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Innovation in PCR

Expanding the utility of a time-tested technique

From traditional and quantitative to reverse-transcription, multiplex, and digital, polymerase chain reaction (PCR) continues to evolve across many iterations.

PCR is an indispensable tool for many applications in scientific research and clinical investigations. Its exquisite sensitivity, relative simplicity, and cost-effectiveness makes PCR stand apart from other nucleic acid amplification techniques, cementing it as a mainstay in molecular laboratories.

Over time, the concepts and applications have been tweaked, adapted, and re-formulated. Additionally, PCR platforms have advanced and evolved, resulting in more streamlined workflows across a growing number of applications.

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Modifications to PCR methods enhanced its utility in healthcare.

The development of real-time PCR, marked a significant technological leap in terms of every-day utility. The approach allows the signal from an amplified target to be read immediately after each cycle (the process by which a target molecule is doubled), enabling analyses of smaller samples with greater accuracy.

Some of the first PCR tests targeted burdensome viruses, including human immunodeficiency virus (HIV), cytomegalovirus (CMV), hepatitis C virus (HCV), and hepatitis B virus (HBV), and more recently have been used to target transplant-associated infectious agents, like Epstein-Barr-Virus (EBV), BK virus (BKV) and adenovirus (ADV).

As the use of PCR broadened into other disciplines and disease areas, the number of organisms, pathogens, or conditions that could be diagnosed with PCR expanded. Using multiplex tests, multiple targets can be detected at the same time from a single sample to form a better picture of a patient’s status.

Identification is essential for infection control and patient management

Much like today, the early days of PCR saw laboratory developed tests (LDTs) play an important role in a molecular lab’s offering.

While these home-brew assays had inconsistent workflows and frequently involved error-prone manual processes, they filled an at-the-time unmet need. As testing matured, its accuracy and efficiency vastly improved. This shaped the regulatory requirements of certain tests (e.g. IVD). Before long, dedicated systems were developed to automate and standardize parts of the workflow.

Female technician in lab coat loading samples into instrument
Close up of two female healthcare professionals

As demand for testing continued to grow, laboratories required more and more analyzers to meet local needs. Floor space, or “footprint”, quickly became a limited resource, making the investment in dedicated systems a luxury many labs could not afford. Today’s leading analytical systems are developed to address these issues, allowing laboratories to scale more easily as testing needs change.

The higher throughput and robust IVD testing menus of these systems allow labs to reduce the number of analyzers required to generate the same number of results while also adding capacity. For additional space savings and value-add, IVD tests and LDTs can now be consolidated onto the same platform. This minimizes the need for dedicated LDT systems while maintaining the workflow benefits of IVD testing, letting labs react flexibly to local needs while efficiently differentiating their test offering.

The far-reaching impact of automation

Automation is arguably the most important development in maximizing the adoption of PCR in healthcare settings.

Minimizing manual touchpoints presents several benefits to patients, technicians, and laboratory leadership.

  • Generating reliable results consistently, sample after sample
  • Eliminating staff exposure to hazardous chemicals and infectious agents
  • Increasing the value-add from laboratory personnel

What began as a time-consuming manual process, spread out across several different rooms with stringent control measures in place, can now be performed in a matter of minutes in an analyzer the size of a shoebox for point-of-care and emergency room settings.

Even core laboratories and established molecular labs can benefit from integrating additional automation. From sample preparation and post-analytical processing, to robust IT solutions and analytics, the ecosystem of innovation surrounding PCR is not slowing down.

Taking on tomorrow’s challenges today

The future of healthcare will be increasingly digital, and PCR is no exception.

dPCR: No longer limited to research applications, digital PCR (dPCR) is emerging as an important clinical tool. dPCR provides ultrasensitive and absolute nucleic acid quantification without using a reference standard, opening new opportunities for standardizing and comparing results between laboratories.

Data digitalization: Outside of the laboratory, digitalization is reducing the time and effort required to get results to patients. This is particularly useful for remote and resource-limited regions battling highly contagious diseases.

Apps: Using a disease management app results can be reported back directly to patients on a smartphone. Improved access to diagnostic information could mark a turning point in the global effort to address the world’s most burdensome diseases.

DNA strand graphic background image
Then, now and next—Roche remains committed to advancing PCR

From the initial investment in PCR in the early 1990’s until today, Roche has been at the forefront of progress with this powerful technology.

From assays and analytics to hardware, software, and robotics, Roche’s drive to improve the diagnostic utility of PCR is extensive. Going forward, Roche will continue to advance the potential of PCR to make real differences in the lives of patients, laboratories and healthcare professionals everywhere.

Watch Brian Earp, VP of Development at Roche Molecular Systems, discuss the future of PCR in diagnostics

Innovation in PCR

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