Highlights of these studies include:

• A mini oral presentation on discussing the chronic psychological stress in advanced non-small cell lung cancer (NSCLC) treated with first-line immunotherapy
• Data on GeneseeqтАЩs cfDNA fragmentomics model to predict the risk of colorectal cancer
• Two clinical trial studies evaluate the efficacy and safety of new drug combinations in NSCLC and thymic carcinoma

List of abstracts that will be presented at the ESMO 2023 meeting:

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This NSCLC TMB kit entered the NMPA special examination and approval procedures for Breakthrough Medical Devices in January 2020. With the NMPA approval, this kit is used for in vitro qualitative detection of TMB in FFPE tissue samples from patients with EGFR/ALK-negative non-squamous NSCLC. This is the first next-generation sequencing (NGS)-based TMB test kit approved in China with a large gene panel covering 425 cancer-associated genes (GENESEEQPRIME). TMB is a predictive biomarker for the efficacy of immune checkpoint inhibitor therapy.

Prior to this, Geneseeq already had one NGS-based CDx kit for NSCLC, ESSENCARE (EGFR/ALK/ROS1/BRAF/KRAS/HER2 mutation testing kit), approved by the NMPA through the Breakthrough Medical Devices pathway. GENESEEQPRIME was also CE-IVD marked by the European Medicines Agency in August 2023 for detecting single nucleotide variants, gene amplifications/deletions, translocations, TMB, and microsatellite instability in patients with solid tumors.

тАЬThis approval will significantly benefit the clinical implementation of immunotherapy in China with a standardized TMB assessment assay,тАЭ Dr. Yang Shao, founder and CEO of Geneseeq Group, said in a statement.

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CE-Marked GENESEEQ multi-cancer minimal residual disease detection (Shielding ULTRA MRD) and GENESEEQ multi-cancer early detection (CanScan MCED) kits introduced earlier this year

The GeneseeqPrime kit utilizes a set of 437 genes linked to solid tumors and the reportable range includes single nucleotide variants (SNVs), insertions and deletions (indels), copy number variants (CNVs), gene translocations and large genomic rearrangements (LGR), as well as tumor mutational burden (TMB), microsatellite instability (MSI), and DNA mismatch repair (MMR) genes. This test provides clinically relevant data that informs and guides therapeutic decisions. It offers crucial insights into pivotal oncogenic genes and possible mechanisms of drug resistance. Apart from the data provided by GeneseeqPrime, the GeneseeqPrime HRD report also incorporates the homologous recombination deficiency (HRD) status that can be used for recommendations in PARP inhibitor treatments. The Hemasalus DNA/Hemarna RNA investigates genetic variations and translocations in 475 genes at the DNA level, while also identifying translocations in 232 genes at the RNA level. This kit aids with clinical diagnosis and facilitates treatment planning for individuals afflicted by hematological malignancies.

тАЬThe CE Mark validation for the GeneseeqPrime, GeneseeqPrime HRD, and Hemasalus DNA/Hemarna RNA kits underscores our dedicationтАЩs commitment to high quality testing standards on a global level,тАЭ said┬аDr. Xue Wu, CEO of Geneseeq Canada. ┬аThe Geneseeq cancer genetic testing kit encompasses a comprehensive assay kit for sequencing, an automated reporting system, and a seamless end-to-end service that covers assay setup and customer support. These kits will now be accessible to healthcare professionals in Europe, enabling them to formulate treatment plans for individuals affected by cancer.

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Here are the key highlights from these studies:

• Performance of cfDNA fragmentonics-based early detection models in gastric cancer and breast cancer populations. The findings shed light on the potential of this approach in improving early diagnosis and subsequent treatment outcomes.
• Novel drug resistance mechanism in ROS1-rearranged non-small cell lung cancer patients. This research provides valuable insights into the development of targeted therapies and the management of treatment resistance in this subset of patients.
• Comprehensive analysis of homologous recombination repair gene reversion mutations. By examining a large pan-cancer population, this study sheds light on the prevalence, clinical implications, and potential therapeutic implications of these mutations.

Abstracts of the studies to be presented:

• Multi-dimensional cell-free DNA-based liquid biopsy for sensitive early detection of gastric cancer.
• Detecting Early Stage Breast Cancer Using Low-Depth Cell-Free DNA Fragmentomics: A Multi-Center Cohort Study.
• Mechanisms of Resistance to Tyrosine Kinase Inhibitor Treatments in ROS1 Fusion-Positive Non-Small Cell Lung Cancer Patients.
• A four-tier classification system of studying homologous recombination repair gene reversion mutations as a mechanism of resistance to PARP inhibitors and platinum-chemotherapy.

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This study enrolled 87 NSCLC patients who underwent curative surgical resections (23 patients experienced relapses during follow-up). A total of 163 plasma samples were collected at 7 days and 6 months post-surgery and were used for both whole-genome sequencing (WGS). The WGS-based cell-free DNA (cfDNA) fragment profile was used to develop regularized Cox regression models, and the models’ performance was evaluated using leave-one-out cross-validation.

The ultra-sensitive and affordable fragmentomic assay has shown promising results in detecting patients who are at high risk of recurrence. The fragmentomic model was able to detect high-risk patients at 7 days and 6 months post-surgery with an increased risk of 4.6 times and 8.3 times, outperforming the targeted sequencing-based circulating mutations. The overall sensitivity for detecting patients with recurrence reached 78.3% while using both fragmentomics and circulating mutation results from 7 days and 6 months postsurgical, which increased from the 43.5% sensitivity by using only the circulating mutations.

тАЬThe non-invasive liquid biopsy assay can effectively detect landmark MRD, which could aid in making informed decisions for post-surgery treatment.тАЭ, says Dr. Hua Bao, author and director of Geneseeq Research Institute.

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