The sensitivity and specificity of a test can’t be determined after pilot testing in 7 people – something an independent perspective might have brought to the story if one had been used.
If an accurate, noninvasive, inexpensive device that evaluated breast lumps could be developed, patients in rural areas in the United States and patients in developing countries would benefit from the information and biopsies might decrease.
But, it is a long and difficult road to commercialization.
The prototype device is said to cost $1000. At this stage of development, the exact cost of the device and of screening is difficult to predict. We’ll give the story the benefit of the doubt given the early stage of development of the device
The story explains why a portable, inexpensive device that could determine if a lump is probably benign or malignant would be a useful tool for patients in rural areas and in developing countries.
Readers should be told before the 5th paragraph that a pilot test on the featured device included only 7 patients.
At this stage of development, any presumed benefits should by couched very carefully. Although the story does provide several provisos, we think that readers should have been told bluntly that because the device is only in very early testing its sensitivity and specificity in detecting breast cancer is purely speculative.
No information is included about possible over-diagnosis that may occur if this device is used to determine if very small lumps that are possibly benign or malignant. Recent studies have focused on the harm done by over-diagnosis and the resulting over-treatment of DCIS and early breast cancers.
The only evidence presented is mention of a pilot test on 7 women who later had diagnostic imaging and biopsies. The developer of the device, Dr. Chang-Hee Won, states “We need more data, but the key is that you can differentiate” benign from malignant tissue. Readers could question Dr. Won’s assertion of the accuracy of the device when its ability to differentiate benign from malignant tissue is based on tests in only 7 women.
The article notes that the goal is to test the device in human trials but that Dr. Won does not currently have funding for a human trial.
No disease mongering.
No independent sources are quoted. The only quotes in the article are from Dr. Won, the engineer who developed the device.
The article does state that the current first steps in evaluating a breast lump are mammography & ultrasound. These screening tools are not readily available in developing countries & in some rural areas of the United States.
The article makes it clear that the device is being developed and that human trials are needed to test its accuracy.
A quote in the final paragraph from Dr. Won, the engineer who is developing the device, points out that “Many, many companies are trying to develop breast cancer screening devices, … but this is different because we want it to be portable and simple, so it could be used in … a doctor’s office.”
After reading this piece, readers have no way of knowing if this profiled device is the only one under development that is portable, simple, and inexpensive.
Elastography, the method used to identify tissue with different “feel” has been under investigation for a number of years. Although other devices underdevelopment may be more expensive, the technology is not new or novel and was originally proposed in the 1990’s
We can’t be sure of the extent to which a news release may have influenced this story. As noted, only the developer is quoted.