The COVID-19 Pandemic: Acquisition of Diagnostic Equipment and Testing Assays for COVID-19 Lays the Groundwork for Vaccine and Treatment Success

By Erik Heine, JPM CBRN Medical Strategic Communications

In early 2020, the world as we knew it began to change. Lockdowns, mask mandates, and travel bans became the new normal as the world fought to slow the spread of the coronavirus (COVID-19). Priorities began to shift, and the development of safe and efficacious vaccines and therapeutics for COVID-19, along with the diagnostic capability needed to identify it, moved to the number one position on the Department of Defense’s (DOD) priority list. The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) has a long-standing history of developing medical countermeasures to combat deadly biological threats. Moreover, in 2020, this elite team of scientists, medical specialists, acquisition professionals, and military experts struck significant blows against this deadly and rampant virus. During the pandemic, in addition to medical and military subject matter experts, acquisition professionals rose to the forefront. DOD medical acquisition is not typically the stuff of myth or legend, and in the movies, you aren’t likely to see acquisition professionals wearing superhero-style hazardous materials suits, researching deadly biological agents, or running clinical trials. They aren’t on the front lines administering their miracle vaccines to patients, and in fact, there are many people who may not even fully understand what “acquisition” in this context means. Medical acquisition professionals, through their efforts to ensure that everything necessary is available when needed, save lives too.

As the race to defeat COVID-19 with safe and effective vaccines and therapeutics continued at breakneck speeds, another critical piece of the equation was proving to be equally important: diagnostic equipment and assays for testing. The JPM CBRN Medical is led by Colonel (COL) Ryan Eckmeier. He is in charge of the organization that is leading the U.S. government’s vaccine, diagnostics, therapeutics, and chemical defense pharmaceutical efforts for CBRN defense. Early on in the pandemic, COL Eckmeier noted the special importance of diagnostic equipment, assays, and acquisition: “Without accurate diagnostic equipment and approved assays, being able to differentiate between those who have COVID-19 and those who don’t isn’t possible. The key ability to ultimately overcome the virus is accurate diagnostics to ‘bridge the gap’ until targeted therapeutics and vaccines are on board.” COL Eckmeier leaned on his acquisition crew; Dr. Jason Opdyke, JPM CBRN Medical’s Joint Product Lead for Diagnostics, was already following the news closely. Dr. Opdyke reached out to other members of his team, including Deputy Joint Product Lead Joel Selzer, Assistant Program Manager Christopher Joyal, and Test and Evaluation Lead Royce Bruce. Over the next 12 months, Dr. Opdyke and his team of acquisition professionals placed highly sought after diagnostic devices into the hands of medical professionals at both DOD and civilian institutions and treatment facilities. They employed creative and unconventional acquisition methods to accelerate delivery of critical diagnostic and assay capabilities, which allowed patients to know their COVID-19 status, ultimately helping to slow the spread and “flatten the curve.”

Thanks to existing industry partnerships, the team was able to rapidly develop and distribute brand new diagnostic equipment and assays that could specifically detect SARS-CoV-2 (the virus that causes COVID-19), in record time. Partnering with other U.S. government agencies made these diagnostic capabilities available for civilian testing, contributing greatly to the country’s pandemic response, with the ultimate goal of securing and improving overall American public health. As COL Eckmeier so often reminds his team, “No one in this space does this alone.” The team, working with the Biomedical Advanced Research and Development Authority (BARDA), leveraged an existing Other Transaction Authority (OTA) with Cepheid, Inc. and developed a rapid COVID-19 diagnostic capability. Through this collaboration, Cepheid completed test optimization/validation activities for their GeneXpert® assays, and on March 20, 2020, almost two months to the day of the first confirmed U.S. coronavirus case, the U.S. Food and Drug Administration (FDA) officially granted an Emergency Use Authorization (EUA) for its use in the COVID-19 outbreak; typically, this process can take years to complete. This capability allowed for timely testing by National Guard Bureau (NGB) personnel who were postured to assist with COVID-19 testing in the most stressed areas of the U.S. The team purchased sixteen Cepheid systems for the NGB, for use in multiple states, to directly support the civilian population. “We had to utilize every possibility within our reach” said Dr. Opdyke; “OTAs, working with previously unused suppliers and vendors, networking with folks who just might be able to help… we knew we had to pull out all the stops to get ahead of this virus.”

Just three days later, on March 23, 2020, the JPM CBRN Medical’s existing industry partner BioFire Defense, LLC, with the assistance of DOD funding, was also granted an EUA from the FDA for the use of their COVID-19 assay, using their FilmArray® diagnostic system. This commercial analyzer (the BioFire FilmArray 2.0, also known as the Next Generation Diagnostics System 1 (NGDS 1) within the DOD), uses assay panels along with polymerase chain reaction (PCR) technology to identify biological pathogens in clinical samples. In total, over a nine month time period, the team developed and procured more than one million tests for the DOD’s COVID-19 response, and purchased nearly 300 additional diagnostic systems to augment existing capabilities. In addition, when the demand for the test and system access began to greatly outweigh the testing capacity, the team explored pooled testing possibilities that streamlined the testing process, and saved thousands of tests as well as hours of system time. These tests, systems, and pooling protocols slowed the virus’ spread, preserved readiness and strengthened national security. As the pandemic accelerated, the team continued to award and execute numerous procurement contract actions within days of receiving direction from the Assistant Secretary of the Army for Acquisition, Logistics and Technology, as well as the Services, to deliver these tests along with medical diagnostic systems to DOD medical facilities and deployed military medical units worldwide. “Due to the speed at which this virus was spreading, we had to innovate, allocate, integrate and create” said Joyal; “we had to be ready to respond to whatever was thrown at us.”

Even though Hollywood is probably not quite ready to write the JPM CBRN Medical Acquisition Team story for the big screen, the team’s efforts during this pandemic will undoubtedly become legendary. COVID-19 is still with us, and as the fight carries on, the team will continue to leverage their project management, contracting, regulatory, quality assurance, and logistics expertise to provide critical diagnostic capabilities to support service members, civilians, and the nation as a whole. Hopefully soon, we can all breathe a little more easily, literally, and the diagnostics professionals can focus their efforts on once again providing U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. Until then, the JPM CBRN Medical team continues to hustle, “nevertheless” delivering what is needed to get this virus (and its variants) under control. Without the efforts of COL Eckmeier, Dr. Opdyke, and this incredible group of acquisition professionals, the light at the end of the tunnel would certainly be much dimmer and more distant.

AUTHOR


MR. Erik Heine supports the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical at Fort Detrick, Maryland. He is a Project Management Professional (PMP) and holds a B.B.A. in Computer Information Systems/Decision Support Systems from James Madison University, in Harrisonburg, Virginia.