Advancements in Precision Diagnostics: New Regulations and Biomarker Strategies

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Advancements in Precision Diagnostics: New Regulations and Biomarker Strategies

Biomarkers and diagnostics play a critical role in fulfilling the promise of precision medicine. In modern medicine, diagnostics are not only used to diagnose disease, but to identify those patients who are most likely to respond to targeted therapies, monitor treatment response, and provide insight into disease drivers and potential drug targets. Moreover, the emergence of the global pandemic—and the subsequent boom in diagnostic development—indisputably demonstrated the importance of diagnostics to protecting population health.

Diagnostics are such an integral component of modern healthcare that the World Health Organization has compiled a list of 122 essential in vitro diagnostics (IVDs). More than half of all oncology trials involve the use of biomarkers, and IVDs influence nearly two-thirds of clinical decisions. In this eBook, we explore timely topics in the diagnostics landscape, from regulatory considerations and next-generation COVID-19 diagnostics to an innovative next-generation sequencing initiative that will help fuel the next wave of biomarker-driven research and development.

About Precision for Medicine

As a precision medicine clinical research organization, Precision for Medicine has brought together new technologies, expertise and operational scale to help the life sciences industry improve the speed, cost and success rate of bringing life-changing therapies to patients. Precision leverages the combined power of clinical trial solutions, specialty lab services and data sciences to drive faster clinical development by maximizing insights into patient biology and accelerate the pace of scientific discovery and approval.

At Precision, we understand how the right data can lead to insights that transform clinical programs and profoundly impact patient health. Our unmatched experience in diagnostics spans the spectrum from preclinical development to product launch and market access, with more than 500 trials conducted for IVDs, companion diagnostics (CDx) and therapeutics and more than 250 marketing clearances and approvals for IVD submissions. Precision is also dedicated to screening its extensive biorepository to uncover new insights on oncology disease drivers, drug targets and novel biomarkers.

 

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