New Optical Cancer Screening Showcased at Medica

When skin cancer is detected early, the survival rate is almost 100 percent. Those are pretty good odds. Unfortunately, skin cancer often is detected later in its course and the odds get worse.

A cancer imaging company based in Vancouver, Canada, recently released new technology designed to improve detection rates. The technology’s “coming out” party came during the Medica medical trade fair being held Nov. 16-19 in Dusseldorf, Germany.

Earlier this month, Verisante received the CE Mark to distribute its Aura device in Europe. The Conformite Europeenne—or CE—approval is recognized by all the 27 member states of the European Union.

“Obtaining a CE Mark allows us access to a market of over 21,000 dermatologists and 500 million people,” said Thomas Braun, the company’s president and CEO. “2011 has been a breakthrough year for Verisante. With Canadian and now European approval, we continue to meet all of our commercialization milestones for Verisante Aura as we move closer to bringing this innovative, life-saving technology to market.

Verisante plans to launch first in Germany, Austria and Switzerland, where distribution channels will be placed to support sales and marketing efforts. 


According to the company’s leadership, the European medical device market is the second-largest in the world, worth more than $78 billion and representing 30 percent of the world market—second only to the United States. Within the EU, the largest markets are Germany, the United Kingdom, France, Italy and Spain. These five countries account for 60 percent of the total EU population, more than 70 percent of the total EU gross domestic product, and approximately 80 percent of the EU medical device market.

Verisante is banking that an aging population and several new members in central Europe, means the medical device market in the European Union will continue to grow. One of its fastest-growing segments is the field of cancer diagnosis and treatment.

For example, in Germany, where Medica kicks off on Nov. 15, the incidence of skin cancers has tripled since 1980 and is about 20 percent higher than the rest of Europe, with melanoma accounting for 2,217 deaths each year, according to figures the company presented at the show. With a population of 80 million, Germany also offers a reimbursement of 150 euros under their state health insurance, which covers skin cancer screenings every two years for people age 35 and older.

“With the rising incidence of all types of skin cancers, innovative tools such as the Aura, which can potentially be used by general practitioners to evaluate suspicious skin lesions quickly and accurately, will become increasingly important to the heathcare system,” according to Harvey Lui, M.D., director of the Skin Care Centre at Vancouver General Hospital, Dermatologic Oncologist at the British Columbia Cancer Agency, and professor and head of the Department of Dermatology and Skin Science at the University of British Columbia. He also is one of the inventors of the Aura device.

The study used to support the CE Mark application was a six-year clinical study completed at the Skin Care Centre at Vancouver General Hospital, where the Aura was used to collect data on more than 1,000 lesions.
Early detection is key to saving the lives of melanoma patients and saving healthcare costs. When melanoma is diagnosed and treated in the earliest stages, the survival rate is 99 percent and it costs about $1,800 to treat it, according to figures presented by the company. In the late stages, the survival rate decreases to 15 percent, while the cost to treat it increases to $170,000. 



Aura is indicated for use for the evaluation of skin lesions that may be clinically suspicious for melanoma, squamous cell carcinoma and/or basal cell carcinoma when a medical professional chooses to obtain additional information to rule out one of the above conditions before making a final decision to biopsy. Basal cell and squamous cell skin cancers together account for about 96 percent of all skin cancers. While early detection of melanoma is critical due to its high mortality rate, it also is important to detect the most common skin cancers early in order to achieve the best results for patients.

Currently if a patient has a lesion, a doctor must perform a biopsy, which is a surgical procedure to determine whether the lesion is malignant or not. However, this new technological approach used with Aura, called optical biopsy, provides a number of practical benefits compared to existing detection methods. Aura is a non-invasive system designed as a tool to aid medical professionals in the assessment and diagnosis of suspect skin lesions as either skin cancer or a benign disorder in less than two seconds.

The device uses Raman spectroscopy technology to biochemically analyze the skin, providing immediate and accurate results. Raman provides information about molecular vibrations that can be used for sample identification and quantitation. The technique involves shining a monochromatic light source (i.e., a laser) on a sample and detecting the scattered light. Company representatives say the device will help to automate the current process of diagnosis, allowing rapid scanning of the 20 to 40 skin lesions on at-risk individuals, improving patient outcomes and comfort.

The company is on course to obtain regulatory approval in Australia by the end of the year, according to the firm’s leadership, and will pursue approval in the United States after that. Verisante also has a developed a device dubbed Core for lung, colon and cervical cancer detection. It has not yet been approved for sale.