PANDEMIC RESPONSE
otherwise be advantageous. On October 14, 2020, USAMRAA issued a contract to BioFire Defense to support investiga- tion of the use of its COVID-19 test with nasal swabs, throat swabs, sputum and saliva—the contract value of those efforts is $1 million.
“Our objective is to wring every bit of value we can out of this test. Our users deserve nothing less,” said Snyder.
SARS-CoV-2 Rapid Diagnostic Lateral Flow Tests for direct antigen detection and serology
The SARS-CoV-2 Rapid Diagnos- tic Lateral Flow Tests for direct antigen detection and serology includes two point- of-care diagnostic tests that will be able to identify persons infected with and infer recent or prior infection with SARS- CoV-2. Tese tests are the SCoV-2 Ag Detect and SCoV-2 Ab Detect, and both will be able to provide results within 15 to 30 minutes of sample collection.
Collected by nasopharyngeal swab, the SCOV-2 Ag Detect
is a direct
antigen-based test that uses a proprie- tary dipstick-like test to detect several SARS-CoV-2 antigen targets present in respiratory samples.
Te SCoV-2 Ab Detect is also a dipstick- like serology test that will use blood collected by finger stick to detect SARS- CoV-2-specific immunoglobulin M and immunoglobulin G antibodies in indi- viduals who meet either clinical or epidemiological criteria to infer recent or prior infection in accordance with FDA guidelines.
Leveraging its existing indefinite deliv- ery and indefinite quantity contract with InBios International, USAMMDA awarded a task order on June 15, 2020,
for $11.9 million to support the develop- ment of both of these diagnostic tests to achieve emergency use authorization and ultimately 510(k) clearance with the FDA. Te DHA is funding development activ- ities occurring in the 2020 fiscal year for emergency use authorization.
approach to fighting the worldwide COVID-19 pandemic.
The WPAC group works together to develop and deliver infectious disease drug treatments, vaccines and
diagnostics to protect and sustain our nation’s warfighters.
To support and fund fiscal year 2021- 2022 development activities to achieve FDA 510(k)-clearance, USAMMDA has partnered with the U.S. Department of Health and Human Services’ Biomedi- cal Advanced Research and Development Authority.
Te intent is to improve testing to deliver faster, more accurate detection of SARS- CoV-2. Tis can streamline surveillance of virus transmission, minimizing the COVID patient’s time in quarantine, reducing asymptomatic contact and reliev- ing the burden on testing labs.
CONCLUSION Te Department of Defense is commit- ted to protecting the health and safety of our warfighters, as well as to leveraging our unique capabilities and partnerships that strengthen the whole-of-government
“USAMMDA teams work every day to develop and deliver a broad array of lifesav- ing medical products for our warfighters,” said Col. Gina Adam, USAMMMDA commander. “Te WPAC PMO’s efforts showcase this breadth and the develop- ment of promising technologies to save lives across the nation.”
Te successful development of these proj- ects is intended to benefit both military and civilian populations. With a mission to develop and deliver quality medical capabilities to protect, treat and sustain the health of our nation’s service members, USAMMDA remains focused on provid- ing life-saving drugs and devices that meet or exceed the intended requirements of the DOD. Without question, the men and women of the WPAC PMO team serve to highlight the determination and profi- ciency of the entire organization.
For more information on the Warfighter Protection and Acute Care Project Management Office and other projects being developed by the U.S. Army Medi- cal Materiel Development Activity, visit the USAMMDA website at https://www.
usammda.army.mil/.
CAREY A. PHILLIPS is chief of public affairs for
Materiel Development Fort
the U.S. Army Medical Activity,
Detrick, Maryland. She has been with USAMMDA for the past 12 years, having previously served in the U.S. Navy as a mass communications petty officer, second class. She holds a B.A. in visual communications from Framingham State College in Framingham, Massachusetts and an M.S. in management with a concentration in marketing from University of Maryland, University College.
https://asc.ar my.mil 49
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