International oncology guidelines, such as those from NCCN, ESMO and CSCO, recommend the use of liquid biopsy as an alternative when tumor tissue samples are inaccessible. Currently, most approved NGS IVD kits on ChinaтАЩs market are designed for tumor tissue testing. GeneseeqтАЩs NGS liquid biopsy kit is capable of identifying mutations in multiple key tumor driver genes in a single test with world-leading detection performance, and provides companion diagnostics for a range of targeted therapies. This kit is expected to fill the gap and marks a pioneering step in ChinaтАЩs precision oncology healthcare.

The kit uses advanced non-invasive liquid biopsy testing technology to accurately identify tumor-driving mutations by analyzing circulating tumor DNA (ctDNA) in the blood, without the need for tumor tissue samples. As a valuable complement to traditional tumor tissue testing, it greatly assists clinicians for timely treatment-decision making and drives personalized precision medicine.

Dr. Xiaonan Wang, CTO of Geneseeq, stated, тАЬThis kit is the third NGS IVD product from Geneseeq to enter the NMPA Innovative Medical Device program, following the previous NMPA approvals of the тАШEGFR/ALK/ROS1/BRAF/KRAS/HER2 Mutation Detection KitтАШ and the тАШGeneseeqPrime NGS TMB Testing KitтАШ for tumor tissue testing. From 6 genes to 400+ genes, from tumor tissue to liquid biopsy testing, Geneseeq has always been patient-need driven, continuously exploring the translation of cutting-edge technologies into clinical practice. The successful inclusion of this kit in the Innovative Medical Device program highlighted GeneseeqтАЩs R&D strength and innovation capability in the field of precision medicine. We believe that with the continuous technology innovation and clinical application, more and more patients will benefit from the technological advancements for life quality improvement.тАЭ

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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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CanScan utilizes low-depth whole-genome sequencing (WGS) on circulating cell-free DNA (cfDNA) from a single tube of peripheral blood, extracting genetic and fragmentomic features to detect early cancer signals with 99% specificity and predict the tissue of origin (TOO) of cancers to help guide next steps for cancer diagnosis. CanScan exhibits promising potential to address unmet medical needs in clinical diagnosis and treatment, particularly for individuals aged 50 and above with an average risk of cancer. The test outperforms current standard of care (SOC) screening methods in common cancer types, such as prostate, lung and liver cancers. It also detects cancer types currently without effective SOC screening methods, such as esophagus, endometrial, gastric, pancreatic cancers and lymphoma.

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. CanScan is currently under real-world evaluation in the Jinling Cohort (NCT06011694), a large-scale prospective multi-center trial. The ongoing recruitment of 15,000 individuals for the phase I trial within the Jinling Cohort is approaching completion.

“The Jinling Cohort aims to further validate the technical performance of CanScan in the targeted screening population,” Dr.Xue Wu, Geneseeq Toronto’s CEO said in a statement, noting that “we will release more results of the Jinling Cohort in 2024.”

This FDA Breakthrough Device Designation follows the CanScan assay kit’s CE approval in January 2023, marking another significant recognition from an internationally authoritative institution.

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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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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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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. Cancer type-specific tests include gene panels informing treatment selection and assessing genetic predisposition in lung, breast, ovarian, prostate, and pancreatic cancers.

This deal is part of a companywide strategy at Geneseeq to work with domestic and international hospitals to improve access to advanced NGS technologies in research and clinical care. The company has implemented this model at partner hospitals more than 100 times.

тАЬNGS-based comprehensive testing is being increasingly used in cancer centers globally and the conversations around in-house testing are more prevalent than ever especially since the pandemic affected logistics and overall turnaround time at central testing labs,тАЭ Dr. Xue Wu, CEO of Geneseeq Canada said. тАЬCollaborating with Hospital de Base on this important project will allow us to improve access to NGS-based research tools and personalized oncology care for Brazilian patients on a large scale.тАЭ

тАЬWe are proud to team up with Geneseeq and leverage their expertise in NGS technologies. Hospital de Base will soon offer our patients a wide range of NGS-based services. It is certainly an exciting time for oncology at Sao Jose do Rio Preto and Sao Paulo.тАЭ said Dr. Daniel Araujo, the Medical Director of the Medical Oncology Division at Hospital de Base.

тАЬWe believe that this new partnership will create a whole new level of capacity in our lab that ultimately will give us much better care for our patients. The experience of our team and the NGS expertise of Geneseeq will be a game changer for the Hospital de Base,тАЭ said Dr. Mauricio Nogueira, the Laboratory Director of the NGS lab at Hospital de Base.

Dr. Jorge Fares, the Executive Director of Funfarme, the hospital foundation also commented, тАЬThis partnership is part of Hospital de Base┬┤s vision and long-term goal of offering our patients and community the best resources available for their treatments. We look forward to working with Geneseeq to achieve this goal.тАЭ

This long-term collaboration will support oncology clinical research and a precision oncology approach for cancer patients within the Brazilian healthcare system, the partners said.

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