When to Launch an LDT: Key Factors to Consider
According to an MLO article, cost is just one element in a complex decision
A new article in Medical Laboratory Observer offers a practical look at the factors to consider when deciding whether to design a new laboratory-developed test or choose a send-out reference lab test or an in vitro diagnostic. Author Sherry Dunbar, Senior Director of Global Scientific Affairs at Luminex, writes that cost is just one important element in that decision.
Other compelling factors include clinical need, turnaround time, performance, staff expertise, and design complexity, Dunbar notes. “For instance, an available IVD for the indication needed might seem quite appealing, but that changes dramatically if the sensitivity and specificity of the test are inadequate,” she writes. “Experienced lab directors might have a good sense of the performance they are likely to get from an LDT, and if those numbers are better than the existing IVD, that’s a strong argument for developing a new test.”
One way to address challenges of design complexity is to build on platforms with established ease of use. “Labs seeking the flexibility to develop their own tests without having to continually acquire new instruments can adopt platforms that use standardized techniques, such as universal thermal cycling profiles, to reduce LDT design complexity,” Dunbar writes.
Cost Implications are Complicated
Though the article looks at all factors, cost is certainly one of the most important. But it’s often misunderstood by lab outsiders who think the calculation of rolling out a new test is simple. “Clinical lab leaders know that the equation is far more complicated,” Dunbar notes. “Assuming that per-test costs for an LDT are lower than the existing alternatives, labs must determine how many tests they would have to run to recover the substantial set-up costs.”
Taking a comprehensive view of all these considerations will give labs the strongest outcomes. “When all of the factors above are included in those calculations, lab leaders are best able to serve their healthcare communities while also giving appropriate attention to the bottom line,” Dunbar concludes.
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