Earlier this year, the Centers for Disease Control and Prevention (CDC) sounded the alarm on an emerging fungal foe [1]. Candida auris, or C. auris, is a drug-resistant and potentially deadly infection for people with weakened immune systems that is spreading rapidly [2]. The rise of C. auris begs the question: when should clinical laboratories begin testing for new pathogens? As the fervor for COVID-19 testing fades, this will become more and more relevant as new and emerging diseases gain attention as potential threats. Small, independent labs and large labs alike will have to respond accordingly, while being mindful of their customers’ needs and ongoing business strategy.
In a recent presentation at the American Society for Microbiology’s 2023 Meeting (ASM Microbe), Scott E. Brady, Founder & CEO of Wise Diagnostic Systems (Wise Dx), shared his thoughts on what infectious disease labs should consider when adopting new polymerase chain reaction (PCR) offerings. “The point of all this is I’m not a scientist,” began Brady. “What I’ve learned over the years is that if you can work with your product management folks…hand-in-hand with the folks on your side, with your clinical laboratory staff, you can really develop excellent products and services that are both good for the lab, good for the business of the lab, and most important, good for the clinical side, the testing side of things a well.”
Watch the presentation here.
Evaluating a new test or service starts here
For Brady, whenever he considers a new product or service offering, he begins by asking himself three basic but important questions to establish the potential value: can I work this into my lab, will the target audience use it, and will I get paid? Infectious disease PCR testing should be practical for a lab to perform and offer meaningful clinical utility. “It’s great if you develop something that you saw at a conference,” said Brady. “And the science might be great, but is the actual end-user, whether it’s a patient, physician, or whatever it is, are they going to need it?” For the question on payment, Brady says labs should consider reimbursement challenges early on.
Another consideration is how to best address new pathogens. According to Brady, listening closely to your customers can help you and your team narrow in on an answer. For Wise Dx, mpox (monkeypox) didn’t make sense to add to their testing menu but C. auris did, given the company’s focus on gastrointestinal disease. During his presentation, Brady also shared the need to consider laboratory information management system (LIMS) requirements, as well as whether testing for a certain infectious disease will raise a lab’s biosafety level, footprint, or staffing needs.
Bringing PCR infectious disease testing to scale
As the founder of a diagnostic company, Brady started small but needed to think big. “Does your platform have the ability to potentially run a test that would allow you to enter a new market with a different type of physician?” asked Brady. What about when volume and demand grow, such as during an outbreak? By asking these questions when selecting a testing platform, labs can set themselves up for success in the long term.
While Wise Dx has worked with several testing platforms, they found both flexibility and scalability in Thermo Fisher Scientific’s offerings. Brady said that although the company originally started with just a gastrointestinal panel and a respiratory panel, they found it was easier to shift to Thermo Fisher’s platform with their QuantStudio offerings, as it allowed them to add other panels like a UTI test. During the COVID-19 pandemic, Wise Dx was also able to accommodate testing at the scale needed to keep up with customer demand using this platform.
Furthermore, while Thermo Fisher does offer off-the-shelf options, Brady found the custom panels especially helpful. Wise Dx was able to go directly to primary care clinicians, specialists, and infectious disease physicians to understand what they were looking for and develop panels to meet their needs.
Easier is better than better
While labs may always be striving to offer new and improved services, ensuring usability and a positive end-user experience is essential. Many potential specimens may not make it to the point of testing or results for a variety of reasons, explained Brady. Perhaps the actual collection process was too difficult for a patient, or instructions were unclear. “If they don’t want to use it or it’s too difficult to use, they’re just not going to send you that specimen,” said Brady.
Subsequently, making it an easier process for both patients and their providers is a must. To make his point, Brady shared a quote from his operations manager: “Easier is better than better.”
For more on the considerations and strategies labs can implement when working in PCR testing for infectious disease, watch Brady’s presentation from ASM Microbe 2023 on-demand.
Click here for information on Thermo Fisher’s infectious disease testing solutions.
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