Rapid detection and surveillance of infectious agents is an unsolved challenge in the medical and biodefense communities. The lack of rapid and accurate diagnostics at the point of care (POC) has led to mismanagement of the newly developed drugs rendering them ineffective through the emergence of drug resistant pathogens. The PI proposes the development of a prototype instrument that does not require highly skilled technicians for POC settings. Issues which will be addressed in the development of the functioning field-deployable prototype include: (1) optimization of the illumination uniformity, (2) auto-focusing onto the sample, and (3) mechanical stability of the setup. The proposed instrument will be integrated with proven sample preparation techniques and evaluated against the bench top platform.
Successful development and launch of the proposed prototype will drastically improve the speed of disease diagnosis, expedite treatment options and ultimately produce better patient outcomes at a lower cost to the healthcare system. The simplicity and ease-of-use of the proposed system augurs well for the use of the technology in point-of-care settings and in providing improved healthcare in developing countries. In the proposed work, the industry participation and mentorship utilizing experienced entrepreneurs and executives will enhance the undergraduate and graduate educational experience by providing an environment for fostering entrepreneurialism and a parallel pipeline for talented engineers and scientist to industry. The strong ties of the executive mentorship program to the Boston business community also contributes to the economic development of the region by launching new businesses and job creation.
The global 2009 H1N1 influenza pandemic, the variant-strain Ebola virus epidemic of 2007, and the most recent Ebola outbreak have demonstrated the need for rapid and sensitive point-of-care (POC) virus detection technology. Filling this need can greatly reduce the probability of epidemics by: (1) facilitating the immediate containment to minimize transmission, (2) confirmatory diagnosis, and (3) providing appropriate treatment regimen. Currently, early detection prior to antibody generation requires real-time PCR, which is time consuming and requires trained personnel working in centralized laboratories. Current rapid tests done at the POC have limited benefits as they are only accurate for symptomatic patients who are producing the test’s specific antibodies or require large virus titers to correctly diagnose the disease. The team has developed a bench-top label-free virus detection platform that can approach the sensitivity of PCR with the advantages of improved speed, multi-pathogen discrimination, and is run by automated software. We have completed the proof-of-concept, demonstrating single-virus detection capability with minimal sample preparation in a variety of bodily fluids, including blood, serum, and plasma. We have developed a prototype instrument that does not require highly skilled technicians for POC settings. Issues that were addressed in the development of the functioning field-deployable prototype included: (1) optimization of the system for operation by a high school graduate technician (2) disposable microfluidic cartridge to contain and process the sample under test. The industry participation and a former post graduate’s spin out of a company based upon this technology application, NexGen Arrays, LLC provided the graduate students and undergraduates with hands on experience in many different areas of the project. One student worked directly with a design firm as an unpaid intern to learn how commercial design firms approach a technology prototype project. Mentorship from experienced entrepreneurs and executives provided an environment for fostering entrepreneurialism, eventually leading to a mentor position on an I-CORPS team. Through NSF supplements for REU students and participation in the NSF RET in Biophotonics Sensors and Systems, this team had the advantage of including undergraduates and middle school and high school teachers in the interdisciplinary team that developed a prototype instrument for diagnostics. A major result from the project was the formation of a startup company has enabled a pathway for transfer of the technology into the commercial domain to allow for insertion into clinics and further collaboration as the technology develops even further. The simplicity and ease-of-use of the diagnostic tool argues well for the use of the technology in point-of-care settings and in providing improved healthcare in developing countries. The team's prototype and program was involved in NSF AIR's Product Showcase in May 2013 and the NSF article provides more details: www.nsf.gov/news/news_summ.jsp?cntn_id=128025&org=NSF&preview=false. In addition, David Freedman, founder of NexGen Arrays provided an interview with NSF that can be viewed here: www.nsf.gov/news/news_videos.jsp?cntn_id=128025&media_id=74324&org=NSF.
