Today, U.S. Rep. Bill Pascrell, Jr. (D-NJ-09), a member of the House Ways and Means Subcommittee on Health, announced that the U.S. Department of Health and Human Services (HHS) awarded a $223,029 Small Business Innovation Research (SBIR) grant to Fort Lee-based Menssana Research, Inc. to fund the development and validation of a rapid and accurate onsite breath test for chronic obstructive pulmonary disease (COPD).

"I commend Menssana Research for taking this important step in better diagnosing and treating this life-threatening disease," said Rep. Pascrell.  "By investing in medical research, we are making a commitment to protecting the health of all Americans while injecting much-needed capital into our fragile economy. It's a win-win. Small businesses like Menssana are the backbone of our economy, and I will continue to fight to ensure they have the federal resources they need to foster innovation in the medical field while creating good jobs right here in New Jersey."

Through this Phase 1 SBIR grant, Menssana will work to develop a rapid new point-of-care breath test, the BreathLink system, to potentially facilitate earlier diagnosis of COPD, monitor response to treatment, and identify subtypes of patients who will benefit from tailored treatments. This research will evaluate the BreathLink point of care system for its ability to provide a safe and cost-effective new test for biomarkers of COPD. The objective of Phase 1 SBIR grants is to establish the technical merit, feasibility, and commercial potential of the proposed federal Research/Research and Development (R/R&D) efforts and to determine the quality of performance of the small business awardee organization prior to providing further Federal support in Phase II.
According to Menssana Research CEO Dr. Michael Phillips, "Breath testing is an excellent way to screen for diseases in their earliest stages. In addition, it is safe, painless and non-invasive. All a patient does is breathe normally for two minutes."

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.

SBIR grants are part of a highly competitive federal program that encourages domestic small businesses to engage in R/R&D that has the potential for commercialization. Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization. By including qualified small businesses in the nation's R&D arena, high-tech innovation is stimulated and the United States gains entrepreneurial spirit as it meets its specific research and development needs. Currently, eleven Federal agencies participate in the program.

Menssana Research develops breath tests for diseases including breast cancer, lung cancer, tuberculosis and heart transplant rejection. The 6-minute Breath test has European Regulatory approval (CE Mark) for both breast cancer and pulmonary tuberculosis. The FDA has approved the Heartsbreath test for heart transplant rejection with a Humanitarian Device Exemption.

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