VERISANTE and the path to its ingenious cancer diagnostic tool
Detecting innovation: Verisante and the path to its ingenious cancer diagnostic tool
By Christopher Rogers
The tool, known as the Verisante Aura™ uses a multimodality imaging and spectroscopy system originally invented at the BC Cancer Agency.
Dr. Haishan Zeng, PhD, one of the co-inventors, is a senior scientist at the BC Cancer Agency’s Research Centre and associate professor of dermatology and skin science at the University of British Columbia. He said that the device has been in development for approximately 10 years.
“We targeted a powerful analytical method called Raman spectroscopy,” he said. “Raman spectroscopy uses a laser to probe molecular vibrations and gives very specific, fingerprint-like spectral patterns for tissue biochemical composition identification.”
However, the technology was not ready to be leveraged on a commercially viable scale; it wasn’t practical for clinical applications.
The team had to make a number of breakthroughs to make it practical, and they did. Zeng said they sped up the data acquisition time from minutes to seconds, developed a compact Raman probe for non-invasive measurement and created a real-time data processing algorithm.
The technology works by measuring biochemical changes in tissues and cells using inelastic light scattering.
“Near-infrared laser light is used to illuminate the skin. Proprietary optics and sensitive light detectors are employed to analyze the back-scattered light. The light scattering patterns are determined by the biochemical compositions,” Zeng said.
This allows for the measurements to be taken in a non-invasive way and the results are displayed on a monitor in real-time.
Zeng said that the technology uses an algorithm to analyze the acquired biochemical information instantaneously and indicate to the physician the probability that a lesion is likely to be cancer. “The probability number is based on the acquired biochemical information, which when combined with a physician’s clinical experiences, improves diagnosis.”
In 2006, Thomas Braun, founded Verisante Technology, Inc. (then T-Ray Science, Inc.) to collaborate with the University of Waterloo on a cancer imaging technology, similar to what the company eventually settled into with the BC Cancer Agency. When the company began, it was a collaboration between only three people: Braun, an accountant, and a medical device engineer.
Braun, who was previously a business lawyer specialized in representing small high-tech companies, corporate finance transactions, mergers and acquisitions, and technology licensing agreements. He felt that starting his own medical device company was a natural evolution for his career.
Braun and his colleagues began by raising money from friends and family and then moved on to accredited investors and business associates.
“It’s not easy to start a company - it’s hard and there are plenty of challenges to overcome but we’ve been finding that when people find out about this technology they realize that it’s something they can relate to because of their personal experience; we’re very excited about it,” he said.
In late 2009 the company went public, and shortly after, in March 2010, began negotiating their current licensing agreement with the BC Cancer Agency.
Braun, CEO of Verisante Technology, Inc., felt that the imaging technology available to be licensed by the BC Cancer Agency, was more advanced than Verisante’s because it was backed by a six year clinical study of approximately 1,000 lesions conducted at the Skin Care Centre at the Vancouver General Hospital. The principal investigator of the study was Dr. Harvey Lui, head of the Department of Dermatology and Skin Science at the University of British Columbia and one of the leading skin cancer experts in the world. The study’s published preliminary results have shown that out of the 274 skin lesions that were flagged for biopsy, the Verisante Aura identified all 34 cases of melanoma.
Through the licensing agreement, Verisante also gained access to the people who work in the laboratories of the BC Cancer Agency like Dr. Zeng. Braun noted that Zeng’s unique background in biophysics makes him invaluable because of his dual expertise in biology and physics.
Zeng discussed the steps involved in developing the Verisante technology. First, the research in biomedical optics was needed, second, the clinical needs had to be understood, and finally, a solution (in the form of the Verisante Aura™) was formulated.
Then, patent applications were filed, a prototype developed, clinical tests were conducted, and finally, results were published. Zeng said the inventor group was assisted in the entire licensing process by the BC Cancer Agency Technology Development Office in finding a commercial partner and entering a licensing agreement.
Verisante is currently listed on the TSX Venture Exchange and has a market cap of $10 million. However, as Braun said, the potential for the company, based on comparable companies in the market is much greater. Braun pointed to a number of other development-stage medical imaging companies that are now achieving market caps of up to $100 million.
“Essentially, once we get our approvals and we start selling, it’s possible that the market could give us a similar valuation,” Braun said. “But the financial market for medical device companies right now is tough, and the market wants to see companies hitting their milestones, getting approvals and start selling. That’s our business model and that’s our value proposition.”
One of the biggest concerns in the lifescience industry is that it’s very difficult for home-grown technologies to get their innovations implemented within Canada.
Luckily, Braun doesn’t foresee this problem. “I don’t, and I really think we need to judge each company and each product on its own merit,” he said. “…In our case, [the Verisante Aura™] is coming out of a government agency (the BC Cancer Agency)…they’ve decided they need this device in order to save lives, and save money.”
Early detection is always the best way to improve cancer survival rates, and the Aura™ would help to simplify the diagnostic process, improving the time it takes to get life-saving information. Also, the early detection will help save the Canadian health care system countless dollars. Braun noted the cost difference between treating an early stage tumour and a late stage tumour jumps from a few thousand to over $100,000. “From a health economic perspective…this is a very attractive proposition,” he said.
The process is very straightforward: 21 biomarkers are scanned in a half second, then if problem lesions are identified, follow-up with a specialist is required for a full biopsy and confirmation with a pathology report.
“With this device I don’t think we’re going to have any problems,” Braun said. “Every dermatologist I talk to thinks this is the holy grail of dermatology - every patient I talk to who has had any kind of a brush with cancer wants to get their whole body scanned.”
Perhaps the most innovative part of the Verisante business plan is that the device can be leveraged for multiple cancer diagnostic tools. A small business like Verisante normally can’t afford to develop multiple products because they just don’t have the resources. But as Braun noted, 95 per cent of the Verisante device is the same, there are simply different probe attachments and algorithms for different internal cancers.
In November, Verisante announced another licensing agreement with the BC Cancer Agency for the early detection of lung cancer. In addition, it now also holds the licenses for all gastrointestinal tract and cervical cancers.
“Essentially, we have a pipeline of technology because you have a device that can be used for all of these different cancers with just a different probe attached and different software,” Braun said.
All that stands in the way are clinical studies for each of the different cancers.
The Verisante Core™ device for lung cancer detection currently has a study underway.
Braun said the initial results are promising, with 50 patients already having been scanned. The lung cancer studies require fewer patients than the skin cancer trial because there are fewer variations of lesions to distinguish between. Braun was hopeful the study would conclude within the next 12 to 18 months, but it depends on the flow of patients.
These devices are being developed with leading experts in their fields. The lung cancer study is being headed by Dr. Stephen Lam, MD, FRCPC, professor of medicine at the University of British Columbia, chair of the Lung Tumour Group and leader of the Lung Cancer Prevention Program at the BC Cancer Agency.
All the devices used to detect internal cancers versus external skin lesions use fibre optic light delivery/collection probes. Zeng said these are being developed to reach inside various internal organs such as the bronchial tree (lung cancer) and the gastrointestinal tract.
The importance of the non-invasive biopsy technology should not be understated.
“It is critically important to have an optical biopsy system such as the Verisante Core™ device to help make informed surgical decisions, because endoscopists and surgeons do not want to take unnecessary biopsies of lung tissue. For optimum patient health, benign lesions should be left alone,” said Lam.
Work has also started on a study for colon cancer. “We’re quite enthusiastic about these other clinical studies that have already begun…We’re going to have a train of products as each clinical study is finished, hitting the market,” Braun said.
Braun is anticipating that the next studies will be straightforward. The plan, after the colon cancer study, is to follow with cervical cancer. The prioritization for the devices is based on the need. Lung cancer is the biggest killer, followed by colon and cervical.
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