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Israeli Diagnostics Firm NanoSynex Aiming for European Market Entry for AMR Test by 2023

NEW YORK – Israeli diagnostics company NanoSynex is on a mission to shake up the market for antibiotic susceptibility testing.

Though the market is currently dominated by offerings from some major multinationals, from BioMérieux to Thermo Fisher Scientific, NanoSynex believes there is a place for its system in labs.

"We offer a rapid antibiotic susceptibility test platform and can provide same-day results," said COO Michelle Heymann, who also cofounded the 3-year old company and is its CMO. "This will allow better patient recovery, limit the spread of resistant bacteria, and cut healthcare costs."

NanoSynex's efforts got a vote of confidence recently when the European Commission awarded the firm a two-year, €2.6 million ($3.1 million) Horizon 2020 grant that will allow the company to build its prototype into a mature product offering ahead of a planned CE-IVD marking and entry into the European clinical diagnostics market by 2023. The US is also in NanoSynex's crosshairs, and a 2025 launch is envisioned, should all go as planned.

"If we end up getting a significant US-based investment in this round, we might change our strategy," said Heymann. "For now, our plans are to enter the US in 2025, once we get some revenue from the European market."

She noted that NanoSynex is planning clinical trials in Europe, the data from which should support a future US regulatory submission.

While the Rehovot-based firm has just nine employees currently, it believes it has the technology and acumen to make a difference.

"Seven hundred thousand people die every year due to antimicrobial resistance," commented Heymann. "It's a huge problem and the World Health Organization has declared it to be one of the biggest threats to humanity," she said. "It's not only important to have such a diagnostic to treat patients faster and to improve the healthcare system, but also to prevent a future epidemic."

The back story

Heymann arrived in Israel five years ago from Brazil. There she met Diane Abensur, a French national with business background applied to life sciences, and they learned of the work around AMR of Shulamit Levenberg, the dean of biomedical engineering at Technion, the Israeli Institute of Technology in Haifa. NanoSynex was subsequently born, with Abensur taking on the CEO role.

Levenberg, who is now CSO at NanoSynex, described a method for antimicrobial susceptibility testing in a 2017 PNAS paper. According to the paper, the approach relies on stationary nanodroplet arrays and can provide results within the same working day. Levenberg and coauthors also presented an algorithm for automating data analysis, as well as a multiplex system that they said could be used in a clinical setting. Jonathan Avesar, lead author on the paper and another Technion scientist, has also joined NanoSynex.

The company's approach relies in part on monitoring the metabolisms of bacteria isolates obtained from urine samples within microfluidic test cartridges. Different antibiotics are applied to the arrayed bacteria samples and continued growth reveals the ineffectiveness of a therapy, while a decrease in growth shows the antibiotic is capable of killing the bacteria. Information regarding the minimum inhibitory concentration (MIC) necessary to treat a bacterial infection is also reported.

"We use a 100 percent phenotypic approach, which means that we can see the bacteria growing and can check that growth by monitoring bacteria metabolism," said Heymann. "We use a fluorescent compound that tracks the metabolism," she added. "If the fluorescence increases, it means the bacteria is growing."

The company's total offering consists of disposable test cards, a benchtop reader, and analysis software. Each card contains 64 different antibiotic treatments, which gives NanoSynex the ability to measure response to different concentrations of several antibiotics. The reader also allows analysis of up to 20 samples in parallel. Its benchtop reader incubates the cards and takes kinetic images of them for the duration of the experiment. The software then builds growth curves on these readings that can tell users the MIC to kill the bacteria, as well as inform users if the bacteria is resistant, susceptible, or intermediary to each of the antibiotics on the card.

According to Heymann, turnaround time is less than five hours, a feature NanoSynex believes will gain it some market adoption. "Other tests don't manage to deliver results in the same day because more than six hours means the results will be delivered the following day," she said.

There is considerable activity in the market these days by diverse players wielding a mixed bag of technologies. There are companies like Hardy Diagnostics, which has developed a lateral flow assay for AMR; Affinity Biosensors, which relies on a technique that measures microbial mass; and Accelerate Diagnostics, which like NanoSynex, offers a platform that monitors phenotypic changes. 

The latter firm won US Food and Drug Administration clearance for an updated version of its Pheno system just last month. The company originally gained clearance for the system in 2017.

The goliaths of the industry are BioMérieux, which offers automated antibiotic susceptibility testing on its Vitek platform, as well as Roche, Thermo Fisher Scientific, and others. For these players, versatility has always been part of the offer. Thermo's Sensititre ARIS HiQ System, for instance, offers access to over 300 antimicrobials with wide dilution ranges.

As such, being a small firm going up against such companies might seem like sending a speedboat to do battle with a battleship. Yet NanoSynex is convinced its technology will give it some leverage.

"The main players in the market are big corporations," said Heymann. "But they have technology that has been around for more than 15 years and are not able to provide same-day results," she said. "Most labs use these, but the gold standard is still a manual process."

The money and the pipeline

NanoSynex's EU Horizon 2020 project commenced on October 1 and will run through September 30, 2022. The company is the sole organization taking part in it. The grant is a European Innovation Council pilot project, which is awarded to small companies for scaling up their offerings. It specifically will allow the company to industrialize its platform and support the clinical trials necessary for CE-IVD marking. According to the grant's abstract, NanoSynex believes it will be cashflow positive by the end of 2026.

According to Heymann, the Horizon 2020 funding will allow NanoSynex to complete product development, run its trials, and enter the market in three years. She noted the company has received about $1.2 million since last year from the Israel Innovation Authority, in addition to $1 million it raised in seed investments in 2018. Next year, the company would like to close a financing round worth $8 million, all of which will help it move close to its goals.

"The plan is to reach a mature level with the product that can allow us to get into the routine market," said Heymann. She did not provide an estimate for how much the system might cost but said it will "align to the market standards."

The company is also preparing a second-generation version of its platform that will enable it to bypass a current culture step prior to analysis, meaning it will be able to analyze bacteria obtained directly from clinical urine samples. "This will be a major change in the workflow," noted Heymann. "We haven't seen many companies doing that."

She noted that the second-generation product will be targeted initially to urinary tract infections and will make use of the same system components, as well as some other tools that will allow users to bypass the culture step and provide results during the same day of sample collection.