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14d
QIAGEN strengthens its portfolio for cancer research, showcasing latest product launches at AACR Annual Meeting 2024 (GlobeNewswire)
"...Three new products, along with the IVD version of QIAGEN’s digital PCR platform QIAcuity set for launch in mid-2024, are to be featured at the annual meeting of the American Association for Cancer Research....The newly launched QIAcuity dPCR PanCancer Kits will allow researchers using QIAGEN’s QIAcuity dPCR system to detect multiple EGFR and BRAF hallmark mutations at the same time and with high sensitivity....To advance research on how the immune system interacts with cancer, QIAGEN has introduced the QIAseq Targeted RNA-seq Panel for T-cell receptors....The PAXgene Urine Liquid Biopsy Set currently being developed by PreAnalytiX, a QIAGEN and BD joint venture, will launch later this year....QIAGEN will also highlight at the AACR meeting the upcoming launch of the QIAcuity system for IVD testing - the expansion of its digital PCR technology from research to the clinical setting."
Clinical data
3ms
QIAGEN Digital Insights launches ultra-fast NGS analysis for somatic cancer (Qiagen)
"QIAGEN Digital Insights (QDI), the bioinformatics business of QIAGEN, today announced their enhanced QIAGEN CLC Genomics Workbench Premium with LightSpeed technology now supports next-generation sequencing (NGS) for somatic cancer secondary analysis. The software accelerator converts raw sequencing data in FASTQ files to interpretable lists of genetic variants in VCF files at unprecedented low cost and high speed."
Launch
6ms
QIAGEN and Element Biosciences partner to offer complete next-generation sequencing workflows for the AVITI System (Qiagen)
"QIAGEN...and Element Biosciences...announced a strategic partnership to offer comprehensive next-generation sequencing (NGS) workflows for the Element AVITI™ System, an innovative sequencing platform."
Licensing / partnership
6ms
Qiagen and Myriad Genetics partner to advance companion diagnostics development for cancer (Myriad Genetics Press Release)
"QIAGEN...and Myriad Genetics...announced a new master collaboration agreement to develop companion diagnostic tests in the field of cancer...The partnership aims to deliver innovative services and products to pharmaceutical companies, enabling the development and commercialization of proprietary cancer tests for the U.S. clinical market, and providing distributable companion diagnostic test kits for the global market."
Licensing / partnership
6ms
Tecan sues Qiagen, Invitae, others for patent infringement (Genomeweb)
"Tecan has sued Invitae, ArcherDx, Integrated DNA Technologies, and Qiagen for allegedly infringing on patents related to nucleic acid enrichment and high-throughput sequencing methods...Tecan asserts in the first complaint that its technology underlies what Invitae, ArcherDx, and IDT refer to as their Anchored Multiplex PCR (AMP) target enrichment technology, which is found in Invitae's Personalized Cancer Monitoring (PCM) service and in ArcherDx's LiquidPlex, VariantPlex, and FusionPlex kits."
Patent
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LiquidPlex™ • Personalized Cancer Monitoring (PCM™)
8ms
QIAGEN receives FDA approval for companion diagnostic to Blueprint Medicines’ AYVAKIT (avapritinib) in gastrointestinal stromal tumors (GlobeNewswire)
"QIAGEN...announced the U.S. Food and Drug Administration (FDA) approval of its therascreen PDGFRA RGQ PCR kit (therascreen PDGFRA kit). This companion diagnostic is intended for use to aid clinicians in identifying patients with gastrointestinal stromal tumors (GIST) who may be eligible for treatment with AYVAKIT® (avapritinib), which is approved in the U.S. for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. The kit is the first platelet-derived growth factor receptor alpha (PDGFRA) assay to receive FDA approval as a companion diagnostic."
FDA event
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therascreen PDGFRA RGQ PCR kit
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Ayvakit (avapritinib)
9ms
Bio-Rad and QIAGEN announce patent settlement and cross-licensing agreement (Qiagen)
"Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) and QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the companies have agreed to settle their patent dispute pending in the U.S. District Court of Delaware pursuant to a global settlement and patent cross-licensing agreement relating to digital PCR technology."
Patent
10ms
Danish National Genome Center selects QIAGEN for variant interpretation in oncology genome sequencing (Qiagen)
"QIAGEN...announced that its variant interpretation and reporting software, QIAGEN Clinical Insight (QCI) Interpret, is being deployed as a part of a national initiative in Denmark to offer sequencing-based solutions for cancer patients." "
Commercial
1year
QIAGEN showcases latest technologies to advance cancer research at AACR Annual Meeting 2023 (GlobeNewswire)
"QIAGEN...announced the launch of QIAseq Targeted cfDNA Ultra Panels that will enable researchers studying cancer and other diseases to turn cell-free DNA (cfDNA) liquid-biopsy samples into libraries ready for next-generation sequencing (NGS) in less than eight hours. The new kit adds another innovation to the QIAseq Targeted DNA product portfolio. It will be one of the central features of QIAGEN’s life-science offering at the 2023 annual meeting of the American Association for Cancer Research (AACR) in Orlando, Florida, from April 14 to 19, 2023."
Clinical
1year
Servier Announces Partnership with QIAGEN to Develop New mIDH1 Companion Diagnostic Test to Support Servier’s Onco-hematology Portfolio (PRNewswire)
"Servier...today announced it has entered into a strategic partnership with QIAGEN...to develop a companion diagnostic test that detects IDH1 mutations. This test will be for use with Servier's marketed and investigational targeted treatments in Acute Myeloid Leukemia (AML)....QIAGEN and Servier are collaborating to develop a PCR-based companion diagnostic test that can be used to rapidly identify AML patients with IDH1 gene mutations. This partnership comes in the light of the published pivotal clinical phase 3 data of the AGILE study which showed that ivosidenib in combination with azacitidine as a first-line treatment for intensive chemotherapy ineligible AML patients with IDH1 gene mutations shows superior results compared to treatment with azacitidine alone."
Licensing / partnership
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Tibsovo (ivosidenib)
1year
SOPHiA GENETICS and QIAGEN Forge Partnership to Combine Strengths in Next-generation Sequencing (Businesswire)
"SOPHiA GENETICS...announced a new partnership with QIAGEN...that will pair QIAseq reagent technology with the SOPHiA DDM™ platform to enhance tumor analysis through next-generation sequencing (NGS). The partnership will allow customers to order QIAseq panels that can be processed through SOPHiA DDM™, a cloud-based platform that analyzes data from various sources to enable entirely new research perspectives. The partnership will initially support somatic variant detection (an alteration in DNA that occurs after birth) using QIAseq Targeted DNA Pro panels for homologous recombination repair (HRR), a special type of biomarker test to find tumors that have certain mutations that may make them sensitive to PARP inhibitors in oncology."
Licensing / partnership
over1year
QIAGEN receives FDA approval for companion diagnostic to Mirati Therapeutics’ KRAZATI in non-small cell lung cancer (Qiagen)
"QIAGEN...has announced the U.S. Food and Drug Administration (FDA) approval of its therascreen® KRAS RGQ PCR kit (therascreen KRAS kit) as a companion diagnostic test to Mirati Therapeutic’s drug KRAZATI® (adagrasib) for non-small cell lung cancer (NSCLC)...The tissue based KRAS companion diagnostic assay, which QIAGEN developed specifically to identify patients with NSCLC that have a KRAS G12C mutation, is instrumental in determining who may benefit from treatment with KRAZATI....With the new approval of therascreen KRAS for NSCLC, QIAGEN has eleven PCR based companion diagnostic indications that are FDA approved – the broadest portfolio of IVD approved PCR based companion diagnostics on the market."
FDA event
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therascreen® KRAS RGQ PCR Kit
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Krazati (adagrasib)
over1year
Qiagen Korea scores local permit for companion diagnostic of Janssen's Balversa (Korea Biomedical Review)
"Qiagen Korea said on Friday it received domestic approval from the Ministry of Food and Drug Safety for Korea's first companion diagnostic (CDx) that can detect FGFR 3 (fibroblast growth factor receptor 3) gene mutations in urothelial cancer patients...With the approval of the therascreen FGFR kit, patients with urothelial cancer can more accurately and safely test for the FGFR 3 gene and receive more appropriate and effective treatment according to their specific genetic mutations..."
Non-US regulatory
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therascreen® FGFR RGQ RT-PCR Kit
over1year
QIAGEN gains CE-marking for in-vitro diagnostic kit and its automated testing platform NeuMoDx under new EU IVDR framework (Qiagen Press Release)
"QIAGEN N.V...today announced the certification of its leading in-vitro diagnostic (IVD) kit and its fully automated NeuMoDx platforms under the European Union’s new In-Vitro Diagnostic Medical Devices Regulation (IVDR) replacing the previous IVDD rules since May. The ipsogen JAK2 RGQ PCR Kit used for myeloproliferative neoplasms (MPN), a certain type of blood cancer, is now QIAGEN’s first IVD kit with IVDR CE-marking under Class C."
European regulatory
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Ipsogen JAK2 RGQ PCR Kit
over1year
QIAGEN clinical insights interpret one outperforms human NGS somatic variant interpretation in scientific research paper (Qiagen Press Release)
"QIAGEN Digital Insights...announced the publication in the Journal of Molecular Pathology of an externally facilitated clinical NGS interpretation validation study, demonstrating that its clinical decision support software, QIAGEN Clinical Insight Interpret One (QCI Interpret One), achieves a higher level of concordance with a panel of experts than human reviewers achieve amongst each other...The study commissioned by QDI and carried out independently by Genomics Quality Assessment (GenQA), investigated classification of variants reported from oncology patient samples."
Clinical
almost2years
Sysmex forms strategic alliance with QIAGEN to provide global cancer companion diagnostics that uses ultra-sensitive liquid biopsy NGS technology (Sysmex Press Release)
"Sysmex Corporation...has announced today that it has formed a global strategic alliance with QIAGEN N.V...for the development of cancer companion diagnostics...Sysmex is working to strengthen its global relationship with pharmaceutical companies in order to develop companion diagnostics and timely launch them by capitalizing on Plasma-Safe-SeqS technology, a liquid biopsy developed by Sysmex using a next-generation sequencer (NGS), while leveraging QIAGEN’s experience in developing companion diagnostics."
Licensing / partnership
almost2years
Sysmex Inostics & QIAGEN highlight cancer companion diagnostics alliance at ASCO 2022 (PRNewswire)
"QIAGEN...and Sysmex Inostics combined forces in July 2021 to accelerate global companion diagnostic access. QIAGEN provides unparalleled global custom cancer companion diagnostics (CDx) development and commercialization capabilities utilizing Sysmex Inostics ultra-sensitive NGS liquid biopsy technology...will present the poster "Plasma RAS dynamics and anti-EGFR rechallenge efficacy in patients with RAS/BRAF wild-type metastatic colorectal cancer: REMARRY and PURSUIT trials." Circulating tumor DNA (ctDNA) was analyzed and monitored using the Sysmex Inostics OncoBEAM™ RAS CRC Kit."
Clinical
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OncoBEAM RAS CRC kit
almost2years
Qiagen gets CE Mark for Therascreen EGFR Plus RGQ Kit for Non-Small Cell Lung Cancer (Genomeweb)
"Qiagen said Tuesday that it has obtained the CE mark for the Therascreen EGFR Plus RGQ PCR Kit — an in vitro diagnostic test for EGFR mutation analysis in non-small cell lung cancer — and has launched the assay in 11 countries that accept the designation."
Launch • European regulatory
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therascreen® EGFR Plus RGQ PCR Kit
2years
Regulator OKs Qiagen Korea's NSCLC mutation detection kit (Korea Biomedical Review)
"The Ministry of Food and Drug Safety has approved Qiagen Korea’s therascreen KRAS RGQ PCR Kit, the first companion diagnostic genetic test reagent to detect KRAS G12C gene mutations in patients with non-small cell lung cancer (NSCLC)."
Regulatory
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therascreen® KRAS RGQ PCR Kit
2years
Regulator OKs Qiagen Korea’s NSCLC mutation detection kit (Korea Biomedical Review)
"The Ministry of Food and Drug Safety has approved Qiagen Korea’s therascreen KRAS RGQ PCR Kit, the first companion diagnostic genetic test reagent to detect KRAS G12C gene mutations in patients with non-small cell lung cancer (NSCLC). The ministry based its approval on a clinical study conducted with Amgen's Lumakras (Ingredient: sotorasib) and the therascreen kit....Qiagen's kit can detect KRAS G12C mutation in tumor tissue samples from NSCLC patients through real-time PCR."
Non-US regulatory
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therascreen® KRAS RGQ PCR Kit
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Lumakras (sotorasib)
over2years
QIAGEN and Denovo Biopharma Partner to Develop Companion Diagnostic Test for the Treatment of Diffuse Large B-Cell Lymphoma (DLBCL) (Qiagen Press Release)
"QIAGEN...and Denovo Biopharma LLC today announced a collaboration to develop a blood-based companion diagnostic (CDx) test to identify patients expressing Denovo Genomic Marker 1 (DGM1TM) who are likely to respond to Denovo’s investigational cancer drug DB102TM for treatment of diffuse large B-cell lymphoma (DLBCL), one of the most common lymphoid cancers...Under the agreement, QIAGEN will develop a diagnostic assay that can detect the Denovo Genomic Marker 1 (DGM1TM) in DLBCL patients, a biomarker discovered by Denovo that predicts the responsiveness to DB102."
Licensing / partnership
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Kinenza (enzastaurin)
over3years
Personal Genome Diagnostics and QIAGEN collaborate to offer integrated genomic testing and interpretation support (Personal Genome Diagnostics Press Release)
"Personal Genome Diagnostics Inc. (PGDx)...announced today that it has entered into a collaboration with QIAGEN to provide comprehensive genomic profiling tests and clinical decision support to molecular labs. Under the non-exclusive agreement, PGDx will be responsible for the distribution of the PGDx elio™ oncology products and kitted solutions. Laboratories that purchase the PGDx elio products will have an option to receive from QIAGEN standardized reporting, driven by professional guidelines for streamlined case review and sign-out. In addition, laboratories will receive access to QIAGEN’s QCI Interpret One for rapid, evidence-based reporting for next-generation sequencing (NGS) oncology tests at scale."
Licensing / partnership
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PGDx elio™ tissue complete assay