Will USPSTF Say No to Breast Cancer Detection Innovations?

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  • 05/30/2012
The US Preventive Services Task Force standard for approving a preventive screening technology is as follows:

You need to show a decline in rates of death in a randomized clinical trial conducted over ten years in mostly white Europeans

The decline in death rates has to be from all causes, not the disease you were screening for

The determination of what a sufficient decline in death rates is  at the sole discretion of USPSTF.

In otherwords,  no new screenings such as this new breast cancer detection tool being developed in Israel.

A game-changer in breast cancer detection

Early detection is the key to improving breast cancer survival rates, but mammography is not the ideal method to accomplish this goal. On this point, medical experts across the globe agree.

Not as clear is what could do the job without the disadvantages of mammography — which often causes pain or discomfort; emits radiation; cannot properly image dense breast tissue; relies on a radiologist’s interpretation of the image; and is not recommended for routine screening of women under age 40 or 50.

Of several approaches being developed worldwide, an Israeli solution pioneered by electro-optical engineer Boaz Arnon holds particular promise in providing a game-changing device for early detection of breast cancer.

Arnon’s mother, Ruth, succumbed to the disease in 2004. Through Real Imaging, the company he founded in 2006, he was determined to offer an accurate alternative that would address all issues of concern and still be cost-effective.

Appropriately named RUTH, the device he invented uses a new trademarked platform he calls MIRA (functional Multidimensional Infra-Red Analysis). Built on principles from existing technologies and mathematics, MIRA enables functional quantitative analysis of 3D and infrared signals emitted from cancerous and benign breast tissue.

“Our solution is not sensitive to age or breast density, and works without radiation,” Arnon tells ISRAEL21c. “We image the patient from a distance of 70 centimeters (25.5 inches), with no physical contact or radiation, and we have developed an automatic method that aims to detect breast cancer early, easily and as cheaply as possible.”

No more guesswork

“Physicians should be highly praised for their success rate in diagnosing breast cancer with the tools available today,” says Arnon, “but still, the death rate from breast cancer is unacceptable.”

Breast cancer is by far the most frequent cancer among women, with an estimated 1.38 million new cancer cases diagnosed in 2008 (accounting for 23 percent of all cancers), and is now the most common cancer both in developed and developing regions.

Though a medical doctor will oversee screenings with RUTH, “automatic” is one of its most key features. Results will not have to be interpreted by human eyes, thanks to the device’s unique process of calibration using mathematical algorithms formulated from three-dimensional models of hundreds of women with and without malignancies. The algorithms provide unprecedented accuracy, as Real Imaging has demonstrated in blind studies.
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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