SOURCE: Menssana Research, Inc.

December 23, 2015 14:00 ET

Menssana Research Breath Test Predicts Lung Cancer

NEWARK, NJ--(Marketwired - December 23, 2015) - An advanced new breath test accurately predicted lung cancer in a blinded clinical study.

The research, funded by the National Institutes of Health and performed in five US hospitals, was reported in the journal PLOS ONE. Menssana Research CEO Dr. Michael Phillips, said: "This is the first time that a breath test predicted lung cancer in a blinded clinical study where the researchers did not know the diagnosis at the outset."

Researchers collected breath samples from 301 patients with and without lung cancer, and analyzed them with gas chromatography and mass spectrometry to identify chemical fragments known as mass ions that are biomarkers of lung cancer.

They then analyzed breath samples from a new group of 215 patients without knowing their diagnosis. Using an algorithm derived from the first phase of the research, the breath test predicted lung cancer in the new group with 71% overall accuracy.

Dr. Phillips said: "Lung cancer is the leading cause of cancer death in the USA but screening and early detection can reduce the number of deaths by 20%. Breath tests could open a new pathway to faster, better, and cheaper screening for lung cancer."

Low-dose chest CT is currently the gold-standard for lung cancer screening but more than a quarter of all results are false-positives, often necessitating needless further testing. However, a breath test combined with chest CT would be more accurate than chest CT alone by potentially reducing the number of false-positive and false-negative test results by more than two-thirds. Patients would benefit from dramatically fewer needless additional tests, while healthcare costs would be reduced.

"People generally prefer breath tests to x-rays or blood tests because they are safe, painless and non-invasive. They are also inexpensive and convenient, and could eventually be used to screen for several diseases in their earliest and most treatable stages."

The lung cancer breath test has a CE Mark in Europe, and Menssana Research has initiated an application to FDA to approve the test in the USA. Menssana Research also develops breath tests for other diseases, including breast cancer and pulmonary tuberculosis. FDA approved Menssana's Heartsbreath test for heart transplant rejection as a Humanitarian Device Exemption.

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