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HeartsbreathBreath Test for Heart Transplant Rejection

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The HeartsbreathTM test is a non-invasive breath test for breath biomarkers that predict the probability of grade 3 rejection in heart transplant recipients who received their transplants in the preceding year. It employs a breath collection apparatus (BCA) for collection of volatile organic compounds in breath onto a sorbent trap, as well as for the collection of a separate sample of room air.

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Analysis of the organic compounds in breath and room air is performed by gas chromatography and mass spectroscopy, which are laboratory tests.

The Food & Drug Administration approved the Heartsbreath test for clinical use as a Humanitarian Device exemption.