Following this article, we have posted the Abstract of the first clinical study evaluating this technology, published in 2013.
Press Trust of India, 10 June 2015
A wireless handheld device which will enable any health care worker to conduct a breast cancer examination within five minutes and access the results on a smartphone or tablet would be launched next month in the US and India, a top US official has said.
The device is the outcome of US Commerce Department's Economic Development Administration investment of $1 million in a proof-of concept centre to bring life-sciences research to the market, US Commerce Secretary, Penny Pritzeker told the students of Columbia University on Tuesday.
"Scientists at Drexel University, working with the centre, developed a hand-held, wireless breast cancer scanner, called the iBreast Exam. This device will enable any doctor or health care worker to conduct an exam within five minutes, and then access the results on a smartphone or tablet," Pritzeker said in her address to the 'Future of Urban Innovation Summit' in New York.
"We expect this product to be available for commercial use in the United States and India starting next month - a tangible result of strong collaboration between an urban hub, academic innovators, and public funding," she said...
The device is the outcome of US Commerce Department's Economic Development Administration investment of $1 million in a proof-of concept centre to bring life-sciences research to the market, US Commerce Secretary, Penny Pritzeker told the students of Columbia University on Tuesday.
"Scientists at Drexel University, working with the centre, developed a hand-held, wireless breast cancer scanner, called the iBreast Exam. This device will enable any doctor or health care worker to conduct an exam within five minutes, and then access the results on a smartphone or tablet," Pritzeker said in her address to the 'Future of Urban Innovation Summit' in New York.
"We expect this product to be available for commercial use in the United States and India starting next month - a tangible result of strong collaboration between an urban hub, academic innovators, and public funding," she said...
Continue reading:
J Am Coll Surg. 2013 Jun;216(6):1168-73. doi: 10.1016/j.jamcollsurg.2013.02.022. Epub 2013 Apr 23.
Xu X1, Gifford-Hollingsworth C, Sensenig R, Shih WH, Shih WY, Brooks AD.
Author information
Abstract
BACKGROUND:
Mammography is key to detection of breast cancer in high-risk populations. Currently, aside from palpation and risk-assessment questionnaires, there is no prescreening test that can improve the accuracy, safety, and cost effectiveness of screening low-risk populations. The piezoelectric finger (PEF) is a radiation-free, portable, and low-cost breast tumor detector we developed to be used as a prescreening tool.
Author information
Abstract
BACKGROUND:
Mammography is key to detection of breast cancer in high-risk populations. Currently, aside from palpation and risk-assessment questionnaires, there is no prescreening test that can improve the accuracy, safety, and cost effectiveness of screening low-risk populations. The piezoelectric finger (PEF) is a radiation-free, portable, and low-cost breast tumor detector we developed to be used as a prescreening tool.
STUDY DESIGN:
Patients presenting with breast abnormalities detected by palpation or imaging were enrolled in this IRB-approved study. The PEF testing was performed with the patient in supine position before undergoing biopsy or surgical excision. The locations of the lesions detected by PEF were compared with those confirmed on imaging or pathology.
Patients presenting with breast abnormalities detected by palpation or imaging were enrolled in this IRB-approved study. The PEF testing was performed with the patient in supine position before undergoing biopsy or surgical excision. The locations of the lesions detected by PEF were compared with those confirmed on imaging or pathology.
RESULTS:
A total of 40 patients were enrolled and 46 lesions were confirmed by imaging or pathology. The PEF reported 55 lesions, with 9 false positives and 2 true positives not originally found on imaging or palpation. The overall sensitivity of the PEF test was 87% (40 of 46). In women 40 years old or younger, overall sensitivity was or 100% (19 of 19). In women who had a lesion visible on mammography, PEF had a sensitivity of 83% (24 of 29). Of these, in women aged 40 years or younger, PEF identified all 7 mammographically visible lesions, including 2 malignant lesions. When compared with ultrasound, PEF correctly identified 87% (34 of 39) in this group. Of these, in women aged 40 years or younger, PEF identified 100% (19 of 19) of all ultrasound-visible lesions.
A total of 40 patients were enrolled and 46 lesions were confirmed by imaging or pathology. The PEF reported 55 lesions, with 9 false positives and 2 true positives not originally found on imaging or palpation. The overall sensitivity of the PEF test was 87% (40 of 46). In women 40 years old or younger, overall sensitivity was or 100% (19 of 19). In women who had a lesion visible on mammography, PEF had a sensitivity of 83% (24 of 29). Of these, in women aged 40 years or younger, PEF identified all 7 mammographically visible lesions, including 2 malignant lesions. When compared with ultrasound, PEF correctly identified 87% (34 of 39) in this group. Of these, in women aged 40 years or younger, PEF identified 100% (19 of 19) of all ultrasound-visible lesions.
CONCLUSIONS:
The PEF identified abnormalities in all 39 patients who presented with breast abnormalities and did not demonstrate any false negatives that would prevent the patients from additional evaluation, which makes it a good prescreening tool. In addition, PEF demonstrated 100% sensitivity in women aged 40 years or younger, a traditionally low-risk population.
Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.
PMID: 23623223 [PubMed - indexed for MEDLINE]
The PEF identified abnormalities in all 39 patients who presented with breast abnormalities and did not demonstrate any false negatives that would prevent the patients from additional evaluation, which makes it a good prescreening tool. In addition, PEF demonstrated 100% sensitivity in women aged 40 years or younger, a traditionally low-risk population.
Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.
PMID: 23623223 [PubMed - indexed for MEDLINE]
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