Oncology remains the most specimen-intensive field in clinical development. The World Health Organization (WHO) projects that new cancer cases will reach 35 million by 2050, a 77% increase compared with the 20 million cases in 2022.1
Companion diagnostics (CDx) underpin this shift. By 2024, the US Food and Drug Administration (FDA) had approved approximately 60 CDx assays, with next-generation sequencing (NGS) accounting for nearly a fifth.2
Each relies on access to well-preserved biospecimens and controls. As regulators increasingly link therapeutics to diagnostics, secure, compliant biorepository solutions and CDx have become central to approvals for oncology products.
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