COMPANY:

Qiagen

"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."

"QIAGEN...announced signing a master companion diagnostics (CDx) agreement to develop a NGS CDx for OncXerna’s product candidate, Navicixizumab, and a non-exclusive license to the Xerna™ TME panel....QIAGEN and OncXerna have agreed to collaborate to advance the Xerna™ TME panel towards IVD (in-vitro diagnostic) regulatory approval as a NGS companion diagnostic for Navicixizumab, which is being developed by OncXerna as a treatment for patients with ovarian cancer."

"Labcorp...announced the availability of therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for treatment with LUMAKRAS (sotorasib), a new treatment option developed by Amgen...QIAGEN...developed the assay, and Labcorp applied its scientific validation process to be able to offer the assay through its CAP accredited, CLIA-certified specialty labs. Using the lung biopsy specimen, the assay identifies whether a patient with NSCLC has a specific mutation in the KRAS gene and is eligible for treatment with LUMAKRAS™ (sotorasib) which was developed by Amgen."

"QIAGEN...announced a global strategic alliance with Japan’s Sysmex Corporation (Tokyo Stock Exchange, First Section [Ticker Code: 6869]) for the development and commercialization of cancer companion diagnostics, which will leverage both QIAGEN’s leadership in this field and Sysmex’s Plasma-Safe-SeqS technology for next generation sequencing (NGS)...The alliance aims to foster collaborations with pharmaceutical companies for the development of drug treatments for cancer and promote early clinical adoption of ultra-sensitive liquid biopsy companion diagnostics."

"Oncocyte Corporation...has signed an agreement with QIAGEN N.V. to support the launch of Amgen’s LUMAKRAS (Sotorasib)...QIAGEN was selected by Amgen to develop a tissue-based companion diagnostic (CDx) for the new therapy with indications in lung cancer, and QIAGEN selected Oncocyte as a “Day One” clinical lab for offering the QIAGEN Therascreen RGQ KRAS CDx test."

"QIAGEN...announced the launch of an expanded scope of companion diagnostic (CDx) claims for the therascreen® KRAS RGQ PCR Kit (therascreen KRAS Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in the identification of non-small cell lung cancer (NSCLC) patients that may be eligible for treatment with LUMAKRAS (sotorasib), a newly approved therapy developed and marketed by Amgen Inc. (AMGN). The therascreen KRAS Kit is the first companion diagnostic test to obtain premarket approval from the U.S. Food and Drug Administration (FDA) for use to identify the KRAS G12C mutation in samples of NSCLC tumour tissue."

"QIAGEN...announced a global collaboration with Mirati Therapeutics Inc. (NASDAQ:MRTX) to continue developing a tissue-based KRAS companion diagnostic to identify patients with cancers that have a KRASG12C mutation who may benefit from treatment with adagrasib, Mirati’s investigational, highly selective and potent oral small molecule inhibitor of KRASG12C. The agreement initially focuses on a companion diagnostic test for non-small cell lung cancer (NSCLC), and allows for further development of tests for other Mirati oncology programs."

"QIAGEN N.V...today announced the upcoming launch of the EZ2 Connect product line, a next-level automated sample-processing platform whose simplicity, flexibility and speed will benefit biomedical research, forensics and clinical diagnostics...With new approaches for cell free circulating DNA (cfDNA) and nucleic acid extraction from a range of sample types such as FFPE, EZ2 Connect catalyzes analytical quality, a valuable tool for example in cancer research."

"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."

"QIAGEN announced today the exclusive rights to license and distribute the COSMIC Database for commercial use from the Wellcome Sanger Institute. The COSMIC Database joins QIAGEN’s leading portfolio of hereditary and somatic genetic mutation interpretation software and databases that includes IPA, HGMD, QCI Interpret, QCI Precision Insights and OmicSoft Oncoland…Under the multi-year agreement, QIAGEN will leverage its experienced software sales team and global customer network to grow the adoption and utilization of the COSMIC Database."

"QIAGEN...announced a strategic collaboration with BioNTech...to develop and commercialize a tissue-based companion diagnostic – to be used with investigational cancer treatment BNT113 – which identifies patients with squamous cell carcinoma of the head and neck (SCCHN) that are caused by specific infections by human papilloma virus (HPV)...QIAGEN plans to expand the panel for use across HPV-driven cancers such as cervical cancer and other cancers, in order to provide a universal HPV companion diagnostic (CDx) for QIAGEN’s pharmaceutical partners."

"Bio-Techne Corporation…and QIAGEN N.V. today announced the expansion and extension of a non-exclusive partnership to co-market exosome technology to existing and potential biopharma partners as well as the joint development of new exosome based products. The agreement grants QIAGEN a non-exclusive development license to Bio-Techne's exosome technology for the development of companion in vitro diagnostic products (CDX-IVD) for existing and potential biopharma partners…The two companies also announced the extension and expansion of the existing exclusive collaboration and license agreement that was originally in place between Exosome Diagnostics (now a Bio-Techne company) and QIAGEN."

"QIAGEN N.V…today announced the acquisition of the remaining 80.1% of diagnostics instruments company NeuMoDx Molecular, Inc. for $248 million in cash. The move rounds out QIAGEN’s portfolio of automated molecular testing solutions based on the proven PCR technology."

"HTG Molecular Diagnostics, Inc…today announced the signing of a Commercialization and Distribution Agreement (Master Agreement) with QIAGEN Manchester Limited, a wholly owned subsidiary of QIAGEN N.V…The 10-year agreement provides a foundation for both companies to combine their technological and commercial strengths with the goal to offer pharmaceutical companies global development, distribution and commercialization capabilities for companion diagnostic (CDx) assays based on HTG EdgeSeq, HTG’s novel RNA platform."

"Thermo Fisher Scientific Inc...today announced that its offer to acquire all of the ordinary shares of QIAGEN...has lapsed...Thermo Fisher has terminated the acquisition agreement with QIAGEN, and QIAGEN will pay to Thermo Fisher an expense reimbursement payment of USD 95 million in cash in accordance with the terms of the acquisition agreement."

"QIAGEN N.V....announced launch of its novel therascreen® BRAF V600E RGQ PCR Kit (therascreen BRAF V600E Kit) following U.S. Food and Drug Administration (FDA) approval as a companion diagnostic to the BRAF inhibitor, BRAFTOVI® (encorafenib), which the FDA has approved for use in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy."

"QIAGEN N.V...announces CE Mark certification of its therascreen PIK3CA RGQ PCR kit as an aid in identifying breast cancer patients with a PIK3CA mutation. Market launch is underway....The FDA approved the test last year. It is used as a companion diagnostic for Novartis' Piqray (alpelisib)."

"QIAGEN...announced a strategic collaboration to develop tissue-based companion diagnostics for Amgen’s investigational cancer treatment AMG 510 to identify patients with cancers that have the KRAS G12C mutation. The agreement focuses initially on companion diagnostics for non-small cell lung cancer (NSCLC) but allows for further development of the tests for Amgen’s other oncology clinical development programs."