In April 2020, Congress appropriated $1.5B to NIH including approximately $660M for developing COVID-19 diagnostic tests. NIH turned to CIMIT, the Coordinating Center of an established NIBIB program called the Point of Care Technology Research Network, to design and stand up a new program to support the development, commercialization, and production scale-up of accurate, rapid assays that directly detected the presence of SARS-CoV-2 with antigen and molecular tests. The goal was for approximately 2% of the U.S. population (6 million persons) to be tested per day, with more tests ready for rapid deployment in proportion to national demand. Significantly, the program envisioned having tests on the market by the end of 2020, which was widely seen as aspirational considering that the typical time for bringing a diagnostic test to the American market was 3-7 years. By 12/28/21, not even 20 months since its launch, RADx Tech had reached the capacity to produce 1 billion COVID-19 diagnostic tests, supported 100 companies, and attained 35 FDA EUAs. As of this writing, RADx Tech is working to enable the deployment of 1 billion home-based tests to Americans as announced by President Biden. The work has had an unprecedented impact on individual and public health, the American economy, the approach of NIH to translational research, the public’s acceptance of home-based medical tests, and a new model of collaboration of multiple government agencies around an activity of national importance. These achievements were made possible at unprecedented speed and scale because of many innovative processes designed to combine the best of academic practices with the best of business practices.   

As is painfully clear with covid 19, developing the most sensitive and specific countermeasures and diagnostics for a given pandemic does not prepare us for the next emerging threat. There is a clear and imminent need for diagnostics and broad spectrum therapeutics to minimize the impact of emerging threats. Our team has been working on developing such tools, using the innate immune system as an inspiration for the development of the approach. The diagnostic strategies, and the applications to bacterial and viral pathogens will be discussed.

There are currently more than 2 million SARS-CoV-2 genomes available, with thousands of different COVID-19 Pango lineages, although only a few major clusters. Mutational hot spots along the genome show correlations with RNA structures. We find three major conclusions: this virus has a limited mutation repertoire with few mutations that become fixed; the viral genome undergoes parallel evolution frequently; and finally, we see little genomic recombination.

Pandemics and other disasters stress the ability of our healthcare system infrastructure, resources and staff.  This presentation will describe how the Army’s Telemedicine & Advanced Technology Research Center (TATRC) worked with industry and HHS/ASPR to rapidly develop and deploy the National Emergency Tele-Critical Care Network (NETCCN) to link remote critical care expertise to frontline clinicians in the fight against COVID-19.

The Johns Hopkins University Applied Physics Laboratory (JHU/APL) is part of the Johns Hopkins Center for Point-of-Care Tests Research for Sexually Transmitted Disease (STDs), hereafter known as the Center, and serves as the technical lead for the Technology Development Core.  The mission of the Center is to help companies accelerate their development and overcome/avoid potential hurdles that may arise.

To prepare for and to accelerate the public health response in the event of a future infectious disease epidemic or pandemic, BARDA’s Division of Research, Innovation, and Ventures (DRIVe) is interested in supporting the development of novel digital health and diagnostic technologies that can serve as the first line of defense and augment existing medical countermeasures. The presentation will focus on funding opportunities that are currently open at DRIVe.

The PCR testing revolution starts and ends with accuracy and affordability. Our technology works to reliably, accurately, and affordably detect infectious diseases—which leads to quicker treatment and recovery, increased peace of mind, and even lives saved. See how we’re making our tech accessible to all.

Many current POC diagnostic tests utilize isothermal PCR approaches and diluted samples which do not have good sensitivity and specificity, especially at low viral loads. INT has a fully automated diagnostic system that utilizes traditional PCR coupled with nested detection. A key feature of the system is sample processing incorporating, ultrasonic disruption, magnetic cleaning, concentration of nucleic acids, and a desalting column. This platform can process raw samples, including saliva, oral or nasal swabs, and sputum. Use of saliva provides less patient apprehension, critical in pediatric testing. Data will be presented on COVID-19 detection from saliva.  

Though LAMP technology is suitable for developing assays for POC, one disadvantage is that current LAMP methods can detect only one target/reaction. This is because current methods of detection for amplification products in a LAMP assay are not sequence-specific, thus unable to differentiate between multiple targets if amplified in a single reaction. To overcome this challenge, Varigen Biosciences has developed a novel approach for multiplexing LAMP assays. This method uses standard LAMP primer without any additional steps or probe/primers.

Kaya17 has developed a novel platform for disease testing. Currently, Kaya17 has a very accurate, 15-minute turnaround time, saliva-based test for COVID-19. We are developing a Quad test for InfluenzaA&B, HSV, and COVID-19.

Over the past two decades, the emergence of multi-omic technologies has revolutionized the field of medicine and has significantly impacted the pharmaceutical industry. However, drug development is not the only area transformed by these technological advances. It is also having a significant impact on the consumer products industry as well. In this presentation, I’ll describe the ongoing multi-omics program at P&G and discuss opportunities and challenges for at-home diagnostics development.

We developed a single-tube, multiplex reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay for SARS-CoV-2. In just 60 minutes, this RT-LAMP assay targets two unique SARS-CoV-2 genes and a human control gene. We utilize a novel end-point fluorescence technique called quenching of unincorporated amplification signal reporters (QUASR) to distinguish positive versus negative samples. This single-tube, multiplex assay can successfully identify SARS-CoV-2 in both purified samples and contrived clinical specimens.

FAST-NA Scanner adapts methods from cybersecurity to produce significant improvements in the detection of biological pathogens and toxins in nucleic acid sequences. Using these methods, minimum sequence length can be reduced from 200bp to 50bp while simultaneously reducing false positive rates below 2%. Moreover, detection speed is orders of magnitude faster than BLAST, allowing this to be applied not only to nucleic acid screening, but diverse other applications including combinatorial oligo screening, interpretation of sequencer reads, and screening of sample and design collections.

Next-Generation Sequencing (NGS) has such day Day Zero capabilities with the potential for broad and large-scale testing, however, it has limited detection sensitivity for low copy numbers of pathogens that may be present. Here we demonstrate that using CRISPR-Cas9  to remove abundant sequences that do not contribute to pathogen detection, NGS detection sensitivity is equivalent to RT-PCR. In addition, we show that this assay can be used for variant strain typing, co-infection detection, and individual human host response assessment – all in a single workflow using existing open-source analysis pipelines. This NGS workflow is pathogen agnostic and therefore has the potential to transform how both large-scale pandemic response and focused clinical infectious disease testing are pursued in the future.