Two regulatory moves broaden the toolkit for decentralized testing and translational research. Lex Diagnostics secured FDA 510(k) clearance and a CLIA waiver for its Velo point‑of‑care molecular PCR system and an influenza A/B and SARS‑CoV‑2 multiplex assay, enabling lab‑quality results in six to ten minutes under waived settings. Separately, Bio‑Techne’s Ella benchtop immunoassay platform received CE‑IVD marking, opening EU sales for its cartridge‑based Simple Plex assays across >390 analytes relevant to neuroscience, immunology, oncology and cell and gene therapy research. Both approvals signal tighter integration of rapid molecular and quantitative protein assays into clinical and decentralized workflows. Lex expects US commercialization this year and benefits from prior investment interest by QuidelOrtho; Bio‑Techne positions Ella for translational studies and diagnostic assay development under the EU regulatory framework. Together, the clearances underscore continued momentum in rapid diagnostics and clinical‑trial‑ready biomarker platforms.