At the American Society for Microbiology’s 2023 Meeting (ASM Microbe), Scott E. Brady, CEO and Founder of Wise Diagnostic Systems, was kind enough to lend us a few minutes after his workshop to respond to a lightening round of rapid-fire questions.
Watch the Q&A or read the transcript below for some bite-sized insights from Brady on practical considerations when shifting from traditional methods to molecular technologies like PCR for infectious disease testing.
When you are developing your own custom panels, how do you determine the pathogens or markers that you add to your panels?
Brady: When we’re developing a panel, we typically are going to who the ultimate end customer would be – the physicians that are going to be treating these patients. We’ll also reach out to infectious disease specialists to have them review what we’re looking at, to see if they feel like it’s a valid option for our panel.
Why do you include antibiotic resistance markers when developing your own custom panels?
Brady: When we’re doing infectious disease testing, it’s really important to be able to provide that physician with antibiotic resistance information as quickly as possible so that they can make an informed decision. Not just to know what pathogen they’re treating, but with which treatment to go with and to hopefully avoid giving them a medication which might then not work as effectively. And, to help foster that antibiotic stewardship.
You are very passionate about your assay development approach. What are the benefits to laboratories like yours who are adopting this approach?
Brady: We like to use laboratory developed tests so that we can build our custom panels and really look to provide the test menus and the panels that our customers and physicians would like. It also allows us flexibility to modify the panel over time as we learn about new pathogens, or as new assays become available.
When developing panels, you need to consider how to get reimbursed. How much does reimbursement from various payors impact the development of your panels?
Brady: The ability to get reimbursed for any test is obviously important to a commercial laboratory. We try to find tests that fit in [well] with our target markets that also provide great clinical utility, but also come with a reimbursement that makes it reasonable and practical to provide the test for our patients and physicians.
The analytical and validation testing feels like a long and daunting process. How can labs shrink the amount of time or resources it takes to conduct this process?
Brady: I think the two key areas that you can look at is, one, to look at hiring clinical personnel or look to your laboratory medical director to see what kind of guidance and help that they can provide.
But the other option, too, is to use an outsourced consulting team that can really specialize in these areas, help you to build the panel, validate the panel, and help you get it launched.
There are many decisions that labs need to make when they move from microbiology to molecular biology techniques. What are some of the key challenges a lab may encounter and how did you overcome these challenges?
Brady: When you’re switching from microbiology to molecular pathology, personnel is going to be a key issue to make sure you’ve got the folks with the right experience to help you to perform those tests.
I also think that it’s going to require some floor space in your laboratory, sometimes with unique requirements that might need their own physical space within the laboratory closed off from the rest of the platforms that you’re used to testing.
And the final piece of that is just making sure that your laboratory information system has the ability to accommodate molecular pathology reports and testing.
How does a lab source samples and approach potential sample providers?
Brady: The way that we’ve done [it] is we first go to potential sample providers and see what kind of test menu items they are looking for, what kind of pathogens they’re looking for, what they find valuable, and antibiotic resistance testing. We take that and we also confirm that with our infectious disease physicians, and then we build a panel that’s really optimized for those end users. That makes it a lot easier once we’ve validated and launch it, to go back to those same folks and just say, here’s what you asked for, and that allows us to get the business a little quicker.
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For more on the considerations and strategies labs can implement when working in PCR testing for infectious disease, watch Brady’s workshop presentation (50 min.) from ASM Microbe 2023 or read featured blog article: “To Chase or Not to Chase Every Pathogen” (5 min.).
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