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FDA Virtual Town Hall Series –

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

Moderator: IRENE AIHIE

June 24, 2020

12:15 p.m. 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 session of the call. If you 

would like to ask a question during that time, please press star followed by the 

number 1. Today's conference is being recorded. Any objections, you may 

disconnect at this time. Now I'd like to turn over the meeting to Irene Aihie. 

Thank you. 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 14th in a series of virtual town hall 

meetings to help answer technical questions about the development and 

validations 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 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 specific submissions that might be under review. Now I give 

you Toby.

Toby Lowe: Thanks, Irene. Hi everyone. Thanks for joining us today. I'm going to start out 

by just giving a couple of updates on information that we've put on our Web 

site. We talked last week a little bit about the new information that we put up 

about polling and asymptomatic testing. We did get a couple of updated FAQs 

on that out shortly after last week's town hall. And then this morning we just 

updated a couple of our FAQs on validation and on the bridging policy and 

the modification policy in our guidance.

So those updates were intended to better explain that our recommendation for 

validation for all tests including tests offered under the policies and the 

guidance as well as the tests that have submitted for an EUA prior to offering 

the test that our recommendations for validation for all of those are included 

in the policy guidance as well as in the EUA templates that are referenced 

from the guidance.

We also clarified in the questions, FAQ, about the modifications policy and 

about bridging studies that the policy on modifications for use of a new 

specimen type does not reference bridging studies. So we would recommend 

that developers who are modifying an EUA authorized test for use of a new 

specimen type such as saliva, refer to the policy guidance and the molecular 

diagnostics template for information about our recommendations on validation 

for the new specimen type.

We also clarified in that FAQ that for modifications to an EUA authorized test 

we have indicated that we don't expect a new EUA or an EUA amendment in 

certain situations, for modifications. But we clarified that that does mean that 
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the test is not under the original EUA, so it is being offered as a nonauthorized test under the policies in the guidance if you follow that pathway.

So those were a couple of the clarifications that we put out today. And then 

we - since we put out the FAQs last week including the FAQ on surveillance 

testing, we've gotten quite a few questions about the distinction between 

screening and surveillance and diagnostics testing in terms of testing 

asymptomatic individuals and testing different populations. So we're working 

on getting similar information out about that and I wanted to give a quick 

rundown of how we look at those different terms.

So for surveillance, we generally think of that as looking for information at a 

population of community level. Obviously you'll be testing at an individual 

level but the purpose of surveillance testing is to gain information at that 

population level rather than to make individual decisions at an individual 

person level. Screening on the other hand, is looking for occurrence at the 

individual level in situations where there might not be a specific reason for 

that individual to suspect that they would have COVID-19. So where you 

might be looking at all employees returning to a workplace or all students or 

faculty coming back to a school.

Things like that we would consider to be screening because we are looking to 

make a decision at the individual level there. And then obviously diagnostic 

testing also looking for occurrence at the individual level, but that's done 

when there's a particular reason for that individual to be suspected that they 

may be infected. And so as we have discussed previously, the tests that we've 

authorized so far that are indicated for individuals suspected of COVID-19, by 

a healthcare provider, are generally indicated that that diagnostic testing level 

where there is a reason to believe that individual may be infected. And any 

asymptomatic testing is done at the discretion of the ordering healthcare 
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provider.

So I'd like to provide a little bit of clarification on that. Hopefully that's 

helpful. And now I'll turn it over to Tim, for his update.

Timothy Stenzel: Thanks, Toby. Yes. So we're going to try to provide even more sort of helpful 

hints and tips today on making this whole process efficient for everybody and 

for aiding everyone in arriving at a decision of EUA authorizations as soon as 

possible. So last week I asked folks to contact me if they had not been 

assigned a contact within two weeks of their EUA submission. That's EUA 

not a pre-EUA. And it's my understanding that as of today, all of those subject

EUA submissions have a contact and still there is the opportunity to reach out 

to me for EUAs that have not been assigned a contact within two weeks of the 

date of submission.

We are now also focusing our attention on pre-EUA and where there are 

templates that we've provided under guidance with recommendations that 

would apply to a given pre-EUA, we would ask whenever possible, to use 

those templates to guide the process. If there is something in your 

development or in your plan that is not in the template as far as there are not 

recommendations because you have something that's not been covered, we 

want to in particular, focus our attention on providing developer's that 

feedback that is not present in guidance or templates.

I want to re-review or review as a priority EUA submission and for our review 

staff, which are quite busy. These are EUAs that have data even if all the 

studies aren’t complete we want to review priority submissions on a rolling 

basis. So any applications deemed high priority and have data such as point of 

care, such as high throughput automated instruments such as, you know, those 

are - in both those - the situations at the point of care that does require EUA 
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authorization, the high through put should be obviously and that would be a 

priority.

And then also for any home collection where there's data or there's home 

testing where there is data for us to review. And obviously with home 

collection and home testing those activities require an EUA before 

authorization. You know, in working with our reviewers, we would ask that 

when all reviewers ask for additional information, additional analyses of data 

that maybe you've already provided, or any new data that may be required to 

complete a review, we would ask that you please provide that as soon as 

possible.

And this states that many times we are - will be unable to advance the 

application until we get that requested information. And so we would ask that, 

you know, that that be addressed as soon as we can, when you get those 

requests. Next is a general update. We are obviously now posting all NCI 

results. Once a decision has been made, a regulatory decision has been made, 

and once we complete the QC and QA of those reports. So hopefully, soon 

after the decision we can post those. And as of today, there are results for 21 

of the tests that have been submitted to the NCI and they are now public.

So that is present - that link is present on our EUA page. All right. so another 

helpful hint here is if you could provide information regarding test validation 

using the templates that have been made available online if possible, we 

would greatly appreciate that. And the better organized and the greater the 

clarity of the information that's provided to really assist our reviewers to 

efficiently review that.

If there is something, for example, that they don't understand about the 

application that, you know, they will reach out and ask you questions. And 
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that obviously takes time to do that. So, thanks in advance for helping us in 

that way. Also, if the templates have been updated since you provided 

information, I would ask that you track that. And you may want to proactively 

reach out to our reviewers or the contacts, to ask if those updates might apply 

to you and determine what might be asked for there.

And so proactivity on both of our parts will help speed these reviews. 

Specifically regarding the serology template and the information that we will -

that we asked for in that template, please remember to provide data that is 

specific to each sample that's evaluated in your validation studies. These are 

also called line data. And for clinical agreement study this should include the 

date the specimen was collected for evaluation with the serology test, the date 

the specimen was collected for the PCR comparative results, the sample type 

evaluated plasma, serum, whole blood, finger prick, whatever, and the day 

from symptom onset to the date the specimen was collected, for evaluation 

with the serology test, the result of the PCR test and obviously the serology 

result.

If the serology test reports IGM as well as IGG, these results should be 

provided in separate columns in this line data format. Obviously timing of the 

various tests and symptom onset is obviously important to understand the true 

performance of the test. You know, we do look at what are the results after 

symptom onset; what are the results in days after PCR results? So that helps 

us to understand the true performance of the test and when a test might turn 

positive.

It also informs future users of that test so that they understand those kinds of 

performance characteristics. And then also, when you do study protocols for 

each validation study, please provide those predefined study protocols 

electronically, to our review staff, so they can fully understand the validation 
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testing that you performed with your tests and the measures you used to 

determine if your test met its pre-specified, predefined performance targets. 

And with that, we can turn it over to the operator for questions and we look 

forward to the rest of the call. Thank you.

Coordinator: Thank you. We will now begin the question and answer session. If you'd like 

to ask a question please press star 1, unmute your phone, and record your 

name clearly. Once again, to ask a question, please press star followed by the 

number 1. Our first question comes from (Mark Hagman). Your line is open.

Timothy Stenzel: Hello, (Mark). Make sure you're not on mute.

(Mark Hagman): Can you hear me now?

Timothy Stenzel: Yes.

(Mark Hagman): I'm sorry. Good morning, Toby. Good morning, Tim. This is (Mark Hagman). 

I'm following up on my question from two weeks ago, where I asked about 

fully at home testing, wondering when a new template may be coming out. 

We still have over 1.6 million people who are testing their blood every day, 

who are diabetic and we think that the finger stick technology and validation 

can be done to show that these tests are safe and effective for their intended 

use. So I just would like to get an update on what your feelings are for when 

the next template may come out. Thank you.

Timothy Stenzel: Yes. There are a couple of template updates that we're still working on. And 

we'll - so, for the molecular templates we don't have a section on the 

molecular template, the manufactured kit template for say point of care. So 

we're looking at updating that. And then the at home testing, the first one will 

be for molecular and that is nearing completion and final edits, so hopefully 
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we'll get that out very soon. We also are going to have updates to serology for 

home collection and home testing for serology. So those are all high priority.

The first one to come out will probably be the molecular home testing one. 

The - we can’t exactly say when that date will be. In the interim, we want to 

be able to provide and gain our information through the pre-EUA process for 

those that are developing the molecular point of care, molecular home testing, 

serology home testing, and serology collection incidents.

(Mark Hagman): Thank you.

Coordinator: Our next question comes from (Cory Yekkel). Your line is open.

(Cory Yekkel): Hi. Can you hear me?

Timothy Stenzel: Yes.

Toby Lowe: Yes.

(Cory Yekkel): Okay. It's our understanding that CDC is working on a multiplex assay to 

detect COVID flu A and flu B from a single specimen. Can FDA offer some 

insight on how this fits under authorization? What is FDA's view of a test of 

this type, a test that detects all three versus other tests?

Timothy Stenzel: Yes. So we consider this panel or multi-analyst testing. We have evolved 

through this pandemic first, focusing on getting assays out that can detect 

SARS-COV-2 primarily, or antibodies to COVID. The next phase that will 

begin in the fall, is when we begin to see whether or not there are other 

respiratory viruses that will be causing symptoms other than SARS-COV-2.
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And because we anticipate that there will be a really - a huge amount of 

SARS-COV-2 testing which may make it difficult for labs to test for other 

respiratory viruses, we are now very open to reviewing submissions that 

expand beyond SARS-COV-2 to include other respiratory viruses. We have 

already authorized some who added SARS-COV-2 to an existing panel. 

Those panels were previously cleared or granted by the agency prior to this 

pandemic.

We now are welcoming all comers for panel and we have for analyzed other 

than SARS-COV-2 we are taking an efficiently streamlined approach to 

getting the validation done. It is not at the normal pre-market bar that we set 

and, you know, had set prior to the pandemic. We do add, for those tests that 

have not, other than SARS-COV-2 that have not been cleared previously, to 

the pandemic in lieu of a declaration, we are asking for post-market 

commitments to rapidly move that Fas soon as possible after authorization 

through the regular review process.

So hopefully that addresses your question.

(Cory Yekkel): It does. Thank you.

Coordinator: Our next question comes from (Susan Sharpe). Your line is open.

(Susan Sharpe): Thank you. And thanks again, Tim and Toby, for all of your work. I'm just 

wondering if anybody has any kind of an update they can give us on the 3-D 

printed swabs and where we are with that.

Timothy Stenzel: That's a great question. Toby, do you have - I can say something, but you 

might be a little bit better prepared for this than I am.
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Toby Lowe: Sure. So we did have a town hall specifically on 3-D printed swabs, several 

weeks ago now, at this point. And we did put up some FAQs about 3-D 

printed swabs on our Web site, on our FAQ site. So basically we don't have a 

recommendation specifically, about 3-D printed swabs.

They are considered to be, you know, generally swabs are considered to be 

class 1 devices, so we do have some information on the FAQ page about the 

regulatory requirements there, basically for Registration and Listing, quality 

systems, medical device reporting, corrections and removals, and other 

applicable regulatory requirements, but not pre-market review.

We also posted a link to some resources that are available through the NIH 3-

D print exchange, that we think can be very helpful for developers that are 

considering printing swabs. And we also point to the general labeling 

requirements, because we think that, you know, as with any medical device 

appropriate labeling is important for users to know what it is that they're 

getting. So that's the information that we've got so far on 3-D swabs.

Timothy Stenzel: Thanks, Toby. And just to be clear, we are not asking for, nor are requiring, 

and we won't be doing EUA authorizations for 3-D printed swabs. Thank you.

(Susan Sharpe): Thank you.

Coordinator: Our next question comes from (Andrew). Your line is open.

(Andrew): Hello. Can you hear me?

Timothy Stenzel: Yes.
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(Andrew): Hello? Yes. Hi, Tim. I have a quick question about testing not of COVID 

infection or antibody, but rather testing around associated genetic risk factors. 

So there have been a number of publications in the past few months around

things like HLA blood types and blood types on red blood cells, A, B and O, 

that can potentially be indicators of a risk for more severe Coronavirus 

infection. Would reporting of those kinds of things, rather than status of 

infection or antibody, be considered for enforcement discretion?

Timothy Stenzel: If there are a claim around use for COVID patients, then those claims would 

require an EUA authorization. When we get inquiries about such tests, we 

take a look at what's on the market already and what can be used. And 

determine, you know, if there are a shortages need. But in general, I would say 

if somebody wants to make a claim around suitability and COVID then they 

would need an EUA authorization for that. And so if that's something that's of 

interest to you then you can reach out to your EUA template email address 

and we can address any questions you might have at that time.

(Andrew): Thank you. I'll certainly do that for more detail. But just quickly, to clarify if 

there is no specific claim but rather say linking to information for a patient or 

a consumer that there has been some research around that, would that still 

need an EUA?

Timothy Stenzel: So that's also considered part of labeling. And if you were promoting it - for 

the use in COVID patients in general yes, that is something that we would 

review. If the test is just out there, they are already authorized pre-COVID, 

but clinicians figure out that it can be used without, you know, without the 

developer promoting it for this purpose in any way, then that's all - you know, 

they're still measuring hematocrits out there, for example. They don't need a 

COVID-specific plan for that.
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(Andrew): Right. Okay.

Timothy Stenzel: Toby, do you have anything else to say about that?

Toby Lowe: No. I think you covered it.

Timothy Stenzel: Thank you.

(Andrew): Thank you.

Coordinator: Our next question comes from (Brian). Your line is open.

(Brian): Hi, Tim. My question is about the external controls. It's my understanding that 

with regard to say serology test kits, the lateral flow devices, that you all are 

now asking for proof or evidence of external controls in addition to the 

internal control. Can you expand on that? And is there - are you looking for 

each manufacturer to provide those standards? Are there any US-approved or 

authorized external controls that you are also validating?

Timothy Stenzel: So, I am not aware of any standalone serology controls that we authorized for 

the pandemic. It is helpful for the users to have something that's provided by 

the developers to be able to do quality control procedures on the schedule as 

they deem appropriate or as is required by laws, regs, and statutes and other 

requirements of accrediting agency for example.

So we are asking that because it is just something that we would like to see. 

We will work with developers if there are challenges in obtaining those and 

some of these things could potentially be put into a post-market commitment 

as we try to get tests authorized as soon as possible. Hopefully, that addresses 

your question. But it is an unmet need and we're trying to address that as best 
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we can.

(Brian): Thank you.

Coordinator: Our next question comes from (Tammy). Your line is open.

(Tammy): Good morning. Can you hear me? Good morning.

Timothy Stenzel: Yes. Yes. Welcome.

(Tammy): So my question has to do with, you know, recently there's been let's just go 

ahead and say it, the ID Now and interpretation results and repeat testing 

where it is that for the isothermal method versus PCR, if there is discordant 

results the PCR result is the one to be interpreted. My question is if you're 

looking at two different methods of the same limit of detection or sensitivity, 

like two different PCR methods and you have discordant results, how do you 

go about interpreting or is there any other action to be taken before 

interpreting results?

And I'm talking about a circumstance where it is - you have had collection 

within 72 hours from one PCR method to another.

Timothy Stenzel: Okay. So there are more than one test out there that we've authorized that have 

the limitation that negative are presumed negative. And the language is 

usually conditional that, you know, basically, as clinical signs and symptoms 

warrant, you may want to reselect to another molecular test. And that applies 

to the Abbott ID Now. If that - and then, those tests should obviously be EUA 

authorized. And that would be on the test that I would recommend that you 

would rely on as far as interpreting those two individual test results. 

Obviously taking it into the context of the whole patient experience is 
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important as well. No test is perfect. Even the reflex test may have an issue.

Yes we are now asking in applications that performance assessments be done 

relative to another EUA authorized test instead of just contrived samples 

against the test's own say LOG as required when there were not plentiful 

samples and when there weren't available other tests in which to make a 

comparison. So two different tests can very absolutely have different LODs 

and therefore, potentially for a very low positive, hopefully not commonly, it 

can have discordant results.

And that is a challenge to interpret those results. Each lab that brings up a test 

of their own and gets EUA authorization, or brings in a test from a 

manufacturer, we want to sort of kick the tires on that test to understand just 

what they feel is its performance characteristics. When it's EUA-authorized 

already we're not asking for a full validation. They just want to get their 

understanding of that. Most labs that do this will come to a fairly rapid 

assessment of if they have more than one test in their lab, which test might be 

a little bit more sensitive and which test might - and hopefully both tests are 

equally specific so they're not either coming up with any false positives. And 

therefore if they have that understanding of which test might be a little bit 

more sensitive, they would assess that that is the test that they might rely on 

more readily than another one. If developers are, you know, spending a 

sample from their lab and are assessing some concordance issues, the FDA 

will look at line listing data as I mentioned, for serology, but also for 

molecular tests.

And having a good understanding of what test was performed, if there are CT

results for both, which - what are the CT results for each of the different tests 

for all the results that are positive for each test. And so we can readily see 

things, if an occasional sample might be missed in one comparison if all of 
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those are at the low end of the sensitivity range. And as long as overall 

performance is adequate then, you know, there are pathways to seek and get 

authorization. I don't know if I quite addressed your question.

((Crosstalk))

(Tammy): Yes, and no. So I'm also, you know, with how things are happening real time 

and as, you know, testing becomes into a higher demand and different 

methods will have different levels of operator intervention in order to perform 

the test for us. So as is that laboratory in for performing, you know, 1000 tests 

very for PCR methods versus one versus another where those different 

methods like I said might have a different level of user interaction and 

possible sources contamination produce false positives, you know, it kind of 

sort of complicates the matter when it is, you try to interpret which result is 

the more reliable one not in terms of sensitivity but in terms of like I said, just 

thoroughly environmental circumstances that can affect the quality of the test. 

So does that help clarify what it is I'm trying to look at?

Timothy Stenzel: Yes. And I just don't know that I can, you know, without knowing the specific 

tests which is not appropriate for this specific audience and knowing some 

more details about like, you know, someone might be able with knowledge of 

both tests, give you a little bit more guidance. The one thing to remember is, 

you know, for those who really don't know the details of diagnostics testing. 

There are a lot of variables that can play into the overall performance of the 

test. And the FDA does its best job to further understand the whole sort of 

performance, you know, from sample collections all through to at least result 

reporting from the tests or the instrument that's doing the testing.

And that is that it can be the full review the, you know, understood - the 

results are understood as say positive and negative. And there are many 
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variables along the way. You know, if it's a very manual assay then it 

obviously can be highly user dependent and which is why we normally ask for 

precision suitability with multiple uses, multi-day to try to get at whether - but 

that's not what we ask for under an EUA. And, you know, because we're 

addressing an emergency situation, we are focused on the immediate public 

health and so we don't have those same sort of understanding of the data.

So, you know, in an emergency situation we all try our best to get optimal 

results and but, you know, there are variables in sample collections - different 

people swabbing noses can make a difference. You know, there are these

multitude of variables. And then the reaction themselves are highly complex 

reactions and not a simple, usually not a simple sort of reaction.

So all sorts of variables can come in this test - timing, temperature, and things 

like that. So we assess the overall performance of tests in this emergency. And 

I would urge not over reliance on any one particular result, whether it's 

positive or negative. And that's generally the case in normal clinical practice. 

Yes, we would love to always rely on a test result as being the absolute truth. 

That's unfortunately, you know, an objective that is really sometimes if not 

most of the time, hard to achieve and you could absolutely count on one single 

result, whether it’s within this emergency, during this emergency or after this 

emergency.

(Tammy): Okay. So concerning this, you know, I hate to monopolize the time, but one 

more thing. So you're doing something like it where there's discordant results 

on the pre-symptomatic or asymptomatic patient where it is that typically any 

sort of laboratory result has to be balanced with the patient's history and 

presentation, again this is kind of the real life circumstances - that is that 

providers and personnel have to face as, you know, testing goes on and again 

the increase in demand of the testing especially when it is that new businesses, 
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or businesses are reopening, travel is reopening, and those - that level of 

testing is ramped up across the nation. And any thoughts on that? And I'll 

wrap things up there.

Timothy Stenzel: Yes. And, you know, (unintelligible) and we need to get to further questions 

and again, pre-symptomatic, asymptomatic testing, we don't have enough 

understanding of the viral course, the viral levels and all the different sample 

types. And even with symptomatic patients and the highest performing tests 

out there, even during the middle of the, you know, the most viral load we 

already know that even with multiple samples, perhaps even the same test in 

the same patients, can yield different results just because of some of the 

variables as I suggested.

But also we're add layering on top with the actual biology. Where is the virus 

most being shed right now? Are we sampling that and we sometimes don't 

know the best place on a given patient with a sample. Can we move onto the 

next person. Thank you.

(Tammy): Thanks.

Coordinator: Our next question comes from (Padumi). Your line is open.

(Padumi): Good afternoon. Can you hear me?

Timothy Stenzel: Yes, we can.

(Padumi): Yes. Good afternoon. I really thank all of you for your hard work and the 

excellent work that is done and these virtual town hall meetings have been 

really, really helpful for developers like us. My question is specifically about 

serology testing. As of today, I think around 196 tests are there in the 
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notification list, of which 11 are authorized and I see 48 tests are recalled. So 

it means, you know, there are so much number of tests and you mentioned in 

your earlier I think over 60 times or more number of applications you have 

received.

So the bottleneck here is the limitation of the reviewers at FDA and also the 

limitation of NCI to do an independent validation. My question is, is your 

department asking for additional resources? Is there any timeline when all this 

backlog will be cleared? What is the future like looks like as far as the 

developers are concerned?

Timothy Stenzel: Yes. So as I've explained on prior calls and tried to explain today, we do have 

a whole lot of applications. We have more than doubled our review staff on 

IVD you know, serology and diagnostic tests, molecular management tests. 

And we've added additional support personnel. These reviews do require 

expertise in infectious disease and diagnostics in general, in order to do a 

professional review. And it just isn't overnight that you can hire and train up 

or hire the expertise that you need.

We have received additional funding to hire additional staff, which we have 

been adding. And we have when needed. We have been able to bring in 

additional resources from elsewhere in the FDA. We have had reviewers come 

over from CBER for example, and I want to thank CBER and those reviewers 

who have joined us.

The other thing that we've done and I've mentioned this before, through the 

notification pathway and the guidance, developers, if they qualify, is to notify 

us in their applications. And once received and accepted and posted, the 

developers can market their tests in the US. And we then do the priority 

review. one of those priority reviews is if there are any critical public health 
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concerns. And that would be also a priority review. And so all I can say is that 

we're working our hardest.

We provided the easiest possible pathway for many developers to get onto the 

market. There are certain aspects that we need review on and we focus our 

attention on those high priorities as I mentioned earlier in the call. Thank you 

for your question. We're very dedicated. We're working very hard and as I 

already indicated earlier in this call, we want everybody to have a - every 

EUA application to have a contact to help you get regular updates on our 

direct team, but at least weekly get an update from us prospectively, and not 

waiting on the developers to reach out to us.

So everybody - I want them to get from us, a regular update no less than 

weekly. Thank you.

(Padumi): Thank you.

Coordinator: Our next question comes from (Mark). Your line is open.

(Mark): Hi. Thank you. Who should we contact if we have not been assigned a 

reviewer within two weeks of submission? We received an acknowledgment 

letter on May 16th but we haven't received any communication regarding 

assignment of a reviewer.

Timothy Stenzel: Okay. Is it a EUA, or a pre-EUA?

(Mark): It's an EUA.

Timothy Stenzel: EUA? Well you should have already been assigned so that was someone 

missed that. I apologize. If you send us an email today then, to the templates 
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email address and ask that it be forwarded to me, Timothy Stenzel, I will 

specifically look into it and get down to it and we'll get you assigned 

somebody shortly. And I apologize.

(Mark): I'm sorry about that. What was your name again?

Timothy Stenzel: Timothy Stenzel, S-T-E-N-Z-E-L

(Mark): Thank you.

Coordinator: Our next question comes from (Russell). Your line is open.

(Russell): Hi. Thank you. I want to echo everyone's appreciation for your help and 

transparency. This really makes this a much clearer to understand. You 

mentioned earlier, testing for IGM and IGG and how we structure the data, 

there is several papers out of China had indicated a combination of PCR and 

total antibody as the best accuracy for making the diagnosis. Would we have 

to have a separate submission for total antibody or could we fold that in with 

IGM and IGG?

And if we were to create a multiplex platform and we already had EUAs for 

PCR and for serology, would we have to make a second submission for the 

combined test?

Timothy Stenzel: So I think I understand your question, but I'll give you a chance to address it 

and respond if I'm not quite right on target. So, first of all, I refer folks to the 

CDC guidance document on serology testing and in that I believe it says that 

we don't have any specific recommendation about which isotype and which 

type of serology test that the developer uses. It may say in there that IGM, I 

forget the details, may not have as much value as IGG, the total or pan.
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The performance characteristic is that we expect to see in our template, and 

we're in the process of updating our template for serology to address anybody 

who is interested in IGM only, just as an aside. And if somebody wants to 

come in with, you know, a pan or a total then we would assess that depending 

on how results are reported out. So if someone has a test and it separately

currently reports out IGM and IGG results, we would ask for data to support 

each independent parameter and look at the performance characteristics of it.

We would also assess the overall performance characteristics with the 

combined sensitivity, the combined - and the combined specificity. If results 

of IGM and IGG individually, are shielded from the user and something - and 

it's from a different, you know, a different assessment is made about a positive 

and negative then we wouldn't be looking at individual data. We'd be looking 

at the overall results. Hopefully that addresses your question.

(Russell): Yes. And I guess there was a corollary question which if you don't have time 

to address it is fine, but it has to do with if there is approval for - if you have 

an EUA for both PCR and serology separately, if you combine the testing 

does that require separate EUA?

Timothy Stenzel: So if you want to make a claim, if you're PCR positive and then you're 

serology positive what does it mean?

(Russell): Well I'm thinking more in terms of if...

Timothy Stenzel: Combined tests?

(Russell): Yes. Combined tests. So the indication coming out of China in several papers 

is that combining PCR and total antibodies has been the best way to make the 
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diagnosis for patients who have clinical suspicion.

Timothy Stenzel: Yes. If you want to make the statement in the instructions for use for your 

particular, you know, there's one device in the combining the testing and the 

results, then we'll look at that. If you have two different applications in an 

EUA authorization and you want to combine them to make and additional 

assessment on patient status and your claims for COVID-19, then yes, the 

claims about the combination of the test would be reviewed.

It - potentially if there are EUA authorizations for both already for one 

pathway, it could simply be an amendment to both, with the data and updated 

labeling of both. Unless you would have package the things together and send 

us the list together, which may not be the most efficient. So I think any 

subsequent questions are probably best addressed specifically, to the EUA 

template email address, or one of the other reviewers or contact that you have 

been given for your EUAs. Okay?

(Russell): Yes. Thanks very much. That's really helpful.

Coordinator: Our next question comes from (Ray). Your line is open.

(Ray): Hello. Thank you very much for taking the question. And thank you for 

continuing to sponsor these town halls. This is a question about RUO 

components that may get qualified as a part of a CLIA EUA new submission 

for a molecular test and these components go across the entire workflow for 

RT PCR, enzymes, extraction systems, thermocyclers, the like. If that EUA is 

issued to the CLIA laboratory, what would be the expectations for labeling of 

those components that have found a new use?

Timothy Stenzel: Yes. That's a good question and we've gotten increasing inquiries on that and 
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we are working on further clarification. Toby, I think we already have some 

FAQ on there. Do you want to address that any further at this time?

Toby Lowe: Yes. So I - we are working on getting it considered. We're looking at getting 

more information out on this. And so, you know, there is a difference between 

an RUO component and an RUO test kit. So, you know, we do have a 

guidance document out about appropriate labeling and distribution for RUO 

products. I would encourage you to take a look at that.

If a laboratory is purchasing RUO components and developing their own test 

from scratch and they get authorized for that, then that test is authorized; the 

components are not.

(Ray): Right.

Toby Lowe: So the - if there is a commercial manufacturer that is developing a complete 

test kit and is selling that as RUO to laboratories to do their own, you know, 

so that the laboratory would have to bring that in to their own EUA, that 

would not be something that we would think is appropriate.

(Ray): Right.

Toby Lowe: I'm a little bit unclear of what exact situation you're asking about, but 

hopefully that's helpful.

(Ray): Yes. It is about the former situation where it's just components, not part of any 

design systems for SARS-COV-2 detection. So specifically, there's an 

instrument, high throughput thermocycler that I know is under consideration 

of an EUA by a CLIA laboratory. And the - it's just that situation that that 

instrument is labeled RUO at the moment. And it was, considering what 
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would be the consideration if the EUA issues out.

Timothy Stenzel: None. We will - if they're using an RUO instrument, what matters is the 

validation that shows accuracy of the testing. Even in non-pandemic situations 

I'll just say that LDT developers that seek FDA authorization, can in some 

situations, use RUO instruments. Sometimes it's the only thing that's available 

to a developer. I've had, prior to my FDA experience, I had that very same 

experience and we were able to go on and get a PMA approval, using RUO 

instruments because it was the only thing that was available.

So the FDA in all situations takes into consideration these things. And there 

are ways to mitigate risks, you know, to RUO labeled components and 

instruments. And we are taking a very obviously light approach in this 

pandemic in order to address the emergency while at the same time trying to 

make sure that all tests out there are accurate. So, thank you.

(Ray): Yes. Thank you very much.

Coordinator: Our next question comes from (Colleen). Your line is open.

(Colleen): Hi. I'm (Colleen) from Biochemical Diagnostics. We're a commercial third 

party control manufacturer and we're working on trying to develop the 

COVID control for the serology lateral 2 antibody testing primarily, because 

that's the market that we're in. And I was just wondering if we need to apply 

for an individual EUA or if the lateral flow manufacturers would need to 

modify all of their existing EUAs to let them use an external commercial 

control and any support you have to - or any ideas to help a manufacturer 

support, you know, quality control that would work in the industry currently 

the existing antibody manufacturer of the lateral flow.
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Timothy Stenzel: Yes. So if somebody wants to incorporate your controls into their assay and 

refer to them specifically, then we would want to see the data in relationship 

to their - if they want to include it say in their instructions for use as 

something that they would recommend, we just want to make sure that it’s 

working with their test. So - but as far as offering controls independent of the 

specific assay, we definitely are encouraging that. Toby, I would just turn it 

over to you for any considerations that might be important.

Toby Lowe: No. I think that you covered it there.

Timothy Stenzel: Okay.

(Colleen): So would each lateral flow manufacturer have to revise their EUA or would 

our EUA lift their devices and support - do we send the supporting data or do 

they need to resubmit?

Timothy Stenzel: Well we would - go ahead, Toby.

Toby Lowe: So as Tim was saying, it depends on how they're including it in their assay. So 

if they are referencing by name that would be a step that's included in their 

instructions for use, so that would require their EUA to be updated. I would 

have to look back at the serology EUAs to see how controls are incorporated 

because I'm not positive. But I think that would be an update to their IFU. So 

it's a pretty easy update, but we would want to see the data.

(Colleen): Okay.

Timothy Stenzel: And an individual control manufacturer would want to have information 

about, you know, those - the performance - those other manufacturers' tests. 
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You know, that may require - well I just don't know how to go about that right 

now. I would suggest that you approach this at the EUA template email 

address.

(Colleen): Okay.

Timothy Stenzel: It's not a common request. We generally are not reviewing individual controls 

unless they're incorporated as part of an assay.

Toby Lowe: Right. I believe the controls themselves would be possibly exempt, so we 

would want to see that they are registered and listed appropriately. And then 

the assays could incorporate them into their IFUs. So...

Timothy Stenzel: And I do think that's specific performance claims that are not used in any one 

particular assay or a set of assays you mentioned by name, might require more 

than what's covered in class 1 exempt. So if that's something that you're really 

interested in then please come to us with what you want in a question, to the 

EUA templates email address.

((Crosstalk))

Toby Lowe: They are Class 1 exempt if they are not tied to an assay.

(Colleen): Okay. Terrific. Thank you. I appreciate your help. And I also like these 

workshops every week. I think they provide a lot of value to manufacturers. 

So thank you for the effort you're putting into it.

Timothy Stenzel: You're welcome. You're welcome. Thank you, everyone.

Irene Aihie: Operator, are we done with our questions?
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Coordinator: Yes, ma'am. That was the final question.

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 Web page at 

www.FDA.gov/Training/CDRHLearn, by Tuesday, June 30th. If you have 

additional questions about today's presentation, please email CDRH-EUASupport@FDA.HHS.gov. As always, we appreciate your feedback. Following 

the conclusion of today's presentation, please complete a short, 13-question 

survey about your FDA CDRH Virtual Town Hall experience. The survey can 

be found at www.FDA.gov/CDRHWebinar, immediately following the 

conclusion of today's live webinar.

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

Coordinator: Thank you. And this does conclude today's conference. All parties may 

disconnect.

[End of segment]