GENESEEQ TECHNOLOGY


Associated tags: DNA, Medical imaging, Circulating tumor DNA, Nucleic acid thermodynamics, Neoplasm, CNV, Patient, Cancer

Locations: ONTARIO, EUROPEAN UNION, EUROPE

FDA Grants Breakthrough Device Designation for Geneseeq's Multi-cancer Early Detection Solution

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Wednesday, January 3, 2024
Food, Nucleic acid thermodynamics, Risk, Multimedia, FDA, Lung, Cancer, Ageing, Trial of the century, DNA, Prostate, Esophagus, WGS, SOC, Lymphoma

TORONTO, Jan. 3, 2024 /PRNewswire/ - Geneseeq announced that its multi-cancer early detection solution, CanScan™, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).

Key Points: 
  • TORONTO, Jan. 3, 2024 /PRNewswire/ - Geneseeq announced that its multi-cancer early detection solution, CanScan™, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).
  • 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.
  • 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.

Geneseeq Gains CE Marks for NGS-based Test Kits for Solid Tumors and Hematological Cancer

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Tuesday, August 22, 2023
Genetically modified food in the European Union, DNA, MMR, CE marking, TMB, LGR, Microsatellite instability, HRD, Bone marrow, NGS, Cancer, DNA mismatch repair, Multimedia, RNA, CNV, Drug resistance, Chromosomal translocation, MSI, Genetic testing, SNV calling from NGS data, PARP, Gene, Vaccine

TORONTO, Aug. 22, 2023 /PRNewswire/ - 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.

Key Points: 
  • TORONTO, Aug. 22, 2023 /PRNewswire/ - 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.
  • In addition to the 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 , Geneseeq currently offers five CE-marked cancer genetic testing kits tailored for various clinical situations.
  • These kits will now be accessible to healthcare professionals in Europe, enabling them to formulate treatment plans for individuals affected by cancer.

Geneseeq receives CE Marks for MRD and MCED tests

Retrieved on: 
Tuesday, January 24, 2023
Circulating tumor DNA, Patient, Daou Technology Inc., DNA, MRD, Neoplasm, Nucleic acid thermodynamics, Council of the European Union, ATG, CE, Liquid biopsy, Medical imaging

TORONTO, Jan. 24, 2023 /PRNewswire/ -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.

Key Points: 
  • TORONTO, Jan. 24, 2023 /PRNewswire/ -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 markings will enable Geneseeq to expand its global business operations and establish new partnerships in the European market.
  • 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.
  • "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 Dr. Xue Wu, Geneseeq Technology CEO.

Geneseeq Publishes Promising Early Lung Cancer Detection Results in AJRCCM

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Tuesday, November 15, 2022
American Journal of Respiratory and Critical Care Medicine, Circulating tumor DNA, DECIPHER, Plasma, Survival, Clinical Laboratory, Nanjing Medical University, EDM, Squamous cell carcinoma, Neoplasm, AUC, CLIA, ISO, College of American Pathologists, Cancer, College, BPM, Adenocarcinoma, Trial of the century, Multimedia, FSC, FSD, Program, American Journal, Lung cancer, Patient, Nucleic acid thermodynamics, DNA, CNV, WGS, Critical Care Medicine (journal), Machine learning, Medical imaging, Pharmaceutical industry

TORONTO, Nov. 15, 2022 /PRNewswire/ - Geneseeq Technology Inc. ("Geneseeq"), a company focused on advancing cancer genomic profiling through cutting-edge next-generation based technologies, today 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).

Key Points: 
  • TORONTO, Nov. 15, 2022 /PRNewswire/ - Geneseeq Technology Inc. ("Geneseeq"), a company focused on advancing cancer genomic profiling through cutting-edge next-generation based technologies, today 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).
  • Geneseeq has extensively evaluated a multi-dimensional, early cancer detection model based on cfDNA fragmentomics and achieved consistent and excellent performance.In this study, Geneseeq and Jiangsu Cancer Hospital demonstrated the high predictability, stability, and robustness of this model in a early-stage lung cancer population, including patients with extremely low circulating tumor DNA (ctDNA) levels.
  • The remarkable performance of our early cancer detection model has given us confidence in its real-world and clinical application", says Dr. Hua Bao, author and the director of Geneseeq Research Institute.
  • With a series of DECIPHER early cancer detection studies published in high-impact journals, Geneseeq also announced the progress of a large-cohort, prospective, early cancer screening clinical study named "Jinling Cohort" at the Nanjing headquarters earlier this year.