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FDA Virtual Town Hall Series –

Immediately in Effect Guidance on 

Coronavirus (COVID-19) Diagnostic Tests

Moderator: Irene Aihie

July 22, 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 in a listen-only mode until the question 

and answer session. At that time if you would like to ask a question press Star 1. 

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

at this time. It is my pleasure to introduce Miss Irene Aihie. Thank you, ma'am,

you may begin.

Irene Aihie: Thank you. Hello, I am Irene Aihie of the CRHs Office of Communication and 

Education. Welcome to the FDAs 18th 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 through CDRH and provide a brief update. Following 

opening remarks we will open the lines and take your questions related to 

today's session. Please remember that we are not able to respond to questions 

about specific admissions that might be under review. Now I give you Toby...
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Toby: Hi everyone. Thanks for joining us today. Just a couple of updates from last 

week or since last week rather. Earlier this week we issued a new FDA Voices 

blog post by Dr. (Shuren) and that discusses our ongoing work supporting and 

advancing COVID-19 diagnostic test accuracy and availability. And that can be 

found on the FDA Web site.

We also earlier this week issued a guidance document on transport media. I 

know we've had a lot of questions on that topic in the town halls recently. And 

so I hope that everyone finds that useful. The document is about our 

enforcement policies for viral transport media during the COVID-19 public 

health emergency. And it outlines a few different policies for commercial 

manufacturers of VTM and sterile PPS and saline as well as high complexity 

CLIA certified laboratories that are developing their own transport media.

Along with that guidance we've put out a new FAQ page specific to viral 

transport media and questions related to that new guidance document. The 

easiest way to find that FAQ is probably from the testing FAQ page where we 

link over to that new FAQ page. We also updated a couple of the testing 

supplies related FAQs on the test FAQ page. There were a lot of FAQs in that 

sentence - sorry about that.

And then the last update that I have today is that we have revoked the umbrella 

EUA for serology tests. From our perspective we see this as fairly 

administrative. In the three months since we issued that umbrella EUA no tests 

have been added to it because we found that it is more appropriate for us to 

individualize the EUAs for each specific test so that we can allow for a broader 

indication for scopes of authorization on individualized conditions of 

authorization that are specific to each unique test.

So this is - we had intended for the umbrella EUA to remind the administrator 
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of progress from our end. But it turns out that doing individual EUAs is actually 

the more streamlined process for us. So this does not change anything from the 

perspective of what we expect to see in EUA requests. We're still using the NCI 

data to inform our decisions for the individual EUAs as we have been doing and 

we will continue to do that. But we did just want to flag that for you.

And with that I'll turn it over to Tim.

Timothy Stenzel: Thank you Toby and hello everyone. Thanks again for joining us. I'm just going 

to give you some updates. So maybe that can address some potential questions. 

We are working on a number of template additions and updates. And 

unfortunately, they're not publicly available yet although if any developer has 

any questions on any of these topics send us an email to the template email

address box. And we've given quite a bit of thought to most of these already and 

can provide feedback.

So that includes what we used to call home testing for molecular diagnostics 

indirect antigen. That will be transitioning to being called a non-laboratory 

testing because the setting may not always be home could be schools or places, 

et cetera.

We're working on updates to the regular molecular template to include more 

information about pooling, more information about simple, or Dorfman pooling 

as well as what to do if you want to pool swabs. We're also updating language 

having to do with development of multi-analyte tests including things, like, Flu 

A, Flu B in addition to SARS.

We are working on finalizing what used to be called the serology home 

collection which will now be the non-laboratory serology collection template. 

We are working also a little bit further out will be what we used to refer to as 
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serology home testing which will now be serology non-laboratory testing.

And then finally we've been requested to update our direct antigen template to 

allow for recommendations for multi-analyte testing. So just like molecular

with direct antigen you can put more than one target on the direct antigen test so 

you could for example look at Flu A and B again in addition to SARS.

And so with that update from Toby - those updates from Toby and me we can 

go ahead and take some questions now. Thank you.

Coordinator: Thank you. If you would like to ask a question please unmute your phone, press 

Star 1 and record your name clearly when prompted so I may introduce you. If 

you would like to withdraw your question you may press Star 2. Again to ask a 

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

Please standby. And our first question is from (Jackie Chan). Your line is open.

Jackie Chan: Hello, good morning. We have a total antibody test that can also measure 

acidity and it is also a neutralizing assay. And for the neutralizing assay we 

have correlation data to PRNT so that's the plaque assay and also to the 

pseudovirus neutralizing assay. And then right now we are trying to prepare for 

the pre-EUA discussion with FDA. And aside from the basic requirements of 

the serology test so that's the clinical agreement and cross reactivity and 

stability.

We also plan to do linearity and also have supporting co-relations data to the 

two gold-standard method. And for the acidity claim so the K on and K off, we 

plan to use BLI as the gold standard method in the measurement. We are just 

wondering if you think this is enough for the initial pre-EUA talk and if there 

are other data that your team might want to see in the application for 

neutralizing assay and for the acidity assay. Thank you.
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Timothy Stenzel: Yes, I think so. I think you're very well prepared for the first conversation. And 

you've hit on all the important points for neutralizing tests. Those could either 

be, like, you said the PRNT which is considered by us to be the gold standard 

method for determining neutralizing antibody. Or it could be as you said for 

your - sounds, like, for your assay that you're developing an assay that could 

correlate to results on the same samples with a neutralizing reference method.

And absolutely open to that. We are looking for those strong correlations. We 

also realize that semi-quant or quantitative serology assays are going to be 

required probably to do this well of course. And so you talked about linearity 

there, dynamic range, how you calibrate, how you quantify, is all going to be 

important information. And we've been working with our other federal agency 

colleagues to understand this landscape to adopt new criteria that we can use to 

assess these technologies.

So we are making substantial progress on being prepared to review these 

submissions. And of course as soon as we are thinking it's more crystallized,

we'll do a template that will deal with semi-quant, quant and neutralizing type 

for serology assays. Okay?

Jackie Chan: Okay great. Thank you. And then for the acidity part the K on and K off 

measurement because so with a neutralizing assay it would tell you if the 

antibody is actually neutralizing the virus. But then it does not show anything 

about the acidity on whether that antibody is actually sticking to the virus. So 

our assay can also do that and it can also measure that.

So right now we plan to use BLI technology to like as the gold standard for the 

K on and K off measurement. And I'm just wondering if you think this will be 

acceptable.
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Timothy Stenzel: I'm not expert enough in that kind of test validation method. You know I'm 

fairly familiar with bicore and other technologies, like, that. But not actually 

measuring that in an assay. So - and seeking EUA authorization for that it 

sounds very intriguing and, you know, perhaps could be important to not just 

measure the presence of neutralizing antibodies. But maybe the strengths of 

those bonds.

But - and I don't know yet. It's the first time, you know, that I've been thinking 

about this. The team's probably thought about this already. So I would defer to 

the team on this. And so I'm not even familiar with the technology mentioned. 

I'll have to look it up. But it sounds, like, you're very knowledgeable so I expect 

you're going to have a very well-informed discussion with the FDA. And I look 

forward to following your progress.

Jackie Chan: Okay thank you.

Coordinator: Our next question is from Mark Heston and going forward we will just be 

taking one question per caller. Again Mark Heston your line is open.

Mark Heston: Yes good morning Tim and Toby, Mark Heston calling. I have a couple 

questions but I'll stick it to one. My main question is a reclarification. You said 

that you were updating the templates from to a non-laboratory status for at 

home. I was wondering if there's anything on the Web site about that. And my 

carryover question is when are we going to see a template for fully at-home 

testing?

Timothy Stenzel: Oh yes so that's exactly the template that I'm talking about. We're just instead of 

calling it at home because we've gotten developers say well, we want to be in 

other locations that are not in labs that have a CLIA certificate and could be 
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performed entirely by non-healthcare workers. The home is a subset of that. 

Workplace is another subset. Schools might be another subset.

So that it will be an umbrella template for all those situations. So it's very far 

along and I just wanted to give an update before the call because we get that 

question every week and we're working hard on it and we'll get it out as soon as 

possible.

Mark Heston: Okay thank you very much.

Coordinator: And our next question is from (Raphael Rubio) you may go ahead.

Raphael Rubio: I'm calling on behalf of doctors and healthcare providers that need a current and 

plain understanding about COVID-19 screening. Earlier this year you made a 

statement that the FDAs diagnostic policy allows for the use of IgM and IgG 

fingerstick tests without FDA authorization as long as they're labeled correctly 

not used as the sole basis for diagnosis or exclusion of infection and not the 

results are used in coordination with a healthcare provider.

As the healthcare providers can you clarify for us if we have the right to 

purchase these tests from a distributor if they're properly labeled and use them 

for screening but not diagnosis at our point of care?

Timothy Stenzel: So we consider screening - it's not really a diagnostic for serology. But we'd 

consider that governed by FDA regulation. So we allow those tests to come to 

the market and be distributed. However prior to authorization they're restricted 

to the use in CLIA high complexity lab situations. So you could - a 

high-complexity lab could have a patient, you know, draw station. So as long as 

that testing is under a CLIA certificate that's from a high-complexity lab then 

that's allowed.
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But as far as true point of care no, that requires a CLIA waiver certificate. No 

we haven't yet, unfortunately, authorized a serology point of care test for that 

environment. We're very interested in it. As soon as somebody submits 

acceptable data, we'll authorize it as a high priority.

Raphael Rubio: Okay thank you.

Coordinator: Our next question is from (Elaine Barry) you may go ahead.

Elaine Barry: Hi good afternoon. Thanks for taking my call. I'm a little new at this and I was 

listening, you know, I've been listening for a couple of weeks. I was just 

wondering if you could kind of take me through the process of the EUA 

template submission.

So, like, once the templates are populated and submitted how long does it 

typically take for someone to review it and respond and what kind of a response 

can we expect? Will it be, like, a feasibility assessment or specific guidance? 

One of the products that I'm facilitating has (unintelligible). I'm really anxious 

to get word from you to know whether we can proceed and how we can 

proceed.

Timothy Stenzel: You're breaking up a little bit when you were describing what the technology 

was that you were considering submitting. Can you just go over that again so I 

know what kind of test it is?

Elaine Barry: Actually I'm not really at liberty to say. But it is does have military readiness 

applications. And we're just wondering, like, what kind of guidance might we 

expect from the EUA or the review and how long that might take once we 

submit to get some kind of response.
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Timothy Stenzel: Okay can you tell me whether it fits in the bucket of serology, molecular or 

direct antigen?

Elaine Barry: Yes serology.

Timothy Stenzel: Okay serology. So serology are allowed to submit or at least validate and notify 

us. And then we'll review that notification and we can decide to post that 

notification on our Web site. And then if you certified that you validated for the 

intended purposes following the guidelines you can begin marketing that test 

while we review that submission. We will do an initial assessment of that 

submission to make sure there are no public health concerns. To make sure that 

it is complete. And to assess whether it is one of the high priorities.

The reason for high priority is we've gotten so many applications needing so 

many high priority applications that especially those that require EUA 

authorization to be able to market the test versus a serology test that can be 

marketed following notification. You know we want to get to those applications 

first that require our review and authorization.

So and both assessments will be done. If there's any concerns whether it's 

incomplete or we think the data doesn't look good we will reach back out to 

you. If it is classified as a high priority as soon as there is room on the reviewer's 

plate, they'll move that in ahead of lower priority application. And if you're 

deemed to be a lower priority application you will still be given a contact to 

keep you updated weekly on your submission and be able to ask questions, and 

get any sort of reassurances that you need about where things stand.

I’ve directed the office that within two weeks of those EUAs, hopefully a lot 

sooner than that now that we've cleared some backlog because there's hundreds 
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of applications, that we can get to that much quicker than two weeks. So you 

should hopefully get an assignment - a user, reviewer or somebody that you can 

otherwise contact to get a status update. Hopefully that clarifies that process.

Elaine Barry: Yes it does thank you very much. And in the event that we wouldn't be able to 

go down that EUA pathway should we just go ahead and, you know, start 

preparing for an IDE submission?

Timothy Stenzel: So an IDE we've typically not been reviewing IDEs for this pandemic. So it 

would depend on the particular situation. And say you want to use it in a clinical 

trial situation where an IDE would be required, then yes. So you can email us at 

the template email address to address any concerns you might have about 

potential need for an IDE. But in most cases, we haven't seen a need for an IDE 

but you may have special circumstances.

Elaine Barry: That's kind of what I thought. Okay great, thank you so much.

Timothy Stenzel: Yes.

Coordinator: And before we go to the next question just as a reminder, we are taking one 

question per caller. Our next question comes from (Todd Lewis). You may go 

ahead.

Todd Lewis: Hello. Our lab is conducting a lateral flow assay for COVID. And my question 

is who is responsible for reporting the results? Do you know that answer? Is it 

the clinical lab or is it - if we're going through a practitioner do, we report to the 

practitioner and then practitioner reports it to the...

Timothy Stenzel: Yes, if the testing is being done in a CLIA lab and they're high, moderate or 

waived. It is the laboratory's responsibility to report that result. If you're going 
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to develop a test that might be used in a non-laboratory setting, then we are 

asking reviewers what your plan is to make that data available to the 

government so that we can track that information. So we just upfront want to 

hear your plan about how you would do that. But if the testing is all done within 

a CLIA lab it's the CLIA lab's responsibility.

Todd Lewis: Okay. And is there a central location to report that or what agency would that be 

through?

Timothy Stenzel: Well those are details you would - I think (Toby) do you know? I think you go 

through the regular reporting which may be directly to the CDC. But I know the 

department also has a different system. You know what this was set up I believe 

by the CDC not by the FDA...

Todd Lewis: Okay.

Timothy Stenzel: ...and/or the HHS. So I would refer you to them unless, Toby, you can provide 

any additional assistance.

Toby Lowe: There's a guidance that HHS put out about laboratory data reporting and what 

goes with it.

Todd Lewis: Okay.

Toby Lowe: We have that linked from our FAQ page. So if you go to our FAQ page to the 

section titled COVID-19 related test data and reporting FAQs, the first question 

has a link to the HHS guidance.

Todd Lewis: Okay thank you.
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Toby Lowe: Yes.

Coordinator: Our next question is from (Wendy Jule) your line is open.

Wendy Jule: So I thank you for taking my question and thank you (Toby) for doing all those 

things. So Tim just mentioned that the FDA is updating the pooling guideline in 

the template. And we are actually following the current guidelines and had all 

the validations that are collected and analyzed. We are actually will submit our

EUA very soon like this week in a couple days.

So I'm just wondering will the new guidelines affect us or are we just don't have 

to worry about it?

Timothy Stenzel: It should not. We're basically providing some more helpful information. The 

criteria are essentially the same. So we're adding, for example, if you want to 

pool swabs there's some additional studies that would be important, you know, 

if you put multiple swabs in one VTM you would accumulate potentially more 

mucin which can inhibit DTR reaction.

Also you could have really, really high virus. If the members of the pool all had 

high virus and then suddenly you have a sample that has a lot more virus than a 

normal sample would be which can potentially inhibit the reaction as well. Well 

not necessarily inhibit the reaction but use up the reactants more quickly than 

expected and potentially give you a false-negative result.

As far as simple Dorfman pooling or even combinatorial pooling the guidance, 

recommendations aren't going to really change. What we're doing is providing 

some more helpful information to those labs that want to develop this. We'll 

likely have an efficiency table so you can look at the percent positive in your 

population. You can look at what the ideal pooling ratio would be and what the 
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efficiency of that pooling would be.

Obviously the lower the pool the less the efficiency. The higher the percent 

positive, the lower the pool that you want to do because otherwise you're 

breaking apart every pool. So it's just a little bit more theoretical calculation, 

information to help labs figure out, you know, what pooling ratio do you want 

to use and what can they expect as far as efficiency gains and some additional 

helpful details.

We're hearing that some labs for example are struggling to de-convolute and 

maybe even convolute because some of the - especially the high through-put

systems don't have an easy way to do that. They may not have a lab information 

system to do that. And so we're providing some more helpful information about 

software because right now some of the labs we're talking to are doing manual 

de-convolution and manual report editing. And that's obviously a challenge for 

lab workflow. And a potential risk for misidentification of patients okay? 

Hopefully that's helpful.

Wendy Jule: Yes thank you very much.

Timothy Stenzel: Yes.

Coordinator: And our next question is from (Jess Teribary) your line is open.

Jess Teribary: Yes hello, good afternoon. I just - we are developing a multiplex and we want to 

report the isotypes separately and I just wanted to gain a little bit more clarity on 

the sensitivity requirement for A and M. And if you do have visibility on the 

antigen specificity for those, like, is there a difference in the sensitivity 

requirements for the spike versus the nuclei captured? But if not, what is the 

general sensitivity for M and A in reporting separately?
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Timothy Stenzel: So we haven't - I don't know that we've authorized an A yet. For M we have 

authorized M within a multiplex. And we've also authorized M alone. So M in 

the presence of an IgG say we are allowing it to be down in the 70 percent range 

for positive — percent positive agreement or sensitivity whereas IGG, those 

same devices are expected to be 90%. 

We're really wanting serology and then IGM alone, we set the bar at 90% 

because we're really wanting to hit the 90% bar for sensitivity to make these 

tests as useful as possible. We think that's importantly clinically to not have 

false negative for serology and otherwise it lowers the usefulness of those tests.

For IGA like I said we haven't authorized it so it's probably best for me to say 

that it's good to engage in a dialogue here because A-M combination is not 

something that we've authorized yet. I would expect that we still want to see 

one — at least one of those analyzed to be positive at the 90% level. 

But again I think it's best because it's not something that we’ve — made a 

public decision on yet, that you engage with our team through either the 

Pre-EUA pathway or the EUA pathway. If you already have data you can just 

go right to EUA.

Man: Okay thanks and so yes, if we're hitting the target of 90% for G and then A 

could be a little bit lower then.

Ben: Like I said, G definitely at 90%. M alone definitely 90% and in combination 

70%. But we have not authorized an A yet and until we do and set that 

performance expectation based on actual data that we see it's premature to say 

anything.
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Man: Okay. Okay, thank you for your guidance.

Ben: You're welcome.

Coordinator: And our next question is from Dale Schwab. You may go ahead.

Dale Schwab: Hello. Thank you for publishing the data — the guidance on the transport 

media. That was very helpful. I do have a question on the transport media

guidance. Whether it applies only to testing for COVID-19 (SARS) or if it's 

also applies to other testing for other viruses such as influenza because coming 

up, we're going to have people submitting those other transports that haven't 

been 510K authorized for other tests besides SARS.

Woman: Right. That's a good question. The guidance applies to transport media that —

as described in the guidance so it is not all transport media but the types of 

transport media validated in the way that is described in the guidance, for use

with molecular or antigen assays during the COVID-19 public health 

emergency so that it's not limited to SARS-CoV-2 to molecular and antigen 

pathways.

Dale Schwab: And also culture? Is that applied to culture or just molecular and antigen?

Woman: I believe just molecular and antigen if I read it. Let me just double-check 

exactly how we wrote it.

Tim: The guidance has to do primarily with you know, either adherence or close 

proximity to the CDC's VTM formulation which should also as long as it meets 

all the other criteria should work for culture. Of course, if you're going to try to

culture virus during this pandemic, be sure you have a BSL3 or above facility.
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Man: They may use it for other herpes cultures, I mean, herpes virus cultures and cell 

lines that don't support SARS but that's causing some confusion, the guidance 

on what exactly it should be for. And some of these media are not going to be 

the exact CDC media. We're seeing a lot of that out of China.

Toby: The guidance applies to transport media that is validated as described in the 

guidance which does tie it to the CDC formulation. So other formulations 

would not fall under this policy.

Dale Schwab: Unless you talk to the FDA I think which is in another section in the guidance.

Woman: That's correct.

Woman: Thank you.

Woman: You're welcome.

Coordinator: And our next question is from Pervy. You may go ahead.

Pervy: Hello. We have a nasal swab EUA under the review right now and our 

customers/potential customers have been struggling trying to get the nasal swab 

and the VTM to send us the samples. They are requesting if we can provide that 

to them. We are non-direct manufacturers of either of those.

But we can put together a convenience kit where we can source the nasal swab 

and the VTM from different suppliers. And if we chose to do so would that 

require the company’s label identifying it as a part of our kit even though it's an 

LDD submission? And would that mean we would have to create an IFU 

around it and send an amendment to the EUA? Thank you.
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Tim: Toby this is somewhat of a challenging one, right? So can you tell us if the 

provider of the collection kit is already sort of FDA-authorized either by the 

existing exemptions or authorizations that have been given to that company or 

would this be something outside of that sort of setting?

Woman: They are authorized under different EUAs and several places and they are quite 

well established in terms of providing swabs to most of the people who require 

it. It's just that the customers are like, if we can have a one-stop solution we

would not have to source VTM and nasal swabs ourselves. We're just providing 

it, yes.

Toby Lowe: Yes. I think that you could include in your EUA submission.

Woman: Okay. And would that mean I would also have to create an IFU and put the 

company's label on that kind of convenience kit?

Timothy Stenzel: Let me handle this one Toby. So if the company you’re working with already 

has been authorized for this collection kit, if they're willing to give you 

basically a letter, — right of reference letter. That's going to really ease 

anything that you might have to do. And if they give that in the right of

reference and the data all support what you're going to do in all likelyhood that 

is essentially a paper exercise to update in your EUA with it. 

I'll just say that it's important that whoever provides such — and we considered 

collection kits to be a device - to make sure that it works, that it's not — got 

contaminated media, it has the right swabs, maybe — hopefully that are sterile, 

those kinds of things. But it sounds like it's already been reviewed by the FDA 

which makes this potentially very, very simple to use. So you can ask the 

company for a right of reference to their data and their submission. They're 

willing to do that then just update us with information about it either in your —
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with your existing review or your existing contact here at the FDA.

Woman: Thank you.

Toby: So I would also encourage you to look at the convenience kit guidance. If these 

are all components that are already legally marketed and you're not modifying 

the labeling. The convenience kit guidance would apply to you.

Pervy: Perfect. I will do that. Thank you so much. That really helps.

Coordinator: And our next question is from (Nadia Herminez). You may go ahead.

Nadia Herminez: Hello. I have a question regarding researches only. I notice there are several 

products out there, the serology products that are for research use only. Are 

those the ones being used by the screening by CLIA high-complexity labs or 

how are these research use only being monitored?

Timothy Stenzel: You want to handle this one Toby?

Toby Lowe: Sure. So research use only test kits should not be used for screening. Screening 

is considered to be clinical use. They're considered to be IVD tests and we 

would expect appropriate IVD labeled products to be used for those clinical 

uses. RUO products really should only be used for research and that would not 

include clinical testing and returning the results in a CLIA lab, that we do have 

a guidance document on RUO labeling of IVD products that would be good to 

reference.

Nadia Herminez: So because I'm seeing ROU on the market and how is the FDA regulating this 

and...
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Toby Lowe: If you see specific RUO products that you have concerns about, we would 

appreciate you sending that information to us and you can send it to the CDRH 

EUA template mailbox.

Nadia Herminez: I know we can't do more than one question. So does the FDA regulate sales

outside the U.S. for the COVID project or only within the U.S.?

Timothy Stenzel: The short answer is inside the U.S. but there are certain probably expert 

requirements that the FDA may, if it's manufactured in the U.S. then it's 

exported, that the FDA may need to get involved with. (Toby) if you have any 

more details or do we direct specific questions on that to our templates email 

address?

Toby Lowe: Yes. I think that would be best if there are export questions.

Woman: Great. Thank you very much.

Coordinator: And before we go to the next question as a reminder, we are allowing one 

question per caller. Our next question is (David Hong). You may go ahead.

David Hong: Yes thank you. Can you hear me?

Timothy Stenzel: Yes.

David Hong: Last week you answered a question regarding saliva and serology and described

that your serology notification template was really designed for blood analytes

rather than saliva. I wonder if you had considered serum coming from oral fluid 

which is then used in both the animal and human communities for antibody 

testing in other context for almost 20 years. Would that type of serology run in 

an ELISA test count for the serology test plate since that serum ultimately 
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comes from blood through mucosal tissue?

Timothy Stenzel: That is not the exact same sample type that we've set up the current templates 

for. And so we haven't authorized anything for — until — for that yet. That's 

definitely something that we're very willing to engage with you on and to figure 

out how to validate that — that sort of test and make sure that it performs well. 

So if you've already engaged with the FDA on this and we're getting good 

feedback great. if you haven't yet, I encourage you to do so and we look forward 

to the discussion.

David Hong: Thank you.

Coordinator: Our next question is from (Mark Wagner). You may go ahead.

Mark Wagner: Hello. Can you provide an update on the timeline for a EUA request for review? 

Earlier you mentioned that point of care testing for serology tests would be 

reviewed as a high priority. We submitted an EUA for a fingerprint 50-minute

IGM, IGG serology test more than 10 weeks ago and the only updates we've 

received is that our request is in line for review, and we'd really like to see some 

movement on the test.

Timothy Stenzel: So yes. I can personally check on that. This is Dr Stenzel so just send us an 

email at the templates email address and ask to connect with me and I will look 

into it for you.

Mark Wagner: Thank you.

Coordinator: Our next question is from (David Adams). You may go ahead.

David Adams: My first question — my question was going to be similar to the one that just 
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came up about the timeline of submitting status of long ago submitted —

submissions for the review process. So I guess I will follow that and then I will 

— so rather than ask that question, I will ask a different one, and that is 

can you give any estimation or any information about what type of information 

would be needed for the non-lab testing you mentioned. Are you preparing a 

template for that or — because it sounds like you want — you're encouraging 

submission of that and have not received any. Can you give any more 

information about the 

Timothy Stenzel: Is this serology?

Man: Yes.

Man: The non-lab.

Timothy Stenzel: So we haven't authorized a non-lab collection and we haven't authorized a 

non-lab test, and we are working on a template to provide the recommendations 

for that. It really helps us to get it right if we have been actively reviewing such 

submissions and seeing the data and seeing what the important things are to 

look for prior to putting out a template.

So I would encourage you to engage with us through the template email address 

to ask about how you would undo that. We can definitely provide at least some 

significant feedback on how to do that now because we've been discussing it for 

a while now.

(David Adams): Before that template comes out are we able to submit in any case or do we have 

to wait for the template?

Timothy Stenzel: Yes. You can submit. It's just that there’s lots of questions. Is it going to be 
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OTC? Is this going to be prescription? What are the user studies? What are the 

validation studies? It depends on all those things. So I hate for you to do a lot of 

work and then have to go back and redo some work because it didn't achieve the 

end that you wanted. 

But yes, we're always willing to take in any EUA submission with your data 

and really to get the high priority, all the application really needs to be 

complete, we can't prioritize something that's not a complete submission.

David Adams: Okay, all right.

Coordinator: And before we go to the next question as a reminder if you would like to ask a 

question please unmute your phone, press star 1 and record your name clearly 

when prompted so I may introduce you. Our next question is from Leigh 

Mariano. You may go ahead.

Leigh Mariano: Thank you for taking my call. So I want to know how long that they take after 

we submit our sample to you for — to your lab for the product evaluation and 

also do you encourage us to submit whole blood test for the antibody test to 

you.

Timothy Stenzel: So I take it this is the serology test and you submitted something to the NCI for 

testing already?

Leigh Mariano: Yes.

Timothy Stenzel: Okay. And have you submitted an EUA for the file?

(Leigh Mariano): Yes.
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Timothy Stenzel: Okay. So our process is to — if it's been more than two weeks you should have 

somebody assigned to the submission. If not email me (Dr. Stenzel) and I'll 

track it down why you don't have it within two weeks. But the process is we 

take a look at your EUA package and make sure that everything looks okay. If 

you notified us that you want to launch then we give you confirmation of that 

notification. 

And then if everything looks good you go into the queue at NCI and currently 

the time once a test arrives at NCI it's about three weeks before they can do the 

testing. So there's a fairly significant backlog. But you know, once you get in

you get assigned a place in line and we track that, okay?

Leigh Mariano: So where can we get that tracked? Do we get it? For example, if we submitted 

to or if we submitted to that do they do an online status link so that we can track 

where our test is in the process. After they send the sample to NCI, we have not 

heard from them more than a month. So do we wait longer to hear from 

someone or do we check or where can we check?

Man: So have you been assigned a contact within our FDA office?

Leigh Mariano: Yes. We already submitted an EUA and then they told us to send a sample to 

NCI. We already did that two weeks ago.

Man: So that contact can tell you where things stand.

Leigh Mariano: Okay got it. And then you don't have anything like the (unintelligible) that is the 

report that we can track where we are for our submission?

Timothy Stenzel: It's through your contact at the FDA that we provide you that information.
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Page 24

Leigh Mariano: Okay got it. So we want to see if we can submit the whole blood or fingertip for 

our antibody test. Do you encourage us to do that or you have — if we do that, if 

you approve that, that would make it so much easier if we can use the physician 

office lab to make it a test and more efficient to fully utilize the rapid test so do 

you encourage us to do that?

Timothy Stenzel: We are encouraging point of care test submission, yes. So yes, go ahead and get 

the data. I think the serology template has the information for point of care so 

you can follow that those recommendations and submit your data.

(Leigh Mariano): Yes. So far you approved all of those that are whole blood finger tip test. That's 

how we lead ours but we need to decide at what point we need to go back to

submit. Okay, thank you.

Coordinator: And our next question is from David O'Connelly. You may go ahead.

David O'Connelly: Hello. Thanks for taking the question. I have a question about calculating 

the days post PCR confirmation versus days post symptom onset. We’re 

preparing a serology application now, we have some samples that looked at 

days post symptom onset, some that were days post PCR confirmation, and I'm 

wondering if you can give some guidance on how to use those together in the 

application.

Timothy Stenzel: So yes. The serology template has some details on that and if it's not clear 

enough you can go to our template. Well, go to your direct contact for that 

submission, whoever your contact is at our office.

(David O'Connelly): We haven't submitted it yet.

Timothy Stenzel: So the most important date that we if you have days post PCR that's good. 
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Please include it. The most important date in the way that we assess 

performance is post symptom and that is because we expect certain 

performance by certain days after symptoms. 

Basically, after 14 days, the test should have maximal PPA or sensitivity but 

prior to 14 days, the serology test may not have that. It's very important for us to 

know the days past symptoms in order to assess accurately and adequately 

assess the performance, and not bias against data that might be prior to 14 days 

that is falsely negative.

(David O'Connelly): So with both sets of samples, can they be used together in the same 

analysis?

Timothy Stenzel: Well we'll do our best but if you don't have days past symptoms in the sample 

it's going to be really hard for us unless you have — we'll take a look at different 

categories I'm imagining. I can't pre-speak. So submit what you have — if that's 

what you have then we'll assess the adequacy of that information and the 

adaquacy of the performance. 

And you know, we'll do our best to work with you but it'll be a little bit more 

challenging if you don't have days from symptoms on all samples. It doesn't 

matter at all about days with PCR because PCR can be done at any point after 

symptoms and it's variable.

(David O'Connelly): Right.

Timothy Stenzel: Its days post symptom that we've really been centering on to assess 

performance because those are — that's the most reliable way of assessing 

performance one test to another because that's why the patient symptoms not by 

when a particular PCR test is done.
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Page 26

(David O'Connelly): Great, thank you.

Coordinator: And our last question is from (Sean Gimmel). You may go ahead.

(Sean Gimmel): Good morning. Thank you for taking the call. With the letter that FDA issued 

on the 21st with respect to the revocation of IGG IGM tests. We are a high 

complexity molecular lab performing the Abbott test which was authorized on 

April 26. Has the revocation affected that assay?

Timothy Stenzel: Not at all. We didn't revoke any assay. We simply revoked an umbrella policy 

that was put in place to make our work easier. It's internal to the FDA 

paperwork saving situation. If something fits under an umbrella basically 

there's fewer — there's less review that has to happen because all the conditions 

have seen pre-set for authorization so it is simply an efficiency internal to the 

FDA efficiency, our criteria for what is — what the bar is for something that's 

an accessible test has not changed at all. Our great use of NCI testing hasn't 

changed at all.

In the case of central lab tests currently we're not able to really assess central lab 

tests via the NCI because it would require to split panels — blinded panels to 

send out and we're — and those samples could get really well-annotated 

samples that perform well, that have been vetted extremely well by our process 

is a bit of an onerous task so until we catch up with basically the amount of — with the huge 

volume of backlogging NCI with the current serology test there it's — that's our 

focus right now. Hopefully that puts you at ease. Anything — nothing with the 

revocation on the 21st no tests were revoked at all. It's just the policy that was 

revoked.
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Coordinator: And this concludes our question and answer session. I will now turn the call 

back over 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 available on the CDRH 

learn Web page at www.fda.gov/training/cdrhlearn by Tuesday, July 28. If you 

have additional questions about today's presentation please email 

CDRH-EUA-template@fda.hhs.gov.

As always, we appreciate your feedback. Always at conclusion of today's 

presentation, please complete a short 13 question survey about your FDA 

CDRH virtual town hall experience. The survey can be found at 

www.fda.gov/cdrhwebinar immediately following the conclusion of today's 

live discussion. Again thank you for participating and this concludes today's 

discussion.

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

disconnect at this time. Speakers, please stand by for post-conference.

END