Clinical trials at the Rabin Medical Center in Petah Tikva in central Israel show the system to be 92% effective in detecting certain types of skin cancer at an early stage—a higher rate than that of any apparatus currently available. Now a marketable device called Skinscan 650 is close to being ready, Biderman tells ISRAEL21c. “We assume we will have a working prototype by mid-to-late 2011.”
The unique technology is based on the observation that cancerous cells proliferate faster than healthy cells, and their accelerated metabolic activity releases energy at a higher frequency.
“The concept is simple to understand,” says Biderman. “Every living organism emits energy in the form of heat. This energy comes out in wavelengths—i.e. the light spectrum. Every living organism is built of cells, and the wavelengths emit from these cells [and can then be examined electronically]. Most healthy people have a body temperature of 36-37 degrees centigrade, and any difference in temperature can be traced to a medical condition. There's nothing new in this.
“Cancer develops in cells, as the result of something afflicting them that causes them to regenerate and split at a faster rate,” he elucidates. “This increased metabolic activity releases energy at a higher frequency, generating heat—just as the temperature around your pelvic area rises after eating. We're looking at the symptom. The cause cannot be detected so easily.
“There are two groups of skin cancer: Non-melanoma cancers account for 95% of skin cancers, and are known to be less fatal. Most deaths from skin cancer are caused by melanoma cancers. In both cases, early detection will ensure a high level of survival. If melanoma skin cancer has developed, your chances of coming out of it are about five percent. That is why early detection is so important,” he adds.
In most developed countries, it is commonplace for a physician to visually examine suspicious moles, before referring patients for biopsies that usually prove unnecessary and expensive. SCS's technology could make this practice a thing of the past.
Biderman points to the system's user-friendliness. “The doctor simply places the device next to the nevus [benign skin lesion] he wants to check. A light source projects rays onto the scanned lesion, and the body cells absorb part of the rays and reflect the light back—as do all things. That reflection is collected, then turned from optical into digital data for assessment. Our system knows how to absorb the rays emanating from the body and assess in which range of the spectrum the light's rays are coming out and their behavioral patterns [to look for problem areas].”
In July, Georgia-based mBeach Software acquired SCS in a reverse merger move that saw the management of SCS replace mBeach's staff. “The major reason for this move is the [company's] ability to raise funds on the open market in the US. This is an international company that can better focus in the future on developing markets. The Israeli company can now concentrate on research,” says Biderman, now mBeach CEO, who brings 34 years of command and managerial experience, 22 of them with the Israel Defense Forces, commanding field units including an elite Golani battalion, and 12 years in executive positions.
Soon after he assumed his new position, mBeach announced a strategy of targeting new international market opportunities, and identified Russia and the Commonwealth of Independent States (CIS) as among the fastest-growing healthcare markets globally, with a population exceeding 270 million and an increasing demand for advanced medical technologies. These countries report a very low rate of early detection, and skin cancer is typically diagnosed at an advanced stage when treatment options are less effective and costlier. The result is high cancer death rates.
“The [Skinscan 650] product is under review for marketing there, and the regulatory process has already begun. They showed real interest. Their problem stems more from metal factories than from the sun. Industrial pollution is a major health issue in Russia,” says Biderman.
Two stages of clinical trials have already proved the system's feasibility. “We compared our results using patients who had been referred for a biopsy after a doctor had eyeballed a lesion,” Biderman recounts. “We already knew that cancer cells appear in different ranges of the [light] spectrum, depending on the type of cancer, but in the first set of trials we still didn't know what we were looking at.
“Eventually, we started recognizing certain patterns. We learned to recognize what types of lesions are malignant. Now at least we had a name for every type. We found that each type of lesion has particular behavioral patterns. Every lesion has a different 'signature'—like fingerprints. We learned to diagnose the data using proprietary algorithms, and have come to recognize certain [light] pulses as giving information on the type of cancer. At the end of the procedure we compared our results with those of biopsies carried out on patients,” he tells ISRAEL21c.
The second stage of trials, completed in accordance with Declaration of Helsinki criteria, validated the technology's NMSC identification capabilities, resulting in a 92.4% sensitivity rate.
“You have to keep on checking,” Biderman warns. “The chances of developing skin cancer increase as you grow older. If you're over 50 years old, it's recommended that a dermatologist check you at least once a year.”
Posted on October 19, 2010
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