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POINT-OF-CARE BREATH TEST FOR DISEASES

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
96509
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
RR030689
Solicitation Year:
N/A
Solicitation Topic Code:
NCRR
Solicitation Number:
N/A
Small Business Information
MENSSANA RESEARCH, INC.
1 Horizon Road, Suite 1415 Fort Lee, NJ -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2010
Title: POINT-OF-CARE BREATH TEST FOR DISEASES
Agency: HHS
Contract: 1R43RR030689-01
Award Amount: $102,499.00
 

Abstract:

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 p ossible 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 instrumen tation. 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 uploade d 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 Us er-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 t est 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, de monstrating 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 a cademic 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 Breaths canner 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 feas ibility, and for detection of women with breast cancer.

Principal Investigator:

Michael Phillips
2018867004
MPHILLIPS@MENSSANARESEARCH.COM

Business Contact:

Michael M. Phillips
mphillips@menssanaresearch.com
Small Business Information at Submission:

MENSSANA RESEARCH, INC.
MENSSANA RESEARCH, INC. 1 HORIZON RD, STE 1415 FORT LEE, NJ 07024

EIN/Tax ID: 122311733
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No