Genedrive (LSE:GDR) has entered into a collaboration agreement with Thermo Fisher Scientific to develop the Genedrive CYP2C19 HT Kit, a high-throughput pharmacogenetic in vitro diagnostic test designed for use on Thermo Fisher’s QuantStudio 5 Dx PCR platform. The new assay is aimed at centralised laboratory testing and complements the company’s existing rapid CYP2C19 ID Kit for near-patient use. Genedrive is targeting UKCA certification by the end of 2026, with the initial commercial focus on NHS genomic laboratories across the UK.

Not every assay needs the same substrate. But every assay needs the right one.

Diasorin (FTSE MIB: DIA) announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the LIAISON PLEX Gastrointestinal Flex Assay, a fully customizable syndromic testing panel capable of detecting a market-leading 24 gastrointestinal pathogen targets. The new panel expands Diasorin’s growing LIAISON PLEX assay portfolio, which also includes a customizable respiratory assay and three blood culture panels.

Beckman Coulter Diagnostics, a Danaher company and global leader in clinical diagnostics, today announced it has received CE 2797 mark under IVDR for the Access MeMed BV assay, enabling broad availability of a high-throughput host‑response test that helps clinicians differentiate between bacterial and viral infections in approximately 20 minutes.

Diasorin (FTSE MIB: DIA) today announces the U.S. FDA approval of the LIAISON QuantiFERON-TB Gold Plus II assay as a next-generation automated Interferon Gamma Release Assay (IGRA) designed in partnership with QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) to enhance laboratory productivity, workflow efficiency and turnaround time for latent tuberculosis infection (LTBI) testing in the United States.

Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced that a broad portfolio of its Alethia molecular assays has successfully achieved CE marking under the European In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.

The U.S. Food and Drug Administration ("FDA") has granted QuidelOrtho Corporation (Nasdaq: QDEL) ("QuidelOrtho"), a global leader of in vitro diagnostics, 510(k) clearance for the VITROS hs Troponin I Reagent Pack (the "VITROS hs Troponin I Assay"). The assay is intended for the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) to aid in the diagnosis of myocardial infarction (MI).

Leinco Technologies, a leading global provider of in vitro diagnostic (IVD) raw materials, today announced the acquisition of BioClin, Inc.’s proprietary antibody clones used as IVD raw materials. This strategic partnership significantly expands Leinco’s portfolio of critical reagents for endocrine hormone research and diagnostic assays.

Illumina, Inc. (NASDAQ: ILMN) announced today it has entered into a definitive agreement with Standard BioTools (NASDAQ: LAB) under which Illumina will acquire SomaLogic, a leader in data-driven proteomics technology, and other specified assets for $350 million in cash payable at closing, subject to customary adjustments, plus up to $75 million in near-term performance-based milestones and performance-based royalties.

MRC Holland said Thursday that its blood-based assay for Temple, Kagami-Ogata, and Russell-Silver syndromes has received certification under Europe's In Vitro Diagnostic Regulation (IVDR).