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By Limbus Medical Technologies

Q&A: The Role of the IVDR Conformity Assessment in Genetic Diagnostics

In this Q&A, Sonja Strunz, head of the regulatory affairs department at Limbus Medical Technologies in Germany, explains the classification of devices under IVDR and what it means for manufacturers, users, and patients.

By VolitionRx

Global Panel of Sepsis Experts Examines Clinical Potential of a NET-Associated Circulating Nucleosome Assay

The panel concluded that the test has the potential to aid in the early diagnosis of sepsis and to guide and monitor response to therapy.

By VolitionRx

Perspective: The Epigenetic Keys to Unlocking the Full Potential of Immunotherapy

Epigenetics is the key to unlocking the full potential of cancer therapy, including immunotherapies, by revealing deep insights into how the body reacts and responds to medication.

By Seegene Inc

Interview: Updates in HPV Testing and Genotyping for Cervical Cancer Screening

Dr. Marta del Pino_Photo (1).jpg

In February 2023, Seegene met with Marta del Pino at Eurogin, the leading international conference focused on human papillomavirus (HPV) and associated cancers, to discuss the value of HPV testing and genotyping in the new cervical cancer screening paradigm.

By Oxford BioDynamics

Q&A: How a Noninvasive Blood Test is Changing Immunotherapy Treatment

The noninvasive test evaluates eight 3D genomic markers and is the only test that returns a binary result to the ordering physician with high accuracy: “low probability” or “high probability” of response to an ICI.

By VolitionRx

First CE-Marked Assay to Aid in NETosis-Associated Disease Evaluation Has Applications in COVID-19, Sepsis Monitoring

The Nu.Q NETs test is the first approved clinical assay to assess disease severity by quantifying circulating nucleosomes which make up plasma neutrophil extracellular traps, or NETs — snares of DNA expelled by neutrophils to trap and kill invading pathogens.

By Seegene Inc

Seegene Seeks to Curb Oncoming COVID-19 Surges with Routine Syndromic PCR Testing

Seegene has joined hands with LabHouse, a testing center in Vietnam, to launch the In-Life PCR campaign for ride-hailing drivers in Ho Chi Minh and Hanoi, and the company is in talks with testing labs in countries around the world to launch the campaign in more regions,

By PreAnalytix

IVDR-Compliant Liquid Biopsy Preanalytical Workflow Can Address Challenges in Clinical ccfDNA Analysis

Diagnostic laboratories in the EU can utilize the IVDR-compliant PAXgene Blood ccfDNA workflow in a variety of noninvasive ccfDNA-based diagnostic applications.

By F. Hoffmann-La Roche Ltd.

New TMB Recommendations Help to Guide Treatment Decisions in Oncology

Recent recommendations from the ESMO Precision Medicine Working Group and National Comprehensive Cancer Network, coupled with US Food and Drug Administration review and approval, have highlighted the use of tumor mutational burden testing in clinical practice for a number of different tumor types.