Canadian biotech firm Verisante Technology plans this year to launch a Raman spectroscopy-based skin cancer diagnostic, with an instrument for detecting lung and colorectal cancer potentially to follow.
In collaboration with researchers at Vancouver General Hospital's Skin Care Center, the company has tested the point-of-care instrument on roughly 1,000 skin lesions, with preliminary results from the first 274 samples demonstrating that it can distinguish between benign and malignant lesions with a sensitivity of 100 percent and a specificity of 70 percent.
The device, named the Verisante Aura, uses Raman spectroscopy to measure the levels of various biomarkers – including proteins, nucleic acids, and metabolites – in skin lesions. By comparing the patterns of spectra generated by benign and malignant lesions, researchers are able to differentiate the two.
According to Verisante CEO Thomas Braun, the company will apply this summer for Canadian, European, and Australian regulatory approval for the device – which he expects to sell for around $30,000 – using the 1,000-lesion clinical study currently under analysis. The company will likely wait to make a submission to the US Food and Drug Administration until after it finishes a multi-site US clinical trial with the device.
That decision, Braun said, stems from Verisante's concerns about what he called the agency's "track record of rejecting lots of medical devices and drugs lately."
"The industry views this as almost a sort of crackdown," he told ProteoMonitor. "FDA always wants more and more data, so what we plan to do is a small multi-site clinical trial in the US just to validate the data collected in Canada, and then apply."
That process, Braun said, will probably delay release of the product in the US by about a year.
The device might also have difficulty obtaining FDA approval due to its use of broad spectral comparisons – as opposed to the quantification of specific, known individual analytes – to distinguish cancerous from benign lesions.
Braun said he didn't expect this to be a problem, noting that "if you have the evidence and it's solid science, I don't think you should have a problem with the FDA." In the past, however, the agency has been reluctant to approve tests – the initial version of Correlogic's OvaCheck ovarian-cancer diagnostic, for example – that rely on broad spectral comparisons.
FDA aside, approval in Canada, Europe, and Australia will give Verisante access to roughly 50 percent of the global medical device market, Braun said, adding that dermatologists were a potentially strong market for the product because of the field's growing reliance on instrumentation.
"Especially in the last 10 to 15 years all sorts of new devices have been invented for the cosmetic dermatology market," he said. "Devices for removing hair, pigmented lesions, tattoos, spider veins, wrinkles… they all cost a lot of money, but they're all money makers. So we're looking at a market of people who are accustomed to buying devices and charging people for services using those devices."
According to Harvey Lui, one of the inventors of the method, as well as the medical director of the VGH Skin Care Center and head of dermatology at the University of British Columbia, a second round of data analysis currently underway has thus far reinforced the results from the initial 274 samples.
His group is now working to determine which portions of the spectra generated by the device are the most important to diagnosis in hopes that they can reduce the amount of data collected to make the product simpler and less expensive.
Lui's team has also discovered that the device generates additional signals aside from Raman spectra. The researchers are investigating these signals to see if they might increase the test's accuracy, he told ProteoMonitor.
Another team of researchers, headed by UBC professors and British Columbia Cancer Agency scientists Haishan Zeng and Stephen Lam, has invented an endoscopic version of the Raman-spectroscopy system that Verisante has also obtained the rights to. The company intends to use that device – named the Verisante Core – for detecting lung, cervical, and gastrointestinal cancers.
With a grant from the Canadian Institutes of Health Research, Zeng's and Lam's groups are using the instrument in a 200-patient clinical trial for lung cancer. Though it has so far tested only 50 patients, preliminary data was "quite good – reliable and repeatable," Zeng told ProteoMonitor.
Although he declined to provide any statistics on the device's accuracy for detecting lung cancer, he said that "if the numbers held up, it would definitely be clinically useful."
The Core could be particularly helpful, Zeng said, in tandem with the LIFE-Lung fluorescence endoscopy system also invented in Lam's lab. That system uses fluorescence to detect lung lesions well before they would be visible using conventional techniques like CT scans or white-light endoscopy. It has a very high false positive rate, however, which the Core could help reduce.
The Core device "is an ideal tool to be combined with the [LIFE-Lung system]," Zeng said. "That way you get high sensitivity from the fluorescent imaging but with the Raman spectroscopy we reduce the false positive rate."
The researchers are also lining up patients for a 200-subject clinical trial using the device to detect colorectal cancer. That study, Zeng said, will launch within the next few months.
According to Braun, Verisante plans to follow the same regulatory path with the Core device, but, he said, "right now we only have enough funding to pursue the Aura" device. The hope, he added, is that if the Aura is successful, "the market will open up its purse and give us as much money as we want" to develop the Core.
Verisante launched in 2006 as T-Ray Science. At that time the company was focused on developing a skin cancer-detection platform using terahertz spectroscopy. In 2009 the company raised $1.5 million in an initial public offering. It was shortly after that when Braun learned of the BCCA's Raman spectroscopy-based work, he said.
"We looked at it and the clinical study results, and we realized that we would be able to deliver a product to market much sooner if we entered into a partnership with the BC Cancer Agency," said Braun.
In July 2010, Verisante obtained exclusive rights to the skin cancer detection technology in exchange for an undisclosed initial licensing fee, a royalty on sales, an annual license maintenance fee, and 1,655,000 stock purchase warrants. It secured rights to the endoscopic device in November.
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