MENSSANA RESEARCH INC — Department of Health and Human Services SBIR Phase II: NCI

Description

DESCRIPTIONprovided by applicantThe clinical problemBreast cancer is the commonest cancer in womenin whom it is second only to lung cancer as a cause of cancer deathMammography is the mainstay of screening for breast cancerthough its value is limited by its large number of false positive and false negative findingsA new solution the problemThe combination of two diagnostic tests with different biological mechanisms can be more sensitive and specific than either test employed aloneThe BreathLInk breath test for biomarkers of breast cancer could potentially increase the sensitivity and specificity of mammographyand significantly reduce the number of false positive and false negative test results arising from mammographyGoal of the researchWe will test the hypothesis that the BreathLink breath test combined with mammography will result in significantly fewer false positive and false negative test results than with mammography aloneWe will achieve this goal by performing BreathLink breath tests inwomen at five sites who are having mammography for breast related symptoms or signse gbreast massExpected outcomes of the researchWe expect that that the BreathLink breath test combined with mammography will significantly reduce the number of false positive and false negative test results arising from mammography aloneThis research could establish a new paradigm for detecting women with breast cancerThe combination of an intrinsically safe breath test with mammography could potentially reduce the number of needless mammograms and breast biopsies that are now performedwith a commensurate reduction in radiation exposurediscomfortcomplications of biopsiesand costs to the health care system