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Scopio Labs Closes $16M Round, Preps for FDA Submission of Digital Hematology System

NEW YORK – With $16 million in recently closed Series B funding, Israeli digital microscopy firm Scopio Labs is expanding its commercial operations including a planned US Food and Drug Administration submission for automated hematology diagnostics.

Last month, Scopio received the CE mark for its automated peripheral blood smear system, called X100 Full-Field PBS. The company is currently finishing a multicenter study of the system at sites inside and outside the US that it plans to use as part of an FDA 510(k) submission.

Founded in 2015, Tel Aviv-based Scopio has developed a computational digital microscopy approach that, according to the company, allows it to scan sample slides quickly and at high resolution while using lower cost microscopy equipment. The $16 million Series B round, which was led by Olive Tree Ventures, brings the total funds raised by the company to $30 million.

Many existing digital microscopy systems "use very high quality and very expensive optics and mechanics to scan slides," said Itai Hayut, Scopio's cofounder and CEO. Additionally, he noted "they have a trade-off between field of vision and resolution. You can either have a large field of view and low resolution or a small field of view and high resolution."

Scopio, on the other hand, uses low resolution, low cost microscopy hardware to take multiple images of a slide under different lighting conditions and is able to then computationally combine those multiple low-resolution images into a single high-resolution scan that captures the entire slide.

"The [computational] model is based on how the photons behave, how the light behaves," said Erez Na'aman, the company's other cofounder and CTO. "What we do is [similar to] mimicking the way that a lens works, but we are doing it computationally."

This ability to scan large fields of vision with high resolution and relatively inexpensive equipment addresses what Hayut said has been a major bottleneck for digital microscopy. Digital microscopy has made inroads into hematology lab testing in recent years, but the majority of this work is still done using manual microscopes.

Hayut declined to disclose the cost of the system but said that it was priced to fit the budget of smaller labs. He added that the company was also developing a higher-throughput version of the system that it would target to larger facilities.

"We will cover the entire span of microscopy users in labs," he said.

Digital microscopy has two main advantages over manual methods. One, digital slides are easier to share and store, allowing reduced turnaround time and making it more convenient to, for instance, obtain an expert consultation on a difficult interpretation. Two, digital images make AI-based analysis possible, which allow for applications like automated decision support and could enable more advanced automated analyses in the future.

In these respects, the field is somewhat analogous to digital pathology, where FDA-cleared platforms from Philips and Danaher's Leica Biosystems are hoping to win customers initially through the greater convenience provided by digital technology and, longer term, through the application of machine learning tools to automate and speed certain pathology analyses.

The greater convenience of digital formats has proved useful during the ongoing SARS-CoV-2 pandemic, with Philip and Leica receiving enforcement discretion from FDA allowing pathologists to use their systems to work from home using consumer-grade monitors. In March, the Centers for Medicare and Medicaid Services granted pathologists a temporary waiver allowing them to review slides remotely during the pandemic.

Scopio is likewise highlighting the potential advantages of digital microscope given the SARS-CoV-2 outbreak, noting that it can improve pathologist safety by allowing them to analyze slides without the need for them to be physically present in the laboratory. This isn't currently relevant to the US market, however, as the company has not yet received FDA clearance for its devices.

The company currently offers its digital microscopy tools for veterinary hematology and cytology work, which Hayut said has provided an example of the system's potential.

"In veterinary care we have deployed units that enable clinics to get pathology consults on biopsies immediately instead of sending them out using a courier," he said.

With regard to the human hematology applications that the company is pursuing, automated reading of slides is also a major part of the value proposition.

"There is a decision support system that preclassifies different blood cells," Hayut said. "The expert can review the report and correct it or proof it, but it makes for a much better and quicker and accurate kind of working."

The company is also developing digital microscopy systems for the research market that Hayut said will allow users to train custom AI models without requiring them to do their own coding.

"It's kind of a teachable device where the [research], if they have a large amount of sample that they want to quantify some parameter in, they can train the system to identify and quantify these features," he said. "This kind of opens the gate to do very large-scale analyses of microscopy samples, which with manual microscopes is just not possible."

With regard to Scopio's clinical aims, the company is taking aim at peripheral blood smear analysis first and expects to then move into other areas like bone marrow analysis and certain cytology analyses where high resolution is desirable across a larger area than is practical using traditional methods.

The company will have some competition in the hematology space. Swedish hematology company CellaVision, for instance, last year launched sales of its CellaVision DC-1 digital blood analysis system which can also be used to aid peripheral blood smear testing. The platform has a CE mark and the company filed for FDA 510(k) clearance in the first quarter of this year.

Hayut suggested Scopio could eventually move into pathology applications, as well.

"I think there are really great companies doing really great work in pathology, but the bottleneck that we are solving here in making imaging accessible and high quality, I think, is necessary in this field, as well," he said.