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Scope Fluidics Subsidiary Developing 15-Minute PCR System for POC Infectious Disease MDx

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NEW YORK – Warsaw, Poland-based technology hub Scope Fluidics hopes to make a mark in the point-of-care molecular diagnostics market by providing the industry's fastest highly multiplexed sample-to-answer PCR-based system.

Through its wholly owned subsidiary, Curiosity Diagnostics, its PCR ONE system boasts detection of up to 20 targets from raw sample with a total turnaround time of 15 minutes, and an initial menu including multiplexed tests for methicillin-resistant Staphylococcus aureus (MRSA) and Clostridium difficile

Founded in 2010, Scope Fluidics hosts startups developing systems for medical diagnostics, initially beginning its operations by offering contract prototyping of diagnostic devices for med-tech producers, according to President and CTO Piotr Garstecki.

All told, Scope Fluidics now has a team of approximately 40 people, with expertise in biochemistry, engineering, software development, automation, mathematics and data analysis, IP protection, and clinical studies, Garstecki said, and the hub also has its own laboratories, machine workshop, clean room, and pilot-production facilities. Scope Fluidics has also been listed on the alternative market New Connect on the Warsaw Stock Exchange since 2017.

Scope Fluidics currently owns two companies — Curiosity Diagnostics, which was founded in 2012, and Bacteromic.

Each of the companies develops its own products, owns its IP, contracts with suppliers, and produces and introduces its products to the market, Garstecki said.

"As diagnostic systems respond to global needs in healthcare, the business model of Scope Fluidics assumes that each of the subsidiary companies will enter into a partnership with a global provider of diagnostics technologies in order to best leverage the functionalities of the systems," Garstecki said.

As described, the Curiosity Diagnostics PCR ONE system's speed and level of multiplexing are exceptional compared to other commercially available or in-development point-of-care systems.

The Roche Liat, Abbott ID Now, and Mesa Biotech Accula, for example, are limited in the number of targets they can detect at once so don't do highly-multiplexed testing, and have so far stuck to simpler sample matrices.

The Cepheid GeneXpert is also fairly low-plex and considered to be more near-patient than true point-of-care. Other comparable systems might be the Quidel Savanna, which is being developed to run "mini-panels," or the Meridian/GenePOC Revogene and the Binx io systems, which detect 12 and 24 targets, respectively. The latter two also perform true PCR rapidly at the point of care, while the former can run either PCR or helicase-dependent amplification.

From Garstecki's perspective, PCR ONE's main competitor is GeneXpert, "as it is the most popular system and has the widest portfolio of assays available."

The PCR ONE system, however, offers important advantages, Garstecki said.

For example, with its MRSA panel, the PCR ONE test detects two genes conveying resistance as well as integration cassettes to assure that resistance gene comes from S. aureus and not a different strain in the sample, as well as a toxin coding gene. The C. diff test, meanwhile, integrates all of the variants of the bacteria and the toxins it produces in a single cartridge, Garstecki said.

The group has chosen MRSA as its first application because it is a leading cost generator in health systems worldwide with significant morbidity and mortality.

In general, however, there are many other important applications to choose from, and PCR ONE is targeting "one of the most dynamic market segments in diagnostics," Garstecki said, namely the intersection of point-of-care, molecular diagnostics, and infectious diseases.

Although there are a number of competitive systems on the market or being readied for the market, "the range of functionalities of the automated molecular diagnostic systems is really stratified between either highly multiplexed analyzers (e.g. BioFire's FilmArray, [Qiagen's] StatDx), or fast analyzers (LIAT, ID Now) that offer a small level of multiplexing," he said.

GenePOC, with 12 genes and 70-minute turnaround time, falls somewhere in the middle of this range, as does the Binx system, which currently targets sexually transmitted infections and has a turnaround time of 30 minutes and multiplexing of up to 24 genes.

"These are all very impressive and interesting systems," Garstecki said, but he maintained that with more than a decade since the pioneering GeneXpert system debuted, the market is becoming progressively more selective. It is seeking high value, such as highly multiplexed tests, accessible in the "true point-of-care" 15-minute timeframe, he said.  

The PCR ONE system allows the user to deposit a sample onto a disposable cartridge, with sample prep and PCR amplification done automatically to generate a result within 15-minutes.

"The analyzer accepts only one cartridge at a time, and is thus designed either for a [general practitioner's] office, an admission ward, or a hospital laboratory, where it allows both for urgent analyses and for throughput thanks to the short TAT," Garstecki said. 

The PCR ONE system manages this timeframe by performing "ultrafast PCR" using rapid thermal cycling.

Isolated genetic material is mixed with PCR master mix and split into an array of 16, 32 or 64 microchambers, Garstecki said, each containing primers for a specific PCR reaction. Assuming triplicate reactions, the system can analyze the presence of up to 20 different genes in the sample, he said.

"The chambers are periodically illuminated with [infrared radiation], with the use of a patented optical module for simultaneous delivery of a homogeneous blast of IR and for real-time monitoring of the progress of PCR amplification," Garstecki said.

A number of other firms and research groups have been developing systems using so-called "ultra-fast" PCR, such as OnSiteGene, Molecular Biology Systems, Thermal Gradient, GNA Biosolutions, mFluidiX, or the lab of Luke Lee at Berkeley. Many were inspired by pioneering work of Carl Witter at the University of Utah, who has also continued work in the field, most recently co-developing a rapid ID-AST system.

Wittwer is "the guru of rapid PCR" and his work on ultra-fast PCR was "inspirational," Garstecki said, noting that Wittwer visited the group's Warsaw facilities earlier this year.

Scope Fluidics is aiming for CE-IVD marking of the MRSA PCR ONE panel in mid-2020, and is also preparing for the US Food and Drug Administration clearance process, but would ideally like to conduct that in partnership with a distributor operating in the US market, Garstecki said.

The other company that is part of Scope Fluidics, Bacteromic, offers an instrument that can deliver information on phenotypic antibiotic susceptibility of bacterial pathogens, Garstecki said.

It uses microfluidics to create 640 independent culturing zones in a single, inexpensive and disposable cartridge, he said, enabling determination of minimum inhibitory concentration values for all clinically relevant antibiotics in a single test, as well as testing for synergies between up to 20 pairs of antibiotics.

Two major players in this arena currently are the bioMerieux Vitek2 and BD Phoenix systems. Bacteromic will offer cartridges in the same price range and will match the workflow of existing systems, while providing "unmatched information capacity," Garstecki said, testing up to 80 antibiotics to enable targeted antibiotic therapies.

The system can also run up to 60 analyses on 60 independent patient samples in parallel, with random access capabilities, real-time monitoring, and automated interpretation of the results. 

Scope Fluidics has not published any peer-reviewed descriptions of the technologies to date, but Garstecki noted that both of the systems developed by the Scope Fluidics teams were selected at the recent American Association of Clinical Chemistry meeting as semi-finalists in the Disruptive Technology Award competition, which was won by sepsis diagnostics startup Inflammatix.


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