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FDA Virtual Town Hall Series –

Immediately in Effect Guidance on 

Coronavirus (COVID-19) Diagnostic Tests Moderator: Irene Aihie

October 7, 2020

12:15 pm ET

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

listen-only mode until the question-and-answer portion of today's call. During 

that time if you would like to ask a question over the phone line please press 

star 1. Today's conference is being recorded. If you have any objections you 

may disconnect at this time. I would now like to turn the meeting over to Irene 

Aihie. You may begin. 

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

Education. Welcome to the FDA's 29th 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, Director of the Office of In Vitro Diagnostics and 

Radiological Health in the Office of Product Evaluation and Quality from 

CDRH, will provide a brief update. Following opening remarks, we will open 

the lines for your questions related to today's discussion. Please remember that 
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we are not able to respond to questions about specific submissions that might 

be under review. Now I give you Timothy. 

Dr. Timothy Stenzel: Thank you, Irene. And hello again, everyone. Today it will be me. (Toby)

is on a well-deserved leave this week. So I have a few starting discussion 

points. The first thing that - relative to pre-EUA submissions, if a question 

that is asked in a pre-EUA is something that can be answered clearly and 

directly from a template that we've already posted, we will defer to that and 

not generally provide any more direct feedback. 

This will really help us triage these questions because we spend a great deal of 

time on (unintelligible) the templates and keeping them as up to date as we 

can. I've directed the office staff to cut and paste the relevant section into the 

email, if you send it by email, as well as to attach the full template. So I'm 

hoping that, that works for everybody because that would be a very efficient 

way of handling this. 

Next I wanted to revisit positive predictive value. It is - we get frequent 

questions about the application of positive predictive value, in particular I 

think for - currently, for rapid antigen tests. So everybody has seen various 

publications about potential false positives as there have been rollout and use 

in lower percent positive populations in nursing homes and other settings. 

And I just want to reiterate the value of looking at positive predictive value in 

assessing what to do with a positive result, specifically for a direct antigen 

test. But it can apply to any diagnostic test including molecular tests. Because 

in general, if the percent positivity is low in these populations, even with the 

relatively specific test, the number of false positives can be significant. 
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And therefore, we have recommended that, and the CDC does as well, that 

you confirm those results before taking any potential action, especially (in) 

regards patients. Obviously there's less - potentially less impact on healthcare 

workers if they have the false positive that can be confirmed to be false 

positive within a day or so. And then they don't need to be further quarantined 

if there's no other indication to do so. 

But with the patients there can be obviously a little bit more disruption. So it 

is very beneficial to have a plan in place to - when you utilize these tests, to 

have a plan in place to rapidly reflex those positive individuals to a second 

test. And work out a way that we can get a fairly rapid turnaround time on 

those critical. 

It's very clear in some of those preliminary data that I've seen, that the 

deployment of rapid antigen tests have been able to identify positives in low 

percent positive - true positive ways and low percent positive populations. 

And that this may have an incredibly valuable - be an incredibly valuable tool 

in the fight because you may be able to identify those positive individuals 

with the rapid antigen test which is not super sensitive. 

So you're not necessarily seeing, you know, late, you know, I'm not going to 

say late RNA shedding for example, but typically you're going to see patients 

who are potentially and most likely, have the ability to infect others. And so 

if you can identify those in 15, 20 minutes with a quick turnaround test on 

location, if you can identify those individuals you can enhance your ability to 

protect your staff and others (unintelligible) the staff. 

And I just want to go through a different set of numbers than I did last week 

or the week before, with regard to this PPV. So in this case I'm setting the 

percent positivity rate at just over 2%. It's actually 2.3%. The sensitivity of 
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the test I've dialed in 85% and the specificity I've dialed in at 98%. The 

positive predictive value for a positive result is then 50% in this population. I 

kind of selected these numbers to come up with a 50%.

That means one out of two results is a true positive and one out of two results 

is on average, a false positive. So again, it just highlights that you can have a 

very specific test, 98%, in a prevalent population of a little bit over 2% and 

still see significant numbers of false positives. And in my view, there is 

nothing wrong with this test. It is just, you know, the importance of 

recognizing positive predictive value in low incident populations. 

And so the other thing I wanted to mention regarding direct (imaging) tests is 

there, because there has been a good bit of press about it, is whenever we get 

medical device reports or we get other signals of potential problems with any 

test and in particular, any EUA or COVID test. We do look into those NDRs 

and if warranted, we do an investigation. 

We of course, will reach out to the sponsors and understand what they know; 

review the complaints that they've received; and if we can confirm anything 

we will make that transparent to the community, the larger community, the 

testing community, clinical community through various means as soon as we 

can. And, you know, and I have nothing new to announce along those lines 

today, about direct antigen tests. 

So moving onto the final topic in my preliminary remarks, I did want to 

update an important new practice for this community. We've already issued a 

frequently asked question on our Web site and I do have prepared remarks for 

this. It is an important announcement. 
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So today the FDA issued a new frequently asked question for test developers 

to share an update on our prioritization of EUA requests. We recognize that 

we are currently in a different phase of the pandemic with respect to tests than 

we were previously. One second. 

Many COVID-19 tests are now authorized to be run in labs. Presently, over 

250 EUAs for tests are authorized and over 400 tests are already being offered 

following notification under FDA's testing guidance. We prioritize review of 

EUA requests for tests taking into account a wide variety of factors, such as 

the public health need for the product and the availability of the product. 

And we have prioritized with you EUA requests for tests where authorization 

would increase testing accessibility such as point of care tests, home 

collection kits, and at home tests. And - or would significantly increase 

testing capacity, such as tests that reduce reliance on test supplies or high 

throughput and widely distributed tests. So all those should be relatively 

common sense as we go forward. 

In light of this and the recent HHS announcement that FDA will not require 

pre-market review of LDTs, to make the best use of our resources for the 

greatest public health benefit the FDA is declining to review EUA requests for 

LDTs at this time. FDA continues to prioritize review of EUA requests for 

point of care tests, home collection test kits, at home tests, tests that reduce 

reliance on test supplies, as well as high throughput, widely distributed tests. 

This approach will provide greater potential to improve the national testing 

capacity and permit FDA to take appropriate steps to assure that authorized 

tests may be effective. And so with that, I think we can open it up for the 

Q&A. Thank you. 
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Coordinator: Thank you. We will now begin the question and answer session. If you 

would like to ask a question, please press star 1, please unmute your phone 

and record your first and last name clearly when prompted. Your name is 

required to introduce your question. To withdraw your question you may 

press star 2. 

Once again, at this time if you would like to ask a question please press star 1. 

And our first question is from Shannon Clark. Your line is open. 

Shannon Clark: Hello. Shannon Clark from UserWise. So for point of care testing of 

molecular antigen and antibody products, as far as the six different operators,

it's noted that the testing should be performed with the Quick Reference 

instructions only and no training. This is consistent with the CDRH Human 

Factors guidance issued in 2016. 

And typically in Human Factors testing we never ask untrained users to please 

follow the instructions at the beginning of the session because we want to see 

what they're actually going to do in real life. However, for this testing, for the 

testing classified in the templates, is it allowable to please ask them to follow 

the instructions prior to using the product? 

Dr. Timothy Stenzel: That is a new one. Very specific question. I don't know a particular 

reason not to say, you know, that, you know, so there are, or something rather 

like there are instructions to follow in the test. A little bit more benign than 

what you said. But you know what, on this particular question I think it's best 

that we get a specific answer to you. Because I want to - I'm (alliant) with our 

typical practice so that I'm not out of step with what the office has said in this 

detail. 
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So if you send this to the templates email address that's a great question, and 

I'm myself, interested what the response would be. So please ask to include 

me in the discussion when you send that email. 

Shannon Clark: Okay. I'll do so. And just as a benchmark, the CDRH Human Factors team 

does not allow us to say please follow the instructions or to even remind them 

that they're present in the carton because we want to kind of see what they're 

actually going to do in real life. However, if we're only having six participants 

and each one is going to test like I don't know, 20 subjects, we might have one 

that chooses not to follow the instructions and then the study becomes a 

disaster zone. So that's just a consideration. 

Dr. Timothy Stenzel: Yes. No, I think it's a great question. And like I said, I was not aware of 

that potentially nuanced approach to how we recommend validation of point 

of care tests. So...

Shannon Clark: Thank you. 

Dr. Timothy Stenzel: It is - it is a risk. Thanks. 

Coordinator: Our next question is from (Elisa Maldonado-Hovich). Your line is open. 

(Elisa Maldonado-Hovich): All right. Thank you. I have a question regarding the EUA 

notification pathway. For me, the serology antibody pathway, notification 

pathway is quite clear. However, I’m not as clear in regards to the - for 

antibody - excuse me, for antigen tests. So we have a prescription, RX point 

of care for healthcare professionals so in clinic, using (empty) swabs so 

nothing unusual, for antigen tests. 
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So if we're about ready to submit our EUA and believe we validated our, you 

know, clinical data and our submission is complete, based on today's new, you 

know, priorities, announced priorities, can we proceed with the EUA 

notification pathway for an antigen test, and obviously wait for your approval 

before we start the integration, and then submit our antigen application 

template within the 15 days? 

Dr. Timothy Stenzel: Yes. Thanks for this question. So you are allowed to use the notification 

pathway. Once you notify us and you get confirmation from us, you can 

actually begin distribution of your test. 

(Elisa Maldonado-Hovich): Okay. 

Dr. Timothy Stenzel: However, it can only be performed in a high complexity lab until you get 

EUA authorization. And at that point, if it's appropriate to be used in both, in 

all types of environments including high, moderate, and clear way settings, 

then you'll get that, you know, the ability to do that in moderate complexity 

and clear wave site, upon authorization. 

(Elisa Maldonado-Hovich): All right. Thanks for that clarification. And just maybe for near 

future, consider it, you know, consider other routes other than high complexity 

labs since point of care is for healthcare professionals in clinics, which 

oftentimes are not high complexity environments, considering the new 

priority. 

Dr. Timothy Stenzel: I totally - yes, I totally, I totally get that. This is not just involving the 

FDA though. It also involves CMS and I think there's FAQs on this on our 

site as well for CMS in that. Unless we've authorized something it cannot be 

used in a lab other than a high complexity lab, according to my understanding 

of CMS clear rules. So I would also refer you to them. 
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(Elisa Maldonado-Hovich): All right. Thanks for the clarification. I appreciate it. 

Coordinator: Our next question is from Savannah Esteve. Your line is open. 

Savannah Esteve: Hi. Thank you. This is Savannah from UserWise. The other week you noted 

that as long as the participants of a human factor study were English speaking 

that using participants from other countries could be acceptable. 

And I just wanted to highlight that this advice is contrary to the CDRH 

guidance for Human Factors 2016 which specifies that participants should be 

US residents even though the Human Factors group at the FDA has been 

known to accept Human Factors testing from Canada since there is a cultural 

similarity to the US. 

I guess I was just looking for some clarification on that comment from last 

week. 

Dr. Timothy Stenzel: Yes. And also I think I may have misspoke last week and I think we do 

recommend Spanish language as well. So my understanding, in our practice, 

is that we allow and perhaps this is when you - when a clinical study is done 

at the same time, that we allow that to be done outside the US for these kinds 

of tests. 

So I could be wrong. But I think that's typically been our practice. And we 

want to be at least in this emergency situation, as flexible as possible on -

because we do have a number of developers outside the US that have devices 

that may be important and deployable within the US. 

Savannah Esteve: Okay. Thank you, Timothy. 
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Coordinator: Our next question is from (Wendy Strongin). Your line is open. 

(Wendy Strongin): Thank you. In a prior call you said that experts have concerns about 

whether saliva would be sufficiently sensitive for antigen testing. Was that 

based on any data that they had actually collected or that FDA has seen? Or 

was that just a general concern? 

Dr. Timothy Stenzel: So we have seen data to this effect. And it does, you know, obviously alert 

us to a potential issue. There was also a recent press report about two different 

developers who reported they have decided and rapid antigen tests could not -

have decided not to pursue saliva as a sample type. So the FDA remains open 

to it. But we want to see the data to support its use. 

(Wendy Strongin): Yes. I know the press report you're familiar - that you're referring to. But 

it doesn't say anything about what was tried or what the method was. Does the 

FDA have any data that you can make available to manufacturers who are 

interested in this? 

Dr. Timothy Stenzel: We cannot share any confidential - any company confidential information 

with the public. Those companies are welcome to share that. So, you know, 

the companies were named in that press report so you're free to approach them 

and ask them for anything that they might have that might help you. 

But typically, you know, a rapid antigen test, the sample type, you know, 

whether it's, you know, nasal swab or nasopharyngeal swab, it would go 

directly into some sort of (lysis) buffer, you know, and then onto the device. 

And you can imagine the similar workflow for saliva. I mean that would just 

be where I would start. 
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But, you know, picking the right antigen target might be important in saliva 

and also, how you might process that saliva sample in that first buffer might 

be important in order to free up and preserve those protein antigens you're 

targeting. 

(Wendy Strongin): Great. Thank you. I have one additional question about antibody testing. 

The CDC says on its Web site that if someone has antibodies they likely have 

some degree of immunity to SARS-CoV-2. Would you allow a home test to 

have a claim of some degree of immunity conferred by antibodies without the 

manufacturer actually going out and doing studies, which would obviously be 

very, you know, difficult and time consuming to actually prove immunity? 

Dr. Timothy Stenzel: Yes, that's a different - a difficult situation to prove. First of all, if you just 

do one serology test in a low percent positive population the likelihood of a 

false positive result is not insignificant and should be reckoned with. And 

we've talked long ago on this meeting, on this call, about the potential to do 

not just one but a second serology, different serology test to try to, you know, 

firm up that exposure history. 

And then the question about - even about - well, you know, about immunity is 

obviously an important one but very difficult to prove. And in order to make 

claims about that in which somebody might rely on that information and - in 

going about their life, and potentially putting them at risk of being let's say 

reinfected, let's just assume they've had a prior infection but we've already had 

reports of reinfection. 

And until we firm up that understanding that's something that we're not going 

to be able to authorize at this time unless the data's supported. 

(Wendy Strongin): Thank you. 
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Coordinator: Our next question is from (Vajya Daka). Your line is open. 

(Vajya Daka): Thank you for taking my call today. My question is around the FAQ that you 

have put out this morning that FDA is not going to be reviewing any LDT 

submission. But I wanted to - a clarification on the past submission that we 

had. And we had gone with FDA for a round or two, in terms of addressing 

their reviews and concerns on our assay. Can you please clarify that? Thank 

you. 

Dr. Timothy Stenzel: Can you ask that question in a slightly different way? I want to make sure 

I understand the question. 

(Vajya Daka): Okay. Yes. I just wanted - I'm sorry. I just wanted to know if the EUA for 

LDT that we have submitted in the past, will be reviewed or those will also be 

declined to be reviewed. 

Dr. Timothy Stenzel: So you've already been reviewed and you've already been authorized? 

(Vajya Daka): So we're not - so let me rephrase it again. So I am from a high complexity lab 

and we have submitted our LDTs several months ago and also a couple of 

months ago, two of the assays that we have. I just wanted to know if you are 

going to be reviewing those old submissions in giving us EUA status or are 

you going to be declining to review any of the LDTs for EUA approval. 

Dr. Timothy Stenzel: Yes. So there were a few as we approached this, in this new policy, that 

we finished up because they were so close to the finish line and we had 

worked closely with those. And it - and in fairness, it seemed the right thing 

to do. But for those that were further out from potentially being authorized, 

we are going to decline to review those LDT applications. 
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(Vajya Daka): So let me ask you one more question. So we have - FDA had reviewed our 

submission once and then given us feedback and we have submitted those

feedback to FDA. So will those be reviewed or those will be also declined? 

Dr. Timothy Stenzel: Yes. Those will be declined. If you haven't received an EUA 

authorization already then yes, we will be from here forward, be declining to 

review any LDTs. 

(Vajya Daka): Okay. Thank you so much. 

Coordinator: Our next question is from (Jackie Chang). Your line is open. 

(Jackie Chang): Hi. Good morning. I have a question about the 510(k) process. So for a test 

that has already been submitted notification and is pending on an EUA, is 

there a pathway for a manufacturer to submit a PMA or a 510(k) request? 

And then if a manufacturer wants to get pre-market (current)s for neutralizing 

antibody test either through EUA or a 510(k), which FDA panel will handle 

this device? Thank you. 

Dr. Timothy Stenzel: When you mean FDA panel what do you mean by that? 

(Jackie Chang): Like is it clinical chemistry, immunology, like which division? Because 

previously you mentioned there are three parts, three groups that handle all the 

EUAs. So there's molecular biology, there's antigen and there's a serology 

one. So I'm just wondering which one will handle the neutralizing tests. And 

then if it is through a 510(k) will it be the same group of people or a different 

group of FDA division? 
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Dr. Timothy Stenzel: Yes. So we have three teams. We have a serology team, we have a direct 

antigen team, and we have a molecular team. And they divvy up the 

applications by technology so that those that are most experienced in those 

technologies are involved in the review of those technologies. 

And so, you know, if - and we strongly - we'd be very open to receiving test 

submissions for full authorization. For the first COVID test they will be a de 

novo (template). Once we've authorized the first de novo for a given 

category, all subsequent tests in that category will be obviously a 510(k). 

That will need to adhere to the special control recommendation. 

That's a document that has very specific recommendations for validation of 

the test once we've granted a de novo and created a new regulation for a new -

that new class of test. And so our staff are doing double duty. They're - the 

experts in our office who are reviewing EUAs are also going to be reviewing 

de novos and 510(k)s for COVID tests. 

And in addition, our office is still handling all the usual and roughly the same 

amount that we saw last year, of non-COVID tests that come - submissions 

that come to our office. So we're staying very, very busy. 

(Jackie Chang): That's very impressive. My specific question was about the neutralizing 

antibody test. Right now there's no template for a neutralizing antibody test. 

And if we want to go through an EUA pathway and if we are not a point of 

care or any of the priorities that you listed in today's announcement, will we 

still have a chance or should we go through a de novo pathway? 

Dr. Timothy Stenzel: Yes. Yes. Yes. So for kit developers that want to have a neutralizing 

antibody assay or semi-quant or quant, we've already authorized I think at 

least one semi-quant assay. Our EUA team will continue to review those kit 
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submissions. The team is working on - for serology, working on home 

collection, working on home testing and working on a - those are two different 

templates and then a third template having to do with semi-quant, quant, and 

neutralizing. 

And so I believe the team is ready to start making some recommendations for 

neutralizing assays. So if you send an email to our templates email address 

and ask for a specific - for any recommendations having to do with 

development and validation of neutralizing antibody assays, I believe the team 

can start giving you some specifics while we finalize those - that template. 

(Jackie Chang): Oh, this is so great. Thank you. So helpful. Thank you again. 

Dr. Timothy Stenzel: You're welcome. 

Coordinator: Our next question is from (Chris Benson). Your line is open. 

(Chris Benson): Hi Tim. Thanks for taking questions every week. I represent a foreign 

manufacturer of a SARS-CoV-2 molecular test that is undergoing interactive 

review. We submitted a pooling claim and had been asked to test the FDA 

panel with the test. Since the FDA said they will not ship the panel outside 

the US we need to find a US laboratory to perform this testing for us. 

As you can imagine, this can be quite difficult because every lab we've talked

to are extremely busy. Can you tell me why the FDA will not send this 

(normal) reference panel to a foreign manufacturer? Thanks. 

Dr. Timothy Stenzel: Yes. No, a couple of things. And one of them you may want to send me an 

email through the templates email box. I know that we've had - I'm not aware 

of the specific prohibition. I know that we tried to ship internationally. But 
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there has been some shipment problems and - going through customs and 

things like that. 

And I have more than a little bit of experience in trying to ship biological 

materials from one country to another and dealing with the customs issue. 

And it's very challenging. So it may be due to that that they haven't been able 

to overcome that issue. Now it might be that we could work with a company 

that's in a foreign country and figure this all out and map out a shipping 

strategy to get it to the company in enough time so that the dry ice is still on 

the samples. 

But the other thing is that I want to examine your specific case to find out if 

the reference panel results are required to make an upfront decision. It is a 

condition of all authorizations of all tests that when we request that you do a 

panel test and that you do that and report the results to us. 

So if you send me an email with - via our templates email box ask for Doc 

Stenzel, on this particular issue about - well these two issues, I want to look 

into it a little bit more and give you a very specific response. 

(Chris Benson): All right, Tim. Thanks. Yes, it - the requirements of the testing related to 

writing the (pool) monitoring plan and that was the justification for that. But 

I’m happy to contact...

Dr. Timothy Stenzel: Yes. 

(Chris Benson): ...you directly. Yes. 

Dr. Timothy Stenzel: Yes. So we've started to use the reference panel data in a very kind of 

limited way. And for those developers that have, you know, a relatively high 
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sensitivity assay, we've been trying to streamline things like the monitoring 

plan, to make it a little bit easier for those tests that have demonstrated with 

the panel that they have a relatively high sensitivity test. 

We're not really taking any negative actions at all based on some of the 

results. But where we can - we have reassurance from the results that you 

have a relatively high sensitivity test we are looking for opportunities to 

benefit those developers at this time. 

(Chris Benson): Okay. Thanks again. 

Dr. Timothy Stenzel: But we have the ability to put in place a monitoring plan without that 

(being). It's just not as streamlined as we would like to offer. Okay? So it's 

really an effort to help you out. 

(Chris Benson): Okay. 

Dr. Timothy Stenzel: If we can. 

(Chris Benson): Understood. All right. Thank you. 

Coordinator: Our next question is from (Dana Hummel). Your line is open. 

(Dana Hummel): Hi. Thank you for taking my question. What is your recommendation as to 

how researchers can purchase say serology rapid tests if the researcher does 

not have a CLIA certificate or a CLIA waiver? So basically I'm wondering if 

the test kit is labeled as RUO, can a researcher without a CLIA certificate or a 

waiver purchase the kit from a manufacturer? And this would be for either an 

EUA authorized test or a non-EUA test. 
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Dr. Timothy Stenzel: So I forget the exact number of serology tests that we've authorized for the 

point of care setting. I’m not sure if that matters for what you're doing. I 

think it may only be one at the moment. They're very interested in adding to 

that and adding home testing and home collection to serology. What are they 

going to do with this test and results? I can potentially guide you in a good 

direction or a helpful direction here at least...

(Dana Hummel): I...

Dr. Timothy Stenzel: ...as to what the...

(Dana Hummel): I guess maybe surveillance.

Dr. Timothy Stenzel: ...recommendations are. 

(Dana Hummel): Perhaps for surveillance or just general COVID research. 

Dr. Timothy Stenzel: So pure surveillance, you know, you want to know what the percent 

positivity is in a population. That's what you're going to do. You're going to -

they'll probably do this under IRB. That's not so much - first of all, pure 

surveillance testing according to how we define it on the FDA Web site, we 

have elected to not have purview over that kind of testing in this pandemic. 

So, you know, researchers are doing that and following our recommendations 

along with the recommendations of CMS and CDC. I would urge you to 

check out our sister agencies' recommendations on what you can and can't do 

in surveillance testing. But if that's what it's for it doesn't matter what the 

FDA classification of that test is. 

(Dana Hummel): Okay. And then...
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Dr. Timothy Stenzel: We don't require an EUA test for that purpose. And although we might - I 

think are - we may recommend if there is one that it might be beneficial to use 

that because it's obviously gone through some review and you can narrow 

based on - largely on the NCI testing program. You can actually know what 

the performance of that test is based on that program and our review of the 

data in that program. 

(Dana Hummel): Yes. I agree. But if the researcher doesn't have a CLIA certificate or a CLIA

waiver then they're not allowed to buy the EUA test. Right? 

Dr. Timothy Stenzel: I am not aware of that prohibition. Now I don't know if some test 

developers are putting a restriction on that. If they are, I'd like to hear about it 

and I'd like to potentially address it through an FAQ question and answer on 

the FDA side. And then, you know, if there is - and you are getting 

prohibition for true research surveillance use of a EUA authorized test I would 

like to hear about it in detail. And I would urge you to send me an email to 

my attention, to the - through our templates email box. 

(Dana Hummel): Okay. I’m a manufacturer and so I thought that we were not allowed to sell 

our test unless it was a CLIA certified or CLIA waived lab. But you're saying 

if we have some sort of documentation from the researcher saying it will be 

purely used for RUO use only then that would be acceptable? 

Dr. Timothy Stenzel: You know, that would be an adequate potential mitigation for that. But I 

know we've clearly recommended to use - FDA has clearly recommended you 

use EUA authorized tests even for surveillance. So that would be our current 

recommendation. 

(Dana Hummel): Okay. Thank you so much. 
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Coordinator: Our next question is from (Christopher Hanson). Your line is open. 

(Christopher Hanson):Yes. Based on your earlier response to a question, it sounds like pending 

EUAs for - or pending EUA request submissions for LDTs will be declined at 

this time. Will developers who have a pending submission for an LDT 

receive any sort of notification that their submission will be declined at this 

time? And does...

Dr. Timothy Stenzel: Yes. 

(Christopher Hanson):...such - just one other question. Would such declining mean that the 

developer would no longer be able to eventually get PREP Act coverage for 

their tests? 

Dr. Timothy Stenzel: Okay. Yes, we are going through our submissions and determining which 

tests are LDTs and they will get a letter as soon as we can get that out to them, 

explaining that an giving them that information. Regarding PREP Act

coverage, I’m just - I'm going through a prepared - a potential question here. 

It says is this an FDA effort to prevent LDTs from COVID-19 from getting 

PREP Act protection? No. This is an effort to prioritize FDA resources for 

the greatest public health benefit considering the extent in which we can use 

our authority under the FD&C Act, the Food, Drug & Cosmetics Act. The 

PREP Act is a separate statute. 

(Christopher Hanson):Thank you. 

Coordinator: Our next question is from (Tom MacDougal). Your line is open. 
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(Tom MacDougal): Hi there. Thanks for taking my question. I was hoping to expand on an 

earlier one and then ask one of my own. So you said earlier that the first 

clearance submission for each of the categories, you know, serology, 

molecular, antigen, will be a de novo followed by 510(k)s from there. 

And I was curious if, you know, let's say the first serology submission is for 

moderate and high complexity CLIA labs only, can that be followed up with 

510(k)s that are looking at non-laboratory use or point of care use? 

Dr. Timothy Stenzel: As a 510(k)? You know, getting into the details of that I would rather -

my personal druthers is that I would rather have - I'm a (lumper) and not a 

splitter - and to have as broad a categories of de novo grants as possible. It 

does mean we need to write these special controls in a way that would allow 

all of that. 

And whether we're at a juncture to do that with the submission of a moderate 

or a high complexity test, without data on its point of care use is something 

that I would like to examine when we get those submissions and provide that 

feedback. 

Hopefully, we can provide the broadest and sort of bucket in here of these 

submissions so that we frankly, limit not only our work but that of test 

developers as well, regarding de novos. 

(Tom MacDougal): Okay. Thank you. And then just my other question is I'm working with a 

developer who has an antigen test that can be visually read and they want to 

develop alongside it an electronic light based kind of reader system. And, you 

know, I've seen, you know, tests like Abbott already have these on the market 

previously. But for a company that does not, should they week a separate 

approval for this reading system or can it be included in the EUA? 
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Dr. Timothy Stenzel: So we're working on template updates regarding this for direct antigen 

tests. So you can certainly email our template team email box and ask for the 

recommendations for the development of a reader for a direct antigen test. 

And the team should be able to cut and paste from our current thinking on 

recommendations for this and give you as specific an answer as we can on 

that. 

Can - and it may matter whether or not the same developer who developed the 

antigen test is also the one that's developing or responsible for the 

development of the reader. If that's all within one legal entity you can simply 

update your original EUA application with the reader. 

If it involves a separate company then it gets a little bit more challenging, but 

we'd really look to streamline how we do that. And, you know, if that 

company is willing to work closely with you then we can work out all of these 

kinks in the least burdensome way possible. 

(Tom MacDougal): Great. Thank you so much. 

Coordinator: Our next question is from (Griffin Soriano). Your line is open. 

(Griffin Soriano): Hi, Dr. Stenzel. Thanks for taking my question. I apologize. A bit of a long 

one here. But if a test developer must receive EUA for a combo antigen test 

like the one we saw recently from Quidel, do they already need to have an 

FDA cleared rapid influenza diagnostic test? 

And if so, and the developer does not have one, do they need to conduct a 

510(k) study to receive EUA for a combo test or does a combo antigen 
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developer simply need to illustrate their test performance for Flu A/B and 

SARS versus an already approved PCR test for these diseases? 

Dr. Timothy Stenzel: So I don't think the current antigen template, has recommendations for a 

combo or a multi-analyte test. Obviously we just authorized the Quidel test. 

Our molecular template has some good information about the recommended 

development path and validation for combo tests that have non-SARS 

respiratory viruses that we haven't reviewed before in that. 

And that could be a good guide but I believe the team is ready to be able to 

give you specific feedback on our recommendations based on our current 

thinking around this for direct antigen tests. So simply email that. But you 

can look at the molecular to start getting an idea of what we're going to be 

suggesting for such tests. 

We are - take two different pathways depending on whether the tests have 

been previously cleared for say Flu A/B. And, you know, we've already 

reviewed it and we've already, you know, designated perhaps the 

(unintelligible) test and you're adding SARS to it. 

There's less development of work invalidation for such a test than if you're 

coming in new to us in either a combo that's new to us and that you now have 

SARS, Flu A/B, (ADRC) or whatever, and we haven't seen that test before; 

we haven't authorized the non-SARS (analytes) yet, there is a greater 

expectation of validation that we recommend. And that's because we haven't 

seen that test before. And therefore, there might be point of care studies as 

well as the validation (of those). 

Now in pre-market for an EUA for such a device, we're going to be flexible. 

We would like to see as much prospective data as possible. However, we're 
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not, you know, we're not in the middle of flu season yet and we may have in 

fact, because of mask wearing and social distancing plus the usual amount of 

vaccination, we may see a very light flu season going forward in the United 

States. That would be our hope. Hopefully that pans out. 

In which case, there may not be enough prospective samples in a reasonable 

amount - positives in a reasonable amount of time for you to follow our usual 

recommendation. So we are going to be very open and flexible to the use of 

say (bank) samples. (Bank), Flu RC, whatever on your panel. Clearly there's 

plenty, unfortunately, of SARS around today. 

But for those other (analytes) we will - we absolutely will allow the use of the 

samples, (bank) samples, to pre-market, validate your test for EUA review and 

authorization. We would however, in all likelihood have post-market 

commitments and then authorizations that ask you to do a follow up 

prospective study that allows us to really understand the performance of those 

non-SARS (analytes). 

Because that, you know, even in the pandemic that does typically require a 

510(k). And so we are being flexible to assimilate the development of panels 

such as this. And we're trying to do our best to help you (make it). 

(Griffin Soriano): Great. Thank you. And just one quick one. To date, I know you've been 

mentioning this on previous calls, but to date, have you been approached by 

any developers with an EUA for at home COVID testing for active infection? 

Dr. Timothy Stenzel: COVID? And so as molecular or antigen testing at home? 

(Griffin Soriano): Yes, that's correct. 
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Dr. Timothy Stenzel: So what I can say - I can't really talk about who's done what. I think I can. 

There's a lot of interest in that, obviously. But what I'll say is that we have to 

my knowledge, and I get sort of an update every day or every other day about 

this, on particular high priority category tests. We haven't received an EUA 

submission that has, you know, (unintelligible) for our review for an at home 

antigen or an at home molecular test. 

(Griffin Soriano): Great. Thank you very much. 

Coordinator: It looks like that's all the time we have for questions. I'll go ahead and turn the 

call back over to (Kimba Ford)? 

(Kimba Ford): Thank you. This is (Kimba Ford) who's now covering on behalf of Irene 

Aihie. We appreciate your participation and thoughtful questions on today's 

presentation. The transcript and the presentation will be available on the 

CDRH Learn Web page at www.FDA.gov/Training/CDRHLearn, by 

Thursday, October 15. If you have additional questions about today's 

presentation, please email CDRH-EUA-Templates@FDA.HHS.gov. 

As always, we appreciate your feedback. Following the conclusion of the 

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/CDRHWebinars), immediately following the conclusion of 

this live discussion. 

Again, thank you for participating. Please join us next Wednesday. And this 

concludes today's virtual town hall. 

Coordinator: Thank you for participating in today's conference. All lines may disconnect at 

this time. 
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Moderator: Irene Aihie

10-07-20/12:15 pm ET

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END