COMPANY:

Qiagen

"QIAGEN today announced the inclusion of the QIAcuityDx digital PCR System in the Australian Register of Therapeutic Goods (ARTG). This pivotal addition to QIAGEN’s portfolio is now expanding digital PCR into clinical diagnostics, enabling labs to harness its precision and efficiency for applications in oncology and infectious diseases. The instrument and accessories are IVDR-certified."

"QIAGEN...announced key updates to its sample technologies solutions for non-invasive liquid biopsy applications for use in research and clinical applications such as oncology, prenatal care and organ transplantation."

"QIAGEN Digital Insights...today announced the expansion of its strategic partnership with Neo4j®, the world's leading graph database and analytics company. The collaboration will enable Neo4j Graph Database and Graph Data Science capabilities to integrate more deeply with the QIAGEN Biomedical Knowledge Base (BKB) product line, unlocking hidden patterns and relationships in biomedical data, and revealing powerful new insights to advance drug discovery, drug repurposing and translational research."

"QIAGEN...announced the launch of the QIAcuityDx Digital PCR System, a pivotal addition to its digital PCR portfolio now expanding into clinical diagnostics."

"PreAnalytiX GmbH, a joint venture between QIAGEN N.V....and BD...announced the launch of the PAXgene® Urine Liquid Biopsy Set, which enables the reliable analysis of cell-free DNA (cfDNA) from urine with most molecular testing technologies, including qPCR, digital PCR and next-generation sequencing (NGS)."

"QIAGEN...announced an important milestone with the launch of 100 new assays for its digital PCR (dPCR) platform QIAcuity for use in the study of cancer, inherited genetic disorders, infectious disease surveillance, and food and environmental monitoring."

"QIAGEN..announced the launch of its new digital PCR (dPCR) Custom Assay Design Tool for copy number variation (CNV) analysis for use on its digital PCR platform QIAcuity and several other enhancements in its GeneGlobe Design and Analysis Hub, a comprehensive research platform that integrates pre-designed assays with a database of more than 10,000 biological entities including genes, miRNAs, and pathways."

"...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."

"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."

"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."

"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."

"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."

"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."

"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."

"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." "

"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."

"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."

"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."

"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."

"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..."

"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."

"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."

"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."

"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."

"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."

"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 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."

"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."

"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."