Bristol Myers Squibb's Krazati (adagrasib), in combination with Eli Lilly's EGFR inhibitor Erbitux (cetuximab), has received accelerated approval from the US Food and Drug Administration (FDA) for treating adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC). This approval applies specifically to patients who have previously undergone fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and who test positive for the KRAS G12C mutation using an FDA-approved test. The decision by the FDA follows findings from the KRYSTAL-1 study, a multicenter, single-arm expansion cohort trial. Scott Kopetz, from MD Anderson Cancer Center, presented pooled results from this study at the American Association for Cancer Research annual meeting and concurrently published them in Cancer Discovery. According to the pooled analysis, 94 patients who received the recommended dose of Krazati combined with Erbitux showed promising outcomes. Approximately 34 percent of patients responded to the treatment combination, while the disease control rate (including patients with tumor shrinkage and stable disease) was 85.1 percent. Median progression-free survival was reported at 6.9 months, and median overall survival was 15.9 months. Notably, after six months of treatment, 87.8 percent of patients were still alive. Mirati Therapeutics initially developed Krazati, which Bristol Myers Squibb acquired last year. In February, Bristol Myers Squibb submitted a supplemental new drug application to the FDA seeking approval for Krazati plus Erbitux in this specific patient population. The FDA's decision, anticipated by a certain date, aligned with this recent approval. The accelerated approval signifies an important advance for patients with KRAS G12C-mutated CRC who have exhausted standard chemotherapy options. It underscores the potential of targeted therapies like Krazati in addressing specific genetic mutations driving cancer progression, offering new hope in the treatment landscape for this challenging condition.
Read more10x Genomics, Inc. has unveiled its latest innovation, the Xenium Prime 5K Pan-Tissue and Pathways panel, marking a significant advancement in single cell and spatial biology. This new panel boasts enhanced chemistry that significantly increases multiplexing capabilities by an order of magnitude. It promises superior sensitivity per gene, improved specificity, and spatial fidelity, along with integrated multimodal cell segmentation. These features contribute to industry-leading speed and throughput, setting a new standard in the field.
Ben Hindson, Co-Founder and Chief Scientific Officer at 10x Genomics, expressed enthusiasm about customer reception, highlighting the panel's appeal due to its high multiplexing capacity and exceptional performance. He emphasized that the Xenium Prime 5K panel excels across critical metrics such as sensitivity, specificity, and throughput. This launch marks the company's fifth major product introduction this year, reinforcing its commitment to pioneering innovations that empower researchers to achieve groundbreaking discoveries.
Key features of the Xenium Prime 5K assay include its capability to profile 5,000 genes comprehensively across various cell types, states, and signaling pathways in multiple tissue and disease contexts. It promises excellent data quality crucial for unraveling disease mechanisms, understanding therapeutics, and studying cell behavior. The assay integrates advanced multimodal cell segmentation technology to ensure high sensitivity, specificity, and spatial accuracy.
Moreover, 10x Genomics touts industry-leading throughput, enabling researchers to analyze up to 472 mm² of human or mouse tissue in six days or less, facilitating rapid insights. The panel is also customizable with up to 100 additional genes, accommodating various research needs including isoforms, exogenous sequences, and viral elements.
The development of the Xenium Prime 5K panel involved rigorous design using extensive single-cell RNA sequencing data from diverse organs and tissues, along with insights from hundreds of cell types and a comprehensive review of over 750,000 peer-reviewed publications to identify highly cited biomarkers. The assay supports an easy, tissue-agnostic workflow compatible with both fresh frozen and FFPE samples, enhancing its versatility for different experimental setups.
To introduce the Xenium Prime 5K panel, 10x Genomics will host a webinar on June 25, 2024, inviting interested attendees to explore its capabilities firsthand. This launch underscores 10x Genomics' mission to advance biological understanding and improve human health through innovative technologies that redefine research possibilities in oncology, immunology, neuroscience, and beyond.
Bionano Genomics, Inc. has announced a strategic software marketing agreement with Revvity, Inc. aimed at enhancing newborn sequencing research capabilities. Under this agreement, Revvity will integrate and market Bionano’s VIA™ software into their sequencing workflow. The VIA software is expected to augment Revvity’s current capabilities by facilitating the assessment of Copy Number Variations (CNVs) and improving the interpretation of sequencing data.
The collaboration leverages Revvity’s comprehensive sequencing workflow, which includes various stages from DNA extraction of dried blood spot samples, through sample quality control, automated library preparation, sequencing using platforms like Element Biosciences or Illumina, to a hybridization-based NGS panel for detecting variants in over 390 relevant genes. This process is complemented by cloud-based data management and analysis powered by Bionano’s VIA software.
Dr. Erik Holmlin, President and CEO of Bionano, emphasized the transformative potential of the VIA software in visualizing, interpreting, and reporting genomic data. He highlighted its dual role in optical genome mapping (OGM) and Next Generation Sequencing (NGS) applications, underscoring Bionano’s commitment to advancing genomic insights across research and clinical domains, particularly in newborn sequencing research.
Bionano Genomics specializes in genome analysis solutions designed to address complex biological and medical questions. Their optical genome mapping technology and VIA software are pivotal in their mission to redefine genomic understanding. Additionally, the company offers platform-agnostic genome analysis software and proprietary nucleic acid extraction solutions through its isotachophoresis (ITP) technology. They also provide diagnostic services under their Lineagen, Inc. division, utilizing OGM for diagnostic testing.
The partnership with Revvity signifies Bionano’s strategic expansion into newborn sequencing research, facilitating the adoption of advanced NGS solutions globally. By integrating VIA software into Revvity’s workflow, both companies aim to streamline and enhance genomic analysis processes, potentially accelerating discoveries and clinical applications in genetics.