This Small Business Innovation Research (SBIR) Phase I project develops a device to diagnose lung infections from cough with a focus on active Tuberculosis (TB). TB diagnostics inherently have a trade-off between practicality (time, resources, training, cost) and performance (sensitivity and specificity). Furthermore, most current TB diagnostics rely on sputum samples, which are difficult to collect (low practicality) and are usually contaminated by saliva, lowering their quality (low performance). The proposed device is practical: a patient wears a disposable mask and coughs naturally into a novel impactor that breaks up the cough droplets in air and collects their DNA. The impactor avoids both sputum samples and microfluidics for lysing cells. The proposed device?s high performance is based on the automation of the collected DNA with a nucleic acid amplification test (NAAT) specific to TB and multi-drug resistant TB (MDR-TB). The research objectives of the Phase I feasibility project are (1) to simulate a patient?s cough using pulsed nebulization of TB simulant suspension and (2) to determine the limit of detection of the impactor-biosensor system. Anticipated fluorescence results will determine the number of simulated coughs needed for detection.
The broader impact/commercial potential of this project is in eliminating TB. TB is a contagious disease that causes 2 million deaths annually. Approximately 9.3 million people worldwide develop TB every year, of which 4.4 million are undiagnosed. Improving TB diagnostics results in 625,000 annually adjusted lives saved worldwide, and elimination of TB from industrialized countries. The served available market for active TB diagnostics comprises more than 175M tests with a total value of $700M and a potential to reach a total available market of 280M tests. The market can be segmented based on three market needs: (1) improving the active TB diagnostic cycle of care, (2) avoiding sputum collection, and (3) avoiding sputum induction and bronchoalveolar lavage. The proposed device provides a cost effective solution to all three needs. The development of this TB diagnostic device can have wider implications in the cough-sample preparation/diagnostics of other lung infections such as Pneumonia.
Tuberculosis is a contagious disease that causes 2 million deaths annually. Approximately 9.3 million people worldwide develop TB every year, of which∼ 4.4 million are undiagnosed. Of the 88M sputum samples collected worldwide, 29M are collected using sputum induction meth- ods. These methods are unpleasant and expensive. Deton’s initial target is to replace the sputum induction samples. The served available market worldwide for our device in this niche market reaches $360M of which $33M are in the US. Deton’s device is the only product that delivers a safe, effective and comfortable way of collecting samples from these patients to primary health- care clinics at a lower cost of current sputum induction methods. The development of Deton’s device can have wider implications in the diagnosis of other lung infections such as Pneumonia. This Small Business Innovation Research Phase I project develops a device to collect DNA from a patient’s cough droplets as a sample for diagnosing active Tuberculosis (TB). All current diagnostics, with the exception of radiology, rely on sputum samples. Sputum samples are difficult to obtain in a significant portion of the population (> 20%) and suffer from low quality, thereby affecting the diagnostic yield of current tests. Deton is developing a novel sample collection device that circumvents the disadvantages of sputum by collecting bacterial DNA directly from a patient’s cough. Using Deton’s solution, a patient wears a disposable mask and coughs naturally for ~ 10 min. The sample is extracted from the device and diagnosed using current tests. The research objectives of the Phase I project were (1) to simulate a patient’s cough using pulsed nebulization of TB simulant suspension and (2) to determine the limit of detection of the impactor-biosensor system. Deton has been able to achieve these objectives during the performance period.
