New Clinical Trial to Test Effectiveness of BreathLink for Breast Cancer Diagnosis

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The BreathLink device is intended to immediately identify any indications of breast cancer based on a 2-minute sample of a patient’s breath.

Researchers at the University of Southern California (USC) Norris Comprehensive Cancer Center are recruiting participants for a clinical trial that investigates the effectiveness of the BreathLink device for breast cancer diagnosis. The BreathLink device is intended to immediately identify any indications of breast cancer based on a 2-minute sample of a patient’s breath.

Breast cancer is second to lung cancer as the leading cause of cancer death, as more than 232,000 women in the United States would be diagnosed with breast cancer in 2013 and 40,000 would die because of the disease, per estimates from the National Cancer Institute.

Previous research has shown that abnormal volatile organic compounds can be used to detect breast cancer in a patient’s breath. Biomarkers in breath have also been used in diagnosing other disorders including bronchial asthma, lung cancer, active pulmonary tuberculosis, radiation exposure, and heart transplant rejection.


“The developers of BreathLink found that women with breast cancer have an altered pattern of volatile organic compounds in their breath that is different from normal, healthy women,” said Linda Hovanessian-Larsen, MD, a study investigator and an associate professor of clinical radiology and director of Women’s Imaging at the Keck School of Medicine of USC, Los Angeles, California. “The BreathLink system analyzes the volatile organic compounds in breath with gas chromatography in the hopes that we can identify women who are at most risk for breast cancer. However, we are still in the earliest stages of this clinical trial.”

Typically, screening mammography is used to detect early stages of the disease; however, many women do not want to be exposed to potentially harmful radiation and discomfort. Researchers have also noted an association between mammograms and over diagnosis or overtreatment due to the increased risk of radiation-induced breast cancer.

“With about 32 million screening mammograms and about 1.6 million biopsies performed per year, anywhere from 60% to 80% are benign. With so many false alarms, we need to improve the field of breast cancer diagnostics. This trial may be one way of doing that,” said Hovanessian-Larsen.

Following the trial, if the BreathLink device is found effective, it will be used with mammograms and be able to eliminate false-positive tests, and reduce the pain, costs, and discomfort associated with unnecessary testing.

The blind prospective study will include 2000 women who have experienced symptoms or signs of breast cancer. Participants will undergo a mammogram and breath test to demonstrate how the combination improves the specificity of the results when considering a group of women, who have a greater probability of cancer due to prior symptoms. The BreathLink device will be used as the point-of-care instrument, while the BreathBag, an inflatable bag, will collect the samples.

Participants in the study are required to be female, at least 18 years old, and referred for a mammogram because of a breast-related concern.

“BreathLink is a noninvasive testing device that collects, concentrates, and analyzes the organic compounds in a patient’s breath sample within minutes,” concludes a report. “Although the test cannot diagnose disease, it can indicate if the patient should undergo further testing, which can save time and money while preventing additional emotional distress.”