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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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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GeneseeqтАЩs comprehensive genomic profiling panel, GeneseeqPrime^┬о, analyzes genomic alterations in 425 cancer-related genes and assesses key biomarkers, such as tumor mutation burden (TMB) and microsatellite instability (MSI).┬а This pan-cancer panel screens for actionable clinical next steps to therapy by providing valuable insight into key oncogenic genes and drug resistance mechanisms. In Jan 2020, GeneseeqтАЩs TMB Testing Kit in non-small cell lung cancer (NSCLC) became the first comprehensive NGS panel entered into the Breakthrough Medical Devices Program of Chinese National Medical Products Administration (NMPA).

Geneseeq will conduct all analytical, pre-clinical, clinical and other necessary testing studies using IVD instruments and components supplied by Illumina in order to develop and commercialize the IVD kits. The IVD kits will be made available directly to current and future patients acquiring testing services from Geneseeq, as well as testing centers in hospitals. According to Dr. Xue Wu, CEO and co-founder of Geneseeq Toronto, this collaboration will deliver streamlined workflow and produce accurate testing results rapidly. This will help more cancer patients access critical information to optimize their treatment plans, and benefit from precision medicine.

тАЬWeтАЩre pleased to extend our collaboration with Geneseeq to develop assays based on the newly approved NextSeq 550Dx in China.тАЭ said Li Qing, Vice President & General Manager of Greater China at Illumina. тАЬTogether with partners such as Geneseeq, we are able continuously bring in innovative NGS testing products to patients in China, and ultimately help them by unlocking the power of genome.тАЭ

This is the second time that the two companies joined forces to accelerate clinical availability in precision medicine for cancer patients. In 2018, the two companies collaborated on the NMPA approval of the IVD kit, Essencare┬о(EGFR/ALK/ROS1/BRAF/KRAS/HER2 mutation testing kit, Reversible terminator sequencing) for NSCLC.

About Geneseeq

Geneseeq is a research-driven company providing cutting-edge NGS technology to accelerate precision cancer care, with headquarters located in Canada and China. We offer both pan-cancer panels analyzing 400+ genes and cancer-type specific gene panels to help match patients to optimal treatments, including targeted therapy and immunotherapy. Our CAP/CLIA/ISO15189-accredited Chinese site is equipped with multiple advanced NGS sequencing platforms and has sequenced 420,000+ clinical samples. For more information, please follow us on Linkedin┬аand┬аTwitter.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Its focus on innovation has established it as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Its products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit┬аwww.illumina.com┬аand connect with Illumina on┬аTwitter,┬аFacebook,┬аLinkedIn,┬аInstagram, and┬аYouTube.

For any further inquiries related to our┬аproduct and services, please contact partnership.toronto@geneseeq.com.

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