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FDA Virtual Town Hall Series –

Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

Moderator: IRENE AIHIE

July 1, 2020

12:15 pm ET

Coordinator: Good afternoon. And thank you all for standing by. For the duration of today's 

conference all participants' lines are on a listen-only mode until the question 

and answer session. At that time if you would like to ask a question press Star 

1. Today's call is being recorded. If you have any objections you may 

disconnect at this time.

It is my pleasure to introduce Irene Aihie. Thank you ma'am. You may begin.

Irene Aihie: Thank you. Hello. I'm Irene Aihie of CDRH's Office of Communications and 

Communication. Welcome to the FDA's 15th in a series of virtual town hall 

meetings to help answer technical questions about the development and 

validation of tests for SARS-CoV-2 during the public health emergency. 

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

Radiological Health and the Office of Product Evaluation and Quality and 

Toby Lowe Associate Director of the Office of In Vitro Diagnostics and 

Radiological Health - both in CDRH - will provide a brief update.

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

questions about specifics submissions that might be under review.

Now I give you Toby.

Toby Lowe: Hi everyone. Thanks Irene. So I just have a quick update today. We put out a 

couple updates to the FAQs last week. I believe they went out on Wednesday 

but I think it was after the town hall so I don't think I mentioned it. If I did and 

this is a repeat sorry about that. So the first question that we updated last week 

was the question about current validation study recommendations. And we 

updated that question to clarify that the recommendations for testing apply -

the FDA's recommendations for testing apply both to tests for which an EUA 

request is submitted as well as tests that are claiming to be validated and 

offered under the policies in the guidance prior to submission of an EUA 

request.

So those recommendations for validation are included in both the guidance 

and the accompanying EUA templates. So we encourage developers to consult 

those documents for those recommendations. And then the second question 

that we updated is the question on modifications to a previously authorized 

test. And the update in that question was to clarify a couple of points. The first 

is that modifications that are done by a high complexity CLIA Certified Lab 

under the policy in the guidance when we don't expect an EUA it does come 

outside of the scope of the EUA and therefore those tests are being offered as 

non-authorized tests.

And then the other clarification was to point out that we have two different 

policies regarding modifications. One is for tests that are modifying to add a 

new specimen type. And the other is for all other types of modifications. And 

we're pointing out that for new specimen types the guidance does not include 
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validation using a bridging study. So that type of modification we are 

encouraging developers to reference the information in the guidance and the 

templates regarding recommendations for validation of a new specimen type.

So those are all my updates for today.

Timothy Stenzel: All right. Thank you Toby. This is Tim. Welcome this week to our town hall. 

I don't have that many updates. In fact I just have one important 

announcement to make. We have noticed a spike in complaints about one of 

the newest authorized molecular tests. It is the BD SARS-CoV-2 reagent for 

the BD MAX System. There are two sets of reagents that are authorized for 

the BD MAX System. This is only one of them and this announcement only 

applies to the BD SARS-CoV-2 reagent. It does not apply to the BioGX 

SARS-CoV-2 reagents.

The new spikes in the complaints that we saw and have seen concern potential 

false-positive results. This appears to be a low level of approximately 3% of 

the overall positive results. So this is a small subset of the BD MAX positive 

results for this assay. For the time being out of an abundance of caution we are 

recommending that a positive result with this assay be treated as presumed 

positive and that you act accordingly when you are doing readings.

So we are working closely with BD, very interactively with them to establish 

what the root cause is and what the correction will be and what the validation 

plan for their correction will be. Stay tuned for additional announcements 

which is incoming in the near future with more details about what to do about 

this. But for the time being please treat positive results as presumptive 

positive.

And with that we turn - open this up to questions. Thank you.
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Coordinator: Thank you. If you would like to ask a question please unmute your phone. 

Press Star 1. And record your first and last name clearly when prompted so I 

can introduce you. If you wish to withdraw your question press Star 2. Again 

to ask a question press Star 1. It may take a few moments for questions to 

come in. Please stand by.

And our first question is from (Ludna). You may ask your question.

Timothy Stenzel: Hello.

(Ludna): Hi. Can you hear me?

Timothy Stenzel: Yes.

(Ludna): Hi Tim. This is (Ludna) from (Hanson). I just wanted to ask about home 

diagnostic template if we - I know you've mentioned that you're working on a 

template for a true at-home molecular diagnostic template. I'm wondering 

where we are with that. And also in terms of at-home use products can be sort 

of true over the counter and they could also be prescription use. I'm 

wondering what your thoughts are on that and if we have an estimation for a 

template. I know you guys are working really hard. And I know it's a long 

weekend coming up. So I appreciate all the work.

Timothy Stenzel: Yes. So thanks for that question. So we're very open to home testing not just 

for molecular but also a rapid antigen and serology tests. We are in the, we are 

finalizing the home testing template for (unintelligible) molecular and direct 

antigen tests. And we hope to get that out shortly. In the interim if you want to 

send an email to the template's email address and we will at least put your 

name and contact information on a list as that becomes publicly available. We 
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plan to send that out to a number of folks as soon as that is finalized.

So yes. We are open to both prescription home use and to OTC. We call it 

prescription home use because it does require a prescription by a clinician to 

be able to offer this test. And we call it home even though we believe that this 

will be outside of a healthcare center and so it can be deployed in many 

different settings where there are not necessarily healthcare providers. So this 

could potentially be deployed readily at home but in other places such as 

schools and workplaces.

Now the fact that there is healthcare involvement in deciding the 

appropriateness of testing means that there are mitigations with that approach 

that will allow a lower amount of validations being done than for a situation 

such as being over the counter or OTC situations where there will unlikely to 

be healthcare involvement in selecting who buys the test and who performs 

the test and in what situations it's run. So we will be asking for a higher level 

of validation in that situation because there are not mitigations of a healthcare 

provider or worker being involved at all in the testing.

So those exact numbers are being finalized now. And so it would be 

premature for me to talk about that in detail. But when there is a prescription 

involved we're looking for the very least burdensome approach to this and it 

probably will be very similar to what we require, say, for a point of care test 

except in this case we're going to be asking that consumers, that people in the 

setting where you wish the test to get deployed are performing the tests, a 

minimal number of users in the usability study. And so they can demonstrate 

that they can get an accurate result.

So hopefully that's helpful. I'm hopeful that the home collection template will 

be out soon. And we are working on one for serology which will not be as 
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soon forthcoming.

Coordinator: And our next question is from (Cynthia Flynn). You may go ahead.

(Cynthia Flynn): Hi. Thanks for taking the call. I'm wondering for - if we're using an EUA kit 

from a manufacturer and we want to validate a different sample type, say, like 

we can use anterior nares or MT or OP or whatever and we want to validate 

saliva is it appropriate to just use the 30 positive, 30 negative and we could do 

that? Or because it's not our own EUA is that not appropriate.

Timothy Stenzel: As Toby mentioned earlier to me when I asked something that for this kind of 

change a bridging study is not the appropriate way to go. But we would look 

to the template recommendations. And...

(Cynthia Flynn): Right. Also the CT values. Yes.

Timothy Stenzel: Yes. So, that 30 and 30 is - if I remember correctly - is what we would 

recommend. The only thing that's different is of course if you're making a 

claim for an asymptomatic population. And then look to our recommendations 

on the EUA authorization required for that. And of course this doesn't apply to 

home collection and home testing.

Toby anything to add about that?

Toby Lowe: Yes. The only thing that I'd add this came up recently as an issue that we're 

looking as rapidly as possible to resolve is that there are actually no saliva 

collection devices that are authorized for this purpose. So we are working with 

collection device manufacturers to try to resolve that as quickly as possible to 

have more options be available for tests such as yours and labs such as yours 

where you would like to add saliva as a specimen type through the 
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modifications policy.

So we would encourage you to keep an eye on that. And if you have further 

questions about validation of saliva or about appropriate collection devices to 

use please reach out to us through the mailbox.

Coordinator: Thank you. Before we go to the next caller as a reminder if you would like to 

ask a question please unmute your phone, press Star 1 and clearly record your 

first and last name only so I may introduce you. We will be taking one 

question per caller.

Our next question is from (David Houg). Your line is open.

(David Houg): Thank you. First of all thank you guys for the ongoing interface. The 

transparency is really a model for how governments and industries should be 

acting. We really appreciate your incredible hard work. You know the 

situation among serology. We are in a situation with serology where if 

someone gets an EUA that the letter's published, no one can read it. If you 

look at an umbrella test the results of the validation in the umbrella test are 

shown. However there's no way to access validation for tests with an EUA 

which are not - did not go through the umbrella process.

There's no showing at all for the letter that was submitted on notifications. 

And nothing on notification validation result. What's the thought process then 

on why we couldn't have a notification - if people under the notification policy 

can offer their tests publicly, couldn't it be required that the letter that they 

submit and the validations results that they submit to get that notification 

would also be published so at least people who are using the test could read 

that information and decide whether it was appropriate or not to use that test?
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Timothy Stenzel: So I think I want to make sure that I understand your question. I think what 

you're saying probably kudos that we're publishing some data, the NCI data as 

soon as we make regulatory decisions. And that transparency's appreciated. 

And of course any other assays that we authorize all the information that we 

receive in review and make the regulatory decisions on, on that are important 

to put into the instructions for use are there for the labs to view.

I think what you're saying is what are we doing for those tests that - and 

probably particularly for the serology tests - that notify us and have 10 

business days to submit an EUA package? What information can be provided 

about those tests? Is that what you're asking?

(David Houg): About those tests but whether or not they're still in the 10 days or they've 

already submitted the EUA application. If they're out distributing their test in

the market it should be just as easy for a consumer to look on the FDA Web 

site and see what the validation information they claim and the procedure for 

the test they claim and the notification as it is if an EUA is authorized. If the 

test is being consumed the information that a consumer can get on the test 

should be the same. That's the suggestion.

Timothy Stenzel: So the guidance - the current guidance is that through the notification pathway

for the serology tests that developers can validate, notify us and then submit 

their data within 10 business days for our review. We do a triage when it 

comes in, make sure that there are no issues of public health importance. And 

then if there's no issue then they go into the queue.

Toby you can probably make sure that I'm correct in my response here. But 

we do require full disclosure by the developer of their performance. And that 

they follow the guidance and make the statement that we have asked them to 

do, that have limitations on this test. One is until authorized it can only be 
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used in a high complexity lab and all the other caveats that we've asked them 

to put.

Toby I believe we also - and before we post them - and this is what I want to 

verify with Toby right now. That we do verify that they have posted their 

performance on their Web site and only Toby noticed that can we - do we not 

prepare a notification up on our Web site? So Toby if you could confirm or 

deny that update.

Toby Lowe: So I am not positive if we do that for the notifications. We can look into that. 

But Tim’s description of the process absolutely is spot on and we don't 

necessarily receive that validation at the time that they go on the notification 

list because they do have those 10 days before they need to submit it. And so 

we do - we do want the manufacturers to include that performance 

information on their own Web sites. But we cannot put it on our Web site until 

we have completed a review. And then we provide that information with an 

authorization.

Timothy Stenzel: That's correct. So we'll take the question of our process back. But we do 

require that they post on their performance and their instructions for use on 

their Web site. And if you know of somebody that isn't doing that and isn't 

showing performance even though they're notified then we would like to hear 

about it through our templates email or even at our FAQ EUA Web site or 

through the fraud line on that same Web site. Thank you.

Coordinator: And our next question is from (Piero Holitecio). You may ask your question.

(Piero Holitecio): Thank you for the acceptance of this call. Can you hear me?

Timothy Stenzel: Yes. We can.
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(Piero Holitecio): Okay. Thank you. Yes. I have submitted a notification for EUA. And I also 

submitted a notification for a pre-EUA. But somehow I have been lost in the 

shuffle in that I've been assigned to several different reviewers and I have not 

been able to get a response from my reviewers. So I'm going to resend the 

letter out to the template email address to request another reviewer.

And I wanted to make this call last week. But I was unfortunately called on an 

emergency to do this. I would like just to have some attention brought to a 

high throughput serological test that I've been trying to develop but yet I 

haven't had the proper guidance I don't feel. And I've been working on this 

since February. So I'm frustrated as to why I have had several different 

reviewers and no follow-up. And it's a problem that perhaps others have had.

And I appreciate the question from the caller - the gentleman prior to us, two 

prior to us - that the notifications haven't been made public. So the people who 

would like to take them in our tests would - they don't see it publicly stated 

then they don't want to - they don't even want to bother with our tests. So 

something I think would benefit the entire population if something was made 

public that we do have notification in even though that we would state the 

directions on our Web site and that this would meet a proper usage by a 

professional and all of the bullet points that are required in our instructions 

which has been in all of my notifications.

And yet somehow I've been told that it's incomplete. I just want the guidance 

for the proper notifications then. Can that be had by me making this email to 

Toby or to Tim? Is that possible, sir?

Timothy Stenzel: Yes. So I've been making myself available to address some of these issues. So 

if you don't have my email address, which I’m not going to give over again, 
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then I might not be able to...

((Crosstalk))

(Piero Holitecio): I do not have your email address, Tim. I would appreciate it. If someone could 

forward me that email address directly. Because I need a reviewer that will 

help a micro company work through this process. I'm not (unintelligible). I'm 

not BD and so forth. Understand? So people that do some very interesting 

developments are really small companies and we need the guidance. And so 

we need someone who is adept at giving guidance. And unfortunately the 

people that have been assigned to me - and I know they're busy. But I would 

love to have some guidance and directed to someone who could give me 

proper guidance.

I would appreciate it. Because I feel like I have submitted proper notification, 

proper documentation, proper validation. And yet I have been refused and not 

got on the queue to be registered. And I need registration. Otherwise we're 

dead in the water. And I am sure that there are many people listening to this...

Timothy Stenzel: Hello?

Coordinator: And we go to our next caller (Dylan Beauchert). Your line is open.

(Dylan Beauchert): Hi. This is (Dylan) speaking. Thank you guys for taking the time to 

answer all of our questions. Mine is a little brief. But I was wondering when 

you guys will update prevalence for PPV and NTV calculations. I've noticed 

that LA County many others have shown much higher rates than 5%. The 

current estimate used by the FDA seems to give an appearance of lower 

validity for certain tests. And this will ward off certain healthcare providers 

who see these lower values although it might not accurately reflect the test 
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predicted values.

Timothy Stenzel: Yes. So the prevalence of disease and adaptive immune response can vary 

widely across the US right now. It's a good heads up for us to take a look at 

that from time to time and make sure that it is an appropriate prevalence for 

the vast majority of the US. As an example - it's only offered as an example 

and it is not meant to apply to each and every situation.

So we do - on that same Web site - we do provide a calculator to be able to 

plug in the actual performance and prevalence. And from the information even 

that is provided on our Web site insert the performance codes and the user or 

the end-user can see what the predicted positive and negative values are. So 

that tool is provided to all so that this can information can be made available 

to all and to look at the individual situation and make it specific for that 

situation.

So please feel free to use that calculator and encourage the folks that you're 

talking to, to use that calculator. And so we will take that back as to whether 

that 5% is still a good number to use on our Web site. We're unfortunately not 

going to be able to get every possible prevalence and not just high prevalence 

areas or low prevalence areas because it does matter what the prevalence is as 

far as the NPV and PPV.

(Dylan Beauchert): So thank you guys for taking the time and considering the - taking another 

look at that. Appreciate you guys answering all these questions and just 

working hard.

Toby Lowe: Quickly before the next caller I just want to follow up briefly on the previous 

caller if I could just have a minute to do that for the gentleman who was 

asking about his specific submissions. Apologies that you were cut off and 
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please do send an email and we'll follow up with you. I do want to clarify for 

everyone that there are very distinct pathways and if you submit a pre-EUA or 

an EUA that is not considered a notification.

If you are looking to be included on the notification list and to offer your test 

under that policy please be sure that you follow the instructions in that

guidance to send a specific notification email to the EUA mailbox so that we 

are clear that that is what you are requesting and that that is separate from the 

pre-EUA or your EUA submission. That will help quite a bit with the process 

on our end and making sure that you get into the right place.

So again please send us an email so that we can follow up with you and we 

will hopefully get that resolved for you. Thanks.

Timothy Stenzel: Yes. And yes. My apologies as well. I was attempting to make some 

reassurances. But I am willing to get involved and provide some assistance in 

the situation. And I'm willing to do that for all companies who are in need of 

that. We have very busy reviewers. And when situations come up like this I do 

take them seriously. And I do look into them. So please send me an email to 

the template email address and ask for me, Tim Stenzel. And I will do my best 

to assist.

Coordinator: And our next caller is (Cody Luby). Your line is open.

(Cody Luby): Good afternoon, can you hear me?

Coordinator: Yes, thank you.

(Cody Luby): Yes, thank you for taking my call. Thank you for all the information that is 

given in this Town Hall. I have seen the recent last week on June 26 update 
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the FDA combating COVID-19 with their medical devices summary of all the 

tests that are given. It is well-intended and it is really useful for many, but at 

the same time, sorry to use the word it looks like discriminating. Yes, 

especially for those serology test developers who have notified FDA and 

whose names are there in the list. 

As of today 193 manufacturers are there in the notification list. Of which I 

think around 11 are authorized. And about 182 are not authorized but in the 

notification list. But those names are not there in your recent June 26 

announcement. And not only that, I think in general, word is kind of a 

considered like that but you have US stock regulations are involved, 

something like June 12th afterward if any developer has got authorization, 

their names are bold.

So, all these things will cause confusion. Already we are not able to sell our 

kit. Because many of the people are telling that you don't have authorization. 

And even though we say that the list is there a notification list, our name is 

there. And FDA in the Town Hall, time and again, mentioned that is good 

enough for people to buy the test and using the labs in the manner in which it

needs to be used. But we are really having a very hard time in convincing 

those people. But this list stuff, giving the people that authorize and then you 

know, bold, putting the names bold in some cases, really are hurting us very 

badly. 

Can you really do something to rectify and then help us, so that you know we 

can tell that our kits can be used in the lab? Really, we need your help. 

Man 1: Toby do you want to take a crack at this, Or do you want me to?

Toby Lowe: Sure, we have a quick question for you. You mentioned that some are noted in 
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bold.

(Cody Luby): Yes.

Toby Lowe: Where on the website are you seeing that?

(Cody Luby): This is, I can send you the website, but it is actually the updated on 26 it is a 

complete list of FDA combating COVID-19 with medical devices. So, in 

every page on US authorizations are in bold. So, it kind of gives all the 

authorizations not only in vitro diagnostics and medical devices and 

everything. And some other kits are the manufacturers are their names are 

bold, because authorizations (unintelligible).

Toby Lowe: Right. So just to clarify on that document. The bold is to indicate what has 

changed from the previous version. So, every time that document is updated 

the new additions are included in bold. I don't think that we had intended for 

the bolds to be interpreted as anything other than an update. So, I will provide 

that feedback to the people who maintain that document. On our on the IVD

specific authorization page, the new authorizations are simply added to the 

table. So, they're not, you know, they're not indicated any differently, other 

than to include the date they are added to the table. And then, the notified tests 

are listed separately on the notification list on the FAQ page.

So, there's not really any way for us to note them differently because they are 

being offered under different pathways and we have not reviewed them and

authorized them at that point. As soon as we do authorize them, they, as you 

mentioned, are noted as authorized and they are included on the EUA list. 

(Cody Luby): What I'm bringing to your attention is the problems that is there in the real 

world. When we say our test is in the notified lists and we show our 
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instructions for use, we show the performance. It is as good or better than the 

authorized test. But the customers are specifically asking to show us the 

authorization letter, then only we can buy. So, that is not the thing that you 

have been telling in the Town Hall, but that is the notion that is there in the 

customer.

So, can you do something to tell them that's not the case?

Toby Lowe: I can take that feedback, and see, you know, think about what might be able to 

be done.

Timothy Stenzel: Yes, I would just say that we're open to those things, but it's not clear to us 

what more we can do than we already tried to do on this Town Hall and 

website. Thank you for your call. I do want to make sure that we get time for 

additional problems.

Coordinator: Our next question is from (Elko Wershocky). You may go ahead.

(Elko Wershocky): Thank you. I had a question regarding the criteria for controls in the EUA 

kit. And that's for the CT values, and it's for the positive controls and also the 

internal controls. And for quite a few of the kits. And it's not unique to 

coronavirus, it's also involves other FDA approved assays the CT values for 

acceptable criteria are often less than 40. And that results in a very wide range 

of acceptability. So, for example from 10 to 39. And I'm just wondering why 

the criteria for CT accessibility isn't much tighter, like 28 to 34. And also 

having tighter criteria for the internal controls allows for better assessment of 

inhibition in individual patient samples. So that's my question. Hopefully, it's 

clear.

Timothy Stenzel: Yes I think what you're asking is how can we better control with an internal 
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control the assay for our SARS-CoV-2 and for adequacy of collection and for 

the adequacy of the extraction in the population of the sample. I think your 

question is and how we can tighten up those specs. Is that the question.

(Elko Wershocky): Yes, for both the internal control and then also like the positive controls in 

the kit. The CT range is often like less than 40. That can result in huge 

variability and it makes it more difficult to assess issues, you know instrument

or extraction problems.

Timothy Stenzel: Yes. I understand and where developers have months or years to develop a 

test and optimize all of these things. Those are obviously things we would 

hope to see. And, however, in responding to an emergency situation and are 

interest is to provide as much testing that we can determine is as accurate as 

possible and as quickly as possible. You know, that's their mission as of right 

now. These are excellent points as some of these tests start converting into 

regular authorization, developers should consider this. Because this is an 

important element that you would like to see in all tests, that we have for more 

routine not emergency authorization. 

You know, I think those developers are sometimes doing that during this 

emergency and show that in their development and in there data may have, 

you know, adapt over others that don't do that. So, point very well taken. 

Ideally we would actually love that. And as we move forward in this 

pandemic, we have updated the requirements for validation doing some 

contrived samples and actual samples. We've been updating some of the 

assays with postmarket requirements.

So, it is an evolving process and it's a good point to make and we will take it 

back to the team to assess how we might incorporate that thinking into the 

future test developments. Thank you.
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Operators: And our next question is from (Thomas Wilchard). You may go ahead.

(Thomas Wilchard): Great. Thank you for taking my call. I want to make a couple of brief 

comments. I apologize, but they're going to frame the context for my question. 

Look, I think we all can agree that we are entering and going to experience a 

massive increase in the rate of infection. We need to come together and do a 

much better job of working together as an agency and an industry. In 

particular, regarding the distribution of kits. My question is regarding, or what 

I will call serology in a general testsand also, in particular, the currently in 

limited supply production antigen test, okay.

I'm wondering why we don't all take a more robust view of what I'll call 

lateral flow pinprick antibody test. And these new (unintelligible) swab 

antigen tests as a triage system, a first line. If we are going to increase testing

capacity at the rate that we need to, we have to turn and make it much easier 

for distribution of both of these types of tests, because we're not going to have 

the capacity, as we learn from Quests when they release a press release a 

couple of days ago, talking about limited supplies and problems in the near 

future for virus microbiology test.

So, my questions are these. Number one, for these types of triage devices 

where everybody understands that you get this test, it's not as accurate, you 

have to have it followed up. Why are we not seeing a more robust system and 

in larger numbers of these tests being allowed to be distributed through a 

CLIA-waived designation? It seems like these tests are not that complicated. 

People that have a waived CLIA designation have plenty of experience. You 

don't need to have - to the extent that we are continuing to limit, a pre-EUA to 

highly complex CLIA lab. These antibody tests and similarly these antigen 

tests as well. And only after EUA expanding them to moderately complex. 
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The difference between the ability to distribute these tests. Three designations 

for the CLIA lab is massive. Okay. If you could move to a system where you 

allow these types of triage first-line tests that are widely available, cheap to 

make and can actually be brought out to the public to be done on a waived 

basis. Okay. That is going to solve our problem as an industry and yours as an 

agency of getting robust testing out to the public.

Currently, I understand your position, you intend to be more

Timothy Stenzel: Maybe you can be a little more direct in your question.

(Thomas Wilchard): How about this, why do we need to, why does every person who has gotten 

an EUA for example for an antibody test, and received an EUA for a highly 

complex and moderate complex have to go back and go through the long 

queue right now of an amendment to the EUA to expand that to a waived

CLIA designation. When we know exactly how these tests operate. We know 

what personnel are able to do them. It doesn't make any sense.

Timothy Stenzel: So, we’ve authorized tests, one antigen and four molecular tests for the CLIA 

waived environment. And we're very interested in authorizing more. And 

we've provided validation details in our serology template, as well as in our 

antigen template. And so, once those studies are performed I have directed our 

office to make point of care testing a priority. 

So, you know, as soon as there is point of care data to review on an 

application, whether it's an original or an amendment. It is a high priority and 

if somebody has a point of care test with all of the point of care studies in it all 

ready and it has been submitted into our office and they're not undergoing 
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interactive review within a few days of submission; I would like to hear about

it. You can send an email address and ask for Tim. I'll look into what the 

issue is. But high level direction to the office is when we have point of care 

test data to review that is priority.

Now, something may have been designed for a point of care setting. But, if we

haven't had data showing that it can perform accurately in that setting, we are 

unable to authorize that. And so, we have provided detail, and 

recommendations on validationto get that deemed CLIA waived. And we can 

provide that for the molecular point of care now informally and we are

working to update the template for the molecular template to allow the point 

of care recommendations for validation to be there as well.

Coordinator: And our next question is from (Andrew Louaday). You may go ahead. 

Andrew? He dropped out of the queue.

Our next one is from (Ray Bandovo). You may go ahead. And again, (Ray 

Bandovo), your line is open. We are not able to hear you.

And our next question is from (Gretchen Johns). You may go ahead.

(Gretchen Johns): Hi, this is (Gretchen Johns) can you hear me?

Timothy Stenzel: Yes.

(Gretchen Johns): We're having a lot of trouble getting reagents, which I know everyone is just 

before our high throughput instruments and rapid tests. I was wondering 

what’s the status of pooling and are there any vendor-approved EUAs for 

pooling or do you have to do that on your own or, you know, it's getting to the 

point of desperation. So, any help you can give us that that'd be great.
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Timothy Stenzel: So, we are absolutely open to pooling. We have not authorized a pooling 

scheme yet. We are asking for EUA submissions. Labs or manufacturerscan 

come up with their scheme, validate it and notify us and submit within 15 

business days. And we'll review those schemes and look to authorize them. 

You can use, for this, you can either use your own EUA authorized test or you 

can use a manufacturers' test to do this. And, we’ve started looking at some 

preliminary data about pooling. It's not unfortunately going to be a panacea. 

Yes, it will address reagent shortages. Yes, it can expand our capacity to test 

more and more patients with the given infrastructure that we have, but nearly 

all pooling schemes will reduce the sensitivity of the assay. And therefore, we 

do predict that patients, especially low positive patients may be missed in 

pooling schemes and called falsely negative so we’ve made the 

recommendation that negatives are called presumed negative when samples 

are pooled, just to alert the ordering clinicians or healthcare workers that if

clinical signs and symptoms warrant, they may want to follow up with a nonpooled test for certain patients. And the other thing is early preliminary data 

suggests smaller pools are more likely to have less sensitivity drop, which 

makes complete sense.

So, we would urge caution in this approach and fully validate your pooling 

scheme. And have a pretty robust design, so that you know that if you're 

missing any positives that its a really low amount. But given the situation, we 

understand, and we'll be working with developers, we’re updating information 

about pooling, pooling schemes. And some of the concerns we have and some

additional guidance once we gain more information about which pooling 

scheme may be working the best and minimize the test with false negatives. 

But some of the early data that we've seen, suggests that there could be a 

larger percentage of false negatives, depending on the population that you're 

pooling. So caution is warranted here.
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Let’s see, what other things could come up. The important thing is that one of 

the pooling schemes that may have less risk, although not zero for false

negative is to put multiple swabs into one VTM. You could have potentially 

increased inhibition that needs to be guarded against. Obviously the other 

challenge of doing that is, how do you de-convolute a positive pool and know 

which one of the swabs was positive. So, the schemes for that are 

unfortunately complicated as well because they either mean going back to 

everybody who is in that pool or requiring two swabs of each individual and 

then swabs are often in short supply.

So, this is a very challenging situation. The FDA is open to it. We’re out of an 

abundance of caution, we're asking for submissions and EUA authorization at 

least for the time being so we can figure out which schemes are going to work. 

We are, and we are encouraging all manufacturers to come in with pooling 

applications as well. So that those are automatically, you know, once they are 

reviewed authorized available for customers to use.

Coordinator: And our last question is (Nate Masely). You may go ahead.

(Nate Masely): Hi. Can you hear me?

Coordinator: Yes, we can.

(Nate Masely): Hey, actually my question I'm a pharmacist and I think you just answered my 

question. It's regarding the pooling testing, and we were looking at the 

potential strategies of how to do that. If you had a positive in the pool. And as 

we were considering is having each patient do two swabs so that once the pool 

came back positive, you'd have a second swab. It sounds like that's something 

you're considering, but there may be a shortage of swabs?
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Timothy Stenzel: Yes. It does put pressure on swabs which have been in short supply at times,

currently. And also, what do you do if you have a high volume, what do you 

do with those swabs, how do you store them, how do you inventory them, 

how do you go back to them easily. So, unfortunately, there's no, you know, 

ideal options here. I’m just saying that the FDA is open to different options 

and wanting to work with developers on what will work for them. And of 

course, it all depends on the incidence of positives in your population.

So, some pooling schemes, particularly combinatorial schemes, . they don't 

work, for really high prevalence, high incidence situation where the 

prevalence of positive results is high or the incidence of positive results is 

high. And the, you know, most of those are relatively low. Thelow incidence 

populations, low prevalence populations are going to be better for 

combinatorial schemes and simple pooling is going to be better for higher 

prevalence but once you reach about 20% positivity almost any pooling 

scheme is less ideal.

Coordinator: And that concludes today's question and answer circle, I like to turn the call 

back to Timothy Stenzel.

Irene Aihie: Hi (Lesley). Thank you. This is Irene Aihie, and we appreciate your 

participation and thoughtful questions. Today's presentation and transcripts 

will be made available on the CDRH Learn Web page at 

www.fda.gov/training/cdrhlearn by Tuesday, July 7. If you have additional 

questions about today's presentation, please email cdrh-euatemplates@fda.hhs.gov - and 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 
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survey can be found at www.fda.gov/cdrhwebinar immediately following the 

conclusion of today's live discussion.

Again, thank you for participating. This concludes today's discussion.

Coordinator: And this concludes today's conference. Thank you for participating. You may

disconnect at this time.

[End of segment]