Erica Tennenhouse, PhD
As coronavirus cases skyrocket in the US, laboratories across the country continue to ramp up testing. Meanwhile, medical technology companies are working around the clock to secure emergency use authorizations from the Food and Drug Administration (FDA) and supply enormous quantities of products and tests to meet the demand.
Clinical Lab Manager spoke with Dave Hickey, the worldwide president of integrated diagnostic solutions at Becton, Dickinson and Company (BD), about the company’s efforts to meet the needs of ongoing testing with its molecular and serology tests, an antigen test in the works, and a plan to boost the supply of swabs.
A healthcare executive with over 20 years in the in vitro diagnostics industry, Dave Hickey began his career as a clinical biochemist at Warrington General Hospital, UK in 1979 and now serves as the worldwide president of integrated diagnostic solutions at BD. He manages the strategic and financial performance of the BD diagnostic systems business on a global basis. This includes responsibility for the microbiology, molecular diagnostics, women’s health and cancer, and point of care portfolios. Prior to taking office as worldwide president of BD diagnostic systems in July 2016, Dave served as VP/GM for the clinical microbiology business at BD. Previously with Siemens Healthcare Diagnostics, Dave joined BD in May 2014 where he served as the CEO of its Core Laboratory Business Unit, with revenues in excess of €2 billion. Along with full P&L accountability, he had ownership for the business unit’s global R&D, sales, marketing, service, and quality management functions.
Q: What is BD doing to boost coronavirus testing in the US?
A: There are several areas that we are very actively engaged in really across the whole testing spectrum, from sample collection all the way through to the various different types of testing that you’re seeing out there in the press and the media; and then something that we’re working on, that we’ve made a public statement on, but is still not released to the market.
Q: How is BD helping to alleviate the current swab shortages?
A: In the area of swabs and collection, which are primarily needed for the molecular testing, we have a very strong OEM relationship with Copan Diagnostics who is the manufacturer of the swabs. One of the things we have been working on is increasing the capacity and the types of swabs that are coming into the country that can be used for molecular diagnostic testing. When you look at a normal year outside of this COVID pandemic, there’s more than enough swabs. But with this significant increased demand for testing, there is a sense of urgency to not only increase capacity of the historically approved swabs but also to make available a different validated and approved wider range of swabs, such as rayon, that are normally available in much higher quantities. We’ve been leading and working across industry coalition to do that, partnering with agencies like the FDA, and we ourselves are doing our own studies on the BD MAX to prove and validate the clinical utility of regular culture swabs, nasal swabs, and different types of transport media for use in molecular testing. We expect to be submitting that data to the FDA for their approval within the next calendar week or so. That would actually take our swab capacity to potentially over three million devices a week, whereas today we’re probably close to one million.
Q: Can you tell me about the molecular tests BD has developed for coronavirus?
A: All of our molecular testing efforts are on the BD MAX molecular platform, and a lot of our focus right now is here in the US. One of the benefits of the BD MAX is it’s an open system so the ability for labs and organizations like the Centers for Disease Control and Prevention (CDC) to develop their own tests is one of the features and attributes of the platform. The BD MAX was one of the first instruments used in China, working with the CDC to develop assay protocols for coronavirus, and then some weeks ago now we launched an assay in Europe with our reagent development partner CerTest. Transitioning to the US, we’ve actually had two emergency use authorization approvals; one is with a reagent partner called BioGX and a press release is coming in the next 24 hours on our own organic assay that we’ve developed which, together with the BioGX test and the CerTest test, will give us significant capacity.
Q: How many molecular tests do you expect to offer?
A: On a global basis we anticipate being able to provide about one million tests a month on the BD MAX for coronavirus. Our strategy there has been primarily based on leveraging the existing install base. On a worldwide basis we have over 1400 units. Here in the US we have in excess of 600 units across 47 states. The nice thing about the BD MAX is it’s a fully automated, integrated platform that will give a result in less than three hours with very little operator intervention, so the value proposition for the BD MAX is expedited results and that it’s simple and easy to use.
Q: Has BD also developed a serology test for coronavirus?
A: We announced last week a three-way partnership to bring a serology test based on the measurement of antibodies to coronavirus into the US, at least to start. Then we’ll be looking at what we can do to make that test available outside the US. The manufacturer is a company called BioMedomics and they’re the small reagent manufacturing company that initially did the work on this test. BD, with our global reach and footprint, we bring scale, sales, marketing, and regulatory medical knowledge. We will be distributing the test through Henry Schein because of their reach in the US, but also we anticipate that this test will be used extensively in the point-of-care, so when you look at the reach and access that Henry Schein has, we selected them as our partner for that.
Q: What is the clinical utility of the serology test compared to the molecular test?
A: The molecular test is a direct test for the virus itself whereas the serology test looks at whether people have built up antibodies or built immunity. It’s got the ability to detect and diagnose those patients and health care workers that had a predisposition or have been exposed to the virus, even if they were asymptomatic, because the antibodies would develop several days later. The clinical utility here is it’s a great way to triage whether you need to send somebody for the molecular test or not, because if you did screen somebody and they had positive antibodies, you could really reassure them that they’re not at risk of getting the recurrence of the infection. If they were negative, you’d probably still want to make sure they are following all the safety precautions of isolation, etc. It’s a great way to look at community surveillance and community prevalence of infection. Most of the dialog right now is associated with health care systems and government agencies looking at it as a critical part of their get-back-to-work strategy.
The final comment I would make on the serology test is that it’s a simple blood test, so when you look at the criticality of supply around swabs, here now is a point-of-care immunology test that you can do very decentralized; it uses a very simple finger prick and 20 microliters of capillary blood, which you put onto a lateral flow cartridge and then you visually read the test result within 15 minutes or less. The analogy there is it’s very much like a pregnancy test: you impregnate the strip with the blood, you wait 15 minutes, and then you look for a line to tell you whether you’ve got antibodies or not and if you’ve built up immunity.
Q: Can you tell me about the antigen test that you have in the pipeline?
A: We are working very rapidly on a direct antigen test. This would be a measure of the virus itself, and it would be on our BD Veritor platform. The BD Veritor is a point-of-care device and we have close to 30,000 units just in the US. It’s the platform by which we test for influenza A, influenza B, group A strep, and respiratory syncytial virus. If we could develop a truly point-of-care, CLIA-waived antigen test and get that out across the nearly 30,000 units, and units that could potentially be connected with an informatics platform to look at surveillance, that would meet a huge need in the market for all the ongoing testing when the lab-based capacity is really challenged. We’re working toward that, and based on everything we know now, we would hope to be distributing that test sometime in the month of May.
It would use a swab as its collection device, not blood, but because of the demand on swabs we’re validating several different types of swabs as the protocol. This Veritor platform sits in a vast array of testing facilities—it sits in diagnostic labs themselves, physicians’ office labs, acute care testing centers, we have channel and chain into retail pharmacy. The device itself is CLIA-waived, so anybody who’s got a CLIA license like pharmacy retail or even labs that have got CLIA licence so they can decentralize their testing can use it—we see that as a significant opportunity.
Q: What role will the antigen test fill in the testing landscape?
A: I think serology and antigen have very different roles. Serology is really about looking at the broader population as a whole, looking for immunity, making it a critical part of the get-back-to-work management plan, whereas the Veritor antigen test would still be directly and acutely diagnostic. I think to me, what it would do is, it would just increase the capacity of testing immensely because if you think about the workflow right now for these molecular-based assays, you’ve got to take a swab, you’ve got to get it to the laboratory, you’ve got to wait for the lab to do the analysis, you then have to wait for the turnaround time to come back. A great analogy here is flu. When you think about when we’re in flu season, how many of us just go with flu symptoms to our primary care physician and they do a quick 10-minute test while you wait, and then they triage accordingly. That to me is the big value here—you could get a direct diagnostic test in a real point-of-care environment with a simple nasal swab collection and result 10-12 minutes later.
Q: Which of your coronavirus testing products are experiencing the greatest increases in demand at the moment?
A: It really is everything. The level of orders is beyond the norm for swabs and collection devices, the transport media, both viral transport media and saline that we would normally transport the swabs in, all flavors of the molecular tests, and now that we’ve launched the serology assay, there’s a lot of demand for the serology tests. And then the only other thing that I haven’t talked about is the BD MAX instrument itself. A lot of customers without molecular capability, so these could be hospital labs, reference labs, or acute testing-based labs, are looking for something that can get testing done very quickly, so we’re also seeing significant demand for the BD MAX instrument itself.
Q: With such high demand, how are you prioritizing which labs receive these products and tests first?
A: We’re doing it based on what we believe to be the most fair and equitable allocation strategy. So we look at the demand that is coming in through the door, we look at our production capacity—and I should say to maximize that capacity, the company and our associates are putting in extraordinary efforts in terms of three-shift-a-day systems, 24 hours a day; we’re literally working around the clock to maximize everything—and we’re looking at where the BD MAX install base might be and how we can service that base. We try and align as best we can to where the government-reported hotspots are. When you look at the data that comes out from the CDC and the White House at diagnostic task force briefings, they have these hotspot zones which are correlated to where the most critical testing is required, so we try and align to the hotspots so to speak. Right now, it really is based on a methodology of allocations.