FDA Virtual Townhall

Moderator: Irene Aihie

07-29-20/12:15 pm ET

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FDA Virtual Town Hall Series –

Immediately in Effect Guidance on 

Coronavirus (COVID-19) Diagnostic Tests

Moderator: Irene Aihie

July 29, 2020

12:15 pm ET

Coordinator: Good afternoon and thank you all for standing by. For the duration of today's 

conference, all participant's lines are on 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 Ms. Irene Aihie. Thank you, ma'am. 

You may begin.

Irene Aihie: Thank you. Hello. I am Irene Aihie of CDRH's Office of Communication and 

Education. Welcome to the FDA's 19th in a series of virtual town hall meetings 

to help answer technical questions about the development and validation of 

tests for SARS-Co-V-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 
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Radiological Health, both from CDRH, will provide a brief update.

Following opening remarks, we will open the line for your questions related to 

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

questions about specific submissions that might be under review. Now, I give 

you Toby.

Toby Lowe: Thanks, Irene. Thanks, everyone for joining us on these town halls. I have a 

couple of updates. As we've discussed previously, we are - we've been working 

on updating some of our EUA templates that are available for you all to help 

facilitate your EUA submissions.

And yesterday we updated the Molecular Diagnostic templates, both for 

commercial manufacturers and laboratories to include additional information 

on our recommendations for validation of pooling strategies. As well as, 

multi-analyte respiratory panels. And in the manufacturer template, also 

included recommendations for point-of-care testing.

Along with those template updates yesterday, we updated the FAQs. So we 

updated the question on the FAQ page related to pooling. And we added 

questions related to point-of-care and multi-analyte respiratory panels.

And then just before this call we finally got out the much anticipated, formerly 

known as, at-home test. Now known as non-laboratory use test template for 

manufacturers of molecular and antigen diagnostic tests. So that was just posted 

about 20 minutes ago, along with an update to the FAQ about those types of 

non-laboratory or at-home tests. And with that, I will turn it over to Tim.

Timothy Stenzel: Thank you, Toby, and welcome everybody. We look forward to these 

conversations and assisting in any way that we can.
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A couple of updates. One is on LabCorp. Many, if not most of you, have seen 

that we have authorized LabCorp for both pooling and an asymptomatic claim. 

So this is the first authorization where the FDA has authorized a test developer 

to claim performance in the asymptomatic population. And we welcome 

additional, both pooling and asymptomatic submissions.

I want to just briefly review pooling, and just make sure that everybody on the 

call today knows that we welcome pooling. With the template updates, we've 

provided even more information on pooling that find, we hope, to be helpful. 

Nothing really has changed in what our recommendations are for validation. 

But I do want to clarify the regulatory pathway for pooling.

As we have seen highly variable results, even on the same platforms in different 

labs. We believe that the science here is still evolving. And we would like to be 

involved in the pooling. However, we've made it very regulatory friendly. That 

is, go ahead and validate your pool. We ask that you follow the 

recommendations if not, and contact us.

But once you've validated the pooling, and if you follow our recommendations, 

you don't even, you know, need to have contact with us. Validate it. Once you 

validate it you can start pooling while you work on pulling the data together and 

submit it to us within 15 business days.

We would ask that you notify us, as well, when you begin that pooling testing, 

and that you've finished validation, so we can be on the lookout for your data 

when it comes in. And then after you submit, and during that whole time, you 

can continue to test. As long as you don't experience any issues.

And we'll receive it. I'll take a quick look at it. We'll assign it to a staff member. 
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If we have any concerns we'll reach out. But all during this time, unless you 

hear from us, you can continue to test. So this is a bit on the honor system as we 

say, that the labs will do a good job validating this. And manufacturers, as well. 

And we look forward to working with you to expand testing in this way.

And then one last update is that you may have seen yesterday, an amendment 

update for Quest testing - their LDT testing. They submitted a new extraction 

method that gives them greater throughput. Normally we don't make these 

updates that big a deal, although they're all important to all the developers. But 

the new update allows Quest to test 36,000 - that's 36K or 36,000 more tests - up 

to, more tests per day.

And then if you add pooling on top of that, which they're already authorized to 

do pooling, then they can substantially increase the throughput.

And we welcome working with all developers, including kits and labs, to help 

you know, provide more testing. And most of these pathways don't require an 

EUA authorization to get started. The new non-laboratory testing template that 

was just posted for molecular testing and direct antigen testing outside of a 

healthcare facility, will add additional testing as well. And then of course the 

non-laboratory collection also adds.

So these are all the things that we are trying to do to help facilitate and to see 

implemented, additional testing across the country.

And with that, we can turn this over to questions. And hopefully, we can give 

you some good answers. Thank you.

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

press star 1, and record your first and last name clearly when prompted so we 
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may introduce you. Again, that is star 1 to ask a question. Our first question 

comes from Shannon Clark. You may go ahead.

Shannon Clark: Hi, this is Shannon Clark with UserWise Consulting.com. I just had a question 

to follow-up. Dr. Stenzel had noted in multiple, previous town halls that the 

threshold for sensitivity for IgM is 70% for serological test kits. And from what 

I understand, that's subject tested two weeks after symptom onset. Not 

necessarily when they got tested with PCR.

So I was just wondering if there's a minimum sample size for IgM results? Can 

we test five individuals and get 100% sensitivity? Or is the minimum sample 

size for IgM results 30 subjects?

Timothy Stenzel: Yes, that's a great question. Happy to clarify. Yes, it's a minimum of 30 

positives per isotype. If all the samples are positive for both IgM and IgG, 

obviously all you need is 30 samples. But if there's not complete alignment 

between IgE and IgM, for example, then you may need to go above that 30.

But as IgM is coming up just about the same time as IgG comes up, in most of 

these patients, hopefully, that's roughly about 30 samples. Thirty positive 

samples total. Hopefully, that addresses your question.

Shannon Clark: And is that 30 positive and 30 negative, or 15 positive and 15 negative?

Timothy Stenzel: For serology it's 30 positive. And then a minimum of - Toby correct me, of 75 

negative. But it also depends on the cross-reactivity testing that you do. There 

are different formulas there, depending on how you do your negatives.

Many developers are doing a whole lot more negatives so that they have a better 

estimate. And we have - it's not a requirement, but they do it to have a better 
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estimate of what their negative percent agreement, is. And so we know what - in 

general, what the specificity is so that we can, you know, we know what 

positive predictive values will be. And negative predictive values will be for 

these serology tests.

Shannon Clark: And in point-of-care testing is it necessary to simulate sample collection in the 

case of - use of a lancet? Or can we use leftover samples that were previously 

collected, and use those as part of point-of-care testing?

Timothy Stenzel: What kind of leftover samples do you have?

Shannon Clark: So there were samples collected by finger stick and kept perhaps, in a vial, 

could we use those as part of our point-of-care testing? Or is it important to 

have a live patient there, and simulate - not simulate, but run through finger 

prick as part of the point-of-use testing?

Timothy Stenzel: Yes, we're open to that. I'm not familiar with how you would stabilize the finger 

prick sample for very long. And so I think that kind of detail would require a 

little bit of dialogue with our expert review staff on how to make sure that that's 

going to work well for you.

Shannon Clark: Excellent. Thanks so much.

Timothy Stenzel: For those who might have a similar question, we do view venipuncture and 

finger prick as different sample types. And then because they are not 

physiologically the same, with the venipuncture you have good mixing of all 

components in the blood. In a finger stick, you can have alteration of that. All 

right? Thank you.

Toby Lowe: And I think to add on to that, if your samples that you're using were not 
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collected in the manner in which you intend to collect them for use of your test, 

we would need to discuss that with you. And consider, you know, whether you 

have any data to demonstrate that - the difference in collection methods does 

not change your results.

Shannon Clark: Perfect.

Timothy Stenzel: Yes, good point Toby. And, to make sure that you don't carry that way of 

collecting and storing into your authorization. Because we can only authorize, 

what we have data to authorize. All right, I think it's time to probably move on 

to the next caller.

Coordinator: Our next caller is (Andrew Waliliae). You may go ahead.

(Andrew Waliliae): Hi, thank you. Hi Tim and Toby. Good to talk to you again. I have a quick 

question around collection devices. The particular one I'm talking about today 

is a saliva collection device. But I guess it's a similar question for collection 

devices in general.

So my understanding, and correct me if I'm wrong, is that a collection device 

would not apply for an EUA by itself. But rather apply with a test maker or a 

CLIA lab. But if the maker of the collection device is themselves a CLIA lab, 

who are using a test that already has a EUA authorization, could they 

potentially use that test, together with their collection device, to do a new 

application? And then use that application for their letter of reference to other 

manufacturers - or other CLIA labs rather, that they may want to sell their 

collection device to?

Timothy Stenzel: Toby, do you want to - you've been kind of focusing a little bit on that.
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Toby Lowe: Sure.

Timothy Stenzel: Do you want to respond?

Toby Lowe: Yes, so I'm not sure I followed all of the pieces there, but let me, you know, start 

from you know, sort of the basics with collection devices.

So collection devices we do consider to be devices. And we do review them, 

you know, generally both before and during the pandemic, as standalone 

devices.

During the public health emergency, specifically for saliva collection devices, 

we do want to ensure that they have been appropriately validated. And we can 

do that in a couple of ways. We have authorized tests that include specific 

collection devices. And so in those cases the collection device is considered 

part of the test system and is authorized as such.

That does not mean that those collection devices have an authorization. They 

are only authorized within that EUA as a system.

Collection devices can also submit their own EUA to get their own 

authorization, similar to how we've authorized a couple of standalone home 

collection kits. We can do that both for home collection and not. Such that the 

collection device itself would have an authorization. And then other tests can 

leverage that authorization and incorporate it into their EUA. So a test could 

request in their EUA, to be authorized for use with that previously authorized 

collection device.

(Andrew Waliliae): Got it. So they could just use their EUA authorized test that doesn't have a 

collection device, with their collection device for the holistic validation?
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Toby Lowe: Right. So right now a lot of tests are authorized, you know, with sort of what we 

would consider, standard respiratory specimens. Like NP swabs and nasal 

swabs. And those swabs also are devices that have regulatory requirements for 

them. Most of them are 510(k) exempt, meaning that we don't need to review 

them.

We would just expect them to follow, you know, the other regulatory 

requirements like registration and listing and adverse event reporting and 

whatnot. But we wouldn't need to see a submission for them.

And then other collection devices like saliva collection devices, do generally 

require pre-market review. And so during the emergency, we are considering 

EUAs for them.

(Andrew Waliliae): Great. Okay, great. Thank you so much.

Toby Lowe: Sure.

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

question press star 1. We are taking one question per caller. Our next caller is 

Jason Robotham. You may go ahead.

Jason Robotham: Hi. I've seen an increased number of antibody tests being advertised and 

administered by doctor's offices, chiropractors, allergists, etcetera. And they're 

being offered as finger-prick tests.

So this raises a lot of questions. But I guess the simplest is whether or not there's 

any way manufacturers or distributors are actually allowed to sell their tests. 

Whether they have EUA or have just provided notification to these types of 
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places, given that they're not likely to be CLIA certified. And to my knowledge, 

no test has been authorized for use via finger prick.

Timothy Stenzel: Thanks, Jason. Yes, we have not - unfortunately, we have not yet had a 

complete package that we could - until - and maybe there's something inhouse 

now. But we haven't had a complete package to - giving authorization to a 

point-of-care, CLIA-waived - deemed CLIA-waived serology test.

We're very open to it. We just ask the developers, you know, follow our 

recommendations or they're going to want to do something else to connect with 

us. We're all on board.

And then we get the data in, we look at it. That will be a big announcement the 

first time, I think you know, we are able to authorize a point-of-care serology 

test.

So all the serology tests currently authorized are either for the CLIA high 

complexity. So the notification path, if a developer has notified us, use the only 

CLIA categorization or laboratory environment they're allowed to market in 

and distribute in and use, is in the high complexity lab.

We have authorized some I believe, in the past. At least some moderately 

complex CLIA category - deemed CLIA categorization. But nothing for 

point-of-care. Nothing - no home tests yet. And I don't think we've authorized a 

non-healthcare collection for serology. We're also very interested in that.

So, you know, folks should know that we've not - and that authorization is 

required for a point-of-care or non-laboratory-based testing and collection. And 

that - I sent already, quite a few warning letters to folks who have not been 

following that recommended pathway. And you know, we're continuing to 
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work on those letters when we find out about that. So you can contact...

((Crosstalk))

Jason Robotham: So I guess, you know, what should we do I guess, as a manufacturer or 

distributor if we find that, you know, these types of places are offering either 

our tests or another test in this fashion? You know, I know there's the fraud 

email that you can send messages to. But doesn't seem like that gets much of a 

response.

Timothy Stenzel: I can guarantee you that we take all of those seriously. We are - I'm relatively 

new to the government, having been here a little over two years now.

The wheels of government sometimes don't work as fast as we would wish. We 

make sure that all our I's are dotted and our T's are crossed. So just because you 

haven't heard about something, doesn't mean it's not in the works.

Jason Robotham: Okay, great. And just a follow-up in the new temp that was issued. Will there 

also be a non-laboratory or at-home template becoming available for serology 

tests?

Timothy Stenzel: Yes. In serology, we're working on three new templates. We're working on a 

non-laboratory collection which has been - has made the most progress. And 

then we're working on both a non-laboratory testing situation for serology, as 

well as, we're working on a recommendation template for a semi-quantitative 

serology, quantitative serology and neutralizing antibody serology. Those are -

all three are combined into one template. And we'll get those out as soon as 

possible.

Anyone who's interested in developing tests for those situations doesn't need to 
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wait to interact with us. We'll do our best to work with you. We're going to 

obviously, to the extent we can, mimic what we've done either in other EUA 

templates for non-laboratory collection and testing now that the molecular and 

antigen template for non-laboratory testing is up. And we already had a 

molecular non-laboratory collection up for a while, now.

There will be some obviously, nuance changes and recommendations on 

validation. And then when you bring in a new technology like neutralizing 

antibodies, either correlation with neutralizing antibodies, or actual 

measurement more directly if they're neutralizing antibodies. That's new 

technology. We do want to get our arms around how best to recommend that.

But in the interim, we are working with any developers who want to come in for 

development of those kinds of situations. Okay.

Jason Robotham: Good. Thank you.

Timothy Stenzel: Mm-hmm.

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

press star 1. Unmute your phone and record your name when prompted. And 

again as a reminder, we are taking one question per caller. Our next question 

comes from (Ahini Fernando). Your line is open.

(Ashini Fernando): Hello. thanks for taking my call. We noticed that you have added PBS as a 

specimen transport medium. Do you recommend that EUA tests have to be 

revalidated with this medium, prior to use?

Timothy Stenzel: I'm sorry, I want to make sure I understand the question. You said, PBS, was the 

question?
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(Ashini Fernando): Yes, PBS as a specimen transport medium.

Timothy Stenzel: Yes. Can you tell me a little bit more details? For example, does it involve 

non-laboratory collection like in a home? Does it - and is it for an LDT or is it 

for a kit - a manufactured kit?

(Ashini Fernando): Actually my - where I'm coming from, it's from a global health perspective. 

So I'm not quite sure where these are collected. But my question is like if it is 

like in a global health setting when you collect it from patients in PBS?

Most of the test platforms are validated with the wider transport medium. So 

I'm wondering do they have to be revalidated with the PBS as a transport 

medium?

Timothy Stenzel: So well from a regulatory perspective how the FDA views this depends. So if 

it's a lab and they simply want to add PBS or normal saline to what they give 

their users - their healthcare worker users to use, but it doesn't involve like 

non-traditional settings like the home, no FDA authorization is required.

If it's a kit manufacturer and they want to claim a normal saline or PBS in their 

kit they can validate, notify us and send validation data just within 15 business 

days, to include that into their kit.

And then of course in the non-traditional collection or testing situation - let's 

talk about collections. The Gates Foundation in partnership with others -- and 

I'm blanking on all the names -- did validate normal saline. And I forget if they 

also did PBS. But we pretty much view those as very similar in the 

non-traditional collection, i.e. home, and did some stability studies in saline.
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And any developers that want to utilize that data of the Gates Foundation and 

their partners, is allowed a right of reference to use that for other applications, 

as may apply. Toby do you want to add anything to that reply?

Toby Lowe: I think you covered it. Thanks.

(Ashini Fernando): Thank you. It's very helpful to know. Thanks.

Timothy Stenzel: Mm-hmm.

Coordinator: And our next question is from (Eric Deppert). You may go ahead.

(Eric Deppert): Hello. Good afternoon everyone. Is international data acceptable when 

applying for your EUA?

Timothy Stenzel: Yes, absolutely. That's not a prohibition for those applications and types that 

are usual. Obviously for serology tests that are amenable to testing at NCI, In

addition to what they might do otherwise for their development and validation 

of that test, we are encouraging folks to submit their tests to NCI for the NCI 

testing. And it can help us make a great regulatory decision.

(Eric Deppert): Okay, perfect. Thank you so much.

Coordinator: And our next question is from (Tom Slezak). You may go ahead.

(Tom Slezak): Yes, thank you. The recent viral transport media guideline is very clear about 

what to do if someone is following the standard CDC SOP.

I'd like a little bit of clarification if an international manufacturer has a VTM 

that is not following the CDC SOP, and how that could be acceptably 
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validated?

Timothy Stenzel: Toby do you want to take that one?

Toby Lowe: Yes, absolutely. So I'm trying to pull up the guidance right now, to find the right 

section for you. But there is a section, I think it is IV.B.4. So Roman Numeral 

IV.B.4, that discusses alternative approaches for additional transport media 

device types.

And so if you are developing a transport media device that is not validated in 

accordance with the CDC recommendations, then we would recommend that 

you follow this section. Which basically, just discusses reaching out to us 

through the EUA Templates mailbox so that you can provide a little bit more 

information about your VTM and the validation. And we can consider whether 

it would qualify for the regulatory flexibility under this pathway.

(Eric Deppert): Okay. Thanks very much on that. I did notice that I'm seeing a lot of the, 

currently for sale VTMs, that are coming in under a wide range of product 

codes, many of which are like general-purpose reagents and so forth. Is that 

something you guys are looking at?

Toby Lowe: As much as we can, yes. So, if there are, you know, devices, VTM or otherwise 

that you think are being offered inappropriately, please let us know and that 

information is very helpful for us.

Timothy Stenzel: Great, I’ve done so, thank you very much.

Toby Lowe: (Great).

Coordinator: And our next question is from (Paul Joseph). You may go ahead.
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(Paul Joseph): Hi. Thank you for my call. I had a question about comparing technology with 

serology COVID test. Essentially, we've run across many companies that are 

developing technologies, essentially to pair up with a non-CLIA waived 

serology test at a point-of-care setting. 

They essentially take a high-resolution photo of the use of the device and they 

transmit that with other data points to a high-complexity CLIA lab and they do 

the confirmation of the results and then they send the data back digitally to the 

point-of-care with the results of the test.

And I'm curious if there's been any discussions with the FDA about any 

particular problems with that, if that's something that the FDA would be open to 

or if there are particular problems.

Timothy Stenzel: So, if the device in question only has a high-complexity designation, all of the 

testing has to be performed by high-complexity lab, (as far as I know).

(Paul Joseph): Okay.

Timothy Stenzel: However, as that CLIA certificate allows. So, there's potentially 

close-to-patient situations that can be fast and appropriately monitored by a 

CLIA high-complexity lab that, you know, might be okay.

Part of (their) point-of-care...

(Paul Joseph): (Do they) ...

Timothy Stenzel: validation involves making sure that lay users, non-laboratory health 

professionals, can perform testing to get accurate results. So, those devices that 
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haven't been deemed CLIA waived, should not be used in a CLIA waived 

environment and we would like to hear about those.

(Paul Joseph): ...okay, that makes sense. And do you think a telehealth component, where 

CLIA lab personnel oversaw the collection and use of the test? And then the 

rest of what I just said where the transmission is sent to the CLIA lab personnel 

for the actual analysis, would that be a potential way to open up these devices to 

be used at point-of-care with CLIA lab personnel?

(Toby): I think that would - that would be a question for CMS.

(Paul Joseph): Sure, okay, that makes sense.

Timothy Stenzel: And not entirely, I want to add to that. So, we - a device that, the FDA wouldn't 

view a device, that hasn’t gone through all the point-of-care testing validation

by non-laboratory personnel, would have concerns, personal concerns about 

that. But I think (Toby's) right and that CMS should be consulted.

But from an FDA perspective, the appropriate flex studies for use by 

non-laboratory professionals, you know, a laboratory professional can pipette

and we know that they can pipette that accurately.

It's hard, by telemedicine, to know that the pipetting done somewhere else by 

non-laboratory personnel is done accurately, even via telemedicine.

So, we appreciate all the creativity that’s being applied to the situation, use of 

telemedicine is - in health, is greatly encouraged and there are appropriate uses. 

And sometimes because of the presence of telehealth and telemedicine, and the 

mitigations of the involvement that way, we can reduce some of the 

opportunities to validate. We can - it is a risk mitigation, but it doesn't 
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necessarily mitigate all risks.

So, we would point all developers to our serology template that has 

point-of-care validation information, and now the new molecular and the direct 

antigen test, have those studies as well on the template. And then a new - an 

update on the molecular update now has for molecular point-of-care 

recommendations for validations.

So, validations performed that way are very important for situations where it's 

non-laboratory personnel carrying out testing. Okay?

(Paul Joseph): Great. That was very clear. I appreciate your help. Thank you.

Coordinator: And our next question is from (Arita Dapati). You may go ahead.

(Arita Dapati): Yes, thank you very much. I'm looking at the new non-lab use template. You 

mentioned that the manufacturers can enroll known positive patients into a 

performance evaluation study. However, in our recent interactions with FDA 

for a POC use indication, for rapid antigen assay, FDA has been pushing back 

on the enrollment of known positives to our clinical study. It seems like a 

contradiction. Can FDA please comment to confirm that the study enrichment 

via enrollment with known positives is okay for a POC use indication?

Timothy Stenzel: In particular, you're asking about use of bank samples for point-of-care 

assessment, is that - and securing, I would guess, positives?

(Arita Dapati): They're actually not banked, they're being collected at a recall site, so they're 

being enriched with positives.

Timothy Stenzel: Yes, well, we're trying to be consistent across the board. And as we evolve here, 
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we want to maintain flexibility. Our recommendations in writing are, you 

know, are that, our recommendations. And if there's any particular 

technologies, there's any alterations to thoses recommendations, review, I 

encourage communication with the FDA to limit potential additional testing 

that may be necessary for an authorization.

So, we understand that sometimes it's difficult to get samples. We've moved 

away from contrived samples for the most part and into actual POC samples. 

We understand that there could be challenges in getting fresh, on the spot

samples. So, we do remain open to alternate assays, but I would say that, you 

know, if you're going to alter from a recommendation, I encourage you to 

discuss that with the FDA.

(Arita Dapati): Okay, yes, these are fresh, on-the-spot samples. It's just that they're being 

gathered at a recall site where folks that have already been tested as positive are 

being recalled to do a secondary test with our device as well as a PCR.

Timothy Stenzel: So, I think what you're saying is can - okay, I'm just trying to understand a bit. I 

think what you’re saying is, in order to limit the size of the study, can you have 

a screen first on another test to know which patients are positive and then come 

in - and have those patients come in and be tested so that you can have a little bit 

more focused clinical study and design...

(Arita Dapati): Yes, that's correct.

Timothy Stenzel: ...as many people. So, we were - so, I understand now. As long as the

comparative test is a good test. I don't see a huge amount of challenges with 

that. There are a couple things we'd want to make sure that the person that's 

re-testing the patient is not aware of the previous results.
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So, and, you know, and then once you bring those patients in and have the 

person performing the test be unaware, that is important. I think if they know 

those settings are going on and being recalled, then they would assume that 

patient was basically positive and they'll be looking for the positive results on 

that patient and we don't want to do this bias in this study, so that's important to 

control that balance and that's the sort of thing that you can discuss with the 

FDA.

But comparative testing is very important, but it'd be a really good test. We are 

starting to see some variabilities of sensitivities of tests. We always try to alert 

the public and users about these things, but there will be performance 

differences and we really want comparative tests to be a good test.

So, I'll just say that we continue to see developers use tests like the Abbott ID 

NOW as the comparative and we stated on this town hall call before that it's 

probably not a good thing to do to use the Abbott ID NOW. There's some of the 

issues that we've publicly stated about some concerns about that device.

By the way, we continue to monitor that situation closely, but it's not a good 

comparative device for a molecular comparator as required.

So, what I'm saying is that the devil’s in the details for the study design that 

you're talking about. I don't see any show-stoppers, we just want to make sure 

that there isn't a bias introduced into them.

There may be additional mitigation that we'll look into, you know, and that 

could be weaved pre-market or it can be considered post-market. If you 

continue to have challenges with this with talking to any of our team members, 

you know, be happy to ask for Dr. Stenzel to get involved in working out some 

of those details if you want.
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(Toby): Yes, I'd also add that if you want to send an email to the templates email box, 

you can have further questions about this specific to your testing, to your 

questions because the - while there is information about point-of-care testing in 

the antigen template currently, it is not very detailed, and so we can provide 

some additional discussion on that for you.

(Arita Dapati): Okay. Thank you so much, it's really appreciated. Yes, we're looking at using 

the Abbott real-time and doing - and so we'll reach out to both the templates 

email as well as to Dr. (Stenzel) to look into the - whether we need, a mix of 

positives and negatives, recalled, or just positives.

Timothy Stenzel: I would ask that if you - if you - if you're getting pushback from some of the 

folks in the FDA, we just want to try to figure out a way forward, I'm happy to 

get involved, but our team is great and most of the time they can help you 

without my help and that would be greatly appreciated too. All right, thank you.

(Arita Dapati): Sure, understood. Thank you.

Coordinator: Our next question is from (Dejia DeCall). You may go ahead.

(Dejia DeCall): Thank you for taking my questions. My question is around the multi-analyte 

respiratory panel. So, what we have been getting, these unapproved samples for 

those tests, primarily PBS, saline, e-swab, and whatnot, but they are paired

with SARS-CoV-2 assay, and we're getting a lot of complaints from our 

(citizens) that they would have to collect two different types of collection 

device VTM for these multi-analyte respiratory panel and they can collect 

anything else for others.

So, my question to you, is FDA going to give us some guidance on how to deal 
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with this kind of situation on those large respiratory panel assays to accept these 

sample types that have not been approved by FDA?

Timothy Stenzel: So, I mean, if they're standard sample types and the media is just different, I 

think our answer - Toby you can correct me - but I think our recommendations 

are that you validate that per your normal laboratory procedures and, basically, 

to CLIA expectations and standards if you're a lab, and that we encourage you 

to, even they - so they are not commonly or validated specifically, you know, 

rather than VTM against normal saline or PBS.

Or, you know, another manufacturers VTM that may not, we do encourage that 

you try your best to test those samples and report out the results. You know, we 

realize that the laboratory expertise can really make a big difference here in 

understanding what's, you know, what you're willing to accept and making and 

ensuring in - within your CLIA quality system what you're comfortable with 

doing.

And also, you know, with you basically controlling all the testing and the 

interpretation on all that, knowing when there might be a problem with a 

particular sample and exercising due caution on those.

But from an FDA perspective - and (Toby) you can add to this if needed - that 

kind of difference, we would not require an EUA submission for - to see, you 

know, saline versus VTM, for example, that's not - it's just something that we 

think one of these flexibilities, adaptability, regulatory tier that - now if 

someone wants to validate and send us data for valid EUA authorization that's 

fine to - we're always open to that, but (Toby)?

(Toby): Yes. I think that all depends a little bit on how the test is authorized, whether the 

authorization is specific to the type of sample that has been validated and 
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authorized. And, you know, generally, we think that it's important, you know, 

for validation to be completed for whatever - whatever testing is being done.

And, you know, particularly for the multi-respiratory panels, we don't, you 

know, we haven't seen as much with different specimen types. So, we would 

encourage you to talk to us about what you're looking to do there.

(Dejia DeCall): Okay, great. Thank you. And I didn't want to bring the bad names, but I guess 

I'm going follow up with it, BioFire, Luminess, and GenMark, they have 20 or 

so analytes. And from our laboratory point-of-view, we'd have to do some sort 

of validation here in the lab for using that as a off-label use of FDA approved 

tests and all of those are nasopharangeal specimen type and VTM.

But for VTM, that's why we would be using off-label, here in the lab and 

validating 20 analytes on a smaller lab which runs on (unintelligible) sample (to 

answer) format is going to be quite a challenge for us because we'd have to go 

back and verify the (LoD) and whatnot, if we're following the right procedures.

So, I would really like to get FDA's help on this because there are many, many 

smaller labs that focuses on the sample to answer format and getting the results 

out without doing all these laboratory developed assay type of validations. So, 

that's where I'm coming from. Thank you, again.

Timothy Stenzel: Yes, so, I think that's a good thing to take back, Toby. I mean, certainly, I think 

we've provided flexibility to allow, you know, FAQ's, perhaps we can expand 

that a little bit. You know, making recommendations about how a lab might 

validate that for their own purposes is a scientific question that, you know, I 

don't know that the FDA is, you know, prohibited from joining in on.

So, I think if labs are wanting some additional, say, recommendations on 
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validations, it's something we need to take back and consider.

(Dejia DeCall): Okay, that would be highly appreciated. Thank you.

(Toby): I think I'd also add that the regulatory flexibilities that we've provided, you 

know, as outlined in our guidance, are related to SARS-COVID-2 testing only. 

They're not - they do not apply to multi-respiratory panel.

(Dejia DeCall): Correct. The problem is the, you know, the VTM is not available in the market 

so people are using whatever they can find. Same thing for the lab, and we 

reject them and they are very unhappy. But this is only - this - we are in 

summer, but when the winter hits out, it's going to get a million times worse. 

And so, I'm kind of trying to think ahead of how to prepare the lab, for year, in 

dealing with the respiratory (unintelligible).

(Toby): Sure. And we're hoping that...

((Crosstalk))

(Toby): ...yes, yes, I think we're hoping also thatthe VTM guidance that we just put out, 

will help with some of those availability issues.

Timothy Stenzel: Yes. We do know that the COVID situation doesn't divide cleanly from COVID 

testing and non-COVID testing in a number of different ways. So, you know, 

for example, if you even sourced new tips for a robot or something, you know, 

it, you know, it's a robot you use for all sorts of testing, COVID and 

non-COVID testing.

What you do for COVID and the impact of COVID has impact on all the 

laboratory testing. So, we have begun these dialogues internally and with others 
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about how we deal that situation. You're - you bring up a great example of how 

- of how everything can - and at some points be interconnected here, and the 

agency and FDA wants to take a holistic view and be as helpful and friendly and 

flexible as possible here in this situation.

So, I thank you for bringing that up that point.

(Dejia DeCall): Okay, thank you.

Coordinator: Our next question is from (Kay Jewell). You may go ahead.

Timothy Stenzel: Hi, (Kay)...

((Crosstalk))

Coordinator: And (Kay Jewell), your line is open, we're not able to hear you. And we'll go to 

our next question from (Bridgett Patell).

(Kay Jewell): Sorry...

Coordinator: You may go ahead.

Timothy Stenzel: (Kay)?

Coordinator: And (Bridgett Patell), your line is open, we're not able to hear you.

(Bridgett Patell): Hi, good afternoon, thanks for taking my call. My question is concerning the 

enforcement policy on viral transport media which is published recently. Is that 

still a validation? This policy states that is important that the VTM are 

appropriately designed and validated prior to distribution to ensure that the 
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transport media will preserve the viral particles without meaningful 

deterioration that could lead to inaccurate test results. 

To reduce the risk of inaccurate test results, only VTM devices labeled as sterile 

should be used in the transport of the clinical specimen and FDA believes that 

the VTM distributed by commercial manufacturer under the policies that we've 

designed and validated consistent with the CDC SOP.

So, could you please clarify with respect to validation, when designed and 

validated in accordance with the CDC SOP would mean validation of sterility 

only? Or, would it mean the validation of sterilization process and performance 

testing that demonstrate the viral particles in clinical specimens and (then the 

virus is detectable)?

At this point, we're unsure of the validation in this policy requires and we'd 

really appreciate any clarification from you on this.

(Toby): Sure, sorry about any confusion there. So, that is indicating - that is what we 

expect for validation, not just for sterility, but for the VTM as a whole. We 

would expect the VTM to be designed and validated consistent with the CDC 

SOP.

(Bridgett Patel): Okay. So, that means the performance testing –as well as performing some LoD 

testing and all of that, correct?

(Toby): That's correct.

(Bridgett Patel): Okay, thank you.

(Toby): No problem.
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Coordinator: And the last question is from (Jore Barren). You may go ahead.

(Jore Barren): Yes. So, I want to ask about pooling and in particular, I understand the current 

guidance is for pools of up to size 5. And, of course, there are a lot of 

algorithmic methods that can improve the robustness when looking at test 

results from multiple pools together. And I'm wondering whether there's been 

any FDA thought about allowing to pool at larger sizes provided that there's an 

algorithm that can account for the possible lesser quality?

((Crosstalk))

Timothy Stenzel: That's a good question.

(Toby): Go ahead.

Timothy Stenzel: That's a good question. We don't limit the pool size to 5. It all depends on the 

situation and the validity of the data, but if you're able to verify a larger pool. 

We also don't specify the type of pooling. We have provided a little bit more 

information say on, if you want to pool swabs rather than pool VTM, you can 

do simple Dorfman pooling. 

You can do matrix pooling as I believe - well, we've authorized, I think, some 

matrix pooling or, I think, thinking about if it's simple matrix where it’s

basically, you know, you just, you know, read the rows in the columns and you 

can identify the sample that way.

There are also what I call more complex or combinatorial pooling which I think 

you're talking about. Realizing, though, that the more complicated the pooling 

is, particularly when you move into combinatorial pooling, the percent typically 
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when you do it, that the percent positive efficiency goes down, right? So, if you 

want to maintain good efficiency on what you're - based on what your percent 

positives are in your population, it can go - it can go way down.

So, I've seen some published, mainly theoretical papers on combinatorial

pooling where really anything over 1.3 positivity in your population didn't 

justify that combinatorial pooling.

So in the situation where we have very low percent positivity, those kind of 

pooling algorithms work best.

(Jore Barren): Okay. So, is there somebody at CDC that we could be - CDC, FDA, any of the 

government agencies that we could be in contact with and would be able to, 

kind of, provide direct - direct responses to some of our technical questions?

Timothy Stenzel: Yes. So, have you reached out to the FDA through our template email address 

or with the pre-EUA? And what we call pre-EUA is simply taking one of our 

templates and putting some information in there and submitting it to us as a 

pre-EUA that can - it's a framework for allowing us to begin dialogue and 

everything's documented and tracked.

(Jore Barren): Okay, can do that.

Timothy Stenzel: All right. Great.

(Toby): And just to briefly add, if you haven't yet seen the update to the template that 

was put out yesterday, it does include a little bit more information on the 

different pool sizes and the correlation between the positivity rate and the 

efficiency.
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(Jore Barren): Thank you very much.

Timothy Stenzel: But that's just for simple Dorfman pooling. With the combinatorial pooling 

which, you know, obviously there’s potentially millions, infinite number of

ways to do - accomplish variable pooling, and we did not provide efficiency 

calculations for that, that depends on your algorithm and the number - the size 

of the pools that you have within there and how many times you retest and 

you'll sample within different pools.

(Jore Barren): Okay. I'll look into those resources and get in touch. Thanks a lot.

Timothy Stenzel: Great.

Coordinator: And that concludes the Question and Answer session. I'd now like to turn the 

call back to Irene Aihie.

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

thoughtful questions. Today’s presentation and transcript will be available on 

the CDRH Learn webpage at www.fda.gov/Training/CDRHLearn, by Tuesday 

August 4th. 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 the 

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

CDRH Virtual Townhall experience. The survey can be found at 

www.fda.gov/CDRHWebinar immediately following the conclusion of today’s

live discussion.

Again, thank you for participating. This concludes today’s discussion.

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

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