Researchers from the British Columbia Cancer Agency this week presented results from a clinical study in which Verisante Technology's Raman spectroscopy-based Core device distinguished between cancerous and benign lung lesions with sensitivity and specificity of more than 90 percent.
The results, detailed in a poster presented this week by BCCA researcher Haishan Zeng at the agency's 2012 Annual Cancer Conference, add to the results of a 129-sample pilot study in which the device demonstrated sensitivity of 96 percent and specificity of 91 percent. That study was published last year in the Journal of Thoracic Oncology.
The latest study added 267 new samples and used a new, higher sensitivity version of the Core device. Verisante did not release the exact performance numbers for the new study, but noted in a release that the results indicate an increase in specificity accompanied by a "slight reduction" in sensitivity. The researchers also plan to present their findings at the SPIE Photonics West 2013 meeting in February.
According to Verisante CEO Thomas Braun, the company is now waiting for completion of additional testing by its BCCA collaborators, upon which it plans to file for Health Canada approval and an EU CE mark followed by US Food and Drug Administration approval.
Braun also provided ProteoMonitor with an update on the company's lead project, its Raman-based Aura device, which is intended for skin cancer screening. The Aura received Health Canada approval, Australian Department of Health approval, and an EU CE mark in 2011 and was slated for commercial launch in the middle of 2012 (PM 1/6/2012).
That launch has been delayed, however, by improvements to the device that necessitated additional beta testing as well as recently added electrical safety testing rules in Europe, Braun said. He added that the company now expects to begin selling the device as early as the end of 2012 and by the end of January 2013 at the latest.
The Core and Aura devices use Raman spectroscopy to measure the levels of various biomarkers – including proteins, nucleic acids, and metabolites – in lung and skin lesions, respectively, to distinguish between benign and malignant lesions. By comparing the patterns of spectra generated by the device, clinicians can differentiate between the two.
In March, a team led by BCCA and Vancouver General Hospital researcher Harvey Lui published a study on the Aura in the journal Cancer Research that found the device could be used to bring skin cancer biopsy ratios – the number of non-melanoma lesions biopsied for each melanoma detected – to as low as 3.8:1 from the current typical range of 58:1 to 21:1.
Since that study, the company has upgraded both the Aura and Core devices to increase their sensitivity. In the case of the Core, this means that data from the 267-sample study presented this week cannot be combined with the results of the 129-sample pilot study, Braun said. In the case of the Aura, it has led to the aforementioned commercialization delay.
"The decision [to delay the launch] was based on advice we got from our scientists and the BCCA that we should beta test [the new device] to make sure that the algorithm that was developed in the clinical studies would work with the new version," he said. "Because this new version is more sensitive, the peaks in the Raman spectra are more intense. So it's possible [the algorithm] needs some tweaking."
The company began this testing in March, installing beta units in five dermatology clinics across Canada. It plans to finish testing by the end of the year at which time, Braun said, it will have commercial units ready to go.
He added that the company has delayed pursuing FDA approval until it begins sales of the device. "We want to go to FDA with a complete package. We can say, 'Look, we have a commercial product ready to ship; we have [study] results published in a high-impact journal; we have 1,000 patients that have been through Vancouver General Hospital.'"
Braun 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. He said the company aimed to complete the PMA process in roughly 12 months, putting it on track for a 2014 US launch.
Braun suggested, however, that while the Aura had received several regulatory approvals and a current Core clinical study underway at BCCA would likely be sufficient for obtaining Health Canada clearance and a CE mark, ongoing studies will be needed to drive adoption in the marketplace.
"The data we have so far is sufficient [for regulatory purposes], but that might not necessarily do you any good when it comes to marketing the devices," he said, noting that doctors "are very risk averse."
The Aura's current price is an estimated $60,000, but this could rise, Braun noted. "As it turns out, everything takes a little bit longer and costs a little bit more that you originally plan," he said. He added that the company's distributers, which include Clarion Medical Technologies in Canada and BO-Pharma BV in Belgium, the Netherlands, and Luxembourg, also wanted stronger profit margins.
"At the end of the day, the amount it costs us to build the device is irrelevant," Braun said. "You have to look at what doctors can earn with it." And, he said, in this regard, there is reason to think it might currently be underpriced.
The physicians doing the beta testing of the Aura average 100 biopsies per month, Braun said. Assuming they used the device on each of these patients they ultimately biopsied, that would mean 100 Aura scans per month.
Braun said that US clinics using biotech firm's Mela Sciences' MelaFind scanner – a similar skin cancer screening device – charge in the $175-per-scan range. At that price, he noted, dermatologists doing 100 scans per month could bring in $17,500 per month. Given that at the current $60,000 price, leasing the Aura costs only $1,100 per month, there might be room for a price bump, he suggested.