Breathtec Leads the Breath Analysis Race for Medical Diagnostics

Introduction

Breathtec is a medical diagnostics corporation which focuses on the commercialization of top of the range breath analysis devices in order to detect serious illnesses. In the past, physicians have learned to assess conditions by breath odor among other things and these changes in breath included production of volatile organic compounds characterized by low molecular weight and high vapor pressures. The VOCs easily cross the blood air barrier in the lungs and are excreted along with the exhaled air thus altering the exhaled levels of volatolome. According to Linus Pauling’s findings, exhaled human breath has hundreds of volatile molecules in low concentrations and since then the field of gained attention as one of the noninvasive means of medical diagnosis.lungs-detail

As such, the exhaled breath samples were analyzed using to methods being a quantitative means and spectrometry or qualitative methods utilizing artificial olfactory systems known as electronic noses. The research resulted in a number of peer reviewed reports illustrating the possibility of the detection and classification of specific conditions such as cancer by the comparison of exhaled breath samples with the use of these health controls. In an increasingly outward approach, diagnosis requires the profiling of specific biomarkers which are emitted from the cells which are in the area that has been affected. These volatile biomarkers can be detected either via the exhale breath or directly from the headspace of the cells.

Early diagnosis and medical applications

Screenshot 2016-06-13 15.40.59Some of the advantages of breath analysis include the noninvasive means of diagnosis and it can be done anywhere and anytime. Analysis time is short and it can be repeatedly done without causing harm to the body of the patient. No breath testing has grown in popularity over the past few years with evolving technologies in sensor and sampling designs.

Breath analysis has the potential to be of global benefit and is the future of medical diagnosis. In most situations, an early diagnosis would mean better prognosis, however, it is sometimes difficult and expensive to test for illness. At the present, breath analysis would present a better way to spot conditions including lung, breast cancer, kidney disease and heart failure. For one, researchers have developed a breath test for breast cancer and it is as accurate as x-ray tests routinely used in health facilities. This would reduce the need for mammograms which tend to be uncomfortable. The same has been achieved for liver disease. The test has been said to provide a relatively accurate estimate for fibrosis and the levels of inflammation. This test would be needed to assess the earlier stages of liver disease to cirrhosis.

The opportunity

Considering its aims to deliver a noninvasive, alternate diagnostic screening aid for conditions like cancer and heart disease, Breathtec is among the forefront in the diagnostic field. Apparently, the company has the option to get a key patent from the University of Florida along with DR. Yost known as the Partial Ovoidal FAIMS Electrode. FAIMS is a mass spectrometry technique which takes advantage of the differences in ion mobility at a high level of electric fields in order to separate ions in the millisecond timescale for someone’s breath after the liquid chromatography separation and before it was introduced to a mass spectrometer.  In this case, FAIMS is an acronym for Field Asymmetric Ion Spectrometry. This device is like a coin sorting machine instead of the fact that ions are the ones being separated using electrical fields. At the time the molecules in a person’s breath have been filtered, they would be identified. Considering the ion filter, only the molecules of interest would be detected.

Now there are biomarkers which are there to find the diseases by revealing the molecular patterns or markers within the blood that can be measured through breath. This is because there is an interface that goes between the blood to breath via the alveoli in the lungs. The molecules with these markers diffuse out of the blood and into the air which is then taken out through exhaling. The blood to air barrier exists within the gas exchange region within the lungs.

As stated earliworking-in-laboratoryer, the company is sitting on a University of Florida patent known as the ‘Partial Oviodal FAIMS electrode’. However, this is not the only research effort the company is looking into within the field. We should also consider the fact that Breathtec is not the only company within the breath analysis field which is pouring funds into research and development for better and more cost effective means of breath analysis and diagnosis. Messana, for example happens to be a private corporation which has had some success in advancing breath testing technology. It is championing a Breath-link system which is currently in clinical studies phase for the detection of disease by the use of breast cancer and heart transplant rejection. It has not been cleared for use though by the FDA. The other company is Owlstone which is advancing on the breath analysis front. It also uses FAIMS as part of its operation like Breathtec, but the main difference between the two is the inner-working of the device.

According to CEO of Breathtec, Michael Costanzo, Breathtec would allow direct device validation using mass spectrometry for the identification of analyses. The device from the company is able to run by itself or as an MS instrument which depends on the manner of analysis which is needed. This is what the Lonestar would not have as a standalone device which is not able to attach to the MS instrument.

The other thing is while Owlstone produces a smaller device, experiments have found that it is not sufficient to monitor the endogenous compounds crucial for the detection of conditions. As such, even though the Lonestar system is able to analyze a sufficient range of the volatile combinations found in a large concentration within the human physique, it does have some issues with the differentiation of lower volatility compounds and at a lower concentration.

Stages of development

The team as led by Dr. Yost has the objective of producing a prototype in the form of a breath testing device which is handheld. The research conducted by the team pertaining to miniaturization is currently in the advanced phases. An interim desktop device, however, would be able to commercialize the technology. The goal of Breathtec is to come up with a handheld device for use in the detection of conditions much like a breathalyzer would for detecting the levels of alcohol in a person’s breath. It would do this by giving real time breath analysis which is quite game changing for the health sector. In the past year, the company was able to complete two transactions for financing projects, thus coming up with a total of 3 million dollars. This would help it in its quest to become one of the most disruptive factors in the diagnostic field. Given time, doctors would not require a majority of tests for any of the major conditions, which would put a number of corporations out of business to say the least. By developing this prototype, the company is illustrating how it is able to detect in a noninvasive and analytic manner, most life threatening illnesses.

If the miniaturized handheld breathalyzer is developed, the technology would revolutionize the way that patients are tested for a number of conditions and thus reduce the diagnosis costs to the patient.

Prof. Hossam Haick of the Technion Institute

Now recently, the company announced that Professor Hossam Haick of Technion University and the developer of the NA-NOSE disease detection sensor has joined the research team as a consultant. Professor Haick is going to be on the frontline of the company’s NA-NOSE disease detection system and is going to be involved with the design of the clinical trials which are going to be undertaken by the corporation. This individual that came up with the NA-NOSE technology at Technion is a respected doctor and expert in the field of nanotechnology and noninvasive disease diagnosis. Apparently, Breathtec entered a licensing agreement on April 11th with the Technion Research and Development Foundation Limited. It is an Israeli private company as a subsidiary of the Israel Institute of Technology with respect to nonexclusive license to particular Technion patents and related to know ho as connected with the disease detection sensors and the detection of some indications from exhaled breath.

As stated earlier, the company holds the alternative to acquire the essential University of Florida patent which has been clarified as the “Partial Ovoidal FAIMS Electrode.” The team in charge of managing the project includes credible professionals from the University of Florida. The agreement with Technion is going to provide Breathtec with a two prong attack plan. While they are busy with the development of the miniature FAIMS prototype, they are going to push forward with tech that already has millions of dollars invested. This would provide the company, the ability to rapidly go ahead with NA-NOSE technology through means of clinical trials and regulatory approvals within the country at least.