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FDA Clears, CLIA-Waives Diasorin Flu A/B, RSV, SARS-CoV-2 Molecular Assay
2025-12-30
Italian in vitro diagnostics firm Diasorin said on Sunday that the US Food and Drug Administration has issued 510(k) clearance and CLIA-waived the firm's first assay for use on the Liaison Nes platform.
EU Unified Patent Court Rules in Favor of Myriad Genetics in Breast Cancer IP Dispute
2025-12-30
The EU's Unified Patent Court last week ruled in favor of Myriad Genetics in its patent dispute with South Korean firm GXD-Bio.
Applied BioCode Submits New Sample Prep Claim to FDA to Expand Use of Respiratory Panel
2025-12-30
Applied BioCode said on Monday that is has submitted a new nucleic acid extraction claim for its BioCode Respiratory Pathogen Panel (RPP) to the US Food and Drug Administration, with the goal of expanding use of the panel by clinical laboratories.
Infectious Disease Diagnostics in 2025: Market Volatility Meets Rapid Technology Advancements
2025-12-30
Following decades of cumulative efforts, a number of infectious disease tests and technologies broke new ground in 2025, hinting at rapid advances in the development of new systems and assays.
MDx, Precision Medicine Firm GenePlus Files for IPO on Hong Kong Stock Exchange
2025-12-30
Chinese molecular diagnostics and precision medicine firm GenePlus Technology said on Sunday that it has filed for an initial public offering on the Hong Kong Stock Exchange.
IVD China last week: MGI, Mindray, BOE, Radiometer, Agilent
2025-12-29
MGI Tech Partners with Cenglang Biotechnology to Deepen Expansion in the Asia-Pacific Region On December 26th, Beijing Cenglang Biotechnology Co.,Ltd. and MGI Tech reached a strategic cooperation agreemen..
MDx, Precision Medicine Firm GenePlus Files for IPO on Hong Kong Stock Exchange
2025-12-24
Chinese molecular diagnostics and precision medicine firm GenePlus Technology said on Sunday that it has filed for an initial public offering on the Hong Kong Stock Exchange.
Singlera Genomics Inks EU Distribution Deal With Pure Medical for cfDNA Assays
2025-12-24
Singlera Genomics said on Tuesday that it has entered into a research and distribution agreement with EU-based international medical company Pure Medical for its cell-free DNA detection products
Zydus Lifesciences to Market Myriad Genetics Cancer Tests in India
2025-12-23
Zydus Lifesciences said on Friday that it has signed an agreement to exclusively commercialize a trio of Myriad Genetics cancer tests in India.
Guardant Health Blood Test Receives Japanese Approval as CDx for Eli Lilly Breast Cancer Drug
2025-12-23
Guardant Health Japan said Monday that it has received approval from that country's Ministry of Health, Labour, and Welfare (MHLW) for its Guardant360 CDx as a companion diagnostic for identifying ESR1 mutations in breast cancer patients.
In Vitro Diagnostic Industry in China - Diagnosis of Blood and Body Fluids XIX
2025-12-23
3.6 Construction of Quality System The standardization and quality control of thrombus and hemostasis testing methods is to perform reasonable management, testing, and assessment of the quality level of the tech..
IVD China last week: Sansure, KHB, Roche, DIAN
2025-12-22
Sansure Biotech and Health-100 Form Strategic Partnership to Advance Quantified, Precision Health Management On December 19, 2025, Sansure Biotech and Health-100 signed a strategic cooperation agreement in Shang..
Personalis MRD Assay Predicts Immunotherapy Response Across Solid Tumors in New Study
2025-12-22
Results of a Phase I clinical trial published on Tuesday demonstrate that Personalis' minimal residual disease (MRD) assay, NeXT Personal, accurately predicts immunotherapy response across multiple metastatic solid tumor cancer types.
Singlera, Breakthrough Genomics Collaborating With U Pitt on Early Detection of Pancreatic Cancer
2025-12-22
Singlera Genomics and its partner Breakthrough Genomics this week announced a research collaboration with the University of Pittsburgh around the early detection of pancreatic cancer.
Chinese University of Hong Kong, MicroSigX Partner to Offer Microbiome Autism Risk Test
2025-12-19
The test stems from findings by CUHK investigators — who recently cofounded MicroSigX as a spinout of the university — that certain gut microbial community features are associated with autism spectrum disorder and could be used to diagnoses the condition.
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