Medical Policy

This document addresses the use of electrical impedance scanning (EIS) for cancer detection.

Note: This document does not address detection of skin cancer. Please see the following related document for additional information on skin cancer detection:

• MED.00004 Noninvasive Imaging Technologies for the Evaluation of Skin Lesions

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Investigational and Not Medically Necessary:

Electrical impedance scanning for cancer detection is considered investigational and not medically necessary for all indications.

This document describes clinical studies and expert recommendations, and explains whether electrical impedance scanning for cancer detection is clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Electrical impedance scanning, also called EIS, is a test that uses a small electrical current passed through the skin to measure how body tissues conduct electricity. Changes in how a tissue conducts electricity may happen when cancer is present. EIS devices have been studied for detecting breast, lung, prostate, and other cancers. Some devices, such as the ProLung Test and IONIQ Breast Test, are designed to help find cancer early. These devices do not have approval or clearance from the United States Food and Drug Administration, also called FDA.

What the Studies Show

EIS measures how easily electricity moves through tissue. Cancer cells may change the shape, size, and fluid content, which can affect how electricity flows through them. Researchers have studied EIS in people with breast, lung, and prostate cancer. In a large review of 51 studies, many studies did not clearly show that EIS could reliably tell the difference between cancer and normal tissue. Only a small number of breast cancer studies showed moderate or good accuracy. Studies of lung and prostate cancer were judged to have poor or unclear results. The authors said larger and better designed studies are needed before EIS can be used in regular care.

Another review looked at a type of EIS called electrical impedance tomography, or EIT, creates images of tissue using EIS. Across 12 studies of breast cancer, EIT showed mixed accuracy. Results varied widely between studies. This makes it hard to know how well the test truly works. One small study of 48 women found some differences in electrical readings between cancerous and noncancerous breast lesions. However, the test did not perform well enough to replace mammography. Researchers suggested it might be used along with other tests, but better studies are needed to know if EIS or EIT improves health. There are no strong studies showing that these tests improve survival or lead to better health outcomes.

Is this clinically appropriate?

EIS and EIT are not clinically appropriate for cancer detection because they have not been proven to improve health. Reviews of many studies found that the test often could not reliably tell the difference between cancer and normal tissue. Results were inconsistent, and many studies were small or had design problems. There are no published studies showing that using EIS leads to earlier treatment that improves survival or quality of life.

When a test has not been proven to work well, it can lead to false results. A false positive result may suggest cancer when it is not present and can lead to more testing or treatment that does not help. A false negative result may miss a cancer leading to poor outcomes. Electrical impedance scanning for cancer detection is not clinically appropriate in any scenario.

(Return to Description/Scope)

Summary

This document evaluates the use of electrical impedance scanning (EIS), including electrical impedance tomography (EIT), for cancer detection and concludes that it is investigational and not medically necessary for all indications. EIS measures tissue conductivity to detect potential malignancies based on the premise that cancer-related changes in cell structure and fluid composition alter electrical properties. Although several devices have been developed to detect cancers such as breast, lung, and prostate, systematic reviews and clinical studies show mixed and generally insufficient evidence regarding their diagnostic accuracy. Many studies demonstrate limited discriminative ability, significant variability in results, and methodological weaknesses, with no strong evidence supporting analytical validity, clinical validity, or improved health outcomes.

While some studies suggest EIS may have potential as an adjunctive tool, particularly in breast cancer screening, its sensitivity and specificity are generally inferior to established modalities like mammography and ultrasound. Meta-analyses report substantial heterogeneity across studies, further limiting reliability. No large-scale, high-quality trials confirm the clinical utility of EIS, and certain proposed EIS devices, such as the ProLung Test and IONIQ Breast Test, lack FDA approval. Although early cancer detection remains a critical goal given the high lifetime risk and mortality associated with major cancers, current evidence does not support routine clinical use of EIS technology for cancer detection.

Discussion

Electrical impedance is a physical concept in which a body part’s impedance (a calculated measure of electrical conductivity) to an applied alternating current can be measured in order to assess tissue composition. There is interest in the clinical application of electrical impedance technology as a non-invasive way to diagnose and manage malignancies. This approach is based on the notion that the electrical properties of bodily tissues change due to the presence of cancer. Although there is some understanding of this process, exactly how tissue electrical impedance changes with the development of a malignancy is not completely clear. It has been hypothesized that as a malignant pathological process progresses, the tissue’s electrical impedance changes due to alterations in cell shape, size, membrane structure and fluid status. Several electrical impedance devices have been developed and proposed to detect lung, breast, prostate and other cancers using a low-voltage electrical current passed through the skin.

In 2020, Pathiraja and colleagues conducted a systematic review of clinical applications of electrical impedance technology in the detection of malignant neoplasms. A total of 51 studies were examined covering 16 cancer subtypes in 7035 individuals. The primary endpoint was defined as the ability to distinguish between malignant and normal tissue. Studies were categorized based on discriminative strengths determined by the area under the receiver operating characteristic curve (AUROC). Categories were “Good,” AUROC > 0.7 or sensitivity and specificity both > 0.75; “Moderate,” AUROC > 0.6 or Sensitivity > 0.7; or “Insufficient,” not meeting the previous criteria or reporting insufficient data. Six studies examined in vivo breast tissue by measuring the electrical impedance of the overlying skin or lesion itself intra-operatively. Only 2 of the 6 studies were judged to have good or moderate discriminative strengths, the rest were insufficient. Two studies addressed lung cancer, although only 1 measured impedance in vivo and both studies were categorized as insufficient. Two studies examined prostate cancer in vivo, and both were judged to be insufficient. Altogether, in vivo electrical impedance studies were generally found to be non-invasive and painless, but with mixed results in terms of ability to discriminate between normal and malignant tissues. The authors concluded that more research and large-scale multi-center in vivo clinical trials are needed before electrical impedance technology can be reliably employed in the clinical detection of malignant tissue.

Andreasen and colleagues (2021) studied whether skin electrical resistance changes could serve as a diagnostic and therapeutic biomarker associated with physiological changes in individuals with malignant versus benign breast cancer lesions. A total of 48 women were enrolled in this study, 24 with malignant cancer and 23 with benign lesions. Skin electrical impedance measurements (a total of 47 per subject) were performed in lymphatic regions throughout the upper body. Impedance measurements from breast lymphatic points (n=4) and non-breast lymphatic points (n=43) were averaged by location and a ratio calculated between non-breast and breast lymphatic regions to generate individual data points for each subject. In 6 subjects who received therapy, additional longitudinal measurements were taken after 6 months to determine the effect of therapy. Significant differences were observed between subjects with malignant and benign breast lesions (p<0.01), and also pre- vs. post-treatment (p<0.05). A diagnostic machine learning classification algorithm was created by training a random forest model with impedance measurements and other subject parameters such as age, body mass index (BMI) and smoking status. Breast cancer was classified using this algorithm with an area under the curve of 0.68, sensitivity of 66.3%, specificity of 78.5%, positive predictive value 70.7% and negative predictive value 75.1%. The conclusion was that electrical impedance technology may be a useful diagnostic tool but is probably more suited as an adjunctive test to standard mammography screening rather than a replacement. Further studies are needed that include healthy controls and where operators are blinded as to subject type during electrical impedance measurements.

In 2022, Rezanejad Gatabi and colleagues published a systematic review and meta-analysis of the accuracy of electrical impedance tomography (EIT), a technology that uses EIS to create maps or images of scanned areas, for breast cancer detection. Twelve studies including 5487 individuals with breast cancer were analyzed. An overall sensitivity of 75.9% (range 26.4-94.6%) and specificity of 82.0% (range 49.0-98.9%) were reported. Significant heterogeneity was found between the studies (I²=93.3%, p<0.01), as evidenced by the wide ranges in sensitivity and specificity, which may affect the quality of the meta-analysis. The heterogeneity was attributed to differences in protocol design, comparisons and methods between the studies. The authors concluded that although EIT is less effective than ultrasound or mammography due to its lower specificity, it may be a useful adjunct technology. However, further large-scale studies will be needed to support the clinical application of EIT.

The body of evidence regarding the analytical validity, clinical validity, and clinical utility of EIS, including EIT, for cancer detection is sparse and of low quality. There are a few prospective studies that have assessed EIS technology in vivo for breast, lung and prostate cancer detection but most have reported either poor discriminative strength or insufficient data to properly evaluate. There are no studies identified in the peer-reviewed published literature that specifically evaluate the analytical validity, clinical validity, or the clinical utility of EIS devices. Use of EIS technology has not been proven to improve net health outcomes.

According to the American Cancer Society (ACS), slightly over 2 million Americans will be diagnosed with some form of cancer in 2026. About 13% of women in the United States will develop breast cancer over the course of their lifetime. Lifetime risk of lung cancer is about 5%, but it is the leading cause of cancer death among all Americans. Prostate cancer is the most common cancer in American men, other than skin cancer, with about 13% of men being diagnosed with prostate cancer during their lifetime. Survival rates are highest during the earliest stages of cancer, so technologies that facilitate early detection are of great interest and value.

EIS technology has been used for some time clinically in the measurement of fluid volumes as well as overall fluid status and body composition (Khalil, 2014). More recently, there has been interest in using EIS to detect pathological changes in tissue, specifically malignancies. It is thought that changes in cell composition and structure in malignant tissue alter the tissue’s electrical conductivity which may be detected by EIS measurements. In particular, the ProLung Test and IONIQ Breast Test (both from IONIQ Sciences, Inc., Salt Lake City, UT) are EIS technologies proposed to detect cancer in the early stages and for accelerated diagnosis. At this time, these devices do not have United States Food and Drug Administration approval.

Electrical impedance: Refers to a calculated measure of electrical conductivity.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure code, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Andreasen N, Crandall H, Brimhall O, et al. Skin electrical resistance as a diagnostic and therapeutic biomarker of breast cancer measuring lymphatic regions. IEEE Access. 2021; 9:152322-152332.
2. Khalil SF, Mohktar MS, Ibrahim, F. The theory and fundamentals of bioimpedance analysis in clinical status monitoring and diagnosis of diseases. Sensors. 2014; 14:10895-10928.
3. Pathiraja AA, Weerakkody RA, von Roon AC, et al. The clinical application of electrical impedance technology in the detection of malignant neoplasms: a systematic review. J Transl Med. 2020; 18(1):227.
4. Rezanejad Gatabi Z, Mirhoseini M, Khajeali N, et al. The accuracy of electrical impedance tomography for breast cancer detection: a systematic review and meta-analysis. Breast J. 2022; 2022:8565490.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Fresh Medical Laboratories. Establish ProLung Test Measurement Collection Protocol for Future Studies. NLM Identifier: NCT04134520. Last updated on October 25, 2022. Available at: https://www.clinicaltrials.gov/ct2/show/NCT04134520?term=ProLung&draw=2&rank=1. Accessed on May 5, 2026.
2. Fresh Medical Laboratories. A Multi-Center Trial of the ProLung Test. NLM Identifier: NCT01566682. Last updated on September 4, 2019. Available at: https://www.clinicaltrials.gov/ct2/show/NCT01566682?term=ProLung&draw=2&rank=5. Accessed on May 5, 2026.

1. American Cancer Society (ACS). Cancer facts & figures 2026. Available at: https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2026-cancer-facts-figures.html. Accessed on May 5, 2026.

ProLung Test
IONIQ Breast Test

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

© CPT Only – American Medical Association