In an announcement at the time, the project was described as a host response-based sepsis diagnostic system leveraging Qvella's FAST-ID combined with gene signature analysis technology from Predigen, a Duke University spinout developing host-response testing.
To support its commercial ramp-up, Qvella has also grown its footprint in recent years, Alavie said, adding employees at its sites in the US and Europe as well as in its headquarters in Canada, bringing its headcount to 90 employees.
Last month, Qvella hired Richard Brock — a 19-year veteran of BioMérieux who had served as that firm's executive franchise director with a focus on automated blood culture — to be its VP of global marketing and lead the commercialization of FAST-Prep.
Qvella has also received investment from BioMérieux. Alavie said the firm continues to be an investor, though it does not have any special rights of access to Qvella's technology.