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Breath Diagnostics, Mayo Clinic Laboratories announce collaboration to develop new diagnostic test that detects lung cancer using patients' exhaled breath

LOUISVILLE, Ky., and ROCHESTER, Minn., March 26, 2019 /PRNewswire/ -- Breath Diagnostics, Inc. and Mayo Clinic Laboratories have announced a collaboration to develop clinical diagnostic tests that use patient breath samples to identify individual biomarkers that can predict a spectrum of diseases. The two organizations will initially focus on a test that can detect lung cancer.

Biomarkers are measurable substances that help in predicting the severity of a disease or infection. Examples of a biomarker include an individual's pulse or blood pressure, or it could be more complex, like certain chemicals that can be detected in blood, tissues or exhaled breath.

The two organizations will develop a breath-analysis test using Breath Diagnostics' patented OneBreath micro-reactor technology. "This technology will capture specific cancer biomarkers from a single breath," says Brian Ennis, President and CEO of Breath Diagnostics. Ennis added, "The test will not expose patients to radiation, and it will provide results in less than 24 hours."

Lung cancer leads U.S. in cancer-related deaths
In the United States, lung cancer is the leading cause of death related to cancer. Early diagnosis is key to long-term survival.

Ennis says, "Lung cancer is a voracious killer, which can have a devastating impact on patients, their families, and the economy."

The proposed OneBreath test for lung-cancer detection addresses an important clinical void by providing a noninvasive, reliable, fast, and low-cost alternative. The test will be used to characterize indeterminate pulmonary nodules and monitor for potential cancer recurrence after surgery.

"Some current lung cancer diagnostic tools can be costly," adds Ennis. "A CT scan can only identify the presence of suspicious pulmonary nodules, and many patients require repeated follow-up CT and PET scans or other invasive follow-up procedures like needle biopsies. Our technology is noninvasive and will be a lower cost alternative."

Mayo Clinic Laboratories to validate testing
Mayo Clinic Laboratories is the global reference laboratory of Mayo Clinic. The organization provides advanced laboratory testing and pathology services to support 4,000 health care organizations around the world.

As part of this collaboration, Mayo Clinic Laboratories will provide mass spectrometry services for the development of the OneBreath test. "With this collaboration, our first endeavor is to validate an assay that will be able to diagnose lung cancer from the breath of an individual," says Paul Jannetto, Ph.D., co-director of the Clinical Mass Spectrometry Laboratory in the Department of Laboratory Medicine and Pathology at Mayo Clinic.

About Breath Diagnostics 
Breath Diagnostics, Inc. is a Louisville, Kentucky-based company formed in October 2014 to commercialize its revolutionary OneBreath™ technology. The breath analysis platform was originally conceived, developed, and patented by scientists at the University of Louisville, which continues to support research and development activities. More information is available at

About Mayo Clinic Laboratories and the Department of Laboratory Medicine and Pathology
The Mayo Clinic Department of Laboratory Medicine and Pathology and its reference laboratory Mayo Clinic Laboratories provide advanced laboratory testing and pathology services to support 4,000 health care organizations around the world. Revenue from this testing supports medical education and research at Mayo Clinic, a nonprofit worldwide leader in medical care, research and education for people from all walks of life. Complemented by collaborations with diagnostic and biotechnology companies, the department maintains a robust diagnostic test-development program, launching more than 150 new tests each year.


Sadakatali Gori, Ph.D., COO, Breath Diagnostics Inc., +5029388486,; Andy Tofilon, Mayo Clinic Laboratories, +5072845005,


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SOURCE Breath Diagnostics, Inc.