FDA Virtual Townhall

Moderator: Irene Aihie

11-04-20/12:15 pm ET

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FDA Virtual Town Hall Series –

Immediately in Effect Guidance on 

Coronavirus (COVID-19) Diagnostic Tests

Moderator: Irene Aihie

November 4, 2020

12:15 pm ET

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

listen only mode until the question and answer session of today's call. At that 

time, if you would like to ask a question, you may press star 1. Today's 

conference is being recorded. If you have any objections you may disconnect 

at this time. I would now like to turn the meeting over to Irene Aihie. You 

may begin. 

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

and Education. Welcome to the FDA's 33rd 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 Toby Lowe, Associate Director of the Office of In Vitro Diagnostics 

and Radiological Health in the Office of Product Evaluation and Quality, here 

in CDRH, will provide a brief update. She is joined by Dr. Brittany Schuck 

and Dr. Kris Roth. 
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Following opening remarks, we will open the lines for your questions related 

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 and thanks everyone, for joining us again this week. So I just 

have a quick update and I have seen that yesterday we issued a letter to 

Clinical Laboratories staff and healthcare providers regarding false positive 

results with antigen tests. So we put that out because we have become aware 

of reports of false positive results in nursing homes and other settings. 

And as we continue to monitor and evaluate these reports, we wanted to share 

some information with stakeholders about this risk and about stuff that can be 

taken by clinical laboratory staff and healthcare providers to help ensure the 

accurate reporting of test results. So that's available on our website and was 

also sent out by email yesterday. 

So a few of the key points there are to be aware of the information in the 

package insert for each test, which does include information about appropriate 

handling of the test cartridge or card -- excuse me -- at appropriate storage of 

those components. If they're not handled properly that can impact the 

performance of the test. 

And also about the time that it takes to read the results and being sure to read 

the results at the appropriate time since reading the test before or after that 

timeframe, can result in false positive or false negative results. We also 

include some information about minimizing the risk of cross contamination 

and pointing to the CDC guidance and recommendations about the use of PPE 

and changing gloves and also cleaning the instrument and the work area in 

between specimens. 
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Then the other point that is made in that communication is about the positive 

predictive value. And just reminding everyone that false positives are 

expected with all tests. You know, any test that's out there will have some 

false positives and some false negatives. No test is perfect. And particularly 

with some of these tests being used to screen individuals in low prevalence 

areas, we do expect there to be a higher incidence of false positives as that 

prevalence decreases. 

So you can find that on our website and take a look at that and let us know if 

you have any questions. The only other update I have is just to remind 

everyone that we will not have a town hall next week. Wednesday of next 

week is Veteran's Day so we will be taking a break next week and we'll be 

back on the 18th. So with that, we can open the line for questions. 

Coordinator: If you would like to ask a question please press star 1 and record your name 

clearly when prompted. To withdraw your question you may press star 2. 

One moment please, for our first question. Our first question comes from 

(Mark Hackman). Your line is open. 

(Mark Hackman): Yes, good morning. Can you hear me? 

Toby Lowe: Yes. Good morning. Or good afternoon I guess. 

(Mark Hackman): Yes. Good afternoon. I'm sorry. It's morning on the West Coast still. Good 

morning, Toby. IT's (Mark Hackman). It's been a while since I've spoken 

with you. It's been a couple of months since I've been on this call. But I'm 

going to ask the same question that I asked a couple of months ago. And it's 

kind of a two part question. But it's really short. 
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My first part is when are we going to see a fully at home test approved by 

FDA? And my second part of the question is, is here currently any over the 

counter devices, and I'm talking about lateral flow devices, that have been 

approved by FDA to this date? I've checked the website and I didn't see any. 

Toby Lowe: Thank you for joining us. I'm glad you've come back. So to - I'll start with 

the second half of your question. There are currently no over the counter 

COVID-19 tests authorized. We are working with any interested parties that 

come to us with, you know, looking to do that and we have set out some 

information in our templates, about over the counter. So we do look forward 

to that. 

And the same is true for fully at home tests. I can't give you any timeline on 

that unfortunately, because that is dependent on developers submitting those 

EUA requests and making sure that they are - that the data is there to support 

that use. But we have, you know, as we've talked about on this call 

previously, we are very interested in that and we have put out information 

about, you know our recommendations as well as our flexibility to consider 

different approaches. 

So we are looking forward to getting to that point. 

(Mark Hackman): Thank you very much. Have a great day. 

Toby Lowe: You too. 

Coordinator: Our next question comes from Shannon Clark. Your line is open. 

Shannon Clark: Hello. This is Shannon Clark from UserWise Consulting, a human factors 

feasibility testing consultancy. I'd like to better understand the FDA's 
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rationale for differences between the molecular and antigen templates, 

specifically related to studies that support a point of care claim. They're not 

OTC or home use but point of care. 

There are pretty significant differences between the molecular and antigen 

template where the molecular template specifies at least four different 

operators while the antigen template remains silent on the matter. The 

molecular template specifies prospectively collected positive specimens, while 

the antigen template allows for either prospectively or retrospectively 

collected samples. 

And also, the molecular template implies no training for healthcare 

professionals, which is very common for human factors and usability testing 

while the antigen template does not comment regarding the use of 

instructions. 

So if you're allowing retrospective sample collections for the antigen template 

but not for the other ones, as well as just one healthcare provider instead of 

four, does this imply that the FDA is uninterested in the process for collecting 

the sample when using antigen tests in the point of care setting? 

So - and then if so, can we use this one expensively trained healthcare 

provided for the antigen point of care study as the point of care indication? 

Toby Lowe: There is a lot in that question. I'm going to try to get to it. But so there are 

differences, you know, obviously there are differences in the templates 

because there are differences - there are four different types of tests and that's 

why there are different templates for them. 
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I would have to double check the details. Unfortunately don't have all the 

templates completely memorized, especially as we update them. But I believe 

that we do request multiple operators for the different templates. And I 

believe that, you know, there's the differences in the test design, you know, 

visually read versus, you know, a more complex instrument, would also 

impact our recommendations for the study design. 

Shannon Clark: Also, perhaps molecular solutions are more complex and require more 

operators, maybe more evidence that untrained users can use it. While antigen 

tests might be so simple that maybe you're less interested in having more than 

one operator, etc. 

Toby Lowe: Right. I mean as I said, they are very different types of tests with most 

antigen tests being visually read and molecular tests having additional steps 

involved. 

Shannon Clark: It just seemed surprising to me that both - what was that? 

Toby Lowe: Sorry. Go ahead, Shannon. I was also going to ask Kris if he wanted to 

weigh in at all on this question. 

Shannon Clark: Yes, please, Kris. 

Dr. Kris Roth: Yes, thanks. No, I mean it is a good question and we do struggle - I wouldn’t 

say struggle, but we do try to accommodate, you know, different approaches 

for these two different tests. Right? So we know antigen is slightly, you 

know, less sensitive than maybe the molecular test. And therefore, you know, 

the testing can be, you know, slightly different. And again, I think the first 

part of your question which maybe of most interest is, you know, I think 
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molecular tests have instrumentation and you can have a visually read antigen 

test. 

And so, you know, those need to be kind of, you know, taken into account 

when the validation is, you know, being performed. 

Shannon Clark: Yes. So I guess when I read between the lines of these templates it just seems 

that the FDA is uninterested in the sample collection. Because many times 

both antigen and molecular will employ a swab. And I know when we do 

sample collection studies for home use, we're very interested in users' ability

to correctly use that swab. 

But the implication here to me is that for point of care use you're not that 

interested in swab, as you do allow prospectively collected samples as well as 

not requiring (unintelligible). 

Toby Lowe: I don't think that was the intended implication. And it would be very helpful 

if there are things that you're reading in the templates that you think are 

confusing or you think, you know, are discrepancies between the templates 

that don't appear to make sense to you. If you can send those in to the EUA 

mailbox that would be very helpful, so that we can take a look at that and 

make sure that there are no unintentional discrepancies. 

Shannon Clark: Excellent. Will do. Thank you so much. 

Toby Lowe: Great. 

Coordinator: Our next question comes from Christie Bergerson. Your line is open. 
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Christie Bergerson: Hi Toby, Kris and (Brittany). This is Christie Bergerson from Exponent 

Consulting. My question is not as detailed. I had a question pertaining to 

research use only components that are used as part of a submission. 

So after the submission is authorized, do those components named in that 

submission, which might have been research use only before, need to change 

their labeling? So for example, if a company uses a certain instrument with 

their assay and that instrument is labeled as RUO, after authorization would 

that instrument marketing materials need to be changed to remove the RUO 

label? 

Toby Lowe: So if you're distributing instrumentation that is covered under your EUA it 

should be labeled as an EUA instrument. Yes. 

Christie Bergerson: Okay. Thank you. 

Toby Lowe: Great. 

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

(Tom MacDougal): Hi Toby. Hi all. I had a quick question about the study to support the 

asymptomatic claim that's in the new antigen template. I see it's now asking 

for 20 asymptomatic positives but also mentions that it may be possible to use 

archived specimens. And I just wanted to ask if you guys could maybe shed 

some light on what any maybe post authorization requirements would be if we 

were to go forward with archived specimens. 

Toby Lowe: That's such an interesting question. Kris, do you know if we're including post 

authorization studies or requirements if we use archived specimens? 
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Dr. Kris Roth: So I mean typically, we'll have a post authorization study if there's some kind 

of open questions at the end of your submission. So if there are - I think, you 

know, during the review, you know, this is a very detailed question, right? I 

think there are a lot of aspects to what go into a post market study or not. And 

so I would tend to leave that up to the individual reviewer. 

And I would say there's not kind of a blanket policy. So yes, if you use 

archived you must have a post market study. I don't think that is the approach. 

I think there are maybe some deficiencies that could be identified because we 

know that archived sample are, you know, or can be at least, somewhat of a 

biased population. 

So if there are those questions at the end of the study then, you know, that 

may be applicable for a kind of post market approach, a post authorization 

approach. Excuse me. 

Toby Lowe: Yes. I think that...

(Tom MacDougal): Great. 

Toby Lowe: ...would be a good question to discuss with your review team. And I did just 

pull up the template to take a look. And the discussion about archived 

specimens does ask that you contact FDA to discuss those alternate study 

designs. So that would be helpful for this one. 

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

Toby Lowe: Sure. 

Coordinator: Our next question comes from (Mark Wagner). Your line is open. 
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(Mark Wagner): Hi. Thank you. I was wondering if you could comment on what the FDA is 

looking for from distributors of at home collection tests. Are there any 

requirements for distributors of an EUA authorized at home collection test 

when the distributor does not hold the EUA? 

Toby Lowe: Yes. So the - all of the EUAs include conditions of authorization for 

distributors in the authorization. So those would be spelled out there. And if 

you have any specific questions about those that would be a good question to 

send into the mailbox so that we can make sure that we understand the 

specific situation and can provide the appropriate feedback. 

(Mark Wagner): Okay. Thank you. 

Toby Lowe: Sure. 

Coordinator: Our next question comes from Todd Lewis. Your line is open. 

Todd Lewis: Hello. My name is Todd Lewis from DNA Diagnostics Center. And my 

question is if we have an EUA approved molecular test and we wanted to 

change the sample collection part of that and there was an EUA approved -

say it was approved for nasal swabs and we want to use saliva collection that 

was approved, how should we go about that? 

Do we have to send in a brand new EUA or is there some type of bridging 

study, or we do a verification study? 

Toby Lowe: So we do have recommendations in the molecular template for validation of 

saliva including validating adding saliva as a specimen to a test that has been 

already validated for nasal specimens. In terms of the regulatory approach, is 
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this your own EUA that you're - that you are the EUA holder and you'll need 

to add saliva, or are you a laboratory that is looking to add saliva testing to a 

commercial test kit? 

Todd Lewis: We were going to use somebody else's EUA but we can do it as an LDT too. I 

mean we could poke around that way. But and if you can marry the two and 

just do a verification in the - I guess of the LDT. Yes. 

Toby Lowe: So - right, so if you're - if you're looking to add saliva as a specimen type to an 

EUA authorization, we would just ask that you submit - the EUA holder 

should submit a supplemental EUA request including the validation that we 

recommend in the template for saliva. And then that could be added provided 

that the data supports it. It could be added to the authorization. 

For a lab looking to add saliva as a specimen type to another entity's 

authorized test, we would also hope that you would use the FDA 

recommendations for validation that are in the template. We have indicated in 

our guidance and there's also the HHS LDT statement, that we would not 

expect to see an EUA request for that modification. 

But we would expect it to be done - for the saliva collection to be done with a 

legally marketed saliva collection device. The collection device otherwise 

would need to come in for authorization if it's not one that is already 

authorized. 

Todd Lewis: Right. Okay. And it doesn't have to be standalone, it can be part of another 

test kit? 

Toby Lowe: Can you clarify that? 
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Todd Lewis: So some test kits have that in the collection device built into that EUA and 

some collection devices have an EUA just as standalone. 

Toby Lowe: Right. So if there is...

Todd Lewis: As a matter...

Toby Lowe: ...a collection device that is included in - within an EUA for an assay, then 

that collection device is only authorized for use with that assay. In order for a 

collection device to be more broadly legally marketed it has to have that 

standalone authorization. 

Todd Lewis: Okay. All right. That answers it. Thank you. 

Toby Lowe: Great. 

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

(Roberta Badsen): Hi, yes. My question is - my name is (Roberta Badsen). I'm from Tempest 

Labs. Just a question about if you have a test authorized under EUA and you 

do receive a false positive are you required to report that via the MDR

process? 

Toby Lowe: We would expect false positives to be reported both to the EUA holder, it 

sounds like you are the EUA holder...

(Roberta Badsen): Yes. 

Toby Lowe: ...and to FDA. 
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(Roberta Badsen): Okay.

Toby Lowe: So you could send that into the - through the MDR process or through the 

EUA reporting mailbox that should be on your letter of authorization. 

(Roberta Badsen): Thank you very much. 

Toby Lowe: Sure. 

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

(Elaine Allen): Hi. This is (Elaine Allen). I'm calling from Agilent. I'd like to first appeal to 

everyone, all the listeners, for their patience because today is my second day 

in the environment of developing tests for the COVID. So my questions are 

very basic. May I ask, and I have a few, what is the average approval time 

from submission for an EUA to final approval? 

Toby Lowe: I don't believe we have ever judged - that we've been giving out at the 

moment. We do have some information on our FAQs that talks about the time 

for review and generally it is - it does vary based on the quality of the 

submission as well as where the submission falls in our priorities. 

(Elaine Allen): Okay. That's great. And does that - does the approval time perhaps, is it 

affected if it's a serology testing or antigen testing type EUA? 

Toby Lowe: We do have different teams that are working on serology, antigen and 

molecular tests. So they are each - they each have their own queues of tests 

that they're working through. 
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(Elaine Allen): Okay. So it depends on them. Now the minimum test requirement says 30 

positive and 30 negative for clinical data. Is that still the acceptable sample 

size for EUA approval? 

Toby Lowe: So the recommendations for validation are in the templates on our website and 

those are - all of the current recommendations are in there. 

(Elaine Allen): Okay. Templates. Okay. So then...

Toby Lowe: I think generally we do - we do try so that we can get through as many callers 

as possible, we do try to ask callers to limit themselves to one question. So I 

would ask that you maybe pick your next top question and then we'll move 

onto the next caller. 

(Elaine Allen): Thank you very much. I appreciate it. Like I said, I appreciate your patience. 

And this is my last question. Is the agency still utilizing enforcement 

discretion for promotion and sales of EU products up to 15 days prior to the 

submission of the EUA or could we preview our intention to our customers 

more than 15 days in advance? For example, coming soon, so that our 

customers know we're working on this important project? Or how far in 

advance can we do that? 

Toby Lowe: So the policy that we have in place is regarding, excuse me, does indicate that 

you can notify FDA once you have completed validation and you are 

intending to begin to offer your test. So once you have notified FDA you -

under that policy, you would then begin offering your test. And within 15 

days - and this is for a molecular test, within 15 days you would submit your 

EUA request. For a serology test it would be within ten business days. 

(Elaine Allen): So it is the 15 days prior to submission? Am I understanding that correctly? 
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Toby Lowe: Once you have notified - once you have completed validation and notified 

FDA we expect to see an EUA request within ten or 15 days depending on the 

kind...

(Elaine Allen): Okay. 

Toby Lowe: The type of test. 

(Elaine Allen): Okay. So promotional materials, can we promote it prior to the 15 days? 

Toby Lowe: The test should not be offered for use prior to completing validation and 

notifying FDA. 

(Elaine Allen): Okay. Okay, great. Great. Thank you. And thank you all for your patience 

for my multiple questions. 

Toby Lowe: Thank you. 

Coordinator: I would like to remind participants that to ask a question please press star 1 

and record your name clearly when prompted. To withdraw your question 

you may press star 2. Our next question comes from (Win Lee Chou). Your 

line is open. 

(Win Lee Chou): Thank you. Yes. This is a follow up with an earlier question. I just want to 

clarify it. And so for the standalone device such as the approved home

collection kit, the saliva as well as the swabs, so you are - I already have a inhouse EUA assay for LDT assay. And what I need to do if I want to do home 

collection, I can just buy the standalone kit and that's it? There's not any 

additional test whatsoever, right? 
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Toby Lowe: So we have indicated that we do expect tests for home collection to be 

authorized prior to being used for home collection. So we would expect you 

to submit an EUA request for that. Excuse me. If you are looking to use one 

of the authorized home collection kits which I believe the standalone home 

collection kits are only for nasal swabs at this point.

I believe that we have collection devices authorized for saliva, but not home 

collection kits. And so if you do want to use one of the authorized home 

collection kits you - the first step would be to reach out to that company to

partner with them. 

And then they would be able to give you a right of reference to the data that 

you'll need to submit to FDA for your EUA request. 

(Win Lee Chou): Okay. So yes, I just wanted to clarify. So as far as I know there is a one, 

home collection swab, the nasal swab kit testing approved, right? Standalone 

kit. So then there's a saliva collection solution. They have to pick up an 

EUA, the standalone as well, or maybe I got it wrong? So even with that...

Toby Lowe: So there are several standalone home collection kits that have been authorized 

for nasal swabs. 

(Win Lee Chou): Okay. 

Toby Lowe: And there are no...

(Win Lee Chou): For saliva. Yes. 

Toby Lowe: ...home collection kits authorized for saliva. There are...
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(Win Lee Chou): Okay. 

Toby Lowe: ...I believe three EUAs for saliva collection devices but they...

(Win Lee Chou): Okay. 

Toby Lowe: ...can only be used for home collection when they are part of an authorized 

home collection kit. They are not...

(Win Lee Chou): Got it.

Toby Lowe: ...a home collection kit on their own. 

(Win Lee Chou): Got it. So for the standalone, those swabs, those kits, standalone, if I use the 

standalone together with my test, do I still need to submit some EUA for FDA 

or I’m okay? 

Toby Lowe: We have indicated that we expect to see EUAs at this stage, for all tests, 

excuse me, all tests that are intended for use with home collection specimens. 

(Win Lee Chou): You will use a standalone device. So you still in - need to see the EUA 

application for that. Right? 

Toby Lowe: That's correct. And if there's a specific situation and a specific collection kit 

that you would like to get input on, you can send an email to the email 

address...

(Win Lee Chou): Okay. 
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Toby Lowe: ...and we can clarify. 

(Win Lee Chou): Okay, great. Thank you very much. 

Toby Lowe: Sure. 

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

(Justin Binding): Hi. Can you hear me? 

Toby Lowe: Yes. 

(Justin Binding): Okay. My name is (Justin Binding). I come from a smaller medical center. 

And we're seeing about using our current PCR instrument in these kits. We're 

currently working with the manufacturer that has an assay that is EUA - that 

has the EUA approval, and the software has EUA approval but the - but it 

doesn't have the emergency use authorization for the software with that 

instrument. 

We're trying to - we're working with them to see if - about adapting it and 

developing a lab developed test. But I saw on the FDA site that you're 

currently seeing about only approving emergency use authorizations for like at 

home kits and collection kits and other ones that would be more widely 

distributed. 

Are we still able to receive the emergency use authorization or would we have 

to go through CLIA and our accrediting agency for a lab developed test? 

Toby Lowe: We have indicated that we are not - that we are declining to review EUA 

requests for LDTs at this time. But what I would encourage you to do if 
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you're working with the manufacturer of the test kit, is I would recommend 

that you work with them to possibly collaborate with them on the validation 

and have them submit a supplemental EUA request to add the components 

that you're interested in using, to their EUA as that would also help other labs 

that may want to use the same combination...

(Justin Binding): Okay. 

Toby Lowe: ...of components with that test kit. And then the EUA holder could update 

their authorization. 

(Justin Binding): Okay. So that - that would - could still see approval if the manufacturer 

actually also submits it just to amend their current EUA? 

Toby Lowe: That's correct. 

(Justin Binding): Okay. All right. Thank you so much. 

Toby Lowe: Sure. 

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

(Lindsay Miles): Hi. I have a question about manufacturing the viral transport medium. We 

are following all CDC guidelines for the sterility checks A and B. But my 

question is do we actually have to perform or is there a requirement that we 

validate or verify that sterility check? Or if we're following CDC guidelines 

are we covered? If we are required to validate, how do we approach that? 

Toby Lowe: You know, I have not looked at that guidance in a little while. I believe that 

we, for notification under the policy that we've put out, that we would just 
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expect you to confirm that you are following the protocol and have validated 

that. And that you have internally validated that the VTM is sterile. 

(Lindsay Miles): And so my question though is what does that mean? Because the CDC 

guidelines don't have a method validation process. So we are completely 

following their guidelines but, you know, we're just wanting to make sure that 

we have everything covered but there's not really any guidelines for a method 

validation for the sterility check that we are following, per their guidelines. 

Toby Lowe: Sure. Let me just see if I can find this very quickly. Otherwise, I would ask 

you to send the question in so that we can make sure that we are able to get 

you the right information there. 

(Lindsay Miles): Okay, thanks. I appreciate it. 

Toby Lowe: Yes. I'm not seeing this in my very quick review of the information and I 

don't want to take too much time on the call. So of you could send that into 

the mailbox so we can get you an answer to that. 

(Lindsay Miles): Okay. And one - I'm sorry, one quick follow up question to that. So I know 

you mentioned that it's just to validate that the VTM is actually sterile. So 

kind of what - how I interpret that is that the sterility check is the validation 

that the VTM is sterile - is a sterile medium. 

Toby Lowe: That's correct. 

(Lindsay Miles): Great. And I'll follow up with sending to the mailbox that - that's how we're 

interpreting it but we just want to make sure that we're following all 

guidelines and protocols that you guys have. 
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Toby Lowe: Great. And Kris, did you want to weigh in at all on this one? 

Dr. Kris Roth: Yes. Just briefly, you know, sterility is a statistical evaluation. Right? So it's 

just a matter of how long and how much of the VTM you test. So I think 

that's perhaps why we're not having a kind of a concrete recommendation in 

that notification guidance because it's not - I think there's multiple ways that it 

could be done. 

And so as Toby mentioned, I think, you know, if you have a protocol in mind 

I think we'd be glad to comment on it. We have done that in the past. But just 

keep in mind, I think there are, you know, multiple ways to take a look at 

sterility. 

(Lindsay Miles): Okay. We'll send in the question and a follow up to the mailbox. Thank you. 

Toby Lowe: Great. Thank you. And thanks, Kris. 

Coordinator: Our next question comes from Julianna. Your line is open. 

Julianna Chen: Hi Dr. Lowe. My name is Julianna Chen and I'm with Hologic. Thank you 

with - like so much, for taking my call. We do have a question that we would 

like your help to clarify. We're starting to see like many individuals face 

published travel requirements for travelers entering their states. And then 

these requirement are written in a way that they need to be a SARS-CoV-2 

PCR test.

Our test is one of the few non-PCR nucleic acid based amplified tests so it's 

one of the NAATs. And just poses a challenge for the travelers as they would 

still need to quarantine with a negative result from our test. And we've been 

seeing similar use of the term PCR used in places for descriptors for like 
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amplified technologies instead of NAAT, or molecular IVD being used in like 

many programs for return to work and return to school at the local level. 

So we are hoping FDA could help us with two things - one being that if you 

could help us update the FAQs to recommend to policy developers that they 

could use generic descriptors such as NAAT or molecular IVD when possible, 

so these tests are not solely based on PCR technology. And that we will not 

get - the other non-PCR test will not get excluded.

And then that will help to educate the public health and policy officials at the 

state and then at the local level, about the distinctions in between those two 

types of tests. 

Toby Lowe: Absolutely. 

Julianna Chen: And then another one - sorry, being that if we could have FDA look at the 

letter to clinical labs and HCP about antigen tests, if FDA could help clarify 

that NAAT or molecular tests may be used to test antigen negatives instead of 

just PCRs but - or (RTPCR) as recommended, that would be really great for 

us. Thank you. 

Toby Lowe: Thank you for that. That's an important clarification. And I know that we do 

try to use molecular as a more general term typically. But absolutely, we do 

refer to PCR tests at times when molecular may be more appropriate. If you 

have specific recommendations where you see information is put out and you 

think that we should change some of our wording, you can definitely send that 

in. 

If you can send that in to the mailbox in writing with your recommended edits 

that is incredibly helpful for us. And we will definitely take a look at that. 
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Julianna Chen: Thank you so much. My leadership actually already followed up with you 

and I will definitely send another email to the template address as well. 

Thank you so much. 

Toby Lowe: Great. 

Julianna Chen: And we really appreciate your help. Thanks. 

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

(Bruce Emanuel): Hi. My name is (Bruce Emanuel) and I have a really simple question. Do you 

have approved any EUAs for the CRISPR based of this COVID test? 

Toby Lowe: I’m sorry. I'm having a little trouble hearing you. Can you repeat your 

question? 

(Bruce Emanuel): Yes. Sorry. My name is (Bruce Emanuel) and I have a simple question. Do 

you have approved any EUA for CRISPR based testing? 

Toby Lowe: Yes. I believe that there are tests authorized with that technology and yes, I 

believe - it looks like there are two. You can actually search on our - on the 

EUA page by the attributes of the test. And CRISPR is listed for two of them. 

(Bruce Emanuel): So by any chance will it be able to find also how long it took for them to get 

the approval? 

Toby Lowe: We - only list the authorization dates, not the dates that the EUA requests 

were received by FDA. 
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(Bruce Emanuel): Thank you. I appreciate you. 

Toby Lowe: Sure. 

Coordinator: I show no further questions in queue. I would now like to 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 made available on the CDRH 

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

November 12th. If you have additional questions about today's presentation 

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

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

live 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. 

END