Menssana Research, located in the small business incubator program at New Jersey Institute of Technology (NJIT), is seeking companies to license its federally-approved Heartsbreath test, a life-saving technology. Since 1985, Menssana has been developing a unique series of two-minute breath tests. The Heartsbreath Test is the company’s first to secure Food and Drug Administration (FDA) approval. Several more tests, including one for lung cancer, are in the pipeline.
The Heartsbreath test determines whether patients with heart transplants are showing signs of rejecting their new heart. It is non-invasive and risk-free. FDA approved the test for clinical use as an adjunct to biopsy.
“We are at the point where it makes sense to interest other companies in licensing this breath test so that it can be sold to hospitals and doctors,” said Menssana founder and CEO Michael Phillips, MD. Phillips is a clinical professor of internal medicine at New York Medical College, Valhalla, NY, and a Fort Lee resident. The Enterprise Development Center (EDC) at NJIT, which keeps new technology businesses alive and growing in New Jersey, operates the incubator program.
“One day I hope to see our breath testing equipment, which is relatively small and easy to use, in every physician’s office and hospital lab,” Phillips added. “Our tests can not only save lives, but they can make medicine less frightening for millions of people,” (EDITOR'S NOTE: To interview Phillips either in his lab or by telephone, contact Sheryl Weinstein at 973-596-3436.)
“Doctors have used breath to uncover disease since the time of Hippocrates in Ancient Greece. We’ve known for more than 2000 years that a diabetic’s breath smells fruity, like rotten apples. We now know that it’s because of the acetone in their breath. Patients with failing kidneys have breath that smells like urine, and diseases of the liver and the lungs also have distinctive odors. We’ve taken ancient medical knowledge and combined it with 21st century science, and the result is an amazing new technology for detecting diseases”.
Phillips has published research in peer-reviewed medical journals—including the prestigious journals Chest (2003) and Lancet (1999) —showing that the breath test can also detect lung cancer, breast cancer, tuberculosis, and pre-eclampsia, a life-threatening complication of pregnancy. Although other researchers around the world are working on similar devices, Phillips said that his company has developed the most advanced technology for breath testing, and has tested it more thoroughly in humans with diseases.
Besides the Heartsbreath test, Phillips is also developing breath tests for other diseases, including lung cancer, breast cancer, tuberculosis, cardiac chest pain and oral malodor. The lung cancer test is the furthest along in development. “This test could potentially save many lives,” said Phillips, “because if lung cancer is detected at an early stage and treated aggressively, the chances of survival are greatly increased”.
The basis of these breath tests is a process called oxidative stress, in which a disease generates excessive amounts of free radicals, molecules with unpaired electrons that make them highly reactive. Free radicals oxidize cell membranes, releasing the volatile organic compounds that are exhaled in the breath. Phillips developed the world’s most sensitive breathalyzer by capturing and concentrating volatile organic compounds in the breath onto activated carbon, then separating them with a gas chromatograph and identifying them with a mass spectrometer. The test detects around 200 different volatile organic compounds in a single sample of breath, in distinctive patterns that can determine health or illness, Phillips said.
From a patient’s viewpoint, a breath test can reduce risk, pain and cost. For example, patients who undergo heart transplants must be checked frequently for rejection of the new heart with a test known as endomyocardial biopsy. This is expensive as well as invasive. The cardiologist must insert a catheter into a vein in the neck, pass it down into the heart, cut several samples from the inner surface of the new heart, and remove them through the catheter. A pathologist then examines these samples under a microscope for signs of rejection.
But using the Heartsbreath test, the patient simply breathes for two minutes in a plastic tube. The volatile organic compounds in the breath are captured in a trap, a stainless steel cylinder the size of a cigarette. A sample of room air is collected on to a separate trap. The samples are then sent to the laboratory for chemical analysis, followed by data analysis with specialized computer software.
Our test is faster, easier, less painful, and a costs a lot less money than a biopsy. Also, it is not going to create future complications for the patient,” said Sukhjit Sidhu, MD, a physician who works in the Menssana Breath Research Laboratory.
If the concept sounds familiar, it is. The breath test is modeled on the breathalyzer machines that police carry around in their cars to test drunk drivers. “The only difference,” said Phillips, “is that our breath test is a billion times more sensitive than the breathalyzers the police use. Thanks to modern analytical technology, we can detect chemical markers of disease that the body produces in minute concentrations.”
Since 1988, the EDC has helped inventors move innovative products out of the lab and into the marketplace. A high-tech business incubator housed in a trio of Newark buildings, the EDC provides office and lab space, financial help, business and technical services, and the shared expertise of the center’s managers.
EDC is open to for-profit enterprises, operating fewer than four years and offering new technologies. The companies must have a business plan, and show evidence that they will be likely to benefit from EDC’s three-year tenancies. EDC aims to reduce risk for fledgling entrepreneurs, ultimately creating businesses that will generate jobs and bolster New Jersey’s economy. To date, EDC has graduated more than 75 companies.