NEW YORK – Startup Scope Fluidics will soon launch a SARS-CoV-2 test on its fully integrated, fully automated rapid point-of-care molecular diagnostic instrument.
The Warsaw, Poland-based firm expects to submit the test along with its PCR One instrument to the US Food and Drug Administration by the end of the year and will follow shortly with a multiplex respiratory viral panel that includes COVID-19, influenza, and respiratory syncytial virus targets.
The PCR One instrument uses a proprietary infrared method to perform 40-cycle thermal cycling in seven minutes. As reported last year, the microfluidic system has the capacity to detect up to 20 targets at a time in parallel. Patient swab samples are placed directly into the cartridge, and the instrument then performs all of the analysis automatically, with minimum handling and hands on time and results reported in less than 15 minutes.
The firm had originally been focused on methicillin resistant Staphylococcus aureus as its first assay and had developed a test with eight targets.
Piotr Garstecki, president and chief technology officer at Scope Fluidics, said he believes the test is "the most comprehensive MRSA detection panel, and also the fastest one."
Scope Fluidics had already completed a pre-clinical validation in collaboration with a large diagnostics network in Poland in which the system was evaluated against the Cepheid GeneXpert and conventional culture-based methods. The study confirmed high sensitivity and specificity of the panel, Garstecki said in an interview, which led the firm to conclude the test was ready to transfer to production.
Supporting that effort, Scope Fluidics recently raised 14 million Polish zloty ($3.6 million), opened a cartridge production site as well as an assembly line for the PCR One analyzers, and also obtained ISO 13485 certification. The firm's technology is patented in the US and Europe, but it also recently expanded the microfluidic components of those patents and it received patents in China, Garstecki said.
The firm had planned a formal clinical trial of the MRSA panel earlier this year, but as COVID-19 swept over Europe this work had to be put on hold. Instead, in April Scope Fluidics switched gears and started work on a COVID panel, Garstecki said.
The panel targets two sequences in each of two SARS-CoV-2 genes, as well as an internal control, for a total of five independent, parallel PCR reactions. Specifically, it targets two regions of the SARS-CoV-2 N gene and two of the Orf1ab gene.
Because the PCR One system is "very flexible," Garstecki said the firm reached the proof-of-concept stage for the SARS-CoV-2 panel in May. But the assay is also the firm's first RNA-focused panel, so it required particular sample prep and integrated reverse transcription, and working out the production protocols has taken a bit longer, Garstecki said.
"We are now hoping to finish the production protocols in the coming weeks and to start clinical validation this fall," he said.
The firm plans to quickly follow the four-plex SARS-CoV-2 detection assay with a syndromic viral respiratory infection panel, Garstecki added.
The respiratory panel will detect and differentiate the four SARS-CoV-2 targets, plus influenza A and B, respiratory syncytial virus 1 and 2, and two H1N1 targets.
Scope Fluidics expects to offer its instruments under a reagent rental program and to have a cartridge cost of $20 to $25, with a $5 cost of production. "As we gain more experience with manufacturing, obviously we will see ways to optimize to reduce the cost," Garstecki said.
A 15-minute sample-to-answer molecular diagnostic test is reminiscent of the Abbott IDNow. The Abbott test uses isothermal technologies rather than thermal cycling, and although the test had some issues with sensitivity, those seem to have been somewhat related to clinicians running it on samples that had been inadvertently diluted in viral transport medium rather than testing directly from swabs.
Garstecki said Scope Fluidics will validate its assay directly from patient swabs, which is the intended sample type, and added that the firm is in the process of closing an agreement to run the clinical validation with a large hospital in central Poland that specializes in COVID-19 cases.
"They are very interested in introducing the system because they see a huge economic and logistical problem with isolation" of patients, he said. Namely, cohorting patients is challenging, Garstecki said, because a wrong decision either way — housing a false-negative infected patient with healthy ones, or a false-positive uninfected patient with sick ones — can be very detrimental.
Therefore, "The more testing, and the faster the testing, the better," Garstecki said.
The firm is working as quickly as possible to meet the demands and plans to initially validate the test in an academic and clinical center in Krakow that has focused for two decades on coronavirus research, then turn to the full-scale clinical validation. Until these studies are complete, however, there isn't any clinical data on the accuracy of the test, Garstecki said, although in the lab it is preforming on par with other commercial tests.
Scope Fluidics is preparing an Emergency Use Authorization submission to the US Food and Drug Administration. It plans to submit before the end of this year, and to "use the opportunity to also register the system for the US," Garstecki said.
Meanwhile, the firm will start the MRSA trial later this month, and it is also talking with potential manufacturing and distribution partners for the system. "We are working internally to ramp up our production capacity, but this will never be sufficient," Garstecki said, so, "we are also talking with large external manufacturers to transfer the production process to a larger scale."
Indeed, as a startup from Warsaw, Scope Fluidics will not be able to build a marketing and distribution network in the US on its own, he said. "We are definitely looking to partner with a company that has the sales arms," he said. The firm has also gleaned from potential US customers that evaluations in the US are critical. Thus, the system will likely need to be tested by US users, but this process is expected to be greatly facilitated by EUA from the FDA.
There haven't been any published, peer-reviewed studies of the system to date because Garstecki said the firm has been focused on development, but the SARS-CoV-2 clinical validation studies will form the basis for at least one published study in the future.
Competition in the rapid point-of-care and near-patient molecular diagnostics space comes from the aforementioned Abbott ID Now, the Roche Liat, and Mesa Biotech Accula, for example, although these systems do not perform highly-multiplexed testing.
Cepheid has an EUA SARS-CoV-2 test that performs well, and the Danaher subsidiary recently debuted 10-color technology with a tuberculosis assay with expectations of developing respiratory panels in the 20-target range.
Other comparable systems that are commercially available or in development include the BioMérieux BioFire FilmArray, the Qiagen STAT-Dx, the Binx Health io system, the Quidel Savanna, and the Meridian Revogene, all of which can run molecular diagnostic panels.
Meanwhile, Binx Health has partnered with Sherlock Biosciences to develop a CRISPR-based assay, and Meridian expects to submit its respiratory panel on the Revogene this fall. Quidel is reportedly nearly finished with the cartridge design for the Savanna instrument, but it is unclear whether the initial panel tests will include a SARS-CoV-2 target.
Compared to competitors, the Scope Fluidics PCR One has some advantages, Garstecki said.
"What we think is unique about PCR One is the combination of speed that matches the speed of IDNow ... and high multiplexing capacity using a physical multiplexing strategy," he said, noting that the latter quality allows panels to be easily expanded or modified.
"The pandemic, I believe, has accelerated the adoption of point-of-care molecular systems, and the benefits of the approach are much clearer to a much wider population of users," Garstecki said. "This has put a lot of pressure, and turbocharged the team to deliver the COVID test," he said, adding, "It has been an intense time, and it will continue for some time, I'm sure."