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.

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it introduces the cobas® HDV test for use on the cobas® 5800/6800/8800 systems, a diagnostic tool for the detection and quantification of Hepatitis D Virus (HDV) RNA, in countries accepting the CE mark. Available on the industry-leading cobas 5800/6800/8800 systems, Roche aims to help healthcare providers in identifying patients and monitoring their care more effectively alongside newly available treatments.

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that its Elecsys IGRA TB test has received the CE Mark, introducing a new blood testing solution for identifying tuberculosis infection (TBI, also known as latent TB) in routine laboratory settings. The new solution enables fast, simple, and efficient diagnosis, and can provide results in under 24 hours. The Interferon Gamma Release Assay (IGRA) itself takes just 19 minutes per patient to process, which is approximately half the time of currently used methods. Laboratories now have an option for IGRA testing, with faster turnaround and scalable throughput on Roche’s systems.

altona Diagnostics today announced that its FlexStar® STI panel has obtained CE marking under Regulation (EU) 2017/746 (IVDR). This completes the IVDR transition for the company’s modular and adaptive STI testing portfolio, enabling laboratories to configure customizable multiplex panels for up to 7 sexually transmitted pathogens in a single sample.

Personalis, Inc. (Nasdaq: PSNL), 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).

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

Abbott (NYSE: ABT), a global healthcare leader, announced today it has secured CE Mark for the world's first dual glucose‑ketone sensing technology for people with diabetes. Branded as Libre Duo and Libre Duo 10 Day, the systems are designed to continuously measure glucose and ketone levels every minute, providing real-time visibility into both glucose levels needed for daily diabetes management as well as rising ketones that can lead to a diabetic ketoacidosis (DKA) emergency. This marks the first time people with diabetes will be able to monitor ketones without traditional blood or urine tests. Abbott plans to begin launching Libre Duo systems in select European countries later this year.

Seegene, a global molecular diagnostics company, announced the European launch of its new antimicrobial resistance (AMR) testing product, Allplex™ MDRO Assay, which is CE marked under the EU In Vitro Diagnostic Regulation (IVDR). The assay is designed to support the detection of multidrug-resistant organisms (MDROs) associated with healthcare-associated infections (HAIs).

Cepheid, a Danaher company, announced today that it has received CE marking under the in vitro medical device regulation (IVDR) for the Xpert GI Panel. This multiplex PCR test is designed to enable fast, accurate detection of 11 clinically relevant gastrointestinal (GI) pathogens from a single patient sample. Leveraging Cepheid's 10-color multiplexing technology on its GeneXpert® systems, the test offers a robust solution for simplifying GI testing workflows and delivering meaningful answers to clinicians.

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it has received CE Mark for Elecsys® pTau217, a blood test developed in collaboration with Eli Lilly and Company and designed to measure the phosphorylated Tau (pTau) 217 protein, an indicator of amyloid pathology and a hallmark of Alzheimer’s disease. The same cutoffs (high and low) of the blood test can be used across primary and secondary care settings, to rule in or rule out amyloid pathology in people presenting with symptoms or complaints of cognitive decline. The early detection of the amyloid pathology is critical for Alzheimer’s diagnosis and treatment, as it enables individuals, families, and caregivers to understand the cause of symptoms, access appropriate care, and actively contribute to the planning of next steps.