NEW YORK – Nexless Healthcare Technology, a Montreal, Canada-based molecular instrument developer, has created an "all-optical" rapid, lightweight real-time PCR system that incorporates plasmonic nanoparticle thermal cycling. The firm is aiming to develop COVID and other infectious diseases assays for the platform and is also hoping to partner with others on further commercializing the core technology.

Plasmonic gold nanoparticles can enable the near-instantaneous conversion of light to heat. When incorporated into a PCR reaction, they help drive thermal cycling to surprising speeds by simply flashing a light or laser on and off. Despite other entities developing systems using similar core technology, Nexless claims to hold the exclusive rights to the novel PCR method.

Daniel Shamir, the founder and CEO of Nexless, said in a recent interview that the firm's plasmonic PCR system is called Kimera, after a mythical creature with many heads. The four-well system uses plasmonic gold nanoparticle thermal cycling and laser light to achieve PCR within 25 minutes, with early call out at eight minutes for samples with high viral load. The Kimera system accepts any standard 200 microliter tube, weighs 4.3 pounds, and is cloud-connected.

Nexless also is developing a lightweight, single-channel system that it plans to sell for less than $200, which could be used at the point of care, or potentially in the home paired with lyophilized assays.

The plasmonic nanoparticle thermal cycling method was invented more than a decade ago and was originally patented by a team of researchers at McGill University.

Recently, Rover Diagnostics described a similar technological approach.

Nexless holds the exclusive license to the technology from McGill, however, Shamir said. Specifically, the company currently has the exclusive rights to commercially exploit the plasmonic PCR patents, he said, although the IP will not be fully assigned to Nexless until a milestone involving regulatory approval is obtained. The team has also filed to register the patent globally.

Nexless ascertained from PCR market reports that there is a $4 billion opportunity after five years of market penetration, Shamir said, meaning that there would be plenty of potential revenue to go around.

"We decided early on that this technology would be available for licensing," Shamir said. "The idea was that we make it accessible to assay developers and other manufacturers that could produce [the Kimera] or create other types of devices that use this technology."

To support this aim, Nexless has built a platform for licensing and OEM, and it is particularly keen on collaborating with manufacturers in niche markets that may be interested in plasmonic nanoparticle thermal cycling.

In parallel, Nexless has designed its all-optical PCR instruments in house, "from the ground up," Shamir said, using the plasmonic nanoparticle-based thermal cycling and partnering with a printed circuit board manufacturer to allow Nexless control over the electronics, software, and firmware, as well as the overall manufacturing process.

From smart building tech to PCR

Scientific and healthcare instrument developers are typically business people with a love of science, or vice versa. Prior to founding Nexless, Shamir was a construction project manager and real-estate investor with a focus on smart building technologies.

He had recently sold a smart building technology joint venture with Terminus Group in China for $980 million when he became ill and was diagnosed with Graves' disease.

Shamir said he was so grateful to his endocrinologist, Mark Trifiro, for helping him that he "wanted to give back."

On his tour of Trifiro's lab seeking projects to support, Shamir became smitten with the plasmonic PCR system that was then in development. Trifiro, a co-inventor on the plasmonic nanoparticle patent, had previously helped found a company called Pronto Medical Technologies with the other inventors. But, the firm had been unable to meet commercialization milestones set out by McGill, Trifiro said in an email, so the rights to the patent had been revoked by the university.

Shamir stepped in to pick up the tech, founding Nexless Healthcare in 2019. He then brought in a team of seasoned engineers, who in turn developed numerous prototype instruments to suit different use cases.

Although the pandemic accelerated the pace somewhat, the team chose to take development at their own pace rather than rush to submit instruments and tests for emergency regulatory evaluation.

"The long view of PCR is not COVID; it is for everything," Shamir said, noting that the system can be adapted to new protocols within minutes.

That said, Shamir and Nexless stepped in to help design a hospital ventilator early in the COVID-19 pandemic in collaboration with Jewish General Hospital in Montreal using 3D printing and widely available components to create an instrument that could be easily reproduced.

"Money is important, but it is also important when you do something positive," Shamir said, adding, "we want to make a difference in the tech space, and we want to include others."

Nexless is currently working on submitting the Kimera and a SARS-CoV-2 test after a successful pilot project with a local testing lab serving travelers provided additional confidence in the system.

Specifically, the firm is in the process of completing the Medical Device Single Audit Program, which is a requirement for certification with Health Canada and a facilitator with the US Food and Drug Administration, Shamir said. Nexless also has instruments undergoing safety testing for obtaining the CE mark as well as other global regulatory evaluations. Once the MDSAP and other certifications are obtained, the firm plans to file with Health Canada and the FDA, and will also submit a RT-qPCR molecular COVID test on the system for Emergency Use Authorization.

"The device is so simple to use that any institution that would like to use it [for COVID screening] could get a CLIA waiver," he said.

In terms of menu for the system, "we wanted to take assays that were already developed and had regulatory approvals, and add the twist of plasmonic to them, instead of reinventing the wheel," Shamir said.

Nexless began collaborating with Ivan Brukner, a microbiologist at the Lady Davis Institute who has championed sample adequacy controls as a method to add confidence to negative molecular testing results.

Brukner created a protocol to take known assays and convert them for use on the Kimera plasmonic system. The overall workflow uses a "very fast sample processing workflow," Brukner said in the interview, as well as dry swab samples.

"With this approach, we have achieved a sensitivity of a minimum of 10 times higher than any FDA-approved hospital-related tests," Brukner claimed.

Increased PCR speed leads to new challenges, Brukner said, so he and his colleagues had to develop a proprietary method to overcome false positives and primer dimers with an approach they dubbed plasmonic DM profiling.

Shamir said it is used as a quality assurance step. "At the end of a positive test, we run a DM and see that it is false or real," he said, adding that the DM analysis takes a few minutes.

Rapid PCR also led Nexless to develop its own contactless thermometer to calibrate the system, because the thermal cycling was too fast for standard off-the-shelf parts.

Shamir noted that the plasmonic nanoparticle thermal cycling technology "has been around for a long time, and nobody has pushed it beyond research." He remains "hopeful" that any IP disputes can be amicably resolved.

"They can approach us, we are very approachable," Shamir said. However, "we will, if we need to, protect our interests."

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