VC004 is a highly selective next-generation NTRK inhibitor developed to overcome acquired resistance to first-generation NTRK inhibitors in NTRK fusion-positive cancers. VC004 has shown excellent in vitro and in vivo activities, a manageable safety profile and promising efficacy. Currently, there are no commercially available next-generation NTRK inhibitors in China. The introduction of VC004 is poised to fill this significant gap in the market, offering a novel treatment option for patients.

Dr. Xiaonan Wang, Co-founder and CTO of Geneseeq, stated, тАЬThrough this deep strategic collaboration, we aim to accelerate the development and clinical application of innovative drugs in China. Our commitment is to provide patients with more treatment options, leading to greater survival benefits.”

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The following is a summary of our studies that will be presented at ASCO 2024я╝Ъ

Poster 1 (Bd# 276) A multi-center study for colorectal cancer early detection among patients with high-risk disease using a cell-free fragmentomics assay.

Poster 2 (Bd# 34) Leveraging cfDNA fragmentomic features in a stacked ensemble model for early detection of esophageal squamous cell carcinoma.

Poster 3 (Bd# 153) Fragmentomics of cell-free DNA as a sensitive biomarker for early detection of pancreatic cancer.

Poster 4 (Bd# 83) Molecular characterization and biomarker identification in pediatric B-cell acute lymphoblastic leukemia.

Poster 5 (Bd# 460) Genomic profiling of non-small cell lung cancer with rare aberrations in EGFR codon L858 and the survival outcome under real-world first-line EGFR tyrosine kinase inhibitor treatment compared to classic EGFR^L858R

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Geneseeq’s mini-oral presentations will release the most recent results from multi-cancer early detection(MCED) case-control study and the тАЬJinling cohort,тАЭ a 15,000-participant perspective MCED cohort study. In addition to the mini-oral presentations, Geneseeq will present ten posters featuring a diverse range of studies covering various aspects of minimal residual disease (MRD), cancer genomics and biomarker identification.

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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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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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Immunotherapy has shown promising results in multiple cancer types, including melanoma, lung cancer, and gastric cancer by harnessing the body’s own immune system to fight cancer. Early-phase clinical trials (PhaseI/II) develop effective immunotherapies by evaluating dose-limiting toxicities and antitumor activity to establish the recommended phase 2 dose (RP2D) for further clinical development. Early changes in circulating tumor DNA (ctDNA) levels over time (kinetics) have been shown to associate with long-term treatment outcomes in patients receiving chemotherapy and targeted therapy. Similar findings have been observed in patients treated with immunotherapy (IO), including immune checkpoint inhibitors (ICIs) targeting programmed cell death 1 (PD-1) or programmed cell death ligand 1 (PD-L1) in melanoma, lung, and gastric cancers.

In this study, the Princess Margaret Cancer Centre researchers analyzed plasma samples from 81 patients with advanced solid tumors who were being treated with investigational immunotherapy agents in 37 different Phase I/II trials. Using the GeneseeqPrime panel, the researchers evaluated the variant allele fraction (VAF) of mutations in ctDNAs at baseline and before the second cycle of treatment (3-4 weeks) with a sequencing depth of around 5000X. ctDNA was present in 75.3% of the samples and a decreased mean VAF(mVAF) from baseline to pre-cycle 2 was associated with longer progression-free survival and overall survival compared to an increased mean VAF. This overall survival increased significantly when there was a greater than 50% decrease in mean VAF. Interestingly, the researchers did not find significant differences in the median mVAF change rate between patients with hyper progressive disease and those with stable or responding diseases.

тАЬOur results suggest that very early changes in ctDNA levels, as determined by a tumor-naive assay, may be a useful predictor of treatment benefit in phase I/II immunotherapy trials. This approach may help identify responders to immunotherapy at an early stage, allowing for the optimization of treatment strategies and improving patient outcomesтАЭ, says Dr. Qiuxiang Ou, author and associate director of Geneseeq Research Institute.

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Highlights of these studies include:

• Data on GeneseeqтАЩs new algorithms based on cfDNA fragmentomics features to predict the outcomes of prostate cancer patients as well as to detect lung cancer brain metastases, pulmonary malignancy, and disease progression.
• Two large cohort studies unraveled the landscape of pathogenic/likely pathogenic germline alterations at pan-cancer scale and lung cancer scale.
• Multi-omics analysis of rare cancer populations including fetal adenocarcinoma of the lung and acral melanoma.

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

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