COMPANY:

Geneseeq

"Geneseeq Technology Inc. announced...its partnership with Jiangsu Vcare PharmaTech to develop a companion diagnostic (CDx) kit and advance the product launch of Vcare’s pan-neurotrophic tyrosine receptor kinase (NTRK) inhibitor VC004 in China."

"Geneseeq will participate in the ASCO with five interesting topics covering the identification of novel biomarkers and early detection of diverse cancer types."

"Geneseeq’s mini-oral presentations will release the most recent results from its multi-cancer early detection (MCED) trial, the 'Jinling cohort,' and the associated MCED case-control 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, biomarker identification, and treatment response."

"Geneseeq announced that its multi-cancer early detection solution, CanScan™, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA)...Built on Geneseeq’s highly sensitive MERCURY™ multi-omics technology, the performance of CanScan™ has been validated in large-scale clinical study series, DECIPHER (Detecting Early Cancer by Inspecting ctDNA Features), in over thirteen cancer types."

"Geneseeq Technology Inc. is excited to share four collaborated studies at the 2023 European Society for Medical Oncology (ESMO) annual meeting from October.20th-24th at Madrid, Spain...Highlights of these studies include:...Data on Geneseeq’s cfDNA fragmentomics model to predict the risk of colorectal cancer..."

"Geneseeq Technology Inc. announced on Thursday that Geneseeq's Non-Small Cell Lung Cancer Tumor Mutational Burden Test Kit (Reversible terminator sequencing method) (NSCLC TMB Kit) has gained approval from the Chinese National Medical Products Administration (NMPA) on October 12, 2023 as a Breakthrough Medical Device....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™)."

"Geneseeq will share three mini-oral presentations and five poster studies at the World Conference on Lung Cancer (WCLC) 2023, which will be held on September 9-12th, 2023 in Singapore. These Geneseeq-collaborated studies cover novel prognostic and predictive biomarkers in lung cancer, molecular characterization of prognosis-related lung cancer subtypes, and multi-omics analysis of lung cancer genomic and transcriptomic features."

"Geneseeq Technology Inc. has announced that three of our next-generation sequencing (NGS)-based cancer genetic testing kits, GENESEEQPRIME NGS Tumor Gene Detection Kit (GeneseeqPrime ™), GENESEEQ Homologous Recombination Deficiency Detection Kit (GeneseeqPrime™ HRD), and GENESEEQ Blood Cancer Gene Detection Kit (Hemasalus™ DNA/Hemarna™ RNA), have obtained the European Union's CE Mark approval. These approvals signify that GeneseeqPrime™ and GeneseeqPrime™ HRD are suitable for solid tumor genomic profiling, while Hemasalus™ DNA/Hemarna™ RNA is cleared for hematological cancer genomic profiling."

"Geneseeq Technology Inc. is set to present four collaborative studies at the 2023 American Society of Clinical Oncology (ASCO) annual meeting, scheduled to take place in Chicago from June 2nd to 6th. These studies, which will be presented both in-person and virtually, highlight significant findings related to various types of solid tumors."

"Researchers from Jiangsu Cancer Hospital and Nanjing Geneseeq Technology Inc. recently released a prospective study in Cancer Research Communication that expands on the clinical value of DNA fragmentomic characteristics in MRD identification for post-surgical NSCLC patients...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."

"Geneseeq co-published a study with Princess Margaret Cancer Centre in the JCO Precision Oncology journal, investigating the use of ctDNA as a prognostic biomarker for immunotherapy in early-phase clinical 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."

"Geneseeq Technology Inc. is happy to share 13 collaborated studies at the 2023 American Association for Cancer Research (AACR) annual meeting from April.14th-19th in Orlando onsite and virtually...Highlights of these studies include:...Data on Geneseeq’s 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."

"Geneseeq Technology Inc. has announced the initiation of the MOTION study in collaboration with ten clinical sites to evaluate the performance of Geneseeq’s minimal residual disease test SHIELDING™ in patients with operable early-stage non-small cell lung cancer (NSCLC)."

"Geneseeq Technology Inc. announced that Geneseeq’s multi-cancer minimal residual disease detection (MRD) and multi-cancer early detection (MCED) kits were both CE Marked for liquid biopsy use in solid tumor patients...The MRD detection kit (Shielding™) employs ultra-deep sequencing technology ATG-SEQ™ to detect low amounts of circulating tumor DNA (ctDNA) in the peripheral blood post-surgical intervention...For early cancer detection, the in vitro diagnostic kit uses highly sensitive next-generation sequencing-based technology MERCURY™ to assess multi-omics features of circulating free DNA (cfDNA) and detect tumorigenesis in health population."

P=NA | N=782 | "Geneseeq Technology Inc...announced high-performing results from a lung cancer study testing the company's early cancer detection model through program DECIPHER (Detecting Early Cancer by Inspecting ctDNA Features)....The model showed a high area under the curve (AUC) of 0.984, 0.987, and 0.974 for differentiating lung cancer patients from healthy individuals in the three validation cohorts. The model's robustness, repeatability and reproducibility were also tested, yielding great performance results. Most notably, the model can identify both squamous cell carcinoma and adenocarcinoma with a 93.3% and 87.0% sensitivity, at a 95.0% specificity. 'It is also sensitive to early pathological features, with a sensitivity of 83.2% at 95.0% specificity for stage I lung cancer, and a sensitivity of 85.0% for tumors less than 10mm'."

"A recent prospective study published in the Journal of Clinical Chemistry, led by the Shanghai Fudan University Cancer Center and Geneseeq Technology Inc., demonstrated the clinical utility of cell-free DNA 5’-end motif profile in the prediction of pCR in LARC patients undergoing nCRT treatment...The extracted cell-free DNAs (cfDNAs) were subjected to targeted deep sequencing of 422 cancer-related genes at an average depth of 4000X, and cfDNA 5’-end motif profiles were extracted to construct an elastic-net logistic regression model to predict non-pCR status before surgery."

"A recent prospective study published in the Drug Resistance Updates, led by Sun Yat-sen University Cancer Center and Geneseeq Technology Inc. demonstrated that the analysis of ctDNA points to drug resistance mechanisms to the combination of vemurafenib, irinotecan, and cetuximab (VIC) in BRAFV600E mCRC patients, allowing accurate guidance for clinicians in personalized treatment strategies...Tissue and plasma samples were profiled using whole-exome sequencing and the 425-gene Geneseeqprime panel sequencing, respectively."

"A recent prospective study published in the Journal of Hematology & Oncology, led by Jiangsu Oncology Hospital and Geneseeq demonstrated the clinical utility of longitudinal ctDNA monitoring in MRD detection and prognosis prediction in patients with resectable NSCLC...Both tissue and plasma samples were sequenced using the 425-gene Geneseeqprime panel."

"With a mission to expand the boundaries of cancer care, the annual European Society for Medical Oncology (ESMO) Congress will be held both in person in Paris, France, and virtually on September 9th...This year, Geneseeq continuously shares more interesting discoveries made in cancer detection, diagnosis and monitoring...Abstract 1681P Testing the generalizability of cfDNA fragmentomic features across different studies for cancer early detection"

"The World Conference on Lung Cancer (WCLC) is the world’s largest international meeting on lung cancer and thoracic oncology, which will be held on August 6~9th 2022. In this exciting gathering of clinicians and researchers, Geneseeq will be sharing a poster discussion and five poster presentations...Poster EP16.02-024...Plasma ctDNA Organ-Specific Genomic Patterns and Origination Analysis in Advanced Non-Small Cell Lung Cancer..."

"Geneseeq is teaming up with Hospital de Base in Sao José do Rio Preto, Brazil to build an NGS-based precision oncology diagnostic lab in-house to advance clinical research and offer comprehensive genetic testing to cancer patients in Brazil. Under the terms of the agreement, Geneseeq and Hospital de Base will co-build the NGS lab and establish a variety of Geneseeq’s NGS-based genomic profiling tests, consisting of comprehensive pan-cancer gene panels and cancer type-specific gene panels...The comprehensive panel GeneseeqPrime analyzes 437 cancer-related genes across all solid tumors while reporting microsatellite instability (MSI) and tumor mutation burden (TMB). GeneseeqPrime HRD, a test that integrates GeneseeqPrime with homologous recombination deficiency (HRD) score evaluation to inform the treatment selection of PARP inhibitors will also be available."

"The liquid biopsy-based cell-free DNA (cfDNA) analysis has emerged recently as a promising non-invasive approach to the clinical practice of disease detection. A study from our research program DECIPHER (Detecting Early Cancer by Inspecting ctDNA Features) published in the journal of Ebiomedicine, led by the Chinese Academy of Medical Sciences, Peking Union Medical College, and Geneseeq Technology Inc., has developed a new machine learning model for sensitive detection of stage I lung adenocarcinoma (LUAD) using cfDNA breakpoint motif feature."

"Combining Geneseeq’s early screening technology MERCURY and a multi-dimensional fragmentomics model, we have published a series of early screening studies under the DECIPHER (Detecting Early Cancer by Inspecting ctDNA Features) program and showed excellent performance in different cancer types...The cancer origin model demonstrated an overall 93.1% accuracy for predicting cancer origin in the test cohort (97.4%, 94.3%, and 85.6% for PLC, CRC, and LUAD, respectively)."

"Geneseeq will participate in the ASCO with eight interesting topics spanning novel biomarkers for immunotherapy, early detection, minimal residue disease as well as the impact of psychological distress on the disease outcome of the patients."

"A recent prospective study published in the journal of Molecular Cancer led by the Chinese Academy of Medical Sciences and Geneseeq Technology Inc., demonstrated the time-dependent clinical utility of circulating tumor DNA (ctDNA) to detect the minimal residual disease (MRD) and predict prognosis in CRT-treated inoperable localized NSCLC patients."

"Geneseeq and collaborators are excited to present nine posters at the American Association for Cancer Research (AACR) 2022 (April 8, 2022, 12:00PM-1:00PM)...Using Geneseeq’s next-generations sequencing (NGS) gene panels, we’re able to identify novel genomic biomarkers to inform treatment strategies across different cancers...The genomic features and known biomarkers are comprehensively evaluated among different cancer subtypes and age-associated subgroups, which are also of potential value to the patients."

"Geneseeq and Shanghai Fudan University, Zhongshan Hospital published a prospective study in Hepatology further expanding the usage of Geneseeq’s MERCURY technology, a novel multi-dimensional fragmentomics approach, in the DECIPHER (Detecting Early Cancer by Inspecting ctDNA Features)-liver program."

"In the CALIBRATE(monitoring post-surgery CAncer recurrence by ctDNA LIquid Biopsy RATing)-NSCLC program, Geneseeq and the Chinese Academy of Medical Sciences published a recent prospective study in Nature Communications, employing SHIELDING, Geneseeq’s newly launched MRD product to dynamically monitor residual circulating tumor DNA (ctDNA) in non-small cell lung cancer (NSCLC) patients who received surgery with/without adjuvant chemotherapy (ACT). The researchers demonstrated pioneering works of using residual ctDNA to guide ACT and applying cutting-edge mathematical models to predict recurrence risk."

"Geneseeq was invited by Takeda Pharmaceutical...to participate in the launch ceremony of the Takeda Lung Cancer Diagnosis and Treatment Alliance to sign off on the two companies’ strategic partnership. The companies jointly stated that they will actively respond to the overall requirements of China’s 'Precision Medicine Plan', advance lung cancer precision medicine development, standardize precision diagnostics in clinical care, and improve patient access to personalized medicine."

"Geneseeq and Shanghai Fudan University Cancer Center published a prospective study in the Journal of Hematology & Oncology applying Geneseeq’s MERCURY technology, a novel multi-dimensional fragmentomics approach, to demonstrate a powerful ability to detect the early-stage CRC (stage 0/I) and advanced colorectal adenoma (advCRA). This is by far the largest cohort study conducted on stage 0/I CRC early detection by liquid biopsy."

"Geneseeq Technology Inc...and Zai Lab, Ltd....announce new strategic collaboration in Shanghai, China. The companies will collaborate to facilitate the R&D and commercialization of Zai Lab's cancer drugs through business partnerships in clinical trial patient recruitment, central laboratory testing, companion diagnostics development and marketing activities."