Hakim M.,Russell Berrie Nanotechnology Institute |
Broza Y.Y.,Russell Berrie Nanotechnology Institute |
Barash O.,Russell Berrie Nanotechnology Institute |
Peled N.,Tel Aviv University |
And 4 more authors.
Chemical Reviews | Year: 2012
An emerging approach for diagnosing LC relies on volatile organic compounds (VOC), viz. organic compounds with relatively high vapor pressure or volatility, that can be detected in the headspace of cancer cells or blood samples, and/or in the exhaled breath. Identification, separation, and integration of the peaks in measured chromatograms for each sample. This might involve the use of Gaussian and non-Gaussian peak-fitting software, algorithms for the numerical calculation of the peak area, and algorithms for background compensation. Using internal standards might improve the reliability of the results, allowing a compensation of spectral shifts prior to the peak integration. The available statistical tests differ in the assumptions concerning the tested groups or populations: Gaussian and non-Gaussian populations, paired and unpaired groups, comparison between two or more groups. Source
Agency: Department of Defense | Branch: Defense Advanced Research Projects Agency | Program: SBIR | Phase: Phase II | Award Amount: 750.00K | Year: 2007
The technical problem: In the event of a terrorist attack with a “dirty bomb”, there would be an urgent need to distinguish between those who have and have not been exposed to radiation, in order to perform rapid triage. First responders and emergency health workers would require a biological dosimetric test for radiation exposure that is rapid, accurate, and non-invasive. The opportunity: a mobile breathalyzer could potentially provide a non-invasive radiation bio-dosimeter by measuring volatile organic compounds (VOCs) in the breath that are biomarkers of oxidative stress. The rationale: Radiation exposure results in increased oxidative stress. Hydroxyl radicals are generated by ionizing radiation either directly by oxidation of water, or indirectly by the formation of secondary partially reactive oxygen species (ROS). These compounds cause lipid peroxidation of cell membranes, liberating volatile n-alkanes and their metabolites that are excreted in the breath. Results of the Phase I research provided proof of principle that irradiation in humans resulted in significant changes in breath VOCs consistent with increased oxidative stress The proposed research: In Phase II, we will establish the dose-effect relationships between irradiation and changes in the breath test, and to determine the time relationships of these changes.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 102.50K | Year: 2010
DESCRIPTION (provided by applicant): Background: An advanced breathalyzer system has been developed to collect and analyze volatile organic compounds (VOCs) in alveolar breath in picomolar concentrations (parts per trillion). This technology has made it possible to identify breath biomarkers of diseases including lung cancer, breast cancer, and pulmonary tuberculosis. The problem: These tests employ laboratory-based technology that is slow and expensive, requiring highly trained staff and costly instrumentation. A new solution: The Remote Diagnosis System (RDS): The RDS is a rapid and cost-effective system for point-of-care breath diagnostics. It employs a portable Breathscanner that collects, concentrates, and analyzes breath biomarkers. Data are uploaded via the internet to a central computer that interprets the data with a diagnostic algorithm, and transmits a report to the user by e-mail. Advantages of the RDS: 7 Patient-friendly - breath testing is intrinsically safe, painless and non-invasive 7 User-friendly - clinical staff can be rapidly trained to operate the RDS 7 Convenient - the RDS operates anywhere, in a small footprint of table-top space 7 Rapid response - breath samples are analyzed and interpreted in minutes at the point-of-care 7Cost-effective - low capital cost of instrumentation, compared to laboratory assays 7 Safe - the RDS instrument employs non-inflammable helium carrier gas A new application of the RDS- Detection of breast cancer: In a pilot study, a laboratory-based breath test employing accurately identified women with breast cancer. In a recent validation study, the breath test identified breast cancer with accuracy superior to imaging with film or digital mammography. A point-of-care breath test yielded similar results, demonstrating the feasibility of detecting breast cancer with the RDS. Clinical role of the RDS: Breath testing is an ancillary procedure that is complementary to, not a substitute for, breast imaging or biopsy. The RDS could dramatically reduce utilization of these tests by identifying high-risk patients who require further testing, while safely excluding low-risk patients who do not. Short-term objectives: In Phase I, we will evaluate the RDS for: a. technical feasibility at three geographically diverse academic clinical sites, and b. clinical value in a pilot study of women with breast cancer versus cancer-free controls Long-term objectives: a. Scientific: Validate the RDS as a new tool for detection of breast cancer. b. Regulatory: Obtain FDA approval of the RDS for clinical use. c. Commercial: Market the RDS in the USA and overseas. PUBLIC HEALTH RELEVANCE: The Remote Diagnosis System (RDS) is a rapid and cost-effective system for point-of-care breath diagnostics. It employs a portable Breathscanner that collects, concentrates, and analyzes breath biomarkers of disease. Data are uploaded via the internet to a central computer which then transmits a report to the user by e-mail. We will evaluate the RDS at three clinical sites for technical feasibility, and for detection of women with breast cancer.
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.07M | Year: 2016
DESCRIPTION provided by applicant The clinical problem Breast cancer is the commonest cancer in women in whom it is second only to lung cancer as a cause of cancer death Mammography is the mainstay of screening for breast cancer though its value is limited by its large number of false positive and false negative findings A new solution the problem The combination of two diagnostic tests with different biological mechanisms can be more sensitive and specific than either test employed alone The BreathLInk breath test for biomarkers of breast cancer could potentially increase the sensitivity and specificity of mammography and significantly reduce the number of false positive and false negative test results arising from mammography Goal of the research We 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 alone We will achieve this goal by performing BreathLink breath tests in women at five sites who are having mammography for breast related symptoms or signs e g breast mass Expected outcomes of the research We 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 alone This research could establish a new paradigm for detecting women with breast cancer The combination of an intrinsically safe breath test with mammography could potentially reduce the number of needless mammograms and breast biopsies that are now performed with a commensurate reduction in radiation exposure discomfort complications of biopsies and costs to the health care system PUBLIC HEALTH RELEVANCE BreathLink is a rapid point of care breath test for biomarkers of breast cancer that could reduce the number of false positive and false negative test results arising from mammography The combination of the BreathLink with mammography could potentially reduce the number of needless mammograms and breast biopsies that are now performed reducing radiation exposure discomfort complications of biopsies and costs to the health care system
Menssana Research, Inc. | Date: 2013-03-06
A tool for telemedicine including an improved breath collection system of human breath to facilitate the analysis of volatile organic components (VOCs) contained in human breath in which breath tests can be performed at remote sites for rapid detection of different diseases. The system can include a standoff breath collection device including an arcuate structure for concentration and analysis of volatile organic components (VOCs) at the point-of-use that avoids the use of mouthpieces found in conventional breath collection apparatuses.