FDA Townhall

Moderator: Kemba Ford

03-03-21/11:15 am CT

Confirmation # 2037405

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FDA Virtual Townhall

Moderator: Kemba Ford

March 3, 2021

12:15 pm ET

Coordinator: At this time all participants are on listen-only mode. Today’s conference is 

being recorded. If you have any objections you may disconnect at this time. 

And now I would like to turn the meeting over to Ms. Kemba Ford. You may 

begin.

Kemba Ford: Thank you. This is Kemba Ford of CDRH’s Office of Communication 

Education. We apologize for a delay in starting today’s call. We do want to 

welcome you to the FDA’s 45th in a series of virtual town hall meetings to 

help answer technical questions about the development and validation of tests 

for SARS-CoV-2 during the public health emergency.

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

and Radiological Health and the Office of Product Evaluation and Quality and 

Toby Lowe, the 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 

the development and validation of tests for SARS-CoV-2. Please remember 

that during today’s town hall we are not able to respond to questions about 
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specific submissions that may be under review. Now I will turn the call over 

to Timothy.

Dr. Tim Stenzel: Yes apologies for the delays. We had multiple technical issues. And I’m not 

sure that everybody who wants to be is on the call quite yet. We did have a 

formal remarks that we are ready to present but I think we’re going to delay 

on that until we have a, you know, as many people call in as possible. People 

should look to their emails if they're - if you know of folks who are having 

trouble connecting with the connection information.

And with that I think we'll get into - right into questions. We'll take questions 

for a little bit then we’ll pause and do the usual announcements. And so 

operator if you are able to set up the questions that would be great.

Coordinator: And if you would like to ask a question over the phone please press Star 1. 

One moment. Thank you for your patience. Our first question comes from 

Shannon Clark. Your line is now open.

Shannon Clark: Hello. This is Shannon Clark with UserWise Consulting. I have a question 

about point of care molecular or antigen tests. For those using a mid-turbinate 

swab after the clinical evaluation testing is complete can we add an additional 

swab with perhaps the same fit, form and function as originally used swabs to 

the test kit?

So imagine that the point of care testing and clinical evaluations have now are 

completely done, it’s been like a month, can we add another swab with the 

same fit, form and function as originally swab and include both swabs in the 

emergency use authorization just to ensure continuity of the supply chain due 

to concerns about well what does this one swab that's authorized is no longer 

available?
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And then also like what are the aspect of fit form and function that would be 

concerning to the FDA in this context. Does that make sense?

Dr. Tim Stenzel: Yes, no I think I understand and we absolutely want to ensure adequacy of 

supply chain my - our prepared remarks was going to speak to some supply 

chain, potential supply chain issues in our focus on making sure that that’s not 

an issue. 

So if it’s also a mid-turbinate swab and it is just a different provider but 

different swab manufacturer, you know, it’s unlikely to cause a review issue.

But that’s the sort of question to ask the review team.

We're going to be very supportive of adding additional alternatives especially 

if it’s just the same body site. So if it’s mid-turbinate to mid-turbinate with 

antigen tests that is - that’s going to be easier than if you moved to a different 

site or location. And that might need additional validation but hopefully 

minimal and perhaps only analytical validation at most of additional swab that 

is the same as the study swab.

Shannon Clark: Thank you so much.

Coordinator: Thank you. Our next question, I believe the name is (Seth), your line is now 

open. Okay moving on to the next question. It comes from (Richard). Your 

line is now open.

(Richard Montegna): Thank you. This is (Richard Montegna). We received a EUA authorization 

back in April for a PCR-based test that use respiratory samples. And then we 

subsequently amended that to include saliva that was collected with a 

healthcare worker. 
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We are now working to have a self-collection kit developed and we put 

together a usability study which we actually sent a draft off to one of the lead 

reviewers the other day. And it got back to us yesterday and suggested that we 

send it in as a pre-EUA. My question is, is a permissible to restrict that preEUA to just the usability study or will you require that we fill out the whole 

template? Thank you.

Dr. Tim Stenzel: I think you can just fill out the new items and refer to your previous 

submission...

(Richard Montegna): Okay.

Dr. Tim Stenzel: ...for all other details.

(Richard Montegna): Okay.

Dr. Tim Stenzel: The reason that they're asking for that is so that we - with all the thousands of 

applications we receive, we want to make sure that we track things in our 

electronic system. And by sending it in rather than just an email that is a preEUA, that gets logged in and tracked and everything gets connected and we 

don’t lose - we don’t risk...

(Richard Montegna): Okay.

Dr. Tim Stenzel: ...losing it.

((Crosstalk))

(Richard Montegna): All right thank you very much, appreciate that.
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Coordinator: Thank you. Enter next question comes from (Kumin Mudi). Your line is now 

open.

(Kumin Mudi Enconteserin): Good afternoon and thanks for taking the question. I am (Kumin 

Mudi Enconteserin) from Tetracore. Actually I have seen your article Dr. 

Stenzel, in the New England Journal of Medicine recently about the COVID19 antibody test today with your experience. What I would like to ask you is 

at least for molecular tests there are some reference standards that are made 

available by FDA and the other - the government agencies. Has anything been 

done for serology tests done with (x air spaces) or can you kind of throw some 

light on what are the steps that are given by the agency or the other 

government partners to provide reference material for serology assay 

developers? Thank you.

Dr. Tim Stenzel: Yes that's an important question. We still are evaluating tests at NCI as an 

inter-government agency, interagency government effort obviously NCI and

CDC, BARDA, FDA and that program's still active and we are sourcing 

samples for that. Toby may know more details. 

I know we are still looking for the ability to send out samples and I haven’t 

gotten an update recently from them that says that they’re ready to send those 

so I expect that they're still working on it.

It has been a bit of a challenge to source of these samples and so, you know, 

in enough quantity to provide to all developers, have noted that WHO has 

recognized an international standard. I don’t - I know it’s available for 

molecular. I don’t know if it’s available for serology yet so that certainly 

could play - could be helpful to you.
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I will take a note. We'll specifically query the interagency group and provide 

an update next week on a serology, a sample panel or anything like that.

(Kumin Mudi Enconteserin): So you've got any priority for this or it is low priority?

Dr. Tim Stenzel: Well we’ve been working on that for a long time but if we have challenges 

just keeping samples going through the NCI effort. And we don’t have any 

extra. We haven't probably been able to move that. So the NCI evaluation 

program would take priority over sending out panel material.

(Kumin Mudi Enconteserin): Thank you.

Coordinator: Thank you. And our next question comes from (Ellen Allen). Your line is now 

open.

(Ellen Allen): Oh hi. Thank you. We recognize FDA’s efforts to prioritize the EUAs and 

terminate or decline acceptance of new EUAs based this prioritization 

scheme. Are there any guidelines FDA can provide for us who have EUAs

that have been accepted and are pending review and how long those 

authorizations can be expected if they’re not a priority EUA?

Dr. Tim Stenzel: Yes I think this is now a good time to do our introductory announcements 

Toby. I’ll just address the specifics of this question and then I do have...

(Ellen Allen): Hello?

Toby Lowe: Tim, if you’re still talking, we can’t hear you.

Coordinator: One moment. It looks like we are experiencing a little technical difficulty. 

Please stand by. 
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Toby Lowe: Okay so it looks like Tim may have gotten disconnected. Are folks able to 

hear me?

(Ellen Allen): Yes I can hear you.

Toby Lowe: Okay great. So to address your question about, you know, review timeline and 

prioritization we are, you know, continuing as we talked about before to have 

large volumes of submissions. And we are having to prioritize those 

submissions. 

We, you know, discussed previously that we prioritize based on the public 

health need and we consider, you know, factors such as whether the product 

would serve a significant unmet need particularly in terms of access such as at 

home specimen collection or at-home testing or the ability to expand the 

availability significantly such as the quantity and manufacturing capacity. So 

those are some of the considerations that go into our prioritizations.

And additionally we, you know, we are trying to review it as quickly as 

possible but we do use those prioritization factors to determine, you know, the 

order in which we review and where we spend our resources. And we also 

consider, you know, how complete a submission is in terms of whether we can 

move that forward. 

So Tim it looks like you might be back on. We just went through a little bit on 

prioritization but if you want to go into more detail please do.

Dr. Tim Stenzel: Yes I - sorry. Hopefully I’m not crackly. I think I might not have a good line 

but I don’t want to risk disconnecting. Well, I got disconnected.
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Toby Lowe: Yes, you sound good now.

Dr. Tim Stenzel: So okay. The priorities - so if somebody has come in, and there’s two different 

kinds of lower priority. So if someone’s in and you have not have an active 

reviewer but we haven’t made a determination, we will get to your 

applications as soon as possible.

And this is especially true for those who have notified the FDA and are 

allowed to sell their tests in the United States prior to an FDA authorization. 

We are making some other decisions and sending out de-prioritization letters. 

And I did want to go over that now in more detail.

And so we do continue to receive a high volume of EUA requests and want to 

again share our priorities. As we’ve stated before, we believe we're at a 

different stage in the pandemic now than we we're even a half year ago or 

several months ago in terms of tests available and testing needs. And so 

accordingly we have prioritized reviews and authorizations of EUA requests 

that take into account a variety of the factors as discussed in the guidance 

emergency use authorization and medical products and related authorities. 

And, you know, important to this is the public health need for the product and 

the availability of the product, you know, how much product could be brought 

into the US over time and certain things like - I’ll go into some of those other 

details but, you know, product availability is also important.

We have for example prioritized review of EUA requests that have to do with 

increasing test accessibility, for example point of care tests, home collection 

kits, home tests and those tests that would significantly increase testing 

capacity, for example tests that significantly reduce reliance on test supplies

that may limit access as well as those tests that are extremely high throughput 
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and widely distributed and can run on platforms that are widely distributed in 

order to best address public health needs.

But if you’re a notified test and you’re allowed to be on the market you may 

be in a lower priority than this but you can stay on the market. But we are on 

new test submissions, we are occasionally making determinations that we're 

not likely to get to those EUAs and so there's a different kind of response from 

the FDA.

It’s important to ensure and it’s critical to ensure adequate supply chains for 

authorized tests and avoid spot shortages and widespread shortages of testing 

supplies. So especially for priority tests we would like to avoid those 

shortages that could happen with diversion of supplies away from nonpriority 

tests.

Also, you know, diverting as way of an explanation for these priorities in 

more detail, diverting reviewer time to reviewing EUAs that would minimally 

contribute to expanding US testing capacity or patient access to testing would 

delay the review of EUAs for tests that would better serve the public. That’s 

the reason for some of the shuffling and the priority, prioritization that’s going 

on now with tests that have been submitted.

Additionally even for priority tests if the data in that EUA request is not 

supported to use, the data isn't good enough, we have an obligation at the 

FDA to decline an EUA authorization to protect the American public. 

When we do receive a complete submission -- this is important -- with good 

data for a priority test we move quickly to authorize it as we have done this 

week with the authorization of another home test, Quidel QuickVue test. It is 
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by prescription right now but the developer has publicly stated that they intend 

to come in with an over the counter submission.

And we look forward to that submission as we do for any home test, home 

collection whether it be by our point of care test, whether it be by prescription 

or for the home test over-the-counter.

And so we do not sit on good priority tests that have complete submissions. 

We are committed to ensuring the public has access to a wide variety of test 

options and those most - in those reviews that we're doing now we believe do 

to this prioritization are the most critical ones needed to address the pandemic 

at this stage.

So at the start of the pandemic we have since the start of the pandemic we 

have authorized over 300 tests and almost 250 molecular tests, five home tests 

now, over 40 collection home kits. So this access has been very important.

Initially there's a concerted effort by the US government to invest in 

increasing production of select tests and supporting development of certain 

tests through the RADx program. I’d refer you to the RADx and other 

elements of the US government talk about their prioritizations.

We do believe this may in fact be a more effective strategy at this point in 

increasing testing capacity and access over a more broad approach to, you 

know, making all tests of equal priority shall we say.

If you have a question about determining whether a test that you have in 

development would be considered high priority review, we recommend that 

you submit either a pre-EUA or even just an EUA or just an email, either a 

pre-EUA or an email to our EUA template email box which is cdrh-eua-
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templates@fda.hhs.gov with information about the features of your test in 

either a pre-EUA or an email as I've said. 

It's helpful to have information about your intended patient population, the

patient setting whether it’s central lab, point of care, home collection or home 

testing, what it's throughput is, you know, on an instrument for a given shift 

with a single staff member in the lab and what your manufacturing capacity is. 

This will help us to assess how we would prioritize such a EUA request. 

So that was in great detail. I hope that is all helpful for folks to understand our 

current priorities and why we’re making those priorities and why we’re

making this clear now. Toby anything to add on that?

Toby Lowe: No, I think that was - that covered all of that, right?

Dr. Tim Stenzel: I do also want to make a couple of other brief announcements and then turn it 

back over to Toby for the rest of the call as I’m going to have to drop off 

again today. 

The Abbott has now authorized - has now been authorized for a nine month 

dating on their Abbott BinaxNOW. There was some reports product in the 

field that may go out of date. Abbott has addressed this through a letter to 

customers on which you can reach out to Abbott about. Many customers have 

now received that I’m aware.

So all products that they’ve produced for the Abbott BinaxNOW from the 

beginning can now have nine month dating. Hold onto that letter if you’re a 

lab. And should CLIA come in to inspect, show them that letter as far as 

whether or not it was okay to run a test kit that has an expiration date on it. 
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This letter supersedes the expiration date on those kit lots that are provided in 

the letter provided by. Abbott. and CMS has signaled that they will review 

those letters, and if the kit lot that you’re using is on that list and you’re using 

it up until the new expiration date you should be fine.

I also wanted to say that there is now an Ebola outbreak in Africa, that there is 

testing going on upon entry to the US from certain locations outside the US. 

We do have still, the emergency still is declared for Ebola and we do have ten 

EUA tests listed on the FDA Web site.

We also granted one De Novo test for Ebola and so just want to make that 

aware for all. And Tony I’m going - to I mean Toby I'm going to turn this 

over to you for continuing to answer questions on this call. Thank you.

Toby Lowe: Great. And I had a couple of updates as well that I can give now while we’re

on a break from questions and then we can jump back to the questions. 

So Tim did already mentioned that this week we authorized the Quidel 

QuickVue At-Home home test. And that was an additional home test to add to 

the availability there. We’ve also recently authorized several home collection 

tests for direct to consumer nonprescription use. So those can be found on our 

Web site as well.

If you - if you’re looking at that EUA table and you search for DTC, Direct to 

Consumer, those will all come up if you’re interested in taking a look at those.

I also wanted to give a clarification to a point that was discussed on last 

week’s call. There was a question regarding a comparative test for flu for use 

with or for validating multi-analyte SARS-CoV-2 tests. And so we just 

wanted to clarify that we do have recommendations regarding which flu test 
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should be used as a comparator. And we prefer molecular free tests that have 

been cleared in the last five years or at least that have clinical data from the 

last five years to ensure that those comparators are still testing currently 

circulating strains.

And if you have a question about an appropriate comparator you can reach out 

to the EUA mailbox and we would recommend doing this before performing 

your study to ensure that you confirm that you’re using an appropriate 

comparator before collecting data. And with that I think we can turn it back to 

questions.

Coordinator: Thank you. Our next question comes from (Franco). Your line is now open.

(Franco): Thank you Toby. So first I’d like to point out that her - our test probably at 

least in our opinion qualifies as a priority test because it’s designed to be selfused at home and it's the pure naked paper strip. The closest one to it would be 

the one that you just approved by Quidel except Quidel's is by prescription.

And our plan is to make it over-the-counter or DTC. And I wanted to ask you 

if you could tell if there is a difference between OTC and DTC? That’s one 

thing.

The other point I wanted to make was that in - during all this time that we 

have been trying to get the validation taken care of we have had to identify 

new suppliers, new OEMs because we have some issues with the previous 

ones. And so we now have the ability to work with multiple suppliers,

probably four or five at least which in terms of the production, you know, 

we're talking now tens of millions of tests that could be potentially made 

available, you know, should we be able to complete the validation.
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And my next point is regarding the analytical validation which we actually 

started going through with one service provider, but then we’ve run into some 

issues. So then we had to go back to the drawing board working with a 

different OEM.

And it turns out that this OEM that we are working with says that they can 

provide the analytical information required by FDA. I’m referring to the 

molecular interference, I’m referring to the endogenous effects, you know, the 

hook effect and all that, all those requirements.

The OEM is based in China okay. And the question related to that is would 

FDA be amenable to looking and not only that but actually accepting the 

analytical information that is provided by the OEM related to that?

The other question I have is regarding the reporting component. When we go 

through the usability studies does FDA want us to go through the complete 

reporting process or do we stop it at a simulation level? Do we actually have 

to - I hope my question makes sense. 

So what I’m asking is if we actually have to report the results of the usability 

study in the way that a person would do if they actually got a test once we got 

EUA?

And the final one -- and I am sorry -- this is a lot. I know that there has been a 

design-a-thon going on which was I believe funded by HHS. I wonder if you 

have any resources for the companies that have been chosen in that design-athon so that maybe we can contact them about the reporting component? Sorry 

if I asked you too many questions there.
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Toby Lowe: That was quite a few questions. I will try to address each of those points as 

best as I can. First regarding DTC and OTC that’s - we’ve tried to use that 

terminology to make a distinction between home test and a home collection 

test. So over-the-counter or OTC and direct to consumer or DTC are both 

nonprescription. They are, you know, by regulation really are - these are, you 

know, EUAs but OTC is the official term for what we...

(Franco): Okay.

Toby Lowe: ...use for nonprescription. But most people think about OTC as something 

that you, you know, can purchase, bring home and use completely at home. So 

we've mostly been using OTC to refer to those at home tests...

(Franco): Okay.

Toby Lowe: ...whereas direct to consumer or DTC we usually use when we’re referring to 

a home collection test where the collection is done at home but you need to 

send your sample to a lab for processing. So it’s not performed fully in the 

home the way that, you know, a strip like it sounds like yours might be.

(Franco): Okay. Right, okay.

Toby Lowe: You had a - I didn’t fully understand your question about multiple suppliers 

and but I know you've mentioned analytical validation from China. As long as 

it’s properly validated or sorry, it's properly documented, you know, there's -

and the data looks appropriate we can accept that. We do prefer that the 

clinical data, especially usability data is done here in the US.

(Franco): Of course.
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Toby Lowe: And in terms of usability we do expect to see for an over-the-counter test we 

would expect both usability and user comprehension to be provided.

(Franco): Right.

Toby Lowe: And I don’t have information about the HHS design-a-thon that you - I would 

suggest reaching out to them directly.

(Franco): Okay so just one further question regarding the reporting part of the test. So 

again this, you know, our test is for self-use at home. So if we're talking about 

the reporting component I don’t want to get into technical but do we, when we 

do the usability do we actually have to go through the entire process? We have 

to complete the reporting meaning that the reporting does go all the way to 

wherever it needs to go just as if a user was actually purchasing an EUA 

approved test or how far do we take the reporting in the usability exercise?

Toby Lowe: Are you talking about reporting that the...

(Franco): The result.

Toby Lowe: ...results to the individual or...

(Franco): Yes.

Toby Lowe: ...report it to public health?

(Franco): Well the reports of the individual test, because my understanding from 

previous calls is that FDA recommends tests that do have some reporting 

capability.
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And I also understand that it's not a must but I take the recommendation is that 

if the application has a reporting component that FDA would be more 

amenable to that application versus one that does not have a reporting 

component. So again do we have to take the reporting all the way to the finish 

line? Does that make sense?

Toby Lowe: You're referring to reporting it to public health authorities, not reporting...

(Franco): Correct. Correct.

Toby Lowe: That’s something that we could work with you during your submission. It’s 

not something that we have that we would hold off an authorization for. So 

that’s something that we would work with you on.

(Franco): Okay.

Toby Lowe: We do want to see usability and user comprehension to the - at least to the 

point where the individual is getting their own result and understanding their 

own result.

(Franco): Okay very good. Sorry for taking so much of your time. Thank you.

Toby Lowe: Thanks.

Coordinator: Thank you. As a reminder to ask a question please press Star 1 and record 

your name clearly when prompted. Our next question comes from (Kathleen 

Copeland). Your line is now open.
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(Kathleen Copeland): Hello. We’re developing a point of care antigen test using saliva 

collection. And we're - and the test is very quick and is expected to be high 

throughput. So my question is around the saliva collection device. 

So if we do this test, you know, with under CLIA waiver at sites like airports 

or offices or something like that where maybe there's a line of people waiting 

to submit their sample, what is the level of supervised - supervision required 

for sample collection?

So in other words can we give the collection device to somebody standing in 

the line waiting to deposit their sample and then as long as the healthcare 

worker tests the sample, looks at the sample to make sure that there's enough 

to do the testing, is that sufficient or is part of the EUA do we have to do 

additional testing in the clinical study?

Toby Lowe: So we would want to see your test validated the way that you intend it to be 

used. So if you intend it to be used for unobserved self-collections then we 

would expect your validation to be done in that same circumstance. And so 

then...

(Kathleen Copeland): Okay.

Toby Lowe: ...that would be, you know, that would be sort of up to you and up to the 

performance of the test of, you know, whether it's impacted by those 

conditions and whether or not anything needs to be adjusted to get appropriate 

performance.

(Kathleen Copeland): But would we have to do more than 30 people net positives and 30 

negatives? Would we have to do different age groups or can we just do all 

comers?
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Toby Lowe: You know, I don’t have the template up in front of me so I don’t want to 

misspeak on that. But I believe that the template does outline what we would 

want to see in those studies. And if you have questions beyond what the, you 

know, for your particular circumstances beyond what the template says, I 

would suggest sending that into the mailbox or submitting a pre-EUA rather if 

you want to discuss your study design. But generally the recommendations for 

study designs that are in the template should be applicable.

(Kathleen Copeland): I guess then my question is which template because for POC we just need 

to follow the antigen test blood for test developers right, not the one for nonlaboratory use?

Toby Lowe: That’s correct. We would want to see, you know, the additional point of care 

consideration for in terms of usability. But you would not need to do the nonlab additions if you’re planning for it to be used at the point of care.

(Kathleen Copeland): Okay thank you.

Toby Lowe: Sure.

Coordinator: Thank you. And our next question comes from (Andrew Louia). Your line is 

now open.

(Andrew Louia): Hi Toby, good to talk to you again. We have a number of people who we’re 

talking to who are interested in submitting some point of care tests. And we 

have just kind of a general question in terms of prioritization for you here 

which is that they’re interested in doing something I know a number of people 

have done where they put in a more simple EUA submission first that’s just 
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for high complexity lab use. And then they want to update the EUA later with 

the point of care or home use or whatever the claim may be.

So in terms of how prioritization might impact that if they notify and it's kind 

of not a high priority and they’re not assigned a reviewer right away, when 

they then get everything together for point of care or home use or anything 

like that and submit that update does that automatically bump it up the priority 

list or might it get stuck in limbo?

Toby Lowe: That is an interesting question. I would suggest that - so I mean yes, it would 

bump them up in priority. It may not be picked up right away, you know, that 

it's - it may not be obvious to our process right away that that is the case and 

so you may need to, you know, particularly flag that you’d like it to be 

reconsidered for prioritization.

You know, generally if a test is designed to be used at the point of care it's not 

going - it's not likely to have as much usefulness in high complexity setting 

because it’s usually not designed to be, you know, high throughput tests that 

are high complexity lab might find use for. 

So it's, you know, we have found in working with developers that it’s usually 

more beneficial to focus on getting all of the point of care testing, you know, 

fully flushed out and ready and then submitting a, you know, fully completed 

submission for the actual purpose that you are intending. It does, you know, 

sort of confuses things to submit it for one use when you don’t really intend it 

to be used there and then update it later.

Coordinator: Thank you. And our next question comes from Shannon Clark. Your line is 

now open.
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Shannon Clark: Oh hello, Shannon Clark with UserWise Consulting. so we do a bunch of 

home use for OTC or prescription only testing with intended users. And 

there's a requirement in the nonlaboratory template to use users with no 

experience with self-collection. 

We're sensing a problem here in the Bay Area California because now all the 

adolescents are going back to school and they're required to self-swab twice a 

week in order to go back to school. So recruitment of adolescents is getting 

more and more difficult as the days go by.

And now the intended users basically all have experience with self-collection

so it would be a little odd to just try to self, just select and cherry pick the 

homeschooled adolescents who have no experience. So do you think the FDA 

might change their position on this requirement to have individuals with no 

self-collection or can we at least reduce this - the requirement to individuals 

with no experience with anterior nares in the case that we're pursuing that 

swab?

Toby Lowe: That’s an interesting situation that I think we may need to have some further 

discussion about. If you could send that question in and flag it for me, I - we 

can have some further dialogue on that.

Shannon Clark: Thanks so much.

Coordinator: Thank you. And I believe our next name was (Zach). Your line is now open. 

Sorry I did not get your name completely. I believe it was (Zach O’Keefe), but 

your line is now open. 

We’ll move on to our next caller. The next question comes from (Seth). Your 

line is now open. 
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And check your mute feature. (Seth) your line is now open. You may ask your 

question. 

Not hearing a response we'll move on to the next question. It comes from 

(Nancy Rector). Your line is now open.

(Nancy Rector): Hi. Can you hear me okay?

Toby Lowe: Yes we can.

((Crosstalk))

(Nancy Rector): Okay great. I do not have a question. I have an answer for the individual that 

asked about the design-a-thon. My company U Do Test is part of - is one of 

the 16 companies in the design-a-thon and we do definitely have a software -

our aspect is a software that connects the patient demographics and 

information to HHS and to state authorities. So is it okay if I provide an email 

address for that individual that was looking for some entry into that - the 

group, the HHS group?

Toby Lowe: Sure.

(Nancy Rector): Okay so they can email us at partners PA-R-T-N-E-R-S@udotest, U-D-O-TE-S-T, udotest.com and we'll get back with you as far as assisting you with 

developing that software and getting you introduced to each of the companies. 

It’s a great network and I am very impressed with what they’re doing what 

HHS has done and I’m very impressed with what you all have done. I’ve been 
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in the industry for a couple of decades and you all are doing a great job so 

thank you.

Toby Lowe: Thank you. I appreciate that.

(Nancy Rector): No problem, that’s it. Thanks.

Coordinator: As a reminder to ask a question please press Star 1 and record your name 

clearly when prompted. Please ensure your line is not muted. Our next 

question comes from (Komudi). Your line is now open.

(Komudi): Thank you for taking my question. Toby I have a request. This call initially 

also there was some technical difficulty and in-between I got disconnected. Is 

there any way that Timothy’s and your statement that was read that can be 

posted instead of us waiting two weeks for the transcript to come?

Toby Lowe: I don’t know that we can get anything up separately from the transcript, but 

the transcript will be posted as soon as it’s available and we'll try and get that 

up quickly.

(Komudi): But it is not recorded, I would like, you know, document that he read that we 

will just - because I just when he was talking about the priority of something 

like that, I got disconnected and I did not get a chance to hear the - what is 

that statement that he read, is there a possibility of making that statement 

available?

Toby Lowe: Oh no, it was not a written statement. But we did, you know, provide some 

information and it, you know, basically it will be in the transcript, but 

information about the prioritization as we’ve discussed before in some of the 

factors that we consider.
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(Komudi): Okay thank you.

Toby Lowe: Sure.

Coordinator: Thank you. Our next question comes from (Scott Turke). Your line is now 

open.

(Scott Turke): Hey thanks for your time and appreciate you doing this. My group has 

licensed a couple new technologies which is rapid testing for COVID. And it 

is based on protein synthesis that we have patented out of two universities that 

were funded by an NIH and the RADx grant that result less than five minutes 

and I can produce it less than one minute.

The thing that I’m wondering is we’ve also developed technology that where 

we can put a QR code on it so if they’re buying an off-the-shelf at Walgreens, 

Walmart -- wherever else it is -- it will actually tell the patient as to whether 

they’re positive or negative and report to the appropriate authorities. 

The thing that we're doing right now is working with Indian Health Services 

but my challenge is is getting this thing to market right now. And I’m 

wondering what is the priority as far as looking at tests that I’ve licensed that 

are NIH and RADx funded versus other tests by other groups because I think 

the vaccines are going to come out and everything else but we're still going to 

need testing and especially in indigent populations.

Toby Lowe: Sure so it sounds like this is a test that you would be indicating or seeking out

claims for over-the-counter, you know, rapid home use -- something along 

those lines. And so that as we said would be a priority. It sounds like this may 

be, you know, a newer technology so I would suggest that you submit a pre-
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EUA so that we can discuss that with you and make sure that when you 

submit an EUA request it includes all of the information and all of the 

validation data that we would want to see.

You mentioned licensing this and so, you know, one thing to look at there is 

whether this is also something that another entity is seeking to get 

authorization for if the manufacturer themselves is coming in.

It's much easier for us if there's a single entity that is coming in for 

authorization for specific technology. And then when authorized they can 

request, you know, additional labeling to be included in the authorization for 

different distributors with different brand names if that's something that the 

manufacturer is looking to do to license it out. But it is...

(Scott Turke): Yes. And we're...

Toby Lowe: ...much simpler...

((Crosstalk))

Toby Lowe: ... with a single submission.

(Scott Turke): Well and that’s what we’re doing from the whole stream of flow is when 

licensing the technology which results in I can manufacture for less than a 

buck and probably get to the retail market for five bucks for airports, mass 

transit, schools and everything else.

But we’ve also built in software to where when you buy it off the shelf at 

Walgreens, Walmart or anything else is that you take a picture of the result 

and it tells you coming back with 99% validity as to whether the result is 
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correct or not. But two is it automatically sends results to the reporting 

agencies. Do I need to...

Toby Lowe: Yes...

((Crosstalk))

(Scott Turke): ...sit there and do an EUA...

Toby Lowe: ...so we would want to see...

(Scott Turke): ...on the software as well?

Toby Lowe: ...validation. Yes, we would want...

(Scott Turke): What?

Toby Lowe: ...to see validation of that software for the reader if it's interpreting the result 

for the patient. We would want to see...

(Scott Turke): Yes.

Toby Lowe: ...validation for that.

(Scott Turke): Okay so I’m fine...

Toby Lowe: But we would want...

(Scott Turke): ...with because I’ve been in the FDA for a long time as far as the validation on 

the studies as far as the validity of the test. But that’s what I’m wondering is 
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because my vision is you buy this thing off of a shelf in a pharmacy and for 

less than five bucks you also get the software that comes to it that does the 

reporting and gives you a validation and an authentication letter that like if 

you want to travel or anything else because it’s 92% to 95% sensitive.

So do I have to sit there and do in EUA on the software and the test or how do 

I combine those two together because we brought the technology to the test,

you know what I’m saying?

Toby Lowe: So you - we would, you know, as I said I would suggest that you submit a preEUA because it does sound like we would want to discuss the approach with 

you. And then we could figure out the best pathway there. But yes we would 

need to see an EUA for this - the software with the test.

Coordinator: Thank you. As a reminder to ask a question please press Star 1. Our next

question comes from (Franco). Your line is now open.

(Franco): Hi Toby. Thank you again. So I actually had a related question to the 

reporting again. So regarding the data how long do we need to maintain that 

data? As a, you know, as a test developer how long do we have to keep that 

and where do we submit it?

Do we have to submit it to some authority from time to time? Do you have 

anything on that because as of now there's only one test right? it's the Ellume

test that is 100% home use, not prescription. So it’s really hard to go and look 

at what others and are doing, you know, to kind of, you know, follow the 

same path if you will.

Toby Lowe: Are you talking about reporting out to public health authorities or...
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(Franco): Yes, yes, yes, yes correct, sorry yes.

Toby Lowe: Okay. I’m not going to unfortunately be able to answer your question about 

how long to store data. I’m not sure that we would expect the individual data 

to be going back to the manufacturer so that's something we would have to 

discuss with the reporting experts. If you send in your question to the mailbox 

we could connect you with the folks there.

(Franco): Okay thank you.

Kemba Ford: Hi. Thank you. 

Coordinator: As a reminder...

Kemba Ford: This is Kemba Ford and we appreciate your thoughtful questions during 

today’s town hall. Today’s presentation and transcript will be available on the 

CDRH Learn Web page at www.fda.gov/training/cdrhlearn by Friday the 

12th. If you have additional questions about today’s presentation please email 

cdrh-eua-templates@fda.hhs.gov.

As we continue to hold these virtual town halls we definitely would appreciate 

your feedback. Following the conclusion of today’s virtual town hall please 

complete a short 13 question survey about your FDA CDRH virtual town hall 

experience. The survey can be found now on www.fda.gov/cdrhwebinar.

Again we apologize for the technical difficulties during today’s Webinar. We 

will work behind the scenes to make sure that next week’s town hall will start 

on time as scheduled. This concludes today’s virtual town hall.
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END