Medical issues and perspectives

QIAGEN Introduces Key Enhancements to Liquid Biopsy Technologies for Advanced Biomarker Detection

QIAGEN  has announced key updates to its sample technologies for non-invasive liquid biopsy applications in fields such as oncology, prenatal care, and organ transplantation. These enhancements include upgraded kits and platforms designed to improve biomarker detection through higher yields of circulating cell-free DNA (ccfDNA). 

The enhanced EZ1&2 ccfDNA Kit now supports fully automated processing of 24 samples with up to 10 mL of serum or plasma, alongside a new urine protocol, addressing the need for larger sample inputs essential for low-frequency mutation detection. Additionally, the QIAsymphony DSP Circulating DNA Kits—available in standard and high-throughput versions—offer flexible solutions for labs of varying sizes, ensuring compliance with CE-IVDR and FDA regulations. 

These updates expand QIAGEN’s automated solutions portfolio, enabling laboratories to perform high-sensitivity downstream analyses such as NGS, dPCR, and real-time PCR. Complementing these advancements is the new PAXgene Urine Liquid Biopsy Set, enhancing cfDNA analysis from urine samples.

Illumina Launches MiSeq™ i100 Series to Accelerate and Simplify Next-Generation Sequencing

Illumina,  has introduced the MiSeq™ i100 Series, featuring the MiSeq i100 and MiSeq i100 Plus Systems, designed to simplify and accelerate next-generation sequencing (NGS) for labs. These benchtop instruments offer easy operation, room-temperature reagent storage, and same-day sample-to-analysis, making NGS more accessible, even for users with limited expertise.

The MiSeq i100 Series builds on the original MiSeq platform while incorporating advanced XLEAP-SBS™ chemistry and technology from the NovaSeq™ X Series. It offers two configurations: the i100 Plus with 100 million reads per run and the i100 with 25 million reads per run. Key features include faster run times (as short as four hours), reduced packaging waste by 85%, and cost-effective consumables.

Push-button workflows support applications like microbiology, oncology, and infectious disease, with real-time metrics available on the instrument or via cloud-based DRAGEN™ analysis. This compact, sustainable system delivers the speed, scalability, and ease required to advance genomic research.

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval from China’s National Medical Products Administration (NMPA) for use as a monotherapy in adult patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations. This approval applies to patients who have previously undergone systemic therapy. The decision is based on promising results from the DESTINY-Lung02 and DESTINY-Lung05 Phase II trials, with full approval contingent upon the success of confirmatory trials.  

Lung cancer is a significant health burden in China, with over one million new cases annually—more than 40% of the global total. Among NSCLC cases, 2-4% involve HER2 mutations, representing a population with limited treatment options. Ying Cheng, MD, PhD, principal investigator of DESTINY-Lung05, emphasized that Enhertu offers a critical new option for patients with this challenging subtype of NSCLC. 

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, highlighted that Enhertu is the first HER2-directed therapy approved in China for HER2-mutant metastatic NSCLC. He stressed the importance of biomarker testing, including HER2, to optimize patient outcomes. Kiminori Nagao, head of Daiichi Sankyo’s Asia, South & Central America Business Unit, noted that this approval follows prior approvals for HER2-positive breast and gastric cancers, underscoring Enhertu’s benefit across multiple HER2-driven cancers.  

In DESTINY-Lung02, Enhertu achieved an objective response rate (ORR) of 49.0% and a median duration of response (DoR) of 16.8 months. DESTINY-Lung05, which focused on Chinese patients, demonstrated a higher ORR of 58.3%. The drug’s safety profile was consistent with previous trials, with no new safety issues identified.  

Enhertu is co-developed by AstraZeneca and Daiichi Sankyo and is approved in over 45 countries, including the US, Japan, and the EU, for HER2-mutant NSCLC.