The studies span multiple tumor typesтАФincluding pancreatic, biliary, renal, gastric, lung, ovarian, and esophageal cancersтАФand collectively demonstrate the power of GeneseeqтАЩs multi-omics platform, integrating whole-genome sequencing, fragmentomics, and AI-driven modeling for non-invasive cancer detection. In addition, SCENT-2 trial study, which was selected for oral presentation (Abstract #7006), evaluated the combination of sintilimab and chidamide followed by P-GemOx in treatment-na├пve ENKTL patients using Geneseeq Hemasalus panel.

All studies were conducted in collaboration with leading cancer centers and reflect GeneseeqтАЩs mission to transform oncology through integrated genomics and AI-powered innovation.

Featured Presentations at ASCO 2025:

About Geneseeq:

Geneseeq Technology Inc. (Geneseeq) is a research-driven leader in precision oncology, utilizing cutting-edge next-generation sequencing (NGS) technologies to advance cancer care. The company provides comprehensive genomic profiling solutions for all tumor types, including pan-cancer and cancer-specific panels, alongside cutting-edge tools for minimal residual disease (MRD) monitoring and multi-cancer early detection (MCED). Geneseeq has reached key regulatory milestones to date, including CE-IVD certification for its solid tumor and hematologic cancer panels, and FDA Breakthrough Device Designation for its MCED test, CanScan┬о. The company has also received approval from the National Medical Products Administration (NMPA) for GeneseeqPrime, designed for tumor mutational burden (TMB) detection in lung cancer.

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At AACR 2025, Geneseeq will showcase seventeen posters from both internal research and collaborative efforts, spanning minimal residual disease (MRD), cancer genomics, biomarker identification, and treatment responseтАФreinforcing our commitment to innovation and excellence across multiple domains, from discovery to clinical impact.

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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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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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This prospective study aims to enroll 405 surgical stage IA-IB NSCLC patients that will be randomized into standard-of-care subgroup and MRD-interfered subgroup with a follow-up period of three years. MRD status is determined by SHIELDING using the plasma samples collected after resection. In the standard-of-care subgroup, patients will receive standard-of-care treatment and follow-up MRD detection every six months. In the MRD-interfered subgroup, the patients are further stratified by MRD status. The MRD-positive patients will receive adjuvant therapy and follow-up MRD detection every three months while the MRD-negative patients will undergo observation and follow-up MRD detection every six months. The primary endpoint is to compare disease-free survival (DFS) between the standard-of-care subgroup and MRD-interfered subgroup, as well as DFS between MRD-positive and MRD-negative patients.

SHIELDING, launched in early 2021, is GeneseeqтАЩs first commercially available MRD product in China for clinical use in the management of early and mid-stage solid tumors.┬аThus far, Geneseeq has released the results of multiple studies evaluating the performance of SHIELDING in different early-stage solid tumors, demonstrating the substantial clinical value of MRD assessment.

тАЬThe initiation of the MOTION study further expands the evidence on clinical values of SHIELDING in real-world settings. WeтАЩre confident that the use of SHIELDING will benefit patients with improved disease outcomesтАЭ, says Dr. Xue Wu, the CEO of Geneseeq Technology Inc.

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The markings will enable Geneseeq to expand its global business operations and establish new partnerships in the European market.

The MRD detection kit (Shielding Ultra) 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.

In 2022, the council of the European Union has decided to improve cancer screening and strengthening cancer prevention through early detection¹.

“Obtaining the CE marks for both our MRD and MCED kits is an important milestone for Geneseeq to bring personalized liquid biopsy tests to patients worldwide,” said┬аDr. Xue Wu, Geneseeq Technology CEO.

About Geneseeq

Geneseeq is a research-driven company that focus on clinical genetic testing and translational research, covering all cancers and sample types. Geneseeq genomic testing services offer both pan-cancer panels analyzing 400+ genes and cancer-type specific gene panels to help match a patient to the optimal treatment. Last year, Geneseeq announced the progress of a large-cohort, prospective, early cancer screening clinical study named тАЬJinling CohortтАЭ at the Nanjing headquarters earlier. The study will recruit 100,000 participants, providing them with a sensitive yet cost-effective early screening test.

¹https://data.consilium.europa.eu/doc/document/ST-14770-2022-INIT/en/pdf

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This study included 128 stage I-III NSCLC patients who received curative surgical resection at the Jiangsu Oncology Hospital. Primary tumor and lymph node metastasis (LNM) samples were collected from surgeries as the standard of care. Plasma samples were collected pre-surgically, 7 days post-surgically, and every three months thereafter. Both tissue and plasma samples were sequenced using the 425-gene Geneseeqprime panel. A total of 645 tissue samples and 628 plasma samples were included in the analyses. The clonal phylogeny of each patient was reconstructed from multi-region tissue sequencing to aid the ctDNA detection.

Interestingly, patients with lung squamous-cell carcinoma displayed more frequent positive ctDNA results than those with lung adenocarcinoma. The detection rates positively correlated with TNM stages and LNM statuses. Smokers were more frequently ctDNA-positive than non-smokers pre-surgically, but not postsurgically. Notably, postsurgical ctDNA monitoring at as early as seven days after surgeries could indicate a high risk of recurrence (HR = 3.90, 95%CI: 1.85-8.20, P = 0.00011), independently of clinicopathological characteristics (multivariate-Cox: HR = 5.49, 95%CI: 1.86-16.20, P = 0.002). ctDNA detection at 3 months and 6 months could also serve as prognostic markers (3 months – HR = 4.32, 95%CI: 2.06-9.08, P < 0.0001; 6 months – HR = 6.19, 95%CI: 2.44-15.69, P < 0.0001). They remained statistically significant after adjusted for clinicopathological characteristics (multivariate-Cox: 3 months – HR = 4.17, 95%CI: 1.80-9.70, P < 0.001; 6 months – HR = 4.59, 95%CI: 1.68-12.50, P < 0.003). Longitudinal ctDNA detection accurately identified patients at high risk of recurrence (univariate-Cox: HR = 7.59, 95%CI: 3.53-16.32, P < 0.0001; multivariate-Cox: HR = 8.33, 95%CI: 3.59 -19.30, P < 0.001) and covered the majority of recurrence cases (73.5%, 25/34). In these cases, ctDNA MRD detection preceded radiographic relapse by a median of 145 days. The time intervals were similar in LUAD (144 days) and LUSC (150 days)

тАЬctDNA could serve as a promising biomarker for risk of recurrence in NSCLC patients who receive curative surgeries. Longitudinal ctDNA surveillance could reliably predict recurrence, opening a window of ~145 days for timely and optimal disease managementтАЭ, says Dr. Hua Bao, author and director of Geneseeq Research Institute.

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This study recruited 119 LARC patients who were treated with nCRT plus total mesorectal excision (TME) from the year 2016 to 2017, and serial plasma samples at baseline, during nCRT, and after surgery were collected and subjected to deep targeted-panel sequencing of 422 cancer-related genes. As the traditional MRI approach was not sufficient to predict pCR, researchers in this study compared different pCR prediction models that incorporate only ctDNA features, only MRI data, or the combination of ctDNA and MRI data.

Notably, by combining the results of ctDNA and MRI, the prediction model (AUC=0.886) demonstrated a superior capacity to predict pCR and non-pCR patients, compared with the models that only utilized one set of data (AUC=0.818 and 0.729, respectively). As a result, the newly developed combination model could more accurately assess the treatment response of nCRT. This could help patients access personalized subsequent treatment plans and help reach the optimal balance between quality of life and treatment efficacy. Moreover, the researchers discovered certain pathological risk features, as well as the detection of some diver genetic alterations in ctDNA, were highly correlated with disease recurrence, so these ctDNA and pathological features could be potentially used to predict patientsтАЩ prognosis for LARC.

тАЬAccurate predictions of response to therapy will direct patients to the most appropriate treatment regimes,тАЭ says Dr. Hua Bao, the Director of Research & Development at Geneseeq. Since 2017, Geneseeq continues to work on minimal residual disease (MRD) monitoring through its CALIBRATE^TM (monitoring post-surgery CAncer recurrence by ctDNA LIquid Biopsy RATing)^┬аprogram for colorectal cancer patients.

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This study recruited 276 stage II/III resectable CRC patients from 2017 to 2020, which is so far the largest cohort in published studies. Tumor tissue was collected at surgery, and serial blood samples were collected preoperatively within 1 week, postoperatively at 1 week, 6┬аmonths after surgery, and every 3┬аmonths thereafter for up to two years. All samples were analyzed using the GeneseeqPrime^TM 425-gene panel for targeted next-generation sequencing. Patients were treated and followed up per standard of care blindly to the MRD detection results.

Strikingly, ctDNA evaluation at as early as one week postoperatively was able to stratify patients with ctDNA detection who had remarkably high recurrence risk (hazard ratio [HR], 10.98, p<0.001). Likewise, at the first sampling time point after ACT, ctDNA-positive patients were ~12 times more likely to experience recurrence (HR=12.76, p<0.001). During surveillance after definitive therapy, ctDNA detection was also associated with extremely high recurrence risk (HR=32.02, p<0.001). Serial ctDNA analyses identified recurrence with a sensitivity of 83% and specificity of 94%, outperformed all other known clinicopathological risk factors, and could detect disease recurrence ahead of radiological imaging confirmation with a mean lead time of 5 months. In addition, dynamic ctDNA change provides a real-time indication of ACT efficacy.

тАЬctDNA evaluation in early postoperative phase during hospitalization would provide timely estimation of patientтАЩs recurrence risk and potentially facilitate decision-making of ACT for high-risk patientsтАЭ, says Dr. Hua Bao, author and the Director of Research & Development at Geneseeq.

Geneseeq announced CALIBRATE^TM, the MRD monitoring program using liquid biopsy in 2017. SHIELDING^TM, launched in early 2021, is GeneseeqтАЩs first commercially available MRD product in China for clinical use in the management of early and mid-stage solid tumors. The focus of the CALIBRATE^TM program has expanded beyond CRC patients with additional data on other cancer types to follow.

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