A potential competitor in the rapid multiplex PCR diagnostics space, BioMérieux said that it will now explore collaborative opportunities in complementary markets around Qvella's field-activated sample treatment, or FAST technology.
BioMérieux sees Qvella's technology as an accompaniment to the BioFire FilmArray diagnostic platform, Frédéric Sweeney, vice president of corporate development and strategic financing said in an email, adding, "Technology that will help to advance microbiology and in vitro diagnostics is a strategic priority for BioMérieux."
Sweeney explained that BioMérieux has a dedicated team of business development professionals who explore and monitor companies, like Qvella, in order to make advancements in addressing growing healthcare threats, such as antimicrobial resistance.
Qvella has primarily focused its development on the fundamental problem of sample preparation, Sweeney further said, including automating the isolation, concentration, and lysis of a small number of pathogens in a whole blood sample.
BioFire FilmArray sample prep, meanwhile, uses silica beads to free the cell components, and magnetic beads to capture the DNA or RNA.
Overall, Qvella's technology "can be seen as a nice complement to many of BioMérieux’s other ranges of microbiology, immunoassay, or molecular biology products," Sweeney further said.
Qvella recently presented preliminary data and announced an updated timeline for the launch of its PCR-based, multiplex blood stream infection (BSI) panel.
The firm noted during a corporate workshop at the Association of Molecular Pathology meeting last month that its BSI test in development requires no extraction or purification. The test uses a fully integrated instrument with an easy-to-use graphical interface and disposable cartridges, and relies on a number of innovative core technologies to detect pathogens directly from whole blood in around 45 minutes.
Firstly, it employs a ribosomal target at the family or genus level to cast a wider net in capturing sepsis-causing pathogens, Qvella's CEO, Tino Alavie, said in a follow-up interview. The firm has balanced this, considering a treatment perspective as well as something that is manageable from a multiplexing perspective, in order "to give the most impactful response to clinicians," Alavie added.
At the AMP workshop, Qvella's scientific administrator Susan Novak reported that a version of the test with 16 reaction wells could detect up to 84 sepsis-causing species. These fit under one family-level, five genus-level, and 10 species-level categories, and covered greater than 90 percent of sepsis cases, according to Novak. The test was also able to identify polymicrobial cases in spiked-in samples.
Qvella's technology also uses a proprietary method for pathogenic cell isolation which involves a hemolysis step followed by centrifugal field and wash steps to generate a cell suspension, Alavie said. Qvella's FAST method is used to treat and lyse cells, after which pathogen nucleic acids can be subjected to array-based multiplex RT-PCR.
One person dies of sepsis every two minutes in the US and delays in initiation of appropriate antimicrobial therapies increase mortality, according to a 2011 review. A presentation at Qvella's workshop highlighted a gap in "rapid" sepsis diagnostics, namely that tests that rely on blood cultures are generally too slow to help in initial treatment decisions.
In the presentation, Larissa May, an emergency room physician who is also an antibiotic steward at the University of California, Davis, said that, from a stewardship perspective, the typical four days to identify a sepsis-causing pathogen is "frankly, unacceptable."
May highlighted that patients are often placed on early empiric, broad-spectrum antibiotic therapy while clinicians wait for lab results that can show the exact pathogen or pathogens that causing the infection. And, in patients with an unknown source of infection, certain pathogens may not be considered in the initial diagnosis, May said in a follow-up interview.
Narrowing of antibiotic spectrum does not occur as early as needed due to current practice patterns and physician behavior, May said, including time constraints of traditional microbiologic testing and a reluctance among prescribers to switch therapies.
"Truly fast tests that [provide results] in less than an hour with high accuracy — with the caveat that this would not obviate the need for confirmatory culture — would enable a much-needed paradigm shift, moving from empiric to initial targeting therapy, earlier de-escalation, and ultimately improved patient outcomes due to more appropriate therapy and improved antibiotic stewardship in healthcare, including for critically ill patients," May said.
BioMérieux, meanwhile, has a company-wide focus on antibiotic stewardship. It's BacT/ALERT Virtuo blood culture platform was cleared by the US Food and Drug Administration earlier this year, and the firm has obtained new indications for its procalcitonin (PCT) diagnostic immunoassay which was recently cleared to guide antibiotic management in suspected sepsis and lower respiratory tract infections.
Subsidiary BioFire manufactures the FilmArray Blood Culture Identification (BCID) assay which was cleared by the FDA in 2013 and tests for 27 pathogens that can cause sepsis, including three common antibiotic resistance markers, in about one hour.
The BCID test has been demonstrated to have clinical benefits. For example, a study in 2015 showed it could lead to reduced use of broad-spectrum antimicrobials as well as earlier de-escalation. And a recent study of pediatric patients with sepsis showed clinical benefits of resistance testing in particular. Both studies also suggested that the clinical benefits of rapid diagnostic microbiological tools are enhanced with a concurrent antibiotic stewardship program, particularly one that includes things like templated comments to guide physician prescribing based on test results. However, although the BCID is faster than conventional culture methods — which can take days and require subculture and phenotypic susceptibility testing — the test still requires a positive blood culture.
Qvella has now lined up all the clinical trial sites for the BSI test, according to Novak.
The firm's timeline to launch includes: US pre-clinical trials from Q2 to Q3 2018; clinical trials, CE mark, and European launch from Q3 to Q4 2018; and FDA submission in Q1 2019.