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Olfactomics Developing Ion Mobility Device for Assessing Cancer Surgical Margins

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NEW YORK (360Dx) – Finnish life sciences firm Olfactomics is developing an ion mobility-based system for assessing margins during cancer surgery, but which may have diagnostic use eventually.

The company is developing its own ion mobility device for this purpose, which it hopes to have completed in 2019, said Antti Roine, Olfactomics' founder and a surgeon and cancer researcher at the University of Tampere.

The firm's initial focus is on assessing margins during breast cancer surgery, but it is also exploring its potential for diagnosing diseases including colorectal and ovarian cancer as well as various infectious diseases, Roine said. Last month researchers associated with the company published a paper in the European Archives of Oto-Rhino-Laryngology using DMS to detect rhinosinusitis.

Roine said that he and his Olfactomics Cofounder, Niku Oksala, professor of surgery at the University of Tampere, have for several years been researching potential medical applications of "electronic nose" technologies. They launched the company in 2015 and closed their first funding round in May of this year. Roine declined to give the size of the round.

"There are a vast number of [applications], but the analysis of surgical smoke seems to be one of the most promising," he said.

Surgical smoke is created when lasers or electro-surgical tools cauterize tissue during a procedure. A number of researchers have been exploring whether this smoke can be captured and analyzed to provide real-time information on the tissue being operated on. In the case of cancer surgery, it is hoped that it could be used to assess cancer margins in real-time, allowing surgeons to determine whether they have fully removed a tumor without having to wait for conventional pathology analysis of tissue samples.

Roine said Olfactomics has targeted breast cancer as its initial focus as this cancer is very frequently treated with surgery "and the margin question is very significant in those cases."

"Approximately 20 percent of patients who are operated on for breast cancer have some residual tumor that has to be removed in a second operation," he said. "Basically, the surgeon doesn't know exactly where the margins are, and thus they are unable to remove all of the cancer."

Roine said he and his colleagues have found that they are able in a laboratory setting to distinguish between cancerous and normal breast tissue and cancerous and normal brain tissue using differential ion mobility spectroscopy (DMS). Both of those findings will be detailed in papers currently under review, he said.

The researchers also demonstrated in a paper published this month in the Annals of Biomedical Engineering that they could distinguish between 10 different porcine tissue types using DMS analysis of surgical smoke.

Olfactomics is not alone in developing in-surgery tools for assessing cancer margins. For instance, Waters is developing its iKnife technology which collects surgical smoke and analyzes it via rapid evaporative ionization mass spectrometry (REIMS) for this purpose.

At the University of Texas, researchers led by Livia Eberlin, an assistant professor of chemistry, have developed what they call the MasSpec Pen, which consists of a handheld, disposable ionization device connected to a mass spectrometer and can be used to analyze the molecular content of patient tissue in real time without destroying the tissue.

The Waters and UT efforts use mass spec to tackle the surgical margin challenge. Olfatomics, on the other hand, uses DMS uncoupled to a mass spec for its sensing, a decision that Roine said the company made based on the fact that DMS instruments are much smaller than a mass spec, making them potentially better suited to the surgical environment.

"The basic difference is that while mass spectrometry operates in a vacuum in most cases, ion mobility spectrometry operates at ambient pressure," he said. "So that removes a large number of engineering obstacles."

"Additionally, mass spectrometry instruments require a lot of maintenance, and they are fairly fragile, delicate devices," he said, adding that DMS devices have proved robust for applications like detecting toxic gasses during military and search and rescue operations "where they have to operate without malfunctioning for long periods of time."

DMS devices are also significantly less expensive, Roine noted, running in the tens of thousands of dollars compared to $500,000 and up for the sort of high-end mass spec instruments used by groups like the Waters and UT researchers.

Of course, mass spec is a much more powerful analytical tool, but Roine said he and his colleagues believed that DMS could provide sufficient performance to assess surgical margins.

He cited the Pareto Principle, which states that 80 percent of an event's effects comes from 20 percent of the causes. DMS, Roine suggested, can provide 80 percent of the performance of a mass spec for 20 percent of the expense and effort.

"If we have a well-controlled environment and we know what we are analyzing and what part of the ion mobility spectrum will effectively discriminate between tissues, it can be done," he said.

Similarly aware of the potential difficulty of introducing high performance mass spec into surgical suites, Eberlin's UT team is looking to connect the MasSpec Pen to a miniaturized mass spec. Much like the trade-off made by Olfactomics, a miniaturized mass spec would provide a lower level of performance than the Thermo Fisher Scientific Q Exactive the researchers have used for much of their work thus far, but whether this reduction in performance will affect their results remains to be tested.

Roine said Olfactomics has done much of its proof-of-concept work with a DMS system sold by Finnish chemical detection firm Environics, but that limitations of that and other commercially available systems have led the company to develop its own DMS device.

Because DMS instruments are commonly used as portable handheld devices, keeping energy consumption low is a priority, he said. However, this means that in these instruments the setting of the electrical currents used to separate molecules of interest are often not very adjustable.

"We have to be able to adjust the sensor," Roine said. "The Environics sensor is somewhat adjustable, but it is not as fast as we would like. So we are currently in the process of developing our own ion mobility spectrometer that is tailored for real-time analysis and will act as the heart of our surgical device. The device will also omit the radioactive isotope in ionization, a component subject to an increasing amount of regulation."

He added that the company will make that device available to other companies and researchers, as well, along with cloud-based analytics service.

Roine said Olfactomics hopes to complete the device in 2019, after which it will be able to start clinical trials with the goal of ultimately winning US Food and Drug Administration approval. He said the company aimed to have the device on the market for use in breast cancer surgery between 2021 and 2023.