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Phillips M.,Menssana Research, Inc. | Phillips M.,New York Medical College | Basa-Dalay V.,De La Salle Health Sciences Institute | Bothamley G.,NHS England | And 5 more authors.
Tuberculosis | Year: 2010

Background: Volatile organic compounds (VOCs) in breath may contain biomarkers of active pulmonary tuberculosis derived from the infectious organism (metabolites of Mycobacterium tuberculosis) and from the infected host (products of oxidative stress). Methods: We analyzed breath VOCs in 226 symptomatic high-risk patients in USA, Philippines, and UK, using gas chromatography/mass spectroscopy. Diagnosis of disease was based on sputum culture, smear microscopy, chest radiography and clinical suspicion of tuberculosis (CSTB). Chromatograms were converted to a series of 8 s overlapping time slices. Biomarkers of active pulmonary tuberculosis were identified with a Monte Carlo analysis of time-slice alveolar gradients (abundance in breath minus abundance in room air). Results: Breath VOCs contained apparent biomarkers of active pulmonary tuberculosis comprising oxidative stress products (alkanes and alkane derivatives) and volatile metabolites of M. tuberculosis (cyclohexane and benzene derivatives). Breath biomarkers identified active pulmonary tuberculosis with C-statistic (area under curve of receiver operating characteristic) = 0.85 (i.e. 85% overall accuracy, sensitivity = 84.0%, specificity = 64.7%) when sputum culture, microscopy, and chest radiography were either all positive or all negative. Employing a single criterion of disease, C-statistic = 0.76 (smear microscopy), 0.68 (sputum culture), 0.66 (chest radiography) and 0.65 (CSTB). Conclusion: A breath test identified apparent biomarkers of active pulmonary tuberculosis with 85% accuracy in symptomatic high-risk subjects. © 2010 Elsevier Ltd. All rights reserved.


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.


Phillips M.,Menssana Research, Inc. | Phillips M.,New York Medical College | Cataneo R.N.,Menssana Research, Inc. | Saunders C.,University of Western States | And 3 more authors.
Journal of Breath Research | Year: 2010

We sought biomarkers of breast cancer in the breath because the disease is accompanied by increased oxidative stress and induction of cytochrome P450 enzymes, both of which generate volatile organic compounds (VOCs) that are excreted in breath. We analyzed breath VOCs in 54 women with biopsy-proven breast cancer and 204 cancer-free controls, using gas chromatography/mass spectroscopy. Chromatograms were converted into a series of data points by segmenting them into 900 time slices (8 s duration, 4 s overlap) and determining their alveolar gradients (abundance in breath minus abundance in ambient room air). Monte Carlo simulations identified time slices with better than random accuracy as biomarkers of breast cancer by excluding random identifiers. Patients were randomly allocated to training sets or test sets in 2:1 data splits. In the training sets, time slices were ranked according their C-statistic values (area under curve of receiver operating characteristic), and the top ten time slices were combined in multivariate algorithms that were cross-validated in the test sets. Monte Carlo simulations identified an excess of correct over random time slices, consistent with non-random biomarkers of breast cancer in the breath. The outcomes of ten random data splits (mean (standard deviation)) in the training sets were sensitivity = 78.5% (6.14), specificity = 88.3% (5.47), C-statistic = 0.89 (0.03) and in the test sets, sensitivity = 75.3% (7.22), specificity = 84.8 (9.97), C-statistic = 0.83 (0.06). A breath test identified women with breast cancer, employing a combination of volatile biomarkers in a multivariate algorithm. © 2010 IOP Publishing Ltd.


Grant
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


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 231.34K | Year: 2015

DESCRIPTION provided by applicant The problem Active pulmonary tuberculosis TB is a leading cause of death from infectious disease throughout the world Two billion people one third of the worldandapos s population are infected with Mycobacterium tuberculosis and million died from the disease in Sputum microscopy and culture remains the mainstay of laboratory diagnosis accompanied more recently by nucleic acid amplification tests NAAT However sputum culture may require several weeksandapos incubation while NAAT is rapid but expensive An ideal diagnostic test would be sensitive and specific for active pulmonary TB non invasive suitable for use in low resource countries faster than sputum culture and less expensive than NAAT A new solution to the problem Mycobacteria manufacture unique volatile organic compounds VOCs as metabolites in vitro A sensitive breath test employing gas chromatography mass spectrometry GC MS identified VOC biomarkers of active pulmonary TB similar to VOC metabolites of M tuberculosis detected in vitro BreathLink is a new point of care breath test employing GC with surface acoustic wave detection GC SAW and it delivers results in six minutes In a multicenter study in India UK and the Philippines BreathLink identified active pulmonary TB with sensitivity and specificity The high sensitivity of the BreathLink suggests that it could be used as a andquot rule outandquot test to identify the majority without TB Experimental plans BreathLink will be validated at medical centers in India and the Philippines for its ability to andquot rule outandquot subjects who are not infected with active pulmonary TB I the Phase I unblinded study the andquot rule outandquot cutoff points will be validated by comparison to the outcomes of chest x ray and with sputum testing with microscopy culture and NAAT In the Phase II blinded study a larger study will be performed with view to confirming the efficacy of BreathLink as a screening andquot rule outandquot test for active pulmonary TB Potential impact of the research If confirmed as effective a andquot rule outandquot breath test could reduce the current high cost of finding new cases of active pulmonary TB and dramatically reduce the deaths and disabilities that TB now causes in high burden countries where health care dollars are scarce PUBLIC HEALTH RELEVANCE BreathLink is a six minute point of care breath test for volatile organic compounds VOCs that are biomarkers of active pulmonary tuberculosis TB As an accurate new andquot rule outandquot test BreathLink could reduce the current high cost of finding new cases of active pulmonary TB and dramatically reduce the deaths and disabilities that TB now causes in high burden countries where health care dollars are scarce


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.


Trademark
Menssana Research, Inc. | Date: 2012-02-06

Medical devices used for the collection, recording, concentration and analysis of volatile organic compounds in human breath; medical systems comprising medical devices, computer hardware, computer software and peripherals, for use in the collection, recording, concentration and analysis of volatile organic compounds in human breath.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 223.03K | Year: 2014

DESCRIPTION (provided by applicant): The clinical problem: Chronic obstructive pulmonary disease (COPD) affects an estimated 16 million people in the USA, and it is projected to increase from the sixth to the third most common cause of death worldwide by 2020. COPD imposes a burden on patients by restricting their everyday activities (e.g. walking up stairs), as well as a financial burden on society because hospitalizations for treatment of exacerbations are increasing. However, COPD is frequently underdiagnosed and more sensitive and specific biomarkers of the disease could potentially reduce its burden on patients and society, facilitate earlier diagnosis, monitor response to treatment, and identify subtypes of patients who will benefit from tailored treatments. A new solution the problem: Recent studies have shown that human breath contains many volatile organic compounds in low concentrations, and some of them are biomarkers of diseases including COPD. More than 70 studies of breath VOC bio


Grant
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.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 2.98M | Year: 2010

DESCRIPTION (provided by applicant): The clinical problem: Approximately 3,500 people worldwide now undergo heart transplantation every year. Most heart transplant recipients are monitored for the development of organ rejection with a series of endomyocardial biopsies during the first twelve months after operation. This procedure is invasive, painful, and potentially hazardous. There is a clinical need for a test to provide the same information about heart transplant rejection as an endomyocardial biopsy, but without its invasiveness, pain, or hazards. A solution to the clinical problem: The Heartsbreath test is an intrinsically safe, painless, and non-invasive breath test for heart transplant rejection that employs volatile biomarkers of oxidative stress. In multicenter clinical studies, the Heartsbreath test was sensitive and specific for Grade 3 heart transplant rejection (now known as Grade 2R). The Food and Drug Administration (FDA) approved the Heartsbreath test for clinical use with a Humanitarian Device Exemption (HDE). The marketing problem: Even though FDA has approved the test for clinical use, the Heartsbreath test is not yet employed in clinical practice because it is not yet reimbursed by insurers. Medicare has not approved a National Coverage Determination (NCD) of the Heartsbreath test because of its HDE status. A solution to the marketing problem: Medicare now offers a pathway to insurance reimbursement of the Heartsbreath test through its program National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development . This program offers a pathway to an NCD for the Heartsbreath test by developing and capturing additional patient data. Experimental plans: We will validate the accuracy of the Heartsbreath test as a predictor of Grade 2R (formerly known as Grade 3) heart transplant rejection, in order to fulfill Medicare NCD requirements. We will perform a cross-sectional multicenter study of 1,000 anonymized patients who have received a heart transplant during the preceding 12 months. We will perform a Heartsbreath test on these patients prior to an endomyocardial biopsy performed as part of their regular clinical care, and compare the results of the two tests. The long-term aims of the research are a. Scientific: To validate the accuracy of the Heartsbreath test as a breath test for heart transplant rejection b. Commercial: To obtain Medicare NCD for reimbursement of the Heartsbreath test, and market the test nationally and internationally. The importance of the research: In clinical practice, the Heartsbreath test could provide a completely safe and non-invasive ancillary test for heart transplant rejection that would reduce the pain and morbidity associated with endomyocardial biopsy, while also reducing the costs of clinical care PUBLIC HEALTH RELEVANCE: The Heartsbreath test is an FDA-approved breath test for heart transplant rejection that employs breath biomarkers of oxidative stress. It could provide a safe and non-invasive ancillary test for heart transplant rejection that would reduce the pain and morbidity associated with endomyocardial biopsy, and also reduce the costs of clinical care. We will validate the Heartsbreath test as a predictor of Grade 2R heart transplant rejection in order to fulfill Medicare requirements for reimbursement.

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