Having obtained Health Canada approval, Australian Department of Health approval, and an EU CE mark this year for its Raman spectroscopy-based skin cancer diagnostic device, Canadian biotech firm Verisante has begun pursuing US Food and Drug Administration approval.
CEO Thomas Braun told ProteoMonitor this week that the firm expects to have a pre-Investigational Device Exemption meeting with FDA sometime in the first quarter of this year and hopes to bring the device, named the Aura, to market in the US by the beginning of 2014.
He said that given the lack of predicate devices, he expects Verisante will have to take the Aura through FDA's premarket approval process, which is typically more costly and time-consuming than the less-stringent 510(k) regime. In June, the company raised $5 million through a private placement to support commercialization of the device.
The Aura uses Raman spectroscopy to measure the levels of various biomarkers – including proteins, nucleic acids, and metabolites – in skin lesions to distinguish between benign and malignant lesions. By comparing the patterns of spectra generated by the device, clinicians can differentiate between the two.
In a study completed in 2011, the company worked with clinicians at Vancouver General Hospital’s Skin Care Center to test the point-of-care instrument on roughly 1,000 skin lesions. Preliminary results from the first 274 samples demonstrated that it distinguished between benign and malignant lesions with a sensitivity of 100 percent and a specificity of 70 percent (PM 3/4/2011).
In collaboration with University of British Columbia researchers, the company has since completed a paper presenting an analysis of the full dataset and is pursuing publication in a peer-reviewed journal.
Using the VGH data, Verisante secured Health Canada approval in October, CE marking in November, and Australian Department of Health approval in December. The company has also entered the regulatory process in Mexico and Brazil and expects, using the same data, to secure Mexican approval for the Aura this year and Brazilian approval within the next two years.
Braun said he was optimistic that the VGH study would be sufficient to obtain FDA approval for the device, but, he said, the agency might require a multi-site study performed in the US.
“[W]e’ve got evidence that it works. We know that Raman spectroscopy works. And how many cases do you need to show that the device correlates with the biopsy results?” he said. “But, of course, every regulator likes to see data from their own country … so we’ll see.”
Braun suggested, in particular, that FDA might require the company to test the device in a more diverse range of settings to demonstrate that it works well outside of a top-tier research hospital like VGH.
“They might say, for instance, ‘Does this work in an independent dermatology clinic in a rural area or do you have to be a professor of dermatology to use this?’” he said. “Will it work with typical staff [with] a basic education? Will it work in different climates?”
If FDA were to demand an additional study, it would likely take several months and cost between $1,000 and $2,000 per patient, Braun said. He noted that clinical cohorts for the Aura were relatively easy to put together due to the high volume of patients at many dermatology centers.
“A busy skin cancer clinic might see 50 people a day,” he said. “So if the FDA said they want us to do [an additional] 500 patients, there are some busy clinics where they could do that in 10 days.”
In addition to preparing its FDA submission, Verisante is planning to commercially launch the Aura in Germany, Austria, and Switzerland in the middle of 2012. Germany, in particular, is a promising market, Braun said, noting that it has 5,500 dermatologists – more than a quarter of Europe’s total and more than half as many as the US.
Germany, which has a population of 80 million, offers under its state health insurance a €150 reimbursement covering skin cancer screenings every two years for people 35 and older.
In an interview with ProteoMonitor in March 2011, Braun said the Aura would sell for around $30,000. Since then, however, marketing, distribution, and materials costs have driven the price closer to $60,000, he said.
In addition to the Aura, Verisante is working to commercialize another Raman spectroscopy-based device called the Core. This device, which was developed by a team headed by UBC professors and British Columbia Cancer Agency scientists Haishan Zeng and Stephen Lam, is an endoscopic version of Verisante’s Raman-spectroscopy system and is intended for detection of lung, cervical, and gastrointestinal cancers.
With a grant from the Canadian Institutes of Health Research, researchers led by Zeng and Lam are using the instrument in a 200-patient clinical trial for lung cancer. In March, Zeng told ProteoMonitor that preliminary data from the device was "quite good – reliable and repeatable."
In June, the researchers published a paper in the Journal of Thoracic Oncology detailing these early results. Their findings showed the Core detected preneoplastic lesions in the lung with a sensitivity of 96 percent and a specificity of 91 percent. According to the paper, the standard detection method of white light bronchoscopy combined with autofluorescence bronchoscopy has an average specificity of roughly 60 percent.
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