Breath Diagnostics Inc, Louisville, Ky, and Mayo Clinic Laboratories, Rochester, Minn, 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. Complex examples include 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 microreactor technology.

“This technology will capture specific cancer biomarkers from a single breath,” says Brian Ennis, president and CEO of Breath Diagnostics. “The test will not expose patients to radiation, and it will provide results in less than 24 hours.”

In the United States, lung cancer is the leading cause of death related to cancer. Early diagnosis is key to long-term survival. “Lung cancer is a voracious killer, which can have a devastating impact on patients, their families, and the economy,” says Ennis.

The proposed OneBreath test for lung cancer detection addresses an important clinical void by providing a noninvasive, reliable, fast, and low-cost testing 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,” explains 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.

As part of the collaboration, Mayo Clinic Laboratories will provide mass spectrometry services for 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, PhD, codirector of the clinical mass spectrometry laboratory in the department of laboratory medicine and pathology at Mayo Clinic.

For further information, visit Breath Diagnostics.

Featured image: Illustration by Axel Kock courtesy Dreamstime (ID 137230671).