This talk will describe a sample-to-answer system that uses gel drop arrays to detect mutations in drug-resistant strains of Mycobacterium tuberculosis. These hemispherical porous gel drops are printed on off-the-shelf films and made of flexible laminates that can be produced with reel-to-reel manufacturing.

MBio Diagnostics has developed a portable cartridge and reader system that delivers multiplexed biomarker immunoassays with a rapid, simple workflow.  The technology is described and examples are provided demonstrating system performance for host response biomarker panels associated with acute infection and sepsis. The MBio platform technology is uniquely positioned to bring multiplexed immunoassays to point-of-care and resource-limited settings.

Realizing the promise of new point-of-care diagnostic technologies requires their tailoring to operate in rural, austere, and otherwise underserved locations and, often, with a very different complement of healthcare providers and other caregivers.  This session will describe efforts to expand the use of telehealth and other point-of-care diagnostic technologies in underserved and under-resourced settings, including examples of what has worked and what has not.

There has been great advancement within the field of radiation biodosimetry in the last decade towards development of new medical countermeasures for radiological and nuclear events. Use of radiation biodosimetry diagnostics for mass casualty screening of large populations has been identified as one of the most critical elements of emergency response for future disasters involving radiation exposure. Our work has centered on development of new dose prediction animal models for unknown received radiation dose using a proteomic approach. The current work examines application of previously characterized dose prediction algorithms to a more heterogeneous population using a diverse panel of biomarkers. Our findings illustrate the challenges and potential solutions for adapting dose prediction algorithms for mass screening in the field setting.

The human innate immune response is capable of universal and rapid recognition of all pathogens. Mimicking this recognition in the laboratory can allow for universal diagnosis of all infection. Our team has developed novel assays for the tailored recognition of pathogen and host biomarkers that are involved in innate immunity. In addition, we have developed a fieldable and ultrasensitive waveguide-based biosensor, with associated sample processing methods for use in remote regions, in order to quickly and effectively guide decision making. Application of these technologies, challenges therein and outcomes of field validation studies will be presented.

The Biomedical Advanced Research & Development Authority's new Division of Research, Innovation, and Ventures in the Department of Health and Human Services is funding development and testing of wearable technologies for pre-symptomatic diagnosis of disease. We are funding multiple projects seeking to improve healthcare and health outcomes by enabling Americans to monitor their own health.

We have developed a device which, using the Bio Impedance Spectroscopy (BIS), passes 256 different MHz to a human body which is noninvasive in nature. Using this, we can calculate intra-cellular and extra-cellular fluid. Using this information, we can detect lymphedma and CHF earlier, thus preventing Lymphedema for the cancer and hospitalization for CHF patients. This presentation will discuss the details around this.

RAIN is a 501c3 non-profit non university-affiliated biotechnology incubator with programs to train and educate future scientists. It has created 4 laboratories to support the needs of growing companies. In addition, its educational and outreach initiatives create awareness within the community of its scientific activities. The lab management policies come from RAIN leaderships' past experiences in academic, industry, and government labs, with modifications made to adapt to lower resources without compromising safety or security. As a result, RAIN's labs have more in common with Do It Yourself (DIY) labs than traditional institutional labs. RAIN has continued to grow with the DIY Bio movement by being involved in the synthetic biology-based International Genetically Engineered Machine competition. Synthetic biology is often associated with DIY biology due to its open-source culture and many DIY labs utilize it in their community projects. Participation in the competition for the past 3 years has allowed RAIN to connect with experts in the field and associated fields like biosafety and biosecurity. RAIN has also created space for other small business developing biotechnology tools.  RAIN's environment allows communication with other entities and monitoring of safety and ethical practices in this rapidly developing sector.

Starting in 2007, the National Institute of Biomedical Imaging and Bioengineering (NIBIB), established a network of centers to enhance the progression of promising technologies to the commercial market. The Johns Hopkins Center for Point of Care Tests for Sexually Transmitted Diseases is one of those centers. It provides resources to industry and organizations at no charge to speed the progression of promising technologies to commercialization. These resources include technology comparisons, access to physicians and other end users, de-identified clinical samples, implementation guidance, critical path funding and other resources to help companies reach the market faster.

Knowing whether a sample is safe or contains a potential pathogen is essential in potential bioterrorism incidents. Conventional approaches of sequencing everything and comparing against large databases are both slow and expensive. By using third-generation sequencing and looking for a relatively small set of known protein functional domains of toxins, we can detect potential toxins in near-real time - that is, in a few seconds, as the sample is being sequenced. This technology can be done with a small hand-held sequencer and a portable computer, all completely offline, and locally powered.

Timely and efficient identification of pathogenic microorganisms is of high importance for public health and safety. Current bacterial pathogen analysis relies on phenotypic identification of the bacterial species by Gram staining and culturing that are sometimes inconclusive, time-consuming, and equipment-demanding, which delay treatment and limit their application to laboratory settings. Most of the currently developed sensing methods are based on optical and/or electrochemical techniques, where selectivity is achieved by using antibodies, their fragments, natural or engineered peptides, or aptamers. Important limitations for using these elements as a part of the sensor are cost, stability and adaptability: they often require special handling and are specific to only a narrow range of analytes. In our work, we present a sensor array for multivariate analysis based on small-molecule ratiometric fluorescent dyes. We demonstrate the sensor's ability to differentiate bacterial species and recognize their Gram status. We also expand the sensor's functionality to include analysis of mixed bacterial samples.

Improving pathogen coverage is essential for optimizing point-of-care diagnostics. We have developed a viral mosaic probe pipeline that generates high-coverage probe sequences for detection of highly diverse and rapidly mutagenic viruses. In addition, the pipeline incorporates thermodynamics for multiplex applications. The molecular probes generated are compatible with traditional molecular diagnostic instruments and are currently used in our biosensor for ultra-sensitive detection of influenza viruses.