Current, Emerging COVID-19 Variants and the Testing Landscape

Drug Topics®: Thanks for joining us here on Drug Topics®. My name is Lauren Biscaldi. I'm the Managing Editor and I'm here today with Joe Mann. Joe, I'm going to turn it over to you to introduce yourself.

Joe Mann: Good morning, Lauren. How are you doing? I'm Joe. I'm a family nurse practitioner by training. I work for Becton Dickinson (BD) as a global medical science liaison. Prior to working for BD, I was working for CVS MinuteClinic as a nurse practitioner, so I am kind of familiar with the pharmacy setting and how CVS was running things. I hope I can offer some insight today as to how pharmacies can start integrating some of these COVID-19 testing options we have available at BD in their pharmacies.

Drug Topics®: Like you said, we're here to talk about COVID-19, which is the topic of the day for the last 2 years. What are some of the biggest concerns surrounding the BA.5 variant of the SARS-CoV-2 virus?

Mann: So, the BA.5 variant has been very concerning because it has a transmission advantage over other previous subvariants of Omicron, like BA.1 and BA.2, which we saw originally take off in January and February. As the virus has sort of evolved and mutated, moving forward, it's gained mutations that give it an ability to escape immunity as well, provided by our vaccines and provided by previous infection. When you combine a highly infectious variant with an advantageous transmissibility profile, along with the fact that it's able to evade immunity provided by vaccines and previous infection, that puts you in a really precarious situation and allows the virus a better opportunity to spread. That's why we've quickly come to find that BA.5 has become the dominant variant both globally and in the United States.

Drug Topics®: Does this variant really impact the effectiveness at all of the currently available testing products on the market?

Mann: That's a great question. I can speak to a BD perspective, but I don't really want to dabble into other competitors, because I'm not as familiar with their variant testing process. At BD, we've taken several steps to ensure the integrity of our assays against these Omicron subvariants, including BA.5. What we've done internally is looked at genomic sequences that are reported on the GISID database and run those sequences against our assay. In terms of the molecular side, we do this on the BD Max primers and probes and run those sequences against the targets of those primers and probes, to make sure that there are no mismatches or issues with detectability or performance. On the Veritor side, we do that as well with our antibodies, we match those antibodies up to the genomic sequences to confirm the antibodies will be able to detect those specific mutations in the nucleocapsid that those antibodies detect. Thankfully, to date, we haven't seen any Omicron subvariant or previous variants of concern that have given us reason to believe our test is less able to detect these variants. Moving forward, we're going to have to continue to evaluate the situation and we meet on a biweekly basis to discuss new and developing variants and the FDA ensures that we do that. Thankfully to date, we haven't noticed any variant that gives us cause for concern.

Drug Topics®: That's super reassuring for people to hear because I feel like I turn around and every day there's a new variant. I didn't even hear about the BA.5 until it was here already. I think it's reassuring that the products are still effective. In the same vein, I want to just zoom out a little bit. Can you provide a high-level breakdown of the different testing options that are available in the pharmacy for COVID-19?

Mann: I'll preface this answer first by saying I think pharmacies are in a very unique position to really address this pandemic. Because [they] really could be potentially a one stop shop. They have not only the testing options available to them, which I'll get into, but also they have the medications that have currently become authorized and approved by the FDA, like Tamiflu for flu, as well as, Paxilovid and other medications for COVID-19. Going into the different testing options available for COVID-19, I know at CVS MinuteClinics in the state of Maryland, we had our pharmacists testing patients through the pharmacy drive thru windows, where they would hand them a swab, instruct them how to self-collect that swab. Once the patient was done collecting the swab and returned it to the pharmacist, the pharmacist would then send that swab to a laboratory for RT-PCR testing. I've also seen this new trend of more point-of-care type testing where we use a rapid antigen or rapid molecular testing platform like our BD Veritor Professional SARS-CoV-2 assay and that is a rapid antigen test that gives results in 10 to 15 minutes. It can be done at the point-of-care. It can be completed by a pharmacist. The pharmacist collects the swab from the patient and they get results in 10 to 15 minutes. Depending on their State Boards of Pharmacy, they can potentially treat in what we call test-to-treat protocols and get patients medications that significantly reduce the risk of hospitalization and severe outcomes from COVID-19. Between all those different types of testing options, along with the BD Veritor home tests and other at-home tests on market today that are available in pharmacies over the counter, pharmacies really do have a conglomerate of testing options available to them to address this pandemic.

Drug Topics®: I wanted to talk a little bit about how the different variants might impact these point-of-care testing options in different ways. And then if you could just touch on the BD Veritor Plus system specifically and how that factors in with the variants.

Mann: Depending on how the test works, and different tests work in very different ways, if the test is a molecular test or if it is a rapid antigen test, they target different areas of the COVID-19 virus. Depending on where the mutations occur in this specific variant you're asking about, the answer can vary significantly test to test. I'll speak to our BD Veritor test. Like I told you earlier, we've obtained live viral isolates that represent BA.1, BA.2, 3, 4, and 5 and tested them live and internally and confirmed that [there are] no issues with detectability or performance. We've seen no evidence of that occurring on our BD Veritor test. How the BD Veritor test works, going on to the second part of your question, it's a very simple procedure. The test is run on an analyzer about the size of the palm of your hand. On this analyzer, we offer a variety of assays including COVID-19, flu, group A strep, RSV. Most recently, we've authorized a combined COVID-19 and flu test that's able to provide a result for influenza A, influenza B, and COVID-19 with 1 swab in 10 to 15 minutes. So, you're able to get those results very, very quickly and potentially, depending on the State Board of Pharmacy that a pharmacist works under, [the pharmacist] can potentially treat for those conditions as well. It's a very useful assay to integrate into pharmacies, due to the one-stop shop idea, where you're able to test and treat all under one roof.

Drug Topics®: Can you talk a little bit about the benefits of the different types of tests that are available and what those might look like?

Mann: The molecular tests tend to be a little bit more sensitive. I was speaking to this earlier how some pharmacies have been doing what we call ‘swab and send’ procedures where they go to the drive thru, collect the swab, and send it to a lab for testing. Those tend to be the most sensitive options out there. Now the downside to those are that, you have typically have to wait anywhere from 24 to 72 hours for the result. When we have these medications that have to be given within a certain timeframe from the onset of symptoms, that can be undesirable, because we're trying to get treatment and identify positive people as quickly as possible so they can isolate from their communities and avoid spreading it to other people. There are trade-offs to each type of test. As far as the rapid molecular, rapid antigen testing side, you give up a little sensitivity. The tests are a little less accurate. However, they are able to quickly process results. Our Veritor assay, for instance, gives results in 15 minutes. You can get those positive results quickly, identify them, and get them to isolate and potentially treated and reduce the risk of hospitalization or serious consequences from these viruses. It's a great solution for pharmacists to consider integrating. With flu season around the corner, it can be very difficult to distinguish from symptoms alone ‘was it COVID?’ ‘is it flu?’ because they both present very similarly.

Drug Topics®: What are the benefits of the BD Veritor at-home COVID-19 test over other at-home COVID-19 tests that are available?

Mann: We put a great degree of thought into how we were going to develop this assay. It has this smartphone technology that's able to walk users through how to collect their sample. It provides simple video instructions, as well as written instructions on an application called Scanwell. The idea was that the tests would be used by what we call naive users, people with not a lot of experience testing. They haven't worked in a lab before and may have very limited understanding on how to perform a test. So, we developed this app with the idea that it would help users walk through the sample collection process, how to collect that anterior nares sample. It's not one of those deep swabs that goes all the way back and has you coughing all over the place. It's a very comfortable swab that goes up about an inch into the nose and you circle around 5 times and then you dip it into an extraction reagent for 15 seconds. You pull the swab out. You throw the swab away. You put the cap on the extraction reagent and apply 3 drops of the extraction reagent on to the testing strip. You then wait 15 minutes and the smartphone app has a built-in timer so you don't need to worry about losing track of time. After that 15-minute time period is up, your phone will ding and that alarm will go off. What's really interesting with our smartphone technology is that we have a computer-based algorithm that uses the smartphone's camera to interpret the test stick and interpret the number of lines that are present on the test stick to determine whether the individual is positive or negative or potentially invalid if they perform the testing incorrectly. A lot of the time with these at-home tests, it can be difficult to distinguish a line between a very faint line. What we tried to do is objectify that process and make it easy for people to interpret their result using their smartphone. I'll end with the final benefit of our Veritor at-home test being automated reporting. For state and federal health authorities, it's mandated in many states that we report the result to these public health authorities and our software is able to do that automatically for the user instead of putting that responsibility on the user. It does it in a blinded fashion by zip code to protect people's privacy, and it sends their result to the federal and state public health agencies so they can use that data to make important public health decisions that keep us safe.

Drug Topics®: That's incredible. That really is like a one-stop shop for COVID testing as new COVID-19 variants emerge. Do you think that the BD Veritor at-home COVID-19 tests will remain a reliable option? For people who are looking to test from the comfort of their own homes and not have to go to a pharmacy or an urgent care or something like that.

Mann: I don't think any diagnostic developer will be able to confidently state their tests will be able to detect all variants moving forward. We sort of have to take this as it goes. I'll speak to BD, we monitor the variant situation very closely. As soon as there's an identified variant of concern, we are very quick to act and obtain and test these live viral isolates on our assays to confirm that no issues with detectability or performance exists. I can't promise that [there won’t] come a variant where the mutations will affect our performance, but I can say it's been encouraging. So far we haven't come across any variant of concern: Alpha, Beta, Delta, the list goes on, we've tested them and haven't run into any situation or evidence demonstrating that we're less able to detect variants of concern as compared to the original Wuhan reference strain. So that's been the encouraging news.

Drug Topics®: So those were all my questions. Was there anything else that you wanted to leave our viewers with as a final thought?

Mann: Yeah, while testing will remain an incredibly important aspect, I think another important thing to remind pharmacists about is to get people vaccinated. I know we spoke earlier about how the vaccines have been less effective preventing infection with this BA.5 variant. However, it's been very clear that being fully vaccinated and boosted still prevents you from having severe consequences and requiring hospitalization or intubation. I know pharmacists, in most cases have access to vaccines and are able to vaccinate people so keeping that at the forefront of their mind to remind their customers to get vaccinated and boosted will be a good thing moving forward, especially as vaccine developers are also working towards developing Omicron-specific vaccines. So, I think that's an important thing. To end on a positive note, we are making progress. As long as we continue to follow the CDC guidelines and guidance, I think we'll be in a good situation moving forward.

Drug Topics®: Thank you so much for joining me today, Joe.