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Precision diagnostics and digital convergence that drive the clinical diagnostics market

Article by: Frost & Sullivan

Healthcare is rapidly becoming patient-centric with a focus on outcomes and value. This has provided opportunities for clinical diagnostics players to advance their instruments, assays and informatics capabilities to address unmet clinical needs and foster their precision diagnostics portfolio. The advances in next-generation sequencing (NGS)-based companion diagnostics (CDx) and liquid biopsy are helping address precision medicine approaches toward diseases such as cancer. Another paradigm that is setting the stage in the diagnostics industry is linking automation with digital technologies to improve efficiency and productivity, such as leveraging artificial intelligence (AI) to improve workflow, accuracy and efficiency.

The blood analysis for circulating tumor cells (CTCs) or circulating tumor deoxyribonucleic acids (ctDNA) has opened new avenues for cancer diagnostics, including early detection of tumors, improved risk assessment and staging. This reveals the relapse and monitors the tumor evolution in the context of cancer therapies. The approval of a companion diagnostic that uses a liquid biopsy and NGS has marked a new era for mutation testing. The United States Food and Drug Administration approved more than 10 breakthrough devices in 2021. The designations boost the development of the tests through clinical trials as a companion diagnostic and multi-cancer diagnostic, including products from leading companies such as Natera, Bluestar Genomics, and Inivata.


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