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FDA Virtual Town Hall Series –

Immediately in Effect Guidance on 

Coronavirus (COVID-19) Diagnostic Tests

Moderator: Irene Aihie

July 8, 2020

12:15 pm ET

Coordinator: Welcome and thank you for standing by. At this time all participants are in a 

listen-only mode. During the Q&A session if you'd like to ask a question you 

may press Star 1 on your phone. Today’s call is being recorded if there are any 

objections, please disconnect at this time. And I like to turn the meeting over to 

Ms. Irene Aihie. You may begin.

Irene Aihie: Thank you. Hello. I am Irene Aihie of CDRH's Office of Communication and 

Education. Welcome to the FDA 16th in a series of virtual town hall meetings 

to help answer technical questions about the development and validation of 

tests for the SARS COV-2 during the public health emergency.

Today Timothy Stenzel, Director of the Office of In vitro Diagnostics and 

Radiological Health in the Office of Product Evaluation and Quality and Toby 

Lowe, Associate Director of the Office of In vitro Diagnostics and Radiological 

Health both from CDRH will provide a brief update. 

Following opening remarks we will open line for your questions related to 
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today’s discussion. Please remember that we are not able to respond to 

questions about specific submission that might be under review. Now I give 

you Timothy.

Dr. Timothy Stenzel: Welcome to our call today. We look forward to having great and productive 

dialogue with each caller. I would just ask that we, you know, continue along 

those veins and will all be great. You know, and otherwise we'll have to move 

to the next caller. And with that I will turn it over to Toby.

Toby Lowe: Thanks Tim. Thanks everyone for joining us this afternoon. I have a few 

updates to share. We’ve had some recent inquiries so I want to share that we are 

welcoming certain immediate requests for collection devices that would 

otherwise need a 510(k) such as saliva collection devices. If you’re interested in 

this please approach us through the templates email address and we can discuss 

if your device may be appropriate for that approach.

We see this approach as being helpful to developers that want to use these 

devices and eliminate some of the validations that might otherwise be required 

for each individual assay. And we’re also looking at other ways to ease the path 

to market for other devices during the emergency.

So for collection device manufacturers who are interested in pursuing this we 

suggest that you take a look at the EUA template for home collection. It may 

not be a perfect fit but that template does include a lot of information that we 

would want to see for standalone collection devices such as stability and 

usability data. So as we continue to work through this, we'll continue to provide 

additional information regarding the process.

And then moving on to some updates from last week and earlier this week we 

have updated FAQs and templates. So late last week we added an FAQ to 
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clarify the difference between surveillance, screening and diagnostic testing for 

COVID-19. We previewed that a little bit in the discussion last week on this 

call. And that last week and again earlier this week we provided updates to the 

molecular EUA template.

So the first update late last week was to add information about multi-analyte 

respiratory panels under EUA. As we approach flu season, we're encouraging 

developers to consider tests that will include SARS CoV-2 along with influenza 

and potentially other respiratory pathogens. And then the second update earlier 

this week was to include more detailed recommendations on validations for 

pooling. 

We’re encouraging commercial test kit manufacturers to submit EUA 

amendments to authorize pooling of your assays so that labs can implement this 

approach. That will be much more streamlined than that each lab having to 

perform their own validation and submit their own EUA to add pooling.

And then a few other updates, last week we also authorized CDC’s combination 

SARS COV-2 and influenza multiplex test. So that’s the third EUA that we’ve 

issued for a combination test like this. (Biofire) and Qiagen both previously 

added SARS COV-2 to their previously cleared respiratory panel. 

And last week we also issued an EUA for the second COVID-19 antigen test. 

That was to Becton Dickinson BD for their BD (Veritor) system for rapid 

detection of SARS COV-2. And then on Monday this week we issued a letter to 

clinical laboratory staff and healthcare providers about false positive results 

with one of the authorized BD molecular tests. 

And Tim mentioned that issue on last week’s town hall as well so that letter can 

be found on our Web site as well. And that’s all I have as an intro so we can turn 
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it over to questions.

Coordinator: The phone lines are now open for questions. If you’d like to ask a question over 

the phone please press Star 1 and record your name. Also please limit yourself 

to one question. If you’d like to withdraw your question press Star 2. Thank 

you. First question in the queue is from (Lily Wong). Your line is now open.

(Lily Wong): Thank you very much for taking my question and everything you and everyone 

at the agency is doing. My name is (Lily Wong) and I am from Boston 

University. A number of universities across the country are planning for the 

coming academic year and need to factor in testing. 

At Boston University we plan to perform high throughput SARS COVID 2 

PCR testing, about 5000 plus tests per day for our students, faculty staff and 

other members of our community as part of our fall 2020 return to campus plan.

As a testing lab we developed a PCR test for use in our high complexity CLIA 

lab for that purpose. We submitted a pre-EUA for our PCR test on June 19. It’s 

been two weeks and we have not yet been assigned to a reviewer so it is our 

understanding that FDA is prioritizing high throughput tests.

Our students, faculty and staff will start to return at the beginning of August so 

we're on a pretty tight timeline. My question is this - our students’ health and 

occupational health providers plan to issue standing physician orders to test 

members of our community as part of our screening program. Since our testing 

will be done under the physician orders does our test still need to have a claim 

for testing of asymptomatic? Thank you.

Dr. Timothy Stenzel: Well okay did you say you had an EUA or a pre-EUA?
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(Lily Wong): We submitted a pre-EUA on June 19.

Dr. Timothy Stenzel: Okay. So it was a question about what the testing plans should be. Is that the 

what the question - or was there full data in the application?

(Lily Wong): No we had...

Dr. Timothy Stenzel: Validation.

(Lily Wong): ...did not include score data in the pre-EUA. We were hoping to have a 

discussion with our assigned reviewer but we have not yet been assigned.

Dr. Timothy Stenzel: Yes so we are for - in the two week is for applications that have data that 

we're making those assignments for. But this is an important project so I would 

be curious and be happy to be involved and get on a call to verify any concerns 

you might have. 

We have provided a lot of templates and the most recent templates on Monday 

have to do with pooling and since you may be looking at pooling if you do 

5000 tests per day. And we hope that those details and the template on Monday 

really help folks out like you.

To answer your question on the standing order all authorizations are at the 

moment still prescription only, standing orders by physicians can be made. And 

yes that physician or that clinician can make that order can say that they would 

like asymptomatic individuals to be tested. And then the lab it comes to we're 

asking that they go ahead and test those samples and report out those results. 

And as long as the lab isn’t making the claim that they have a certain 

performance on asymptomatic patients then that’s all good. If a lab wants a 
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specific claim then we'll work with them. and our templates have the 

recommended validation for a lab or a kit manufacturer that wants to make a 

claim for an asymptomatic claim for their test. So the short answer is on them -

answer your questions are standing orders were fine and yes then they can order 

that asymptomatic testing.

And then our pathways, you may not know this, but it allows labs like yourself 

to validate their tests notifying us and then they have - and then you have - 15 

business days to submit their EUA occupation. And all the while they start 

testing and continue testing while we review the application. And this also 

includes pooling. Pooling falls within that guidance of saying it's validated 

pooling and then make the data 15 business days later.

You may have some questions that may not be addressed by our templates 

already and that’s why I’m willing to get on a call with you to go into more 

detail about that and likely the most efficient way. And so if you send an email 

to the template email address and say that I said you know, I’d like to get on a 

call with you they'll connect with us okay?

(Lily Wong): Okay great. Thank you. Thank you very much for the clarification. And just to 

clarify you’re saying that if the lab is not going to claim a asymptomatic - make 

an asymptomatic claim if we have a standing order from a physician that would

test the asymptomatic population we would then not need to do - provide the -

you know, do the validation testing, you know, logging 20 asymptomatic that's 

required by the, you know, the June 16 updated template correct?

Dr. Timothy Stenzel: That is correct and the physician understands that you haven’t validated I'm 

sure for that indication. But if they have the order, they can order the test on 

anybody that falls under that sort of suspected of COVID. And that could be 

asymptomatic in high-risk situations which going back to school in the fall 
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might fall under that. 

So we have no issue with that and there's a clear description in the - in our FAQs 

on that. Toby, do you have anything to add? I think I may have covered it pretty 

well but you may have something else to add?

Toby Lowe: Yes, I think you covered. You know, the key as Tim was saying is, you know, 

the labs cannot offer the test for a broad - for broad screening if it’s not, if it has 

not been validated in that population but a provider can order it as they see fit.

(Lily Wong): Great. thank you very much.

Coordinator: Next question is from (Mark Heckman). Your line is now open.

(Mark Heckman): Yes good morning Tim and Toby. How are you today? I’m just following up on 

my question that I asked a couple weeks ago. You may have answered it last 

week's call. I was not on it but just wondering when the template for full 

at-home testing is going to be released? 

We still have a lot of people out there that need to be tested quickly and right 

now the way that the big-box tests are going and things like that with there's 

logistic issues getting swabs, reagents and things like that we feel a full at-home 

test right now is ready to go. So I just have to hear you input on that. And if you 

answered it last week just say that answered it last week and I’ll hang up.

Dr. Timothy Stenzel: Well it is a priority and we're very interested in home testing. And we are 

still working on the home testing home collection for serology but we can 

provide feedback to folks who contact us, same for molecular at home testing. 

Toby can you give any other more specific updates than I did? 
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Toby Lowe: No unfortunately we can’t share specific timelines but we are working to get 

that out as quickly as possible.

(Mark Heckman): Thanks very much.

Coordinator: Next question is from (Andrew). Your line is now open.

(Andrew): Hi Tim. How are you? I had a quick question on the umbrella serology testing 

program which is that based on what it says online it sounds like it’s really 

geared towards the lateral flow test and a basic ELISA kit which would 

probably I’m guessing be more of like reagents in a box. 

We have a client who has a device which is a high throughput system for 

serology testing and I was wondering if a device like that would be a good 

candidate for the umbrella program?

Dr. Timothy Stenzel: Yes so the umbrella program - and but Toby you can correct me if I say 

incorrectly is designed for those tests that can go to the NCI, it’s the current 

place where this program is being or these kits are being tested. 

The any test that can easily show up there. And we test it at the NCI. So 

anything that requires large equipment, non-standard equipment so that’s why 

you see primarily at the moment for lateral flow and for ELISA be easily done 

in that environment.

So anything else could be a little bit more of a challenge for us to do. And 

without that NCI testing result that we're asking everyone that falls under that 

do, you know, we have the alternate just regular pathway for review which, you 

know, just includes an EUA submission. 
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You can notify once you validate and follow that guidance and then you can go 

ahead and market a new test while we - and then you're - you’ll submit that 

EUA package within - by two weeks of notification and we start reviewing it at 

that time.

(Andrew): Okay that sounds good. And then just to double check the device in question is 

a pretty small footprint device that can kind of go on a bench top. It’s not really 

large equipment. Would that still be something to do as just a regular EUA with 

a notification?

Dr. Timothy Stenzel: So instruments can be submitted to NCI but there’s - is a pathway to check 

on this and Toby you may know the details. I think you just send a request to the 

template email address they'll move you over to the NCI? We just want to make 

sure that the NCI's comfortable with receiving that piece of equipment and 

operating it there. But it certainly sounds feasible and I know Toby has some 

thoughts too.

Toby Lowe: Yes so I think, you know, to Tim’s point about the NCI testing absolutely, you 

know, reach out and we can connect you with the right people to see whether 

your device can be tested at the - or through the NCI program.

Regarding the umbrella EUA I just want to clarify that the umbrella EUA was 

issued, it was intended to be - to ease an administrative burden mostly on our 

side of things just to remind the administrative process of getting the 

authorizations out. 

As you’ll see we haven’t actually added any tests to the umbrella EUA. At this 

time we have issued all of the serology EUAs, as individual EUAs because they 

were more appropriate for the specific situation of the tests that have been 

authorized.
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So from the developer or the test perspective you’ll submit all the same 

information to us and then we can work with you to determine whether it is 

appropriate to go through the umbrella pathway or the individual pathway. But 

from your perspective it would be the same data that would be submitted, you 

know, with the exception of whether a test is appropriate or not to get the NCI 

testing.

(Andrew): Got it. And I think you answered this on a previous call so apologies if you 

already answer this. But in terms of samples, because the big kind of attraction 

to the umbrella is that NCI is getting all the samples ready which could 

potentially be hard to get for the device manufacturer. Is there any opportunity 

if the manufacturer wants to do the testing themselves to get the samples from 

NCI?

Dr. Timothy Stenzel: So I’ll add that the umbrella applies to those developers who want to claim 

basically serum and plasma. and there. I don’t know but that’s an important 

concept because we only test on serum and plasma at NCI right now. And so 

that’s fine with you you’re if you're fine with your test being serum and plasma. 

And the only testing that’s done other than to let's say somethings like isotypes 

from validation than you can totally use that pathway through the umbrella if 

it’s an appropriate test to be evaluated at NCI, okay?

(Andrew): Got it. Okay very helpful. Thank you so much.

Coordinator: Next question is from (Troy Ogilvy). Your line is now open.

(Troy Ogilvy): Thank you. Thanks so much to you guys. This is the second time that I have 

been on the call. I missed a couple weeks because I’ve been very busy trying to 
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line up the emergency use authorization to get 30 IgG and 30 IgM. Tim the lead 

position that we did finally working with a university in Washington DC is very 

anxious to maybe talk to you get some clarity on therapy and what we can do 

for EUA.

To bring you back to remembrance of what our company is. We have already 

tested and been approved through a couple blind study for lead testing using 

oral fluid where we collect ultra-filtrated blood plasma through our patented 

process. We are already, you know, with blood plasma we know we have more 

accuracy than any venous blood draw or any serology so therefore we’re 

looking to just do the parallel as to how we can help with COVID.

And where we are at right now is just getting clarity on what the EUA would 

particularly need from us. And we would - our lead physician has requested to 

talk to you Tim so that he can be very clear because they test about 1000 people 

a day. We also have our epidemiologist out of Texas which has - can-do 

sampling as well. 

And our tests as you know if you can’t remember it can be a home test. So I 

don’t know if that qualifies for the umbrella and other things. But our test is 

non-evasive, it’s an oral swab and it collects ultra-filtrated blood plasma. So I 

want to know is there anything else that we would need because we're trying to 

get that collection done in the next 30 days to submit as an EUA. 

And is it possible that our lead physician from the Washington DC University 

can speak with you to get very clear on what he would have to do for the 

medical assay?

Dr. Timothy Stenzel: Right. So if - what’s the sample size that goes into, in your collection device 

or into the device itself?
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(Troy Ogilvy): Yes, our collection device is the...

((Crosstalk))

(Troy Ogilvy): ...swab where we collect our - and our patented process is the gum line. We 

collect ultra-filtrated blood plasma. And our clinical study that was already 

done for our lead test which is already approved and marketed with 99.19% 

accuracy with 99% specificity and 96% sensitivity.

Dr. Timothy Stenzel: Okay. And so go ahead and send an email to our templates email address. 

And if, you know, do ask the question of them because they may be able to 

quickly answer it but if not, I'm happy to get involved. And you can just 

request...

(Troy Ogilvy): Okay.

Dr. Timothy Stenzel: ...you know, if they can't answer your question to get me involved, okay?

(Troy Ogilvy): It - yes is there a way Tim that someone could email me maybe your phone 

number because I sent a couple of emails to that template email and it kind of 

gets shuffled?

Dr. Timothy Stenzel: Just asked to speak to - if you’ve had that experience just ask to be 

forwarded - email before to Dr. Stenzel okay?

(Troy Ogilvy): To Dr. - okay so Tim your last name you mean?

Dr. Timothy Stenzel: Stenzel, S-T-E-N-Z-E-L.
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(Troy Ogilvy): You’ve got it. Thank you so much.

Dr. Timothy Stenzel: You’re welcome.

Coordinator: Next question is from Eric Konnick. Your line is now open.

Eric Konnick: Hi Tim and Toby. This is Eric Konnick from the University of Washington in 

Seattle. I have a question about home collection and stability testing. So in the 

most recent EUA template that's online the - we can use a right of reference for 

the quantitative data for up to two day shipping but there's a note that says if you 

plan to allow testing of samples that have been shipped by three to five day mail 

please expand the shipping study times below.

And I went to the document that’s referenced in the in the template, the ISTA 

70 2007 shipping standard and there they have a similar table to what you have 

with just a couple of the individual steps expanded. So is - are we correct in 

assuming that if we follow that standard that would be sufficient for an EUA 

application?

Dr. Timothy Stenzel: No that’s more detail than I can absorb and know. You know...

Eric Konnick: So I’ll give you the scheme within the home shipping and stability standard is 

basically to do excursions based on whether or not you think it’s going to be a 

summer or winter temperature. And so basically for the winter profiles thinking 

ahead, you know, where we're going to be. You know, it’s held at minus 10 

degree C for eight hours a goes up to 18 degree C for four hours, minus 10 for 

two hours 10 degree C for 36 minus ten for six hours.

So this is described in the same document that’s referenced, this ISPA standard. 

But in that when it says okay if you’re going to go to 72 hours you don’t need to 
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expand each one of those conditions equally. You only expand the longest one 

essentially to the requisite amount. I want to make sure that so again, thinking 

ahead, you know, we're in Washington State we do testing for, you know, like 

1/4 of the country in terms of geographic area. 

And so thinking to the winter where, you know, we’re going to have snow 

delays and things like that we really do need to have, you know, up to five day 

shipping time if we’re going to have people collect at home and send in 

assuming they’re going to be self-quarantined that type of thing. 

And so two days really isn't going to be adequate so we really do need to expand 

that. And so we’re just trying to, you know, logistically figure out how we’re 

going to do that and...

Dr. Timothy Stenzel: Yes, no and that’s important right? And that’s why we put that in there. You 

know, to be honest I’m not, I am not the expert in the office about these stability 

shipping studies which you can do by the way entirely in the lab. You don’t 

have to actually ship.

Eric Konnick: Yes.

Dr. Timothy Stenzel: And so you have better control around it. And so you may know (Gina) in 

the office. I don’t know if you’ve ever had direct contact with (Gina) but why 

don't I just connect - I think I have your contact information. Why don't I just 

connect you with her. And she is going to be the one I think is going to be able 

to get you the best feedback. You know, she was the lead reviewer on say the 

last four home collections.

Eric Konnick: Okay.
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Dr. Timothy Stenzel: And so she’s resident expert in home collection okay? So I will connect you 

up with her as soon as possible after this call okay?

Eric Konnick: Okay I’ll maybe I’ll just shoot you an email and that way you have everything 

at the top of your inbox.

Eric Konnick: That will work. Thanks.

Dr. Timothy Stenzel: All right. Thank you.

Coordinator: Next question is from (Margot Enright). Your line is now open.

(Margot Enright): Hi. This is (Margot Enright). Thank you for this forum. We're an antibody test 

manufacturer and I was asked this question so I thought I would direct it to you 

because I wasn’t sure what the answer was. We know that antibody tests and 

PCR measures different things as they measure different stages with the disease 

process. If there's a discrepancy between the antibody test and a PCR test, is 

there a referee to resolve the discrepancy?

Dr. Timothy Stenzel: No there's - so antibodies are used in two - I'd say two of the three main 

types of tests commonly used. And one is antibodies are used to capture an 

antigen. And you call that an antigen test. That's like the rapid flu test or rapid 

strep test. The other type of test actually looks for antibodies in the patient’s 

blood for example that they’ve developed antibodies against SARS COV-2. 

So you as an antibody developer could provide antibodies to both those kinds of 

developers. So and is the answers depend on - the more precise answer depends

on what kind of test it is. So you just start out with - is it a direct antigen test 

where it's a rapid
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((Crosstalk))

(Margot Enright): Yes, no it’s - yes, it’s a rapid antibody test that measures the combination of...

Dr. Timothy Stenzel: Okay.

(Margot Enright): ...combination of IgG, IgM combined...

Dr. Timothy Stenzel: Okay.

(Margot Enright): ...not individually and it's a lateral flow.

Dr. Timothy Stenzel: Right so, you know, at this point, you know, the best truth for antibody test 

development is to know whether or not the person is PCR positive and then you 

know how many days after symptoms you’re performing the validation and/or 

and also we would like to know how many days after the PCR. But having that 

PCR positivity for the patients enrolled in your study tells us yes, they did have 

SARS COV-2. 

And that is actually helpful to developers because you were to try to compare to 

another serology test and may not be gold standard and you might end up with a 

potential false positive because not all a lot of the serology tests don’t have, you 

know, near 100% detection.

So really for developers the serology tests these rapid antibody tests it's best to 

use PCR. And for your positive population that should work great for your 

negative population is somewhat ideal if you can get your hands on pre-COVID 

serum and plasma to do your study setting for specificity because you know that 

those folks weren’t exposed.
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Anybody, you know, post - you know, in population that you’re selecting 

patients from where you know that COVID's been SARS-CoV-2 has been

circulating could have been exposed and they could have been asymptomatic. 

So that’s the challenge. 

So in knowing a little more about the details about what the challenges are and 

what their discrepancies are. And maybe you can just if you can briefly say it 

might be an important thing for me to know and discuss on this forum. So what 

can you just follow-up with more detail about what your concerned about?

(Margot Enright): Yes, the concern was that PCR samples that and then PCR positive some of 

them anywhere from seven days to over 100 days and there are some 

possibilities of discrepancies between the two and if there are discrepancies 

how we would justify and resolve discrepancies.

Dr. Timothy Stenzel: Yes that’s a difficult one.

((Crosstalk))

(Margot Enright): I know that’s why I called you because I didn’t have a good answer either so...

Dr. Timothy Stenzel: So, you know, the discrepancy is that the antibody is not detect it. We know 

that not everybody or not every - most serology tests as I said don’t detect IgG 

at 100% at any point necessarily. Some do at some point, a lot, you know, after 

say 15 days more and more tests are positive because the immune system has 

mounted its adaptive response and antibodies are being are circulating that you 

can test.

If you’re seeing false positives that’s a situation where you have people who are 

screened with PCR but after, you know, SARS COV-2 has been circulating and 
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they are PCR negative whenever they were tested but now they're antibody 

positive that hopefully that doesn’t happen that often.

(Margot Enright): Okay.

Dr. Timothy Stenzel: We do recommend that folks when they do studies you kind of try to get 

most of your samples between two weeks and two months after the PCR 

positive. That protects you both ways because antibodies can wane overtime 

and maybe if they're negative if you test them 100 days out because the 

antibody was there at one point but that now has gone away. 

And another thing is if you have a fairly close time period between PCR test and 

the history of no symptoms and then you do the testing for the negative 

population, you’re more likely just to have truly negative patients. I hope that 

helps.

(Margot Enright): Yes that’s very helpful. Thank you very much, really appreciate it.

Coordinator: Next question in the queue is from (Shri). Your line is now open.

(Shri Enri): Hi Tim. This is (Shri Enri). I wanted to comment and thank you primarily and 

the (NC) team and all of FDA for being so proactive about this EUA process. 

Having a few of them in, myself I’ve thoroughly enjoyed the experience 

working with you guys.

My main question has been answered about the home use tests. I do have a 

question about this particular Webinar series. Is this going to continue on for 

the next couple of weeks or is this the last one scheduled for the future because 

I'd like to hear about the home testing?
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Dr. Timothy Stenzel: Yes, yes, yes no there is probably unfortunately there's a lot more to discuss 

and there's a lot more to come. You know, as schools look to reopen. as

workplaces look to reopen, you know, there are a lot of, you know, important 

questions to be asked. So at least through the month of July we're going to be 

here weekly. And I wouldn’t anticipate an abrupt halt but we'll make the 

decision towards the end of July.

(Shri Enri): Thank you.

Coordinator: Next question is from (Amy Leser). Your line is now open.

(Amy Leser): My question's been answered. Thank you.

Coordinator: Next question is from (Susan Rowley). Your line is open. (Susan) if you’re 

there please check your mute button.

(Susan Rowley): Hi. Is this better? 

Coordinator: We can hear you.

(Susan Rowley): Great. I just wanted to ask given that we're a couple months now into the EUA 

process if the timeline or approximate turnaround time through NCI is about 

still about ten days or has the timeline extended due to the burden placed on the 

NCI organization doing all the independent studies and does that effect then the 

actual review time of the EUA request? Thank you.

Dr. Timothy Stenzel: Yes so I have an overall average time from device receipt to device 

transmission. And right now it’s in the dashboard it's taking about 17 days. So 

that’s about between two and three weeks once a device has been submitted. If 

it’s on - this may or may not depend on whether it’s on the high priority list. I 
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would have to defer to others because we do take a look at application and make 

sure that it’s appropriate to go forward with the NCI. But that’s the data I have 

right now.

So it is moving along at a fairly decent clip. The - and then of course we offer 

the notification pathway for devices to notify us and then the EUA so people 

can market in the mean time. So we are trying to drive all these numbers down 

as fast as possible.

(Susan Rowley): Thank you very much. That’s helpful.

Dr. Timothy Stenzel: All right you’re welcome. And with that I do need to apologize. I’m going 

to turn it over to Toby. And I do today at this time have another pressing 

commitment and you'll be in good hands with Toby. And I’m sure that if there’s 

anything that she wants to check on afterward she can. Thank you, Toby. Are 

you there to turn it over to?

Toby Lowe: Thanks. I’m just going to tell everyone to email Tim.

Dr. Timothy Stenzel: Yes that’s the way it’s going today isn't it. I don’t know about that. My box 

is already pretty full. All right thanks everyone.

Toby Lowe: Thanks.

Coordinator: Next question in the queue is from (Christina Yang). Your line is now open.

(Christina Yang): Hi. This is (Christina). Toby thank you very much for issuing the new pooling 

guidance. And our company’s interest in screening our employees. So we 

would like to know currently are there any CLIA labs testing or commercial 

PCR test kits tested for pooling?
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Toby Lowe: Sure. At this point there are not any EUAs that have been issued that include 

pooling. We are working with developers towards that. And we do note that the 

notification pathway is available for developers that have validated pooling and 

want to begin offering that while we review their EUA.

(Christina Yang): Great. And so Toby when, you know, there is a kit in a pool where we able to 

check the proof list on your Web site under COVID-19?

Toby Lowe: Yes. The it would be, when you do authorize a test kit that includes pooling that 

would be noted in the instructions for use that are posted on our Web site. And 

I’m sure once we offer the first one, we will definitely be announcing that.

(Christina Yang): Excellent. Thank you very much.

Toby Lowe: No problem.

Coordinator: Next question is from (Lewis Promo). Your line is now open.

(Lewis Promo): Yes thanks very much Toby. Does the commercial neutralizing antibody test 

done by immunoassay require an EAU [sic] and if so are, where are they listed 

and where can I find them?

Toby Lowe: So we have not yet authorized any tests for neutralizing antibodies. We are 

again working with the developers on that. That seems to be a common theme. 

And we look forward to doing that. We do - they should be coming in for an 

EUA yes.

(Lewis Promo): Okay so you don’t know when as yet right?
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Toby Lowe: Unfortunately no.

(Lewis Promo): Okay. Okay thank you.

Toby Lowe: Sure.

Coordinator: Next question is from (Machini Fernando). Your line is now open.

(Machini Fernando): Hi Toby. Thanks for taking my question and we're finding this forum has 

really been helpful. My question is do you have – hello? Can you hear me?

Toby Lowe: Yes, yes?

(Machini Fernando): Yes so do you have any guidance on validation of a EUA test on a platform 

that is not specified within the EUA? And if so, what panels do you recommend 

to use for that process?

Toby Lowe: I’m not quite sure I’m following. So you’re looking to get an EUA for a test kit 

without specifying the platform that it should be used on?

(Machini Fernando): No. If there’s EUA approved test can I try to use it on a different platform 

and...

Toby Lowe: Okay.

(Machini Fernando): Yes.

Toby Lowe: Yes so, you’re from a high complexity CLIA lab? 

(Machini Fernando): Actually my focus is elsewhere. It's global health focus. So I just wanted...
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Toby Lowe: Okay.

(Machini Fernando): ...to see if there was any guidance along those lines.

Toby Lowe: Yes. So if you take a look at the COVID-19 test policy guidance that we’ve 

issued there is a discussion for modifications made by high complexity CLIA 

certified laboratories that are modifying the EUA authorized test. And that’s 

for, you know, just like you’re talking about modifications to components such 

as the platform that it's being run on. And it talks about validating those 

modifications using our bridging study and that we would not accept an EUA 

for tests that are validated in that way.

(Machini Fernando): Okay. And Toby thank you. Do you have any recommendations for panels 

that we could use for that process in the diagnosis as well?

Toby Lowe: For sorry, recommendations for what?

(Machini Fernando): Panels, sample panels that we could use for the validation process?

Toby Lowe: Oh to do the validation, sure. If you take a look at our FAQ page there's an FAQ 

about test materials that are appropriate for assay validation. And it’s under the 

test validation FAQ section on the FAQ page. And that’s FAQ lists out from the 

priors of validation materials.

(Machini Fernando): Thank you so much. That’s very helpful. Thank you.

Toby Lowe: Sure.

Coordinator: Next question is from (Kelly Leanhart). Your line is now open.
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(Kelly Leanhart): Hello. Thank you so much for holding this press conferences. I was just curious 

if there was any place that’s publicly available to see where I can find 

information for who working on EUAs for pooling test? Hello?

Toby Lowe: Yes sorry I was just thinking. I don’t think so. So right now the publicly 

available information that we have on, you know, there would name specific 

developers is the notification list that we have on our FAQ page and then the 

authorized EUA list on our EUA page.

(Kelly Leanhart): So if a lab working on the EUA for pooling test wanted to connect with other 

labs working on tests would there be any way for them to connect through you 

guys?

Toby Lowe: That’s - I have to think about - that’s not typically something that we would 

facilitate but we definitely do want to encourage collaboration in this area.

(Kelly Leanhart): Great thank you so much.

Coordinator: Next question is from (Kitsap Peterson). Your line is now open.

(Kitsap Peterson): Thank you so much. I want to start out saying thank you for all the work your 

group is doing. I’ve had email sent your template and got a reply back way after

normal working hours. So I know how hard you guys are working. We got...

Toby Lowe: Yes.

(Kitsap Peterson): ...a little confused and I just want to because the Boston University question 

was similar. We ended up signing a pre-EUA mid-May and we didn’t 

understand the difference between the EUA and pre-EUA. And we were kind of 
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in limbo around for a while until we figured that out and finally got the EUA in 

and got the confirmation letter so we could start working in New York and 

other places that require that.

So maybe making it a little more clear. We are a small company and we are 

relying on revenue from our investment in putting our efforts into participating 

and hopefully containing this epidemic. So the timelines are becoming very 

important for us as some of the contracts that we're working on now are asking 

for a published EUA. So that’s where I think a lot of other smaller companies 

are. And I think I know that you’re prioritizing your work as well so that’s 

just...

Toby Lowe: Sure.

(Kitsap Peterson): ... a shout out to any small companies that are working to participate in this 

work. And the last comment is that we are working...

((Crosstalk))

(Kitsap Peterson): ...on putting this on extend sequencing so we don’t have any scalability issues 

in the future. So that’s our goal we are innovative.

Toby Lowe: Great thank you. And to provide some of that clarification, you know, so that 

you submitted a pre-EUA and then an EUA. It’s unclear to me whether you’ve 

also notified. So if you want to clarify that the pre-EUA process is primarily for 

situations where you have not completed validation and you need some 

questions answered and want to have some dialogue about what appropriate 

validation would be. That maybe is beyond what’s in the guidance and in the 

template.
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And then the notification is what we would expect when you have validated 

your test and plan to begin offering the test prior to an EUA. And so if you are 

currently offering your test you should have either a notification in place and be 

listed on our notification list on our Web site or have received an EUA 

authorization to be listed on our EUA page. So the - there is a difference 

between a notification and the EUA request.

So the EUA request is what you submit when you are ready to move forward 

and present all of your validation data for our review. The acknowledgment 

letter that you get from submitting an EUA request is just an acknowledgment 

that we have your submission in-house. Once we have completed the review 

and have reached a decision then we will issue hopefully an authorization letter 

specifically for your test. And that’s when the EUA would also get posted on 

our Web site.

(Kitsap Peterson): Fantastic thank you. So then there is that process notification list that we 

actually submitted this to you? That’s on your Web site too?

Toby Lowe: So are notification list is on the FAQ page. The first section of the FAQ page is 

what laboratories and manufacturers are offering tests for COVID-19. And 

there's a series of questions in there that list out the names of the laboratories 

and commercial manufacturers that are offering tests under the different 

policies in the guidance documents. And so in order to offer a test prior to 

receiving an EUA authorization you should notify under that policy and get 

listed on one of those lists.

(Kitsap Peterson): I would take that beyond because now that is one of the questions that we're 

getting. So this is fantastic. Thank you so much.

Toby Lowe: Sure no problem.
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Coordinator: Next question is from (Mark Wagner). Your line is now open.

(Mark Wagner): Hi. Thanks for taking my question. I’m hoping to get some clarity on sample 

pooling and test modification for CLIA certified labs. And my question is many 

labs follow the policy for modifications of both previously EUA authorized 

COVID-19 assay. 

For example can a lab do pooling as a modification to the test and validate using 

a bridging study or must they follow the molecular diagnostic template for 

adding a pooling strategy to a previously authorized EUA which would require 

submitting a new EUA or waiting for the test manufacturer to submit an EUA 

amendment?

Toby Lowe: Right. At this time we are expecting EUA submissions, EUA requests for 

pooling. The notification pathway is available for adding pooling as well 

followed by an EUA submission. We don’t believe at this time that bridging is 

an appropriate validation for adding pooling to an authorized test.

Coordinator: Next question is from (Jessica). Your line is open.

(Jessica Wasserman): Hello this is (Jessica Wasserman). For the serology tests for the NCI 

validation is that mandatory or is there an option to submit say with your data 

and then also maybe a third-party validation of some recommended test? Thank 

you.

Toby Lowe: Yes, we think that NCI data is really helpful for validating the serology test. If 

you have a particular situation that you think would be a good alternative 

approach, we would encourage you to speak with your lead reviewer on that.
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(Jessica Wasserman): Thank you.

Coordinator: Next question is from (Sarah). Your line is open.

(Sarah): Hi. Can you please clarify whether an on-site healthcare worker observes 

collection is considered equivalent to a healthcare worker collected specimen

and would not require an EUA?

Toby Lowe: So we...

(Sarah): (Unintelligible) a portion?

Toby Lowe: I'm sorry what was that?

(Sarah): I just - like the home self-collection it’s clear that that would require in EUA. 

I’m just curious about the on-site self-collection if it’s observed?

Toby Lowe: Sure. So we do consider those to be separate and distinct things. We have 

indicated that home collection requires and EUA. On-site health self-collection 

observed by a health provider does not necessarily require a separate 

authorization. We've indicated on our FAQs that both the mid turbinate and 

anterior nares specimens are appropriate for on-site collection.

(Sarah): And is there a definition of a healthcare worker?

Toby Lowe: There is not.

(Sarah): Okay thank you.

Coordinator: Next question is from (Cynthia Swin). Your line is now open.
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(Cynthia Swin): Hi. Thank you very much. Regarding the pooling test I’m a little confused why 

the alumina test isn’t considered a pooled test with the number of samples that 

get pooled in that. I know there's tags on the samples but it still seems like a 

pretty pooled test to me. I know that’s asking about a specific test but it seems 

like, you know, multiple times they said that there's no pooled test but that 

particular high-volume test does pool the samples together.

Toby Lowe: Yes that's an interesting question unfortunately I’m not familiar enough with 

that test. I do know that it was validated and authorized. If you want to send in 

that question, we can direct that to the right individual who will be able to 

answer that for you.

(Cynthia Swin): Yes thanks.

Coordinator: The next question is from (Sina). Your line is now open.

(Sina): Hello can you all hear me?

Toby Lowe: Yes.

(Sina): Hello. Okay fantastic. So thank you Toby and Irene for hosting this call and for 

answering questions. My name is (Sina) and I’m a scientist at the California 

Institute of Technology. And I’m working with collaborators at UCLA to 

develop a NexGen sequencing based/COV-2 test. 

We’ve submitted it for an EUA and I’ve been developing the software to 

process the NGS data and call the samples. So we plan on submitting 

amendments to the EUA so it, can that be done in the interim between EUA 

submission and the EUA being granted. And is it appropriate to submit one 
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solely for analysis infrastructure?

Toby Lowe: I apologize can your repeat the distinction there what you’re asking?

(Sina): Yes sorry. So the first question is can we submit amendments to the EUA in the 

interim between us having submitted the EUA and the EUA being granted so in 

the time period?

Toby Lowe: Yes...

(Sina): And my second question was...

Toby Lowe: ...I would work with your, will work with your lead reviewer about how to 

incorporate anything additional that you're requesting as part of your 

submission.

(Sina): Okay. And the second question is - is it appropriate to submit one solely for the 

software analysis infrastructure?

Toby Lowe: I am not sure I’ll be able to answer that without additional details about what the 

device is doing and what the software would be doing. So it’s probably best to 

have that discussion directly with your lead reviewer so that we can get into 

more of the details.

(Sina): Okay that sounds great. Thank you so much.

Toby Lowe: Thanks.

(Sina): And now I’d like to turn the call over to Miss Irene Aihie.
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Irene Aihie: Thank you (Ted). This is Irene Aihie and we appreciate your participation and 

thoughtful questions. Today’s presentation and transcript will be made 

available on the CDRH Learn Web page at www.fda.gov/training/cdrhlearn by 

Tuesday, July 14.

If you have additional questions about today’s presentation please email 

cdrh-eua-template@fda.hhs.gov. As always, we appreciate your feedback. 

Following the conclusion of today’s presentation please complete a short 13 

question survey about your FDA CDRH virtual town hall experience. 

The survey can be found at www.fda.gov/cdrhwebinar immediately following 

the conclusion of today’s live discussion. Again thank you for participating and 

this concludes today’s discussion.

Coordinator: This concludes today’s call. Thank you for your participation. You may 

disconnect at this time. Speakers, please stand by.

END