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Date Announced: 19 Nov 2010
FDA queries similarities between rival technologies.
BEVERLY HILLS, Calif.--(BUSINESS WIRE)--Cascade Technologies, Corp. (OTCBB: CSDT) announced today that, in response to significant recent attention to the Food and Drug Administration (FDA) panel evaluation of Mela Sciences’ (Nasdaq: MELA) MelaFindTM device, the company has received a number of inquiries about its similar instrument. "We believe," said Dr. Daniel Farkas, Chairman and CEO, "that it is useful to reaffirm our position on the non-invasive detection of melanoma by our SkinSpectTM device under development."
Spectral Molecular Imaging, Inc. (SMI), a wholly owned subsidiary of Cascade Technologies, is pursuing the development and subsequent validation of a medical imaging device – SkinSpectTM – that is geared towards enabling clinicians to achieve reliable, early detection of skin cancers, with emphasis on melanoma, the deadliest form of these cancers: in the US 121,840 new cases of melanoma were diagnosed in 2009, and one person dies of melanoma every hour. The severity and fast growth of this problem calls for quality solutions, involving the best tools that modern technology affords.
In expressing the company’s position Dr. Farkas, explained that: “We all want the very best for the patients, and the methods we develop have to be infused with that objective. Before balancing any cost/benefit considerations, we have to ensure that what we build is both absolutely safe and sufficiently advanced to constitute a significant improvement over current standards. While we are pleased to see that the FDA panel evaluating MelaFindTM – which is a 10-wavelengths imaging device – estimated (narrowly) that the need to save additional lives outweighs the remaining concerns about performance, we believe that we can contribute something additional to this field.
Our enabling technology is true spectral imaging that includes the visible and part of the infrared range, and samples it with 50 different wavelengths. It is known as band-sequential hyperspectral imaging. This core capability was originally developed for satellite reconnaissance, and thus optimized for finding difficult-to-discern objects, barely different from their surroundings. This is very similar to the challenge of early disease, arising out of a normal area and imaged in a reflectance mode. Together with some additional features of our recently completed SkinSpectTM prototype, such as polarization control (that obviates the need for a contact fluid) and autofluorescence, we anticipate that detection of distinguishing features of melanoma will be enhanced. Both safety and performance will, of course, need to be assessed quantitatively in carefully planned testing on patients, after consultations with the FDA.
We forsee learning from the years of experience accumulated in this field, including in the large trial conducted by Mela Sciences. We further expect both high sensitivity and specificity in our trials, based on all our previously conducted biomedical studies utilizing hyperspectral imaging (encompassing cytopathology, histopathology, fresh unlabeled ex-vivo specimens, in vivo preclinical and pilot clinicals, on patients), all of which yielded simultaneous detection sensitivities and specificities of 92-100%.
High sensitivity is clearly important for saving lives. High specificity on the other hand contributes to reducing the number of unnecessary biopsies, thus saving money for patients and the medical system. We maintain our focus on achieving both. We believe that new advanced products such as our SkinSpectTM device, when developed, validate the usefulness of quantitative, high-tech approaches to the difficult challenges of the clinical world, going far beyond what human vision can accomplish.”
Source: Cascade Technologies Corp.
E-mail: farkas@opmol.com
Web Site: www.spectralmi.com/
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