FDA Townhall

Moderator: IRENE AIHIE

07-15-20/12:15 p.m. ET

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FDA Virtual Town Hall Series –

Immediately in Effect Guidance on 

Coronavirus (COVID-19) Diagnostic Tests

Moderator: Irene Aihie

July 15, 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 listen-only mode until the 

question-and-answer session. At that time, if you have a question you may 

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: Hello, I am Irene Aihie, of CDRH’s Office of Communication and Education. 

Welcome to the FDA’s 17th 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, 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 the line for your questions related to today’s 

discussion. Please remember that we are not able to respond to questions about 
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specific submissions that might be under review.

Now, I give you Timothy...

Dr. Timothy Stenzel: Welcome everyone to this week's call and thanks for all that you're doing, 

during this emergency. I'm going to turn it over now to Toby, for some opening 

updates and then we'll open it for questions. Thank you.

Toby Lowe: Thanks, Tim. Thanks, everyone for joining us today. Just a quick update today, 

this morning we made some updates on our FAQ page to the question about 

obtaining viral transport media and swab alternatives. The edits were primarily 

for clarification and additional language around the warning regarding media 

that includes guanidine thiocyanate or similar chemicals. And then the other 

update that we made this morning was to add a new question under the "What 

test should no longer be used or distributed?" section, and that is for 

laboratories that had previously provided notification under the policy in 

section 4A of the guidance but has now been removed from the notification list 

and the tests should no longer be used.

So those are the only updates that we've made to the FAQs since last week's call 

I believe. And now we can open things up for questions.

Coordinator: Thank you. And 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 may 

introduce you. Again, that is star 1 if you have a question. Our first question is 

from (C. Wolfe). Your line is open.

(C. Wolfe): Yes, hi. I've recently seen some neutralizing antibody tests and I was wondering 

what criteria does FDA use or plan to use to assess assays for neutralizing

antibodies, especially assays that involve binding of spike proteins to its

receptors the surrogate to the use of live virus?
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Dr. Timothy Stenzel: How are you going to determine titers part of the assay?

(C. Wolfe): We might want to take a...

Dr. Timothy Stenzel: ...for quantitative?

(C. Wolfe): Yes. I think more semi-quantitative.

Dr. Timothy Stenzel: Okay. Yes, so we're very welcome of EUA applications for neutralizing 

antibody tests. Obviously, there's health determined among other things, folks

who might be good donors for convalescent plasma. And there are two types of 

assays that include say neutralizing claims. One is a routine serology test that 

then - or not routine. One that is say quantitative or tittered and makes a 

correlation to a neutralizing reference method. And notes that at a certain titer

or a certain cut off that there's a certain overlap between the detection of 

antibodies in a patient and a high level of neutralizing antibodies.

And so that's not a direct sort of neutralizing antibody assay. And then there are 

various ways to do this testing more directly and that is often also semi-quant or 

quantitative in order to make that assessment. It may be that a minimum titer is 

required for the significant neutralizing antibodies present. In both cases you 

want to compare ultimately to a validated reference method. How do we know 

that an assay is truly neutralizing or correlates to a truly neutralizing antibody? 

And then there's the added addition of making this semi-quant or quantitative. 

And so, for semi-quants or quantitative assays, I don't believe our current 

templates go into a lot of detail about how to validate that. So, we do ask you 

that you approach us and describe that.

But in many cases, in order to be - to have a good precision and accuracy 
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around quantitation, that there is a calibrator or calibration that goes into effect. 

And then of course an appropriate validation of that quantification portion of 

the assay. So that's about all I can say right now, are the things that we're 

thinking about. For more details, you know, ask questions. The more details 

you can provide, sending an email to our template email address, the better, so 

we can provide more information. This is a relatively new area of review for us 

and before we provide a more definitive feedback and recommendations that 

would be put into a template, we want to understand the assays that we first see 

in submissions, understand their performance, understand that we can establish 

truth to a reference assay, and develop the recommendation based on those 

early applications.

And then we'll, presuming that there'll be more and more, we'll make a template 

available, a template addition available for the them, OK.

(C. Wolfe): Okay. Thank you.

Coordinator: And your next question is from (Lewis Perlmeyer). You may go ahead.

(Lewis Perlmeyer): Sure. I've got just a follow up on the first question person. Are there any 

EAUs being requested for neutralizing antibodies? And if so, are there any that 

have been accepted yet?

Dr. Timothy Stenzel: So, we have not authorized any assays for correlation or actual neutralizing

antibodies. There is very strong interest and we welcome them now of course. 

And I can't really say any more details other than that.

(Lewis Perlmeyer): Okay. Okay, thanks, Tim.

Coordinator: And your next question is from (David Hug). You may go ahead.
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(David Hug): Hi, yes. Can you talk about...

Irene Aihie: Operator, did we lose our caller?

Coordinator: He is still connected.

((Crosstalk))

(David Hug): Can you hear me now? Can you guys hear me?

Dr. Timothy Stenzel: I was worried that I got dropped.

(David Hug): No. Can you hear me now?

Dr. Timothy Stenzel: Go ahead, (David). Yes.

(David Hug): Can you comment on where you see saliva-based serology tests either 

absolutely or in terms of the prioritization of EUA review and separately, 

whether you see IgA as a viable pathway for antibody evaluation versus IgG or 

IgM?

Dr. Timothy Stenzel: So, this would also be a new area for us. So, we haven't authorized any yet. 

And trying to understand what the performance should be and how you 

establish the validation is still something that we're noodling on. You know, 

there is the capability of looking in saliva for - specifically perhaps for IgA. 

And it could be that IgA detection and maybe in saliva, could correlate well 

with some types of immunity. And I’m not saying that’s easy to establish or that 

that’s taken as truth right now and just talking about the potential for such tasks. 

But we certainly don't have any recommendations yet for how you would 
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validate that.

So, anybody who is interested in developing a saliva-based antibody test, it's 

not so much a serology test that we usually think about it, as a blood-based or a 

blood-derived anolyte. But it's, you know, it could have importance. We're not 

going to discount that. So, we would welcome ideas on how to validate and 

proposals. And we'll take a look at them.

(David Hug): Thank you.

Coordinator: And your next question is from (Dana Hubbell). You may go ahead.

(Dana Hubbell): Hi. Thank you for taking my call. My question is regarding the importation and 

sale of RUO or Research Use Only rapid serology kits that we manufacture 

outside of the US. If we would like to import finished kits for research use only 

in the US, do you foresee any challenge with testing clearance from the FDA 

point of view? Of course, these kits will be labeled clearly for RUO and will 

only be marketed for research use only until we receive an EUA. And also,

would we need to provide any sort of official notification to the FDA prior to 

our pre-EUA submission in order to import and sell the RUO kit?

Dr. Timothy Stenzel: Yes. So that's a potentially challenging area and Toby, do you - are you 

prepared to address this, because you've thought a lot about this.

Toby Lowe: Yes. So RUO is a little challenging especially for complete test kits. Complete 

test kits should really not be distributed to clinical laboratories as an RUO. I 

would encourage you to take a look at the guidance document that we have on 

distribution of IVD products labeled for RUO. And as noted in that guidance 

document, it's not appropriate to label a product as RUO and then promote it to 

clinical laboratories with the intent that the laboratory validate the test and offer 
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it for clinical diagnostic use as a laboratory-developed test.

((Crosstalk))

(Dana Hubbell): What about selling to researchers?

Toby Lowe: I'm sorry. Can you repeat that?

(Dana Hubbell): Oh. I said, what about the intent to sell to researchers? That's what I was 

thinking.

Toby Lowe: Sure. So, depending on your plan selling it to researchers may be appropriate. I 

would again, encourage you to take a look at that guidance document because it 

does talk about what you uses are appropriate and not appropriate for products 

labeled RUO.

Dr. Timothy Stenzel: And I would add that we’re really encouraging developers and people like 

yourselves who may be considering distributing serology kits, that they 

consider early on to just go ahead and submit an EUA if ultimately they, you 

know, they should, you know, if you want to market this to clinical labs. So...

((Crosstalk))

(Dana Hubbell): I was just wondering if we could sell the RUO kits in the meantime. But we 

can...

Dr. Timothy Stenzel: Have you been...

(Dana Hubbell): ...definitely considering...
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((Crosstalk))

Dr. Timothy Stenzel: Have they been validated for clinical use of your performance data that

could be used to submit to the FDA?

(Dana Hubbell): Yes. We have some data and we have submitted our test to the NCI.

Dr. Timothy Stenzel: Yes. So, I mean I think that's a gray area. We're not encouraging labs to buy 

RUO kits for this purpose. There are now some authorized kits that they can 

use. And there are notified kits that they can use and to go ahead and purchase 

RUO when there are so many notified tests and already quite a few authorized 

tests, doesn't really make a lot of...

(Dana Hubbell): I agree.

Dr. Timothy Stenzel: ...sense to us. So, if you've got, you know, data for a EUA submission I 

would just encourage you to, you know, notify us if you want and or just submit 

the data.

(Dana Hubbell): Okay. Perfect.

Dr. Timothy Stenzel: And then that's the way to market such a test. Because it sounds like it's 

already been developed for and at least some validation for clinical purposes.

(Dana Hubbell): Yes. Okay. Perfect. Thank you so much.

Coordinator: And our next question is from (Jeff Kerriberry). Your line is open.

(Jeff Kerriberry): Hello. Can you hear me?
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Dr. Timothy Stenzel: Yes.

(Jeff Kerriberry): Oh. You can hear me? Good. Thank you for taking my call. I have a kind of a 

two-part question. The first part being a little general regarding the status of 

quantitation or standardization of the EUA submitted tests and what are the 

current status or thoughts of providing quantitative results based off of the 

standard curve in terms of nanograms per mil or (U) per mil, mass or massless 

units or preferred or anything regarding that. And then how the FDA is dealing 

with multiplex tests that can report individual antigen responses, epitope

responses and separately the isotypes and if there is a better - should this be 

done by the pre-EUA to get better traction on what's required for multiplexing?

Dr. Timothy Stenzel: Yes. Are all your questions having to do with serology tests?

(Jeff Kerriberry): That's correct.

Dr. Timothy Stenzel: Okay. Yes. I did respond to an earlier caller and talked a little bit about 

semi-quants and quants. I think in our template we say that if you want to come 

in with that that there may be some, I don’t know Toby if you have that 

template up. I don't know how much information we provide on validation of 

quant or semi-quant assays. But we're open to it in whatever appropriate units 

that you use to report out your results, we're welcome to consider. And, you 

know, standard curves, you know, calibration, are important for reporting out 

those results. And we want to look at sufficient validation to support a 

semi-quant and quant claim so to speak.

In regard to the multiplex, we have authorized some that report out individually 

IGG and IGM. There's also assays that sort of claim pan or total antibody that 

don't report out individual results. We don't have a preference. We just 

authorized recently our first IGM only for those developers who want to do 
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IGM only. There are challenges with IGM. It may not stick around as long as 

IGG.

(Jeff Kerriberry): Yes. And what about reporting the antigen separately?

Dr. Timothy Stenzel: So, if you have a multiplex assay that can say, you know, I forget the 

antigen that you mentioned, but...

(Jeff Kerriberry): Spike and nucleic acid for instance.

Dr. Timothy Stenzel: Yes. So, an NNS protein, an assay that can report out those separately 

would be fine. It's potentially a way to get two assays in one that could 

potentially improve the positive predictive value without having a reflex test.

(Jeff Kerriberry): Yes. Exactly.

Dr. Timothy Stenzel: So very open to that.

(Jeff Kerriberry): So, all of these kind of subtleties are best addressed via dialog with the FDA 

during the pre-EUA submission process? So, if we get that template going with 

you guys then we can fine tune some of these standardization issues and stuff 

like that?

Dr. Timothy Stenzel: Yes. The more you can propose what your validation would be the easier. 

But really, I mean our templates are pretty good already for individual antigens. 

And the fact that you would report out individually it just matters how you 

would like. And then the validation could be done individually and separately, 

you know, by isotype and by antigen. But then it also depends on how you 

might want to aggregate that data and report it overall. That's probably the 

biggest question and that's not a super important question at the beginning, as 
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long as each isotype and antigen are properly validated and performed well.

And, you know, to any extent that you report something individually we will 

look at that individual performance and make sure it meets our minimum specs, 

and those are pretty well laid out in the template. So, I don't know that a lot of 

interaction with the Agency is required. I think the novelty of this is reporting it 

all out on one test instead of doing it on multiple different tests or doing it one 

test after another.

(Jeff Kerriberry): Yes. So, there is some area to populate the templates regarding standardization 

and then if you have further questions you would get back in response to the 

template?

Dr. Timothy Stenzel: Yes.

(Jeff Kerriberry): Is that correct?

Dr. Timothy Stenzel: Yes. I mean the only - yes, the only area that we haven't necessarily 

addressed specifically to this, is how you report out overall results. Right?

(Jeff Kerriberry): Right.

Dr. Timothy Stenzel: You combine it all together for a positive.

(Jeff Kerriberry): Yes. You can do combined likelihood ratios like the PPV or you can yes, that's 

these are some of the issues we wanted to discuss. And if you see like the CDC

guidance has a criteria for IgM that's 90% sensitive, is that typical? Or a lot of 

cases the IgM disappears, and you get 80%. Is that acceptable? Or no?

Dr. Timothy Stenzel: So, if it's IGM alone and no other markers we know that it needs to be at 
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90%. If it's in conjunction with IGG, IGG needs to hit 90% but IGM can hit 

70%.

(Jeff Kerriberry): Oh, okay. That's good. Thank you.

Dr. Timothy Stenzel: All right. All right, anything else?

Coordinator: And the next question is from (Carol Cooper). You may go ahead.

(Carol Cooper): Hi. Thank you for taking my call and first I want to thank Dr. Stenzel and your 

staff, for the huge amount of work that you are currently doing in trying to keep 

all of us safe. I must say I'm a former bench immunologist who strayed into the 

regulatory affairs area and now I'm a (rep) board member and I guess I have a 

very not so technical request. I do believe that EUA for the specimen collection 

kits is sorely needed. I'm assuming for every molecular assay EUA there are 

several specimen collection kits without a 510(k) clearance. And from what I 

can gather there are - there's so much variability.

We could also assume that specimen collection kit can follow portions of the 

home test, simply, potentially, and some of the 510(k) requirements from the 

existing products that are out there. But an EUA template is not only beneficial, 

it also provides a minimum threshold for all kit developers in this space. So, the 

hodgepodge variability of supplies requires some FDA attention when it comes 

to specimen collection.

((Crosstalk))

Dr. Timothy Stenzel: Yes. I just want to know a little bit more details about what kind of 

specimen collections in what environments that would be collected?
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(Carol Cooper): Not necessarily. Currently, the State of Illinois is collecting from whatever, 

whomever they can get the supplies from. And from what I can tell none of 

these have any type of 510(k) authorization. The - or clearance rather. And the 

EUA authorization would at least make sense that the viral test media as well as 

the swab are somewhat qualified for use. And the EUA would provide that...

((Crosstalk))

Dr. Timothy Stenzel: You're talking about swabs and the VTM.

((Crosstalk))

(Carol Cooper): Yes.

Dr. Timothy Stenzel: Yes. Take it over Toby.

Toby Lowe: Sure. So, I think we discussed this briefly last week on the town hall also 

because we agree the issue of unauthorized collection devices is challenging.

And there's also a desire by developers to expand sample collection to new 

specimen types like saliva and I know that's not one that you mentioned. But a 

lot of collection devices are 510(k) exempt so they should be registered and 

listed and have a quality system and be following FDA regulations. But swabs 

and certain types of media are 510(k) exempt. Some others are not. As you 

mentioned, VTM does generally require 510(k) and we have worked with some 

newer manufacturers of VTM on different issues that have come up there.

And we're working on ways to address that. And so, we are accepting EUA 

requests for specimen collection devices. But it is important to note that we are 

trying to, you know, figure out the best way to handle the issue of unauthorized 

collection devices. And right now, what we're advising companies, especially 
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saliva collection devices have been the area that we've had the most discussion 

around with developers and with manufacturers. And we're advising them at 

this point to refer to the home collection template. While not everything in there 

would be applicable, there is a lot of information there about what we would be 

looking for in terms of validation from the collection device side of things.

(Carol Cooper): Perfect. That's what I assumed. And then fill in the blanks with some of the 

other requirements that you would probably find in the 510(k) which would be 

the eventual clearance?

Toby Lowe: Exactly. Yes.

(Carol Cooper): Okay. So, will there be an EUA template posted?

Toby Lowe: We don't have an EUA template in the works right now for collection devices, 

but we are working on different ways to get the necessary processes in place for 

collection devices. And we'll continue to update as soon as we have more 

information on that.

(Carol Cooper): Okay. Thank you very much.

Toby Lowe: Sure.

Coordinator: And the next question is from (Josima). You may go ahead.

(Josima): Hello? Can you hear me?

Toby Lowe: Yes, we can.

Dr. Timothy Stenzel: Yes, we can.
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(Josima): Yes. This is (Josima) from (OG). Thank you for taking my questions. I have a 

question - I have actually two questions - very quick questions. Do you have an 

EUA on screening samples based on the saliva PCR kit? And also, if we do 

need to do that, I understand we have to do a paired screening. But do we need 

to do even for screening, do we need to pair NP and saliva, or we can just use 20 

saliva samples for screening and contrive them and use it?

Dr. Timothy Stenzel: So, you're really talking about doing saliva for asymptomatic patients? Is 

that correct?

(Josima): Yes. Yes.

Dr. Timothy Stenzel: Are you going to make - are you going to advertise, claim, make the 

statement that you have validated asymptomatic testing? Or, you know, 

because the FDA currently if you get an EUA for - a typical EUA says that 

testing on patients suspected of having COVID, we had stated that it's for 

prescription that if you get an order from a clinician on a patient it doesn't 

matter whether they're asymptomatic or symptomatic.

And you can do that testing. So, it's only if you want to specifically validate 

and make that claim in your information that you can detect asymptomatic 

patients. That would be required to be validated for the FDA. Is that something 

that's important to you? If it is, the answer can change based on that. And would 

saliva be the only sample type?

(Josima): We have done a validation. The last set we paired 30 samples for 

nasopharyngeal and saliva. So, we are using contrived samples, and we took 

negative samples and, you know, (unintelligible). My question is that we want 

to advertise as a screening of asymptomatic patients. So, we will do that not 
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later on, because right now, my question is can we use - right now, contrive 30 

samples for screening submission?

Dr. Timothy Stenzel: Not for asymptomatic. And I - there's screening that really, I think, refers to 

patients who aren't necessarily suspected of having SARS-CoV-2. You may be 

looking at a work population or school population and wanting to test 

individuals and report results back to individuals. So, I'm just struggling a little 

bit to - and I'm not understanding, and I apologize, exactly what you're going 

after here.

Woman 1: We're going after businesses. As you said, you're going after businesses and 

schools, like we get samples from them and screening them if we - you know, if 

they have COVID-19 or not. So, we are developing a diagnostics kit, as you 

said, by prescription only. And for that, we are doing a paired set with both 

nasopharyngeal and saliva. So, my question is, for screening also, do we need to 

have a paired set? If yes, can we use contrived samples for the screening?

Dr. Timothy Stenzel: So, for the screening, really, in your question, has to do with testing and 

claims for screening asymptomatic people. And like I said earlier, you don't 

need that as long as you're not claiming that. But if you're reaching out to 

businesses and saying, we want to have an FDA-authorized test that the FDA 

says is okay to screen asymptomatic patients, then it would require 

asymptomatic studies.

And if you already have an EUA authorized assay or if you've already done the 

EUA-authorized work of 30 positives and 30 negatives and NP and 

cross-validated, too, and you've done a paired study with saliva, and all those 

need to be on natural patients, not contrived. Actual patients, you know, an 

actual patient sample, a swab sample.
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Then, if you want to add to that, the asymptomatic screening claim to an already 

authorized assay, it does require 20 - the first 20 in a, samples that are 

consecutive, asymptomatic samples, compared to another - not yours, to 

another EUA-authorized high sensitivity assay, molecular assay. And I believe 

100 consecutive negative samples for that authorization, and adequate 

performance in order for that authorization to happen.

If you want to - and you've already done the initial validation, so this isn't -

pathway isn't open to you, but for anybody else who wants to start out with an 

asymptomatic claim, then they do their normal study at 30 positive, 30 

negative. But they also include at least ten prospectively, ten asymptomatic 

patients.

Woman 1: Asymptomatic positive or asymptomatic negative?

Dr. Timothy Stenzel: Positive.

Woman 1: Oh, positive. And it looks like that both for whether it’s diagnostic prescribed or 

for screening, you are not - it's not okay to use contrived samples anymore? 

Because initially, in your policy, that was listed, that you could use contrived 

samples.

Dr. Timothy Stenzel: Yes. No, there's - it's better to use actual samples to measure actual 

performance, and so we switched a while back. We're expecting on actual 

patient, and unfortunately, there's more than enough positive patients out there 

right now, so it's not really - in the beginning, there were no samples, at the 

beginning of this pandemic.

And so, we offered this alternate pathway, even though it's not ideal. But now 

that there's plenty of positive patients, that's not a pathway that we're 
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recommending right now.

Woman 1: Okay. That's good to know. Thank you so much.

Coordinator: And our next question is from (Luke Nguyen). You may go ahead.

(Luke Nguyen): Oh, hi. Can you hear me?

Dr. Timothy Stenzel: Yes.

(Luke Nguyen): Yes, we are a glass exam specimen blood capillary device manufacturer. And 

we have a lot of our customers applying for EUAs with our at-home collection 

kit or device. So, I'm just - I have a question. Do we need to submit our own 

EUA? Because our device is actually classified as Class 1 exempt.

Dr. Timothy Stenzel: So, it depends. And if you want to get an EUA authorization for home 

collection, yes, you would need an EUA. If you want to stay a Class 1 exempt 

provider and your customers are going to come in to obtain a home collection 

authorization, which has to happen before home collection can begin, then you 

can rely on their validations.

And we're encouraging collection kit manufacturers to come in for getting 

home collection EUAs. And that's going to be much more efficient, if multiple 

developers are going to use that collection kit for that situation, so that they 

don't all have to do the same study, right? And so, it may be attractive to your 

customers and other developers like you, for their kits, if they get an EUA 

authorization.

And I would even go so far as to say that, you know, seeing the home collection 

situation, that it's ideal if - and the first one would have to come in with a 
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partner, where you work with a partner who has a test where they want a home 

collection. It can be already an authorized test that you're adding this to, or 

somebody who is seeking an EUA authorization.

Because your authorization would be dependent on showing adequate 

performance for specific tests, right? And then - but you could do a lot of things 

upfront, such as usability testing, inadequacy of sample collection in the home 

environment. And then, it would be shipped, right?

And so, during the appropriate shipping study, even to the point of usability 

studies describing having a common set of instructions so that each other 

developer you might work with, test developer, wouldn't have to come up with 

their own instructions for use of your collection device.

And to the extent that you can get all of that reviewed in one package and 

authorized along with at least one other test, then - and you can simply give a 

right of reference to any other developer you want to work with, that can utilize 

the data that you've developed for that collection device, making it much easier 

for any other subsequent test developer to work with you, because they don't 

have to repeat all that.

And if you look at - I think there's an example on the molecular side. There's 

probably others, but the one that's coming to mind is the Everlywell swab 

collection kit that was authorized, and then authorized for use in a number of

other platforms. Toby, do you have anything to add?

Toby Lowe: Yes, sorry if I missed it, but did you say what type of collection device or which 

collection device you were referring to?

(Luke Nguyen): Yes, we - it's - our device kind of looks like a swab, but it's collecting capillary 
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blood through finger prick methods. So, it just - it collects a fixed amount of 

volumetric blood on that tip, and then it will be shipped at ambient temperature 

in a biohazard foil bag to the, you know, the partner lab, so they can do the 

testing.

Toby Lowe: Okay, thank you. So yes, it would - just to piggyback on what Tim said, you 

know, it is important that any lab doing testing and any, you know, test being 

offered is for use with a legally marketed collection device. So, we would, you 

know, ask that you come in with a submission for that device, prior to offering 

it for use with any test.

(Luke Nguyen): Yes, but for the application, because I - we currently have one of our customers 

applying for an EUA with our collection device. So, in our application, would 

we just reference their validated test for our device application?

Dr. Timothy Stenzel: So, you would cross-reference each other, and their test would need to be 

validated with your device.

Toby Lowe: Right, so you could give each other right of reference, and then either - the 

submissions could be done concurrently.

(Luke Nguyen): So, should I submit a pre-EUA or just submit an EUA notification, and then use 

the validated data for our submission? And then also for usability data, we have 

a lot of peer-reviewed literature talking about the usability of our product. Can 

we use those data?

Dr. Timothy Stenzel: It can be supportive. We're still working on templates for home collection 

for serology, and so that's not out yet. So, I would urge you to submit your 

validation plan along with your partner, and we can evaluate that for 

appropriateness since we don't have a template out yet, as a pre- EUA.
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And then, realize that the home collection and home testing is not a notification 

pathway. It requires an EUA authorization before you can begin home 

collection or home testing.

(Luke Nguyen): So, pre-EUA package would be ideal to get, like, have some sort of guidance on 

how we move forward with our usability study or the design of our study?

Dr. Timothy Stenzel: Yes. Yes, we don't have any home collection or home test template out yet. 

We're working hard on them. And we do have a home collection, I'm sorry, for 

molecular. So, you can look at that template and try to derive some information 

from that, as to inform you on a home collection for serology. But obviously, 

there's different issues with serology than with molecular.

So, adapt it to your purposes. Put it in writing and send to us by email. We 

recommend using our template, our serology template for this, but you don't 

have to use that. But we do recommend it. Okay? We're going to move on to the 

next caller.

Coordinator: Our next question is from (Phillip Cowell). You may go ahead.

(Phillip Cowell): Hello?

Dr. Timothy Stenzel: Hi, (Phillip).

(Phillip Cowell): Yes, hi. How are you? Mine's a little different question. I'm with 

Thermogenesis Corporation. I'm the CTO, and we have a kit in, one of the 

lateral flow kits under evaluation for EUA. But there has been a corollary 

project that we've been working on at a high rate, which is a reader that can 

empower, we hope, semi-quantitative information.
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It basically reads better than the human eye, by a considerable margin, and 

provides semi-quantitative information. It also has - it's designed into it, the 

ability to, over time, monitor both seroconversion and seroreversion, we 

believe, and are prepared to provide information. And so, we think it may have 

some public health consequences that are useful.

We have filed a document to CDRH, requesting a meeting, and I know (Dr. 

Whitacre) has been wonderful, is requesting time for us to present, because we 

need guidance. We're focusing on having this available by the end of summer, 

and we're at a period of time where some advice would be useful.

We haven't been able, so far, to obtain that, and I'm wondering if you people are 

so busy, that we're unlikely to have a meeting that works for our trajectory on 

the development itself?

Dr. Timothy Stenzel: Yes, if you're having trouble getting a meeting, just send an email -

(Phillip Cowell): I don't want to be unfair to anyone. I think people are trying - they've given us 

advice, and I know (Dr. Whitacre) is trying to pull the team together. But it may 

be that you're just so busy that it's not going to happen, and we're trying to -

we're a limited resource.

Dr. Timothy Stenzel: Well, we are way too busy. You know, I also - well, I also know we don't 

have, you know, good template information up about a serology meter, for a 

lateral flow device whether it's visual or, you know, nonvisual.

(Phillip Cowell): Yes, we are aware of that. And so, to that extent, we're anxious to show it to 

you, because we feel it does have public health consequences, and it might help 

make all that happen.
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Dr. Timothy Stenzel: Right. So, if - you know, I'm glad that you're getting some feedback. But it 

sounds like you could use some more in a shorter amount of time. And you 

know -

(Phillip Cowell): I think if we can get just in 30 minutes, we could show enough that your interest 

level would be - help us get the rest of the way.

Dr. Timothy Stenzel: Yes. So, I mean, I want to - I get involved early on when we don't have 

templates, so that we can help drive towards providing template information. 

And then, I can step out of it, because if there's a template, there's little need, 

usually, for me to be involved.

(Phillip Cowell): It's a battery-operated, handheld, very rigorous, very inexpensive, and provides, 

you know -

Dr. Timothy Stenzel: Let me just go ahead - we try to stay away from all the specific questions, 

you know, and specific advice. But yes, if you just send an email to the template 

email address and ask to connect -

(Phillip Cowell): We have done that. Attention to who, please?

Dr. Timothy Stenzel: (Dr. Stenzel), S-T-E-N-Z-E-L.

(Phillip Cowell): Okay. We will - I'll redo that, with that attention to. Okay?

Dr. Timothy Stenzel: Yes, okay. I hope to help. So, alright. We have time for another caller?

Coordinator: And our next question is from (Coda Moody). You may go ahead.
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(Coda Moody): Hi, good afternoon. Can you hear me?

Dr. Timothy Stenzel: Yes, hi.

(Coda Moody): I have a question related to the serology assays. The serology assays, one is for 

diagnostic, the second one is for screening, and the third one is for surveillance. 

Can you just, do all three applications need an EUA authorization or the 

surveillance can be done with the research use only test?

Dr. Timothy Stenzel: So, you have a serology test that measures antibodies?

(Coda Moody): Yes.

Dr. Timothy Stenzel: Okay. Well, they should not be used for diagnosis, and should not be used 

for screening. They can be used as an aid, and specifically to detect antibodies, 

and whatever isotypes that you want. And we evaluate and authorize based on 

that, but there's very specific language that should not be used for sole diagnosis 

of SARS-CoV-2, which at the moment, and probably for a long time, if not 

forever, you know, should be a direct detection of the virus assay, whether it's 

antigen assay or molecular.

As far as surveillance goes, surveillance would be looking at sero-positivity 

with a serology test. That, we have publicly stated and it's on our FAQ, that 

surveillance, if it's not reported back to individual patients, it's certainly 

something that is not something that the FDA, at least for this pandemic, is - has 

purview over. So, it can be RUO for that purpose, for surveillance, not reporting 

results back to individual patients.

(Coda Moody): How about screening for the group of people - I mean, it's not - I mean, 

individual tests are done, but it is done in a group, people returning to work or 
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some other things? So, they are not for - I mean, again, the antibodies can say 

only the exposure to the virus or not. So, does that come under EUA 

authorization, or it does not come under that, just like surveillance?

Dr. Timothy Stenzel: Diagnostic testing and screening are - and reporting results back to 

individual patients, at a high level, are under the FDA's purview. Surveillance 

can be done with a non-EUA assay. We ask that it be validated to the same level 

that an EUA assay would be validated, so that the data that's coming out of that 

surveillance testing can be relied upon for surveillance information.

But if you're screening individual patients who are not showing symptoms for 

workplace, return to work, school or return to school, that is something that's 

very clearly under FDA jurisdiction, and will require an EUA for that. It would 

be challenging for a serology test to be used in that manner, because you would 

have to presume that not only do you detect antibodies, but that antibody equals 

immunity.

And while we're open to developers that want to come in and make claims 

about immunity, the study design to demonstrate immunity is - could be rather 

challenging, and we're open to study designs that would show that. I'd also refer 

you to all the CDC guidance on the use of serology, and for this purpose. Toby, 

do you have anything else to add?

Toby Lowe: No, I think you said it.

(Coda Moody): Thank you.

Dr. Timothy Stenzel: Yes, okay. Alright, do we have time for another caller? It looks like we do, 

barely. If there's another caller?
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Coordinator: And our next question is from (Julie Larson). You may go ahead.

(Julie Larson): Hi, thanks for taking my question and thanks for holding these meetings. 

They're very helpful. My question is a follow-on to the earlier question, about 

template use for sample collection kits consisting of, you know, a swab and 

viral media. And I just want to confirm an understanding that they would - that 

those approvals should be thought through the home collection template. Is that 

correct?

Dr. Timothy Stenzel: Well, if you're going for a home collection claim, yes. And then, I would 

refer to what Toby relayed, you know, related to developers. Toby, do you want 

to reiterate anything?

Toby Lowe: I apologize, I didn't quite follow what your question was. Could you just repeat 

it?

(Julie Larson): Yes, it's a follow-on from the earlier question about viral media and the need for 

a template for that. And I just wanted to confirm that, you know, for those who 

don't have an approval and are seeking emergency use approval, it sounded like 

we were saying use a home collection template information for the viral 

transport media approval.

Toby Lowe: So, the home collection template includes a lot of information about what we'd 

be looking for to demonstrate the validation for a collection device. But it is -

you know, it has a lot about usability, and its sample stability. And so, that's 

where I would consider reviewing that with the information that we'd be

looking for.

But that, like I said, we're most interested in EUAs for collection devices for 

things like saliva, where there are not already legally marketed collection 
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devices. For VTM we could also consider that route, but I would also encourage 

you to reach out to us through the EUA template mailbox, so that we can 

discuss your particular situation and see, you know, what the best pathway 

would be for you.

(Julie Larson): Thank you very much.

Toby Lowe: Sure.

Coordinator: And this concludes the question and answer session. I would now like to turn 

the call back to Irene Aihie.

Irene Aihie: Thank you. This is Irene Aihie. We appreciate your participation and thoughtful 

questions. Today's presentation and transcript will be made available on the 

CDRH Learn's webpage, at www.FDA.gov/training/CDRHLearn by Tuesday, 

July 21. If you have additional questions about today's presentation, please 

email CDRH-EUA-Template@FDA.HHS.gov.

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

today's presentation, please complete 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. This concludes 

today's discussion.

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

disconnect at this time. Speakers, please stand by.

END
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