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PANDEMIC RESPONSE


generally meaning they can be taken orally. PLA2 is associated with inflamma- tion, other impairments and destruction in the lung, characteristic of acute respiratory distress syndrome. COVID-19 is one of several diseases that results in acute respi- ratory distress syndrome, which leads to the degradation of lung function, inad- equate oxygen supply and frequently, severe long-term breathing problems and even death.


EMERGENCY USE AUTHORIZATION


The BioFire Defense COVID-19 test was authorized for emergency use on March 23 by the FDA. The test is performed on the BioFire FilmArray instrument, which is already present in many DOD facilities. (Photo courtesy of BioFire Defense)


Together with the industry partner, Ophi- rex, Inc., WPAC PMO is working to develop varespladib as an acute respiratory distress syndrome preventative and treat- ment for COVID-19 patients. Te intent of drug treatment is minimized hospital- ization, critical care treatment and survival of COVID-19 patients. While PLA2 is a major component of snake venom, humans also produce PLA2. For us, it acts in a pro-inflammatory cascade and in disintegration of lung surfactant, a protec- tive layer that prevents fluid retention in the lungs. PLA2 inhibition is therefore hypothesized to reduce inflammation and protect or restore surfactant to aid lung function.


The three WPAC projects selected to receive Tier 1 acquisition program invest- ments are:


Te phospholipase A2 (PLA2) inhibitor, varespladib, for SARS-CoV-2-related acute respiratory distress syndrome treatment. Acute respiratory distress syndrome is marked by inflammation and fluid build- up that diminishes oxygen supply and causes lung dysfunction.


FDA approval of the BioFire Defense COVID-19 test using the statutory 510(k) pathway with Sample Type Expansion under emergency use authorization. Te 510(k) pathway is one mechanism for attaining FDA approval.


The SARS-CoV-2 Rapid Diagnos- tic Lateral Flow Tests for direct antigen detection and serology. A lateral flow diag- nostic test is essentially a "test strip" where a patient sample and sample buffer, liquid, is applied to one end of the strip, which then indicates a positive or negative result.


PLA2 Inhibitor for SARS-CoV-2-related acute respiratory distress syndrome— varespladib


Te secreted PLA2, varespladib, for SARS- CoV-2-related acute respiratory distress syndrome treatment is a small-molecule drug that dampens activity of the molecule called phospholipase A2. Small-mole- cule drugs have a low molecular weight,


“This test detects SARS-CoV-2


nucleic acid with a high degree of specificity and sensitivity. The virus can’t hide from this test.”


https://asc.ar my.mil 47


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