The present and future of in vitro diagnostics are molecular. With global demand for easily accessible molecular diagnostics (MDx) at an unprecedented height, clinical testing labs across the globe depend on real-time polymerase chain reaction (PCR) to provide dependable results quickly. The broad adoption of qPCR testing positions real-time PCR as a dominant method for molecular diagnostics moving forward. But what features unique to qPCR have bolstered its value in the MDx space?
In comparison to “conventional” or end-point PCR testing, qPCR, also known as real-time PCR, can offer quantitative data beyond just the presence or absence of a genetic sequence within a sample—it’s the gold standard for highly sensitive, specific detection and quantification of molecular markers. Because of this, qPCR testing can generate valuable insights in MDx applications, such as the detection of new viral or bacterial strains in infectious disease cases or expression levels of a key mutation in oncology. Additionally, because data are collected during the reaction and no post-reaction processing is required, qPCR offers faster turnaround times and simpler methods than conventional PCR, making it advantageous for routine diagnostic applications.Increased demand for qPCR capabilities has powered innovation of qPCR ecosystems and applications, further demonstrating the utility of this technique. In this piece, we’ll highlight some of the key trends in MDx applications and outline the current state of qPCR ecosystems supporting these applications.
Major Trends in qPCR-based Molecular Diagnostics
The demand for COVID-19 testing increased placement of qPCR instrumentation in MDx labs, and qPCR testing is likely to drive the ~10% growth of the MDx market predicted for 2022. Testing throughout the pandemic has also fueled further development of qPCR-based clinical assays, with both in-house laboratory-developed tests (LDTs) and commercial in vitro diagnostic (IVD) kits expanding. A number of qPCR-based IVD assays for SARS-CoV-2 have surged into the space, quickly expanding testing capabilities to facilities not equipped to develop their own tests. While qPCR-based LDTs remain prominent and advantageous for clinical oncology applications, this increased demand has brought infectious disease states to the top of the list of LDT applications as well.
Expansion of qPCR into new user spaces and the need for high-throughput processing have made workflow automation capabilities another critical trend for qPCR ecosystems. As LDT and IVD development continue to grow, the capacity for qPCR ecosystems to support these capabilities through instrumentation, workflow support, and reliable supplies of components and reagents will be key to success in the MDx space.
The Current State of qPCR Ecosystems
The expansion of qPCR in MDx applications has also highlighted new priorities within the ecosystem of qPCR instrumentation, reagents, assays, and support services. While the individual components of the qPCR ecosystem can offer impressive results, the importance of these pieces working together seamlessly to deliver reliable, quality test capabilities cannot be understated. Demand for fast turnaround times, particularly for large surges of testing and stat requests, make efficiency, high-throughput capabilities, and ease of use more critical than ever. A good MDx test should have several key qualities: analytical validity (the ability to accurately and consistently measure the marker of interest), clinical validity (the ability to detect the associated phenotype of that marker), clinical utility (the ability to be incorporated into routine practice with low risk and high benefit), and economic utility for the lab performing the test. A seamless, thoughtfully constructed qPCR ecosystem can maximize the success of MDx products, allowing tests to perform to their full potential.
The expansion of qPCR instrumentation into new settings has also emphasized the value of user-friendly interfaces and standalone capabilities for use in laboratory spaces of every size. Innovations in smart, connected features of qPCR systems and investment in user support and training have made a significant impact in making qPCR integration easier in MDx laboratories. The Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System* features a responsive touch screen interface that lets users easily set up a run, control the instrument, and analyze plates in one place, minimizing operator error. Additionally, the QuantStudio 7 Pro Dx features security, auditing, and e-signature (SAE) functionality, keeping regulatory compliance support features built-in. As the use of qPCR-based MDx increases, data security is critical to keeping a place in the clinical sphere. In addition, remote run monitoring through an instrument-connected app and hands-free operation let personnel maximize their productivity. Whether integrated to the qPCR instrument or run through an accompanying computer, features of workflow software are becoming more optimized for clarity and ease of use.
Whether you’re new to qPCR or looking to get the most out of your system, responsive and reliable support service is a critical component at every step. Thermo Fisher provides global service and troubleshooting support to minimize downtime and keep clinical processes running. The Applied Biosystems qPCR ecosystem of instruments and products offers a premier-quality, reliable, and user-friendly experience across MDx applications.
To learn more about our qPCR ecosystem for molecular diagnostics, visit QuantStudio Dx Real-Time PCR Systems.
* The QuantStudio 7 Pro Dx Real-time PCR System is not available outside of the United States.