Revvity, Inc. (NYSE: RVTY) today announced the launch of the GSP® T1D 3plex kit, a fully automated, CE-IVDR-certified, multiplex autoantibody (AAb) detection solution to enable population-wide screening programs that identify children at risk of developing type 1 diabetes (T1D) before symptoms appear.

Werfen today announced that its Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin A (IgA) Reagent has received both U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR). Together, these milestones complete the Aptiva APS testing portfolio, which now offers all three APS isotypes, IgA, IgG, and IgM, for both anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ₂GP1) antibodies.

bioMérieux, a world leader in the field of in vitro diagnostics, announces that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat plus (R/STplus) Panel and BIOFIRE® SPOTFIRE® Respiratory/Sore Throat plus (R/STplus) Panel Mini have been CE-marked under the IVDR*. The certification includes conformity assessment for near-patient testing, enabling its use outside traditional laboratories, directly at the point of care. These multiplex PCR** tests can simultaneously detect the most common pathogens responsible for respiratory and sore throat infections, within a timeframe aligned with a typical patient visit.

Amoy Diagnostics Co., Ltd. (“AmoyDx,” SZSE: 300685) today announced that its AmoyDx® HRD Complete Panel has received certification under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR) by TÜV SÜD Product Service GmbH for use as a companion diagnostic to aid in identifying patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations ( germline and /or somatic) who may be eligible for treatment with olaparib monotherapy who have progressed following prior therapy that included a novel hormonal agent.

Yourgene Health (part of the Novacyt Group), an international molecular diagnostics company with a broad portfolio of integrated technologies and services, announces the commercial launch of its In Vitro Diagnostic Regulation (IVDR)-certified Yourgene® Insight DPYD assay, expanding the Company’s clinical genetics portfolio across regulated European markets.

BGI Genomics recently announced that its NIFTY® Non‑invasive Prenatal Testing (NIPT) product has obtained the CE-IVDR Certificate from TÜV SÜD Product Service GmbH (a leading global Notified Body designated under the IVDR).

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Ibex Medical Analytics (Ibex), the global leader in AI-powered pathology solutions for clinical diagnostics and biopharma, today announced that it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for Ibex Breast ER, PR and Ki67. This milestone solidifies Ibex’s position as the market leader in breast cancer diagnostics by rounding out regulatory approval for its entire breast portfolio, which delivers unprecedented value to pathologists, laboratories, and patients. Covering biopsies and excisions, the breast suite comprises a fully IVDR-certified, end-to-end workflow across H&E, HER2, ER, PR, and Ki67-stained whole slide images. This was achieved following clinical studies and a meticulous review process, as required by EU regulations, reflecting trust in the quality, safety and performance of the product.

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the CE-IVDR-certified QIAstat-Dx BCID GN Plus AMR Panel, establishing a comprehensive bloodstream infection testing offering on the QIAstat-Dx platform in Europe.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that Signatera has received certification as a Class C device under the European Union’s In Vitro Diagnostic Regulation (IVDR).