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Bringing In Vitro Diagnostics to Market with Real-World Evidence

In vitro diagnostic (IVD) devices are a unique type of medical device. Although they meet the definition of a medical device, they are not intended to treat a disease or condition. Rather, they are the instruments or reagents that analyze samples taken from patients. IVDs are less invasive than traditional medical devices, but still present a risk to a patient.  

During the COVID-19 global pandemic, there was a sharp rise in IVDs for rapid testing using polymerase chain reaction (PCR), next-generation sequencing (NGS), and serology. The pandemic saw a rise in molecular assays, particularly real-time polymerase chain reaction (RT-PCR) testing, to meet the demand for faster, higher volume testing. In 2019, it was estimated the molecular diagnostics market in the U.S. would grow an average of more than six percent every year for the next five years. 

The response to this challenge of meeting such high demand led to accelerated development of even more diagnostic technologies, such as NGS and CRISPR, under emergency authorization. NGS has been used prevalently in precision medicine, but the pandemic allowed NGS to be used in large-scale, high-volume diagnostics. 

It is expected that by 2027, the IVD market will top $140 billion. Cancer diagnostic testing is among one of the fastest growing tracks, with cancer biomarkers, immunohistochemistry, and molecular testing among the fastest growing. Other areas of growth include substance abuse, immunoassays, cardiac markers, and Point of Care tests for inherited diseases. 

This white paper examines some of the unique aspects of IVDs in an ever-changing regulatory landscape, presenting the concept that real world evidence (RWE) shows promise in optimizing the regulatory decision-making process to bring IVDs to market. 

Download the white paper to learn more.