Respiratory infections are a leading cause of mortality and morbidity worldwide. Respiratory pathogenic bacteria, such as Streptococcus pneumoniae and Haemophilus influenza, are the main causes for chronic respiratory conditions, such as Chronic Obstructive Pulmonary Disease (COPD). Advanced stages of these conditions lead to poor quality of life, limited flexibility in practicing daily physical activity, and an increased risk of death. Altogether, these disease conditions lead to considerable healthcare costs, both for the patient and for the healthcare system.
In many instances, routine tests do not allow rapid accurate identification of viruses or bacteria. In the absence of clear surrogate clinical markers that could discriminate between various sources of respiratory infections, over-treatments with antibiotic prescriptions are evidenced in a large portion of the treated cases. On top of that, inappropriate over-use of antibiotics is associated with high healthcare costs and contributes to the development of resistant pathogens and side effects or further health complications. Unfortunately, the available tests and methods does not enhance the detection of many respiratory infections, primarily due to technological limitations and their complexities, leading to delays in diagnosis and/or discrimination between various type of the respiratory infection.
Accordingly, there has been an increasing interest in recent years in improved methods for diagnosis of many metabolic and infectious diseases. These new methods are expected to be non-invasive and inexpensive, while allowing: (1) screening of high-risk populations for emerging diseases; (2) early detection and prediction of diseases; and (3) evaluation and monitoring of therapy efficacy. Furthermore, assimilation of these methods into diagnostic routines should reduce the use of less efficient methods, leading to more rapid and convenient diagnosis, with financial savings in healthcare systems.
- A proto-type of novel, cross-sensitive nanowire-based sensors to be integrated in the ‘NA-NOSE’ trained to detect target disease related mixtures of biomarkers;
- Novel algorithms to reduce the dimensionality of the ‘NA-NOSE’ information to safely distinguish between healthy and unhealthy individuals, as well as between different sub-types of disease (e.g. different types of cancer);
- Novel, company-manufactured, ready-to-use integrated ‘NA-NOSE’ devices, to be tested in clinical studies/environments for large-scale screening and research;
- A method based ‘NA-NOSE’ to detect and improve the outcome of therapies;
- A method based ‘NA-NOSE’ to guide surgeons during surgery based on tissue analysis; and
- A method for identification of new biomarkers that are related to different stages of target diseases.
Professor Hossam Haick at the Technion – Israel Institute of Technology, has developed and tested the NA-NOSE technology for detecting the volatile biomarkers of diseases. The nanotechnology-based breath test was successfully applied in numerous research phase studies for a wide variety of diseases. In many diseases, the NA-NOSE has shown an ability to distinguish between “healthy” and “disease” states as well as between the different stages of the disease, mainly between the early stages and the advanced stages of the disease. Biomarker-based breath testing using the NA-NOSE technology holds future potential as a cost-effective, fast and reliable diagnostic test for early disease and infection detection as well as ongoing monitoring of disease progression. The NA-NOSE technology would be suitable for use outside of specialist settings and could significantly reduce budgetary burdens at many regional and national healthcare organizations.
Specifics of licensed technology:
- Novel, cross-sensitive nanowire-based sensors integrated in the ‘NA-NOSE’ device trained to detect target disease related mixtures of specific biomarkers;
- Novel algorithms to reduce the dimensionality of the ‘NA-NOSE’ information to safely distinguish between healthy and unhealthy individuals, as well as between different sub-types of disease (e.g. different biomarkers of conditions per licensing agreement);
- ‘NA-NOSE’ prototype devices, to be tested in clinical studies/environments for diagnosis and research;
- A method for identification of new biomarkers that are related to different stages of target conditions.
Breathtec’s entry into a licensing agreement will further investigation and advance development of NA-NOSE disease detection capabilities for the detection of the following indications from exhaled breath: Streptococcus; Methicillin resistant (MRSA); Staphylococcus; Enterococcus; Vancomycin resistant (VRE); Pneumococcus; Hemophilus influenza (HiB); Chickenpox; and the common cold. The testing of the novel ‘NA-NOSE’ prototypes will be carried out in three separate trials:
- Outpatient clinic strep throat study.
- Hospital inpatient MRSA and lower respiratory infection study.
- 2nd outpatient clinic viral infection respiratory infection study.
The easy-to-use (no medical specialists required) ‘NA-NOSE’ technology detects specific disease biomarkers based on a change in the blood chemistry and/or metabolic activity (which is reflected in the chemical composition of the exhaled breath and cell/tissue headspace) rather than by other forms of imaging or invasive blood analysis, thus permitting earliest detection and improved treatment outcomes.
The following outlines general plans for development activities required for pre, launch, and post commercialization activities.
- Outpatient pilot strep study for detection of throat streptococcus infection and normative data.
- Design/build for device suitable for outpatient point of care use in accordance with regulations for FDA class II/III device.
- Batch production of devices in compliance with ISO13485 standard for FDA and Medical Device Directive 93/42/EEC.
- Start pilot inpatient trail for hospital based infections for MRSA, lower respiratory tract infections (HiB, Pneumococcus, staphylococcus enterococcus and zoster). Tandem outpatient pilot viral study for zoster, and common cold.
- Wider scale Phase 1 strep study trials as required by FDA for premarket approval (assuming no predicate device for 510(k)*) to demonstrate device is safe and effective for intended use of strep throat infection.
- Regulatory clearance of the strep device in USA then EU for strep throat.
- Manufacture point of care device for strep throat.
- Regulatory clearance of the inpatient device in USA then EU for MRSA and lower respiratory infections.
- Regulatory clearance of the outpatient viral device in USA and EU for zoster and common cold.
- Manufacture of point of care device for inpatient and viral device.
- Post-market surveillance strep, inpatient and viral study tracking (likely required).
*NB this device may be labelled by FDA as a class III device if there is no predicate at the time of application and this would require a petition to lower class or ‘de novo’ 510(k)
The effectiveness of the ‘NA-NOSE’ in detecting volatile biomarkers specifically and selectively provides a launch pad for identifying other indications of the target conditions which may lead to improvements that could include preventative or ameliorative opportunities prior to full disease onset.
Lead Researcher: Prof. Hossam Haick
Breathtec licenses NA-NOSE technology to detect indications of Streptococcus; Methicillin resistant (MRSA); Staphylococcus; Enterococcus; Vancomycin resistant (VRE); Pneumococcus; Hemophilus influenza (HiB); Chickenpox; and the Common Cold.