Heading off Variant Spread: Point-of-Care Antigen Detection
Ms. Calli M. Rooney
Warfighter Protection and Acute Care Project Management Office
From Combat & Casualty Care, Summer 2021
Ms. Calli M. Rooney, product manager in the Warfighter Protection and Acute Care Project Management Office at the U.S. Army Medical Materiel Development Activity, is responsible for the execution of Army acquisition programs to meet cost, schedule and performance requirements for the advancement of medical solutions for the Warfighter. She holds an M.S. in biotechnology and an MBA from the University of Maryland University College. A member of the Army Acquisition Workforce, she holds Defense Acquisition Workforce Improvement Act Level III certification in Program Management and has achieved Program Management Professional certification.
In May, the U.S. Army Medical Research and Development Command’s (USAMRDC) Medical Materiel Development Activity (USAMMDA) Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO), along with its commercial partner InBios International Inc., announced the U.S. Food and Drug Administration (FDA) had granted Emergency Use Authorization for the COVID-19 Point-of-Care (POC) Antigen Detection Test. This novel test, administered via a nasal swab specimen, can rapidly diagnose whether or not an individual may be COVID-positive.
Combat & Casualty Care spoke with Calli M. Rooney, health science product manager for USAMMDA’s WPAC PMO, serving as lead for the organization’s Rapid Human Diagnostics (RHD) program. As the DoD’s primary resource for military medical solutions, USAMMDA was tasked with developing vaccines, treatments, and diagnostics for COVID-19 since the beginning of the global pandemic. The organization was also called upon to develop and supply critical medical items such as ventilators and personal protective equipment. Rooney discussed the use and importance of the COVID-19 POC test, and further provided much background on how the project came to fruition within such a short timeframe. In light of the increasing numbers of vaccinated individuals throughout our nation, Rooney believes the availability and use of this COVID-19 antigen detection test will become more important in the months ahead.
C&CC: As product manager within the WPAC PMO, please describe your role and responsibilities with regard to the COVID-19 POC Antigen Detection Test project.
Ms. Rooney: My official position title is “Health Science Product Manager,” but in short, I am a product manager within USAMMDA’s Warfighter Protection and Acute Care Project Management Office. One of my responsibilities is to lead and manage the Rapid Human Diagnostics (RHD) program. When the COVID pandemic started, the Defense Health Agency provided CARES Act funding to the WPAC PMO’s RHD program for the development of a rapid diagnostic test for COVID-19. We leveraged an existing collaboration and contract vehicle with InBios International Inc. to quickly award a task order for the development of a COVID-19 point-of-care antigen detection test.
C&CC: Please describe the COVID-19 POC test, including its purpose and benefit.
Ms. Rooney: The COVID-19 POC Antigen Detection Test is a rapid diagnostic for the qualitative detection of the SARS-CoV-2 (COVID-19) antigen in direct anterior nasal swab specimens. This test can be used in individuals suspected of having COVID-19 within five days of symptom onset, or in individuals who do not display symptoms but may have other epidemiological reasons to suspect COVID-19 infection. This test is limited for use in authorized laboratories in point-of-care patient settings, but it is available for use by both the U.S. Military and U.S. civilian populations. Use of this test among our Servicemembers while stationed at home or overseas will help to stop the spread of the illness throughout our military, which in turn will help to promote the readiness of our forces.
C&CC: Please provide background on why this test was created. Is this type of test unique?
Ms. Rooney: This test was created as part of the whole-of-government response to the COVID-19 pandemic. The task order with InBios International Inc. was awarded in June 2020, and within 10 months, we were able to achieve EUA from the FDA. There are similar and comparable tests on the market authorized for emergency use by the FDA in response to the COVID-19 pandemic and many others are still in development. What makes this test unique is that there is no sample preparation or instrumentation required. It can be used for testing both symptomatic and asymptomatic individuals and results are extremely fast (20 minutes); in most cases, an individual will have their test results before leaving the doctor’s office.
C&CC: Please elaborate on the FDA Emergency Use Authorization status, and please speak about when this test may be FDA cleared or approved for widespread use.
Ms. Rooney: The InBios qualitative SARS-CoV-2 antigen detection test received FDA Emergency Use Authorization (EUA) on May 6, 2021, and is authorized for use in laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) that meet the FDA’s requirements to perform waived, moderate-to-high complexity tests. It is also authorized for use in point-of-care patient care settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation. Post-EUA requirements from the FDA include: 1) Completion of the remainder of flex studies within one month of EUA, 2) completion of real-time stability study and must notify the FDA of testing results as the results become available, and 3) conduct studies to support an expanded use within six months of EUA. The expanded use will be to add an “at-home” or “over-the-counter” use claim to the EUA.
C&CC: Given that many people have been vaccinated against COVID-19, and things are improving across the country, can this test be modified to detect other types of viruses as well?
Ms. Rooney: No, this test is specific to COVID-19; however, it is likely to be able to detect the multiple variants of COVID-19 that continue to emerge.
C&CC: What lies ahead for this particular test? Any similar projects upcoming?
Ms. Rooney: Yes, our commercial partner is likely to pursue the expanded use claim I mentioned earlier. Furthermore, the test will undergo the completion of additional clinical studies to support FDA 510(k) clearance, which is a requirement by the FDA for manufacturers to register and notify the FDA of their intent to market a medical device to the public for commercial distribution.
C&CC: As we wrap up our conversation, would you like to add anything else?
Ms. Rooney: Yes, I’d like to say that this effort has been a whole-of-government approach from the beginning, and so many people deserve credit for the success of this COVID-19 test. While our WPAC PMO team serves as the programmatic lead for this Army RHD program, it was initially funded by the Defense Health Agency through the CARES Act, which led to its achieving its FDA EUA status. Additionally, this project is moving forward through funding provided by the Biomedical Advanced Research and Development Authority to achieve 510(K)-clearance.
Without question, this effort truly is an example of our great teamwork throughout the government and the DoD. Our collective work will certainly help to stop the spread of COVID-19 throughout our nation, and perhaps even the world. I’m proud to be a part of this outstanding project.