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Dotz Ventures Into Molecular Diagnostics Market With SARS-CoV-2 Test

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NEW YORK – Israeli technology firm Dotz Nano has entered the molecular diagnostics market with a product for high-throughput SARS-CoV-2 testing called the Mega Diagnostic Platform.

The firm debuted its offering, which consists of assay kits, an integrated diagnostic instrument, and a results management system, last month. Dotz claims its platform allows users to test up to 96 saliva or nasopharyngeal samples within half an hour. Its approach relies on real-time loop-mediated isothermal amplification, or RT-LAMP, technology paired with Dotz's advanced material particles technology to produce results it believes are competitive with real-time PCR.

Based in Kefar-Sava, a city northeast of Tel Aviv, Dotz manufactures carbon-based nanoparticles that are used in a variety of industries for tracing and anti-counterfeiting purposes, ranging from plastics to fuel to tobacco. Diagnostics is a newer market segment for the firm but one it sees as promising, and the company's management is convinced its COVID-19 test is just the beginning.

"We have a whole roadmap that we will start moving into," said CEO Gideon Shmuel, who took the helm of Dotz this year. "Now that we have a robust system for COVID-19, and we know how to leverage it, we can pretty quickly add other viruses to the same platform," he said. "Our customers in the future will be able to use the same system for other infectious diseases."

While run out of Israel, Dotz Nano maintains a parent in Melbourne, Australia, and trades on the Australian Stock Exchange. It also has offices in Tokyo, New York, and Nice, France. Altogether, the firm currently employs 20 people, Shmuel said.

Its core technology was developed by researchers at Rice University in Texas, specifically by cofounder James Tour, who continues to advise the company. It involves the use of graphene quantum dots that can be embedded into products to support tracing and verification. Current products include BioDotz, carbon-based nanomarkers that can be embedded in plants, such as cannabis; ValiDotz, which can be embedded into plastics; and Fluorensic markers, which can be used to trace chemicals as part of oil and gas exploration activities or environmental monitoring.

"The idea has been to develop a highly durable and versatile platform, where particles can go into many different industries," noted Shmuel. Dotz's particles emit color and light, meaning that every pixel captured from them has a particular wavelength. Once embedded into a product, be it a diagnostic assay, a polymer, or a cement, it can then be read and traced through a supply chain.

"We are creating a digital signature using these particles," said Shmuel, "a unique signature for a physical product."

According to Shmuel, Dotz also has some clients in the biomedical market who use its markers in their tests. In part, the firm was inspired to expand into molecular diagnostics because of this. "We started thinking maybe we should also move into the medical space," remarked Shmuel.

Dotz was assessing its opportunity when the COVID-19 pandemic struck. It also saw the potential to apply RT-LAMP technology in diagnostics in order to bridge a perceived gap between the two most common approaches in the SARS-CoV-2 testing market: real-time PCR and lateral flow antigen testing. "PCR is high-quality and very accurate, but it's not cheap and it's not quick," said Shmuel. "Antigen testing is quick and cheap, but the accuracy could be better."

It's an opportunity that others have also picked up on. Biopix-T, a Greek molecular diagnostics company, has developed a point-of-care platform based around LAMP technology, for example. A team at Stanford University has been developing a mass screening platform for SARS-CoV-2 called SnapDx that also relies on RT-LAMP.

RT-LAMP is a nucleic acid amplification technique developed about two decades ago that has been considered an alternative to real-time PCR. In RT-LAMP, two or three pairs of primers are used to make a looped intermediate, which is then amplified as positive and negative-sense concatemers. Changes in pH during the amplification process can be read colorimetrically, and by coupling its carbon nanoparticles to the viruses being amplified, Dotz's approach produces a color field that can in theory be used to detect multiple viruses; red in the case of SARS-CoV-2.

According to Shmuel, Dotz believes it has found the sweet spot in the market, and set out to develop an automated system that is accurate and quick but also less expensive, working with partners in assay development as well as hardware manufacturing, whom he declined to name.

"Obviously, you cannot do everything yourself," said Shmuel. "But we do own all of the IP."

In March, Dotz reached a milestone on its road to the market when it obtained a CE-IVD mark for both the saliva and nasopharyngeal versions of its assay in the EU. In July, the firm announced it had filed a request for an Emergency Use Authorization with the US Food and Drug Administration. Discussions around obtaining an EUA to sell in the US market are ongoing.

Dotz has also publicly announced some sales, too. In the summer, Dotz reported that it had received an initial order for its SARS-CoV-2 test system of $2.1 million from United Arab Emirates-based Hygiene Links, which plans to offer the product to customers in the UAE, Egypt, and Sudan. In September, Dotz announced a two-year distribution agreement with El Alamo, based in Paraguay, which enables the Paraguayan firm to sell and distribute its tests in the South American nation. El Alamo also placed an initial $220,000 purchase order as part of the deal.

While Dotz continues to push its COVID-19 test offering into the international market, it is also eyeing other opportunities in diagnostics though details around its pipeline are being firmed up.

Keren Geras, head of diagnostics at Dotz, said that the firm is exploring the idea of launching kits for influenza, as well as other problematic viruses in the developing world such as Lassa, dengue, and Zika.

"We can help certain countries if we offer those viruses on the platform as well," Geras said.

Geras added that Dotz's offering could be a "game changer," especially for COVID-19, where some antigen tests have accuracy hovering at around 50 percent for asymptomatic people. "That's not good enough," said Geras. "Our platform is different because you can test nearly 100 people in 34 minutes," Geras said. "And I think the world is looking for something like that."

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