@StateDept Official Touts “Robust Health Care System”, Talks BioFire FilmArray For COVID19 Testing at FS Posts

 

Via SSDO Special Briefing, March 24, 2020

QUESTION:  Hi, guys.  Following up a little bit about what Matt was talking about, when it comes to these embassies overseas, I want to clarify something we talked about yesterday.  It sounds to me like, for the moment, these staff members are completely reliant on local healthcare infrastructure for testing and treatment should they get ill.  Is that correct?  And are you planning to stand up any kind of medical capacity at these embassies or is the plan to just try to bring them home and treat them here if we need to?  Thank you.

SENIOR STATE DEPARTMENT OFFICIAL:  Okay.  Well, working overseas for the State Department or for any government agency in a country that may have poor medical resources has been challenging all along.  We have a process in place that generally we try and make sure that people with underlying medical conditions would only go to places where they have local resources that could take care of them.  Obviously COVID presents new challenges.

We do have, like I said earlier, a robust health care system, a medical program.  We have doctors, nurse practitioners, physician assistants, and nurses deployed at almost every mission around the world.  We rely also heavily on local staff that we employ in our health units.  And they’re the frontline.  I mean, they’ll see the patients first, whether it’s COVID, whether it’s anything else, and either provide care directly or to find the best local care available.

In COVID obviously, as health infrastructure overseas breaks down, it’s more of a challenge.  In terms of testing, we have up to now relied on local sources, local – maintain facilities for testing.  I’m not sure if we’ve actually sent back samples to the CDC in Atlanta, but that’s an option as well.  But I heard news today that there’s been approval for a use of a device called BioFire FilmArray, which is an apparatus that we actually have in a number of embassies overseas, so lab testing machines doesn’t require – it requires expertise, but it doesn’t require a special license to use.  And BioFire company just had their approval given for use of – for creation of a cartridge to test for COVID.  So going forward, we anticipate we’ll be able to do a lot more of our own monitoring and testing.  Thank you.

During the briefing, the SSDO said, “ COVID obviously, as health infrastructure overseas breaks down, it’s more of a challenge.”  True, but he did not really answer  the “is the plan to just try to bring them home and treat them here if we need to?” part of the question, did he? 
Also the maker of the BioFire® COVID-19 Test said on its website that it is yet to be submitted for Emergency Use Authorization in the second quarter of 2020, while the BioFire® Respiratory 2.1 Panel us expected to be submitted to the FDA for EUA in the third quarter of 2020:
BioFire® COVID-19 Test

In collaboration with the U.S. Department of Defense, BioFire Defense is developing a fully-automated, sample-to-result assay for the specific detection of SARS-CoV-2, the causative agent of COVID-19. This assay is designed to run on both the BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems and will deliver results in about an hour. The BioFire COVID-19 Test is being developed on an accelerated timeline, with submission for Emergency Use Authorization (EUA) anticipated in Q2 of 2020.

BioFire® Respiratory 2.1 Panel

In parallel, BioFire Diagnostics is developing new SARS-CoV-2-specific assays for addition to the BioFire® FilmArray® Respiratory 2 (RP2) Panel. This new panel will be named the BioFire® Respiratory 2.1 (RP2.1) Panel and is being developed for both the BioFire® FilmArray 2.0 and BioFire® FilmArray Torch Systems. In addition to the detection of SARS-CoV-2, the BioFire RP2.1 Panel will detect 21 additional respiratory pathogens to help clinicians quickly rule in and rule out other common causes of respiratory illness in about 45 minutes. Development of the BioFire RP2.1 Panel is also occurring on an accelerated timeline, and submission to the FDA for EUA and 510(k) clearance is anticipated in Q3 of 2020.

In the meantime, SSDO also said, “In terms of testing, we have up to now relied on local sources, local – maintain facilities for testing.”
What happens in places where there is no local testing?
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