Business Wire
-
Guardant Health Announces FDA Approval Of Guardant360 CDx As Companion Diagnostic For Boehringer Ingelheim's HERNEXEOS
6/11/2026
Guardant Health, Inc., a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360 CDx as a companion diagnostic (CDx) for Boehringer Ingelheim’s HERNEXEOS (zongertinib tablets), the first targeted therapy for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) as an initial treatment option.
-
Predicta Biosciences And CIMA LAB Diagnostics Announce Agreement To Advance Ultrasensitive Blood-Based Diagnostics For Multiple Myeloma And Other Hematological Malignancies
6/10/2026
Predicta Biosciences, a company building ultra-sensitive molecular and immune diagnostic platforms, and CIMA LAB Diagnostics from the Clínica Universidad de Navarra, a leading European University Medical Center, today announced a partnership to offer a combined service that integrates CIMA LAB’s flow cytometry capabilities with the GenoPredicta assay.
-
Personalis Enables Global Biopharma Support With CE-IVD Marked Specimen Collection Kits
6/9/2026
Personalis, Inc., a leader in advanced genomics for precision oncology, today announced that its Personalis EDTA Blood Collection Kit and Personalis cfDNA Blood Collection Kit have obtained Class A CE-IVD marking in compliance with the European Union’s In Vitro Diagnostic Regulation (IVDR).
-
Bruker Showcases Expanding Microbiology & Infection Diagnostics Portfolio At ASM Microbe 2026
6/4/2026
At ASM Microbe 2026, Bruker Corporation’s Microbiology & Infection Diagnostics (BMID) division is demonstrating its expanding portfolio and innovations across microbial identification, sepsis diagnostics, molecular testing, and NGS workflows, advancing clinical research, and faster, actionable infectious disease diagnostics.
-
American Cancer Society Recommends Guardant Health's Shield Blood Test In Updated Colorectal Cancer Screening Guidelines
5/27/2026
Guardant Health, Inc. a leading precision oncology company, announced that its FDA-approved Shield blood test is now included in updated American Cancer Society (ACS) Colorectal Cancer (CRC) Screening Guidelines published today.
-
Argonne Launches First Large-Scale AI Inference Service For Open Science
5/27/2026
The U.S. Department of Energy’s (DOE) Argonne National Laboratory has launched a first-of-its-kind AI inference service to help researchers across the nation accelerate discovery and innovation.
-
Thermo Fisher Scientific's PPD Clinical Research Business Expands Bioanalytical Capabilities With New Laboratory In Gothenburg, Sweden
5/18/2026
Thermo Fisher Scientific, the world leader in serving science, today announced the opening of a new bioanalytical and biomarker laboratory in Gothenburg, Sweden, located within GoCo Health Innovation City.
-
Valar Labs Receives FDA Breakthrough Device Designation For Vesta Bladder Risk Stratify Dx
5/15/2026
Valar Labs, an AI precision oncology company developing diagnostics that predict cancer treatment response from routine pathology slides, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Vesta Bladder Risk Stratify Dx. With this designation, Vesta Bladder Risk Stratify Dx becomes the first AI-powered digital pathology prognostic test in bladder cancer to receive FDA Breakthrough status, marking a significant milestone for the field of computational pathology and for patients with bladder cancer.
-
Charles River Laboratories And MEDIPOST Sign Non-Exclusive MOU To Advance GMP Testing Solutions
5/13/2026
Charles River Laboratories (CRL) and MEDIPOST Co., Ltd. (KOSDAQ 078160) have entered into a strategic, non-exclusive Memorandum of Understanding (MOU) to collaborate on GMP-compliant testing, as well as broader commercial and marketing efforts to advance cell therapy development and commercialization.
-
Lucent Diagnostics Announces Collaboration With Tempus To Integrate Blood-Based Alzheimer's Biomarker Testing Into Clinical Workflows
5/6/2026
Lucent Diagnostics, a brand of Quanterix Corporation, today announced a collaboration with Tempus AI Inc, a technology company leading the adoption of AI to advance precision medicine, to broaden access to a novel blood-based biomarker panel designed to improve detection accuracy for Alzheimer’s disease.