COMPANY:

Thermo Fisher Scientific

"As part of a global, multiyear agreement, Thermo Fisher Scientific today announced it is working with AstraZeneca to develop a solid tissue and blood-based companion diagnostic (CDx) test for Tagrisso (osimertinib). The CDx will help identify patients with non-small cell lung cancer (NSCLC) who may be eligible for treatment with Tagrisso by identifying tumors that exhibit epidermal growth factor receptor (EGFR) alterations including exon 21 L858R mutations, exon 19 deletions or T790M mutations. The collaboration will leverage the Oncomine Dx Express Test on the Genexus Dx System, a fully-integrated next-generation sequencing (NGS) platform featuring an automated specimen-to-report workflow that economically delivers results in as little as 24 hours to bring test results to clinicians and patients faster."

"Thermo Fisher Scientific Inc....announced that it has completed its acquisition of The Binding Site Group ('The Binding Site'), a global leader in specialty diagnostics, from a shareholder group led by European private equity firm Nordic Capital, in an all-cash transaction valued at £2.3 billion, or $2.8 billion at current exchange rates....'The Binding Site expands our existing specialty diagnostics portfolio with the addition of pioneering innovation in diagnostics and monitoring for multiple myeloma. Early diagnosis and well-informed treatment decisions can make a significant difference in patient outcomes, and we are excited by the opportunity to enable further advancements in this area for the benefit of patients'...The transaction is expected to be accretive to adjusted earnings per share by $0.07 in 2023."

"Thermo Fisher Scientific Inc...announced that its SeCore CDx HLA Sequencing System was granted De Novo Classification by the United States Food and Drug Administration (FDA) for use as a companion diagnostic with KIMMTRAK^® (tebentafusp-tebn), Immunocore’s T cell receptor therapy for HLA-A*02:01-positive adults with metastatic or unresectable uveal melanoma—a rare but deadly cancer of the eye. The marketing authorization is the first of its kind, making the SeCore CDx HLA Sequencing System the only commercially available HLA typing companion diagnostic....The SeCore CDx HLA Sequencing System was used to identify HLA-A*02:01 positive patients for enrollment in KIMMTRAK clinical trials."

"Thermo Fisher Scientific...is showcasing its latest innovative research and diagnostic technologies at the 2022 annual meeting and expo of the Association for Molecular Pathology (AMP) taking place at the Phoenix Convention Center from Nov. 1-5. The solutions on display are designed to address a broad range of disease states and include assays and instruments that leverage real-time and digital PCR, as well as next generation sequencing (NGS) platforms."

"The U.S. Food and Drug Administration (FDA) has granted approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in selection of patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-fusion positive advanced or metastatic thyroid cancer and RET-mutation positive advanced or metastatic medullary thyroid cancer (MTC) who may be eligible for treatment with Lilly’s Retevmo (selpercatinib)."

"On September 21, 2022, the Food and Drug Administration granted regular approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test...FDA also approved the Oncomine Dx Target (ODxT) Test (Thermo Fisher Scientific) as a companion diagnostic for selpercatinib."

"Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC)...FDA also approved the Life Technologies Corporation’s Oncomine™ Dx Target Test (tissue) and the Guardant Health, Inc.’s Guardant360® CDx (plasma) as companion diagnostics for Enhertu."

"Thermo Fisher Scientific...launched a next-generation sequencing (NGS)-based assay for research in myeloid measurable residual disease (MRD). As the first NGS-based tests to support both DNA and RNA input, the Ion Torrent Oncomine Myeloid MRD Assays (RUO) provide a comprehensive and highly sensitive MRD assessment from blood and bone marrow samples."

"As part of its ongoing commitment to support clinical oncology research, Thermo Fisher Scientific is calling for new proposals for its Oncomine Clinical Research Grant. The latest request for submissions from the global scientific community will award funding for molecular profiling research that helps accelerate the use of genomic sequencing in oncology...'The Oncomine Clinical Research Grant program aims to fund research furthering our understanding of cancer at the genomic level. The identification of specific cancer biomarkers associated with response or resistance to treatment can inform clinical care and potentially help predict patient outcomes'..."

"Oncocyte Corporation...announced a development and co-marketing agreement for two distributed in vitro diagnostic (IVD) assays on Thermo Fisher Scientific’s Ion Torrent™ Genexus™ System...Under the terms of the collaboration, Oncocyte will clinically validate Thermo Fisher’s existing Oncomine Comprehensive Assay Plus* on the Genexus System, paving the way toward IVD clearance for use in tumor profiling and future submissions as a companion diagnostic...Oncocyte will also develop its 27-gene expression DetermaIO™ test as a distributed kit on the Genexus."

"NeoGenomics, Inc...announced it will use Thermo Fisher Scientific's Ion Torrent Genexus System, the first turnkey next-generation sequencing (NGS) solution that automates the specimen-to-report workflow to deliver results in as little as a single day, in a pharma-sponsored Phase 1 study...As part of the preclinical research investigation, NeoGenomics will receive early access to Thermo Fisher's new Oncomine Myeloid Assay GX v2 to validate the assay on the Genexus System."

"The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to help identify non-small cell lung cancer (NSCLC) patients whose tumors carry epidermal growth factor receptor (EGFR) Exon20-insertion mutations for potential treatment with RYBREVANT^® (amivantamab-vmjw)*, Janssen Biotech, Inc.'s (Janssen's) targeted therapy."

"Thermo Fisher Scientific...launched the Applied Biosystems QuantStudio Absolute Q Digital PCR System, the first fully integrated digital PCR (dPCR) system designed to provide highly accurate and consistent results within 90 minutes...'These early adopters of dPCR technologies have faced limitations, including error-prone operation, imprecision and poor turnaround times'...the QuantStudio Absolute Q Digital PCR System overcomes these limitations and provides an industry-best dPCR platform to enable accelerated innovation in cancer research, rare diseases and much more."

"The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC) who are candidates for EXKIVITY™ (mobocertinib), a targeted drug developed by Takeda Pharmaceutical Company Limited ('Takeda'). EXKIVITY is a small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target EGFR Exon20 insertion mutations."

"Thermo Fisher Scientific today announced the Japan Ministry of Health, Labour and Welfare (MHLW), Japan's regulatory agency, has granted approval for the Oncomine Dx Target Test as a next-generation sequencing (NGS)-based companion diagnostic (CDx) for patients with RET-fusion positive non-small-cell lung cancer (NSCLC) who may be treated with Eli Lilly and Company's selpercatinib (formerly known as LOXO-292)."

"Thermo Fisher Scientific's clinical sequencing business and AstraZeneca today announced they will co-develop next-generation sequencing (NGS)-based companion diagnostics (CDx) to support AstraZeneca's expanding portfolio of targeted therapies. The companies will collaborate under a multiyear, global agreement...NGS-based companion diagnostics are increasingly used to match patients with new therapies for cancer and other diseases."

"The U.S. Food and Drug Administration (FDA) has granted pre-market approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma (CCA) who may be candidates for Servier Pharmaceuticals' TIBSOVO® (ivosidenib tablets). TIBSOVO is an IDH1 inhibitor that is approved for the treatment of adult patients with previously treated, locally advanced or metastatic CCA with an IDH1 mutation as detected by an FDA-approved test."

"Thermo Fisher Scientific...announced a new suite of Ion Torrent Oncomine immune repertoire assays designed to detect potentially malignant clones of T-cells and B-cells, which play a key role in the immune response system. Using proprietary Ion AmpliSeq technology, the new pan-clonality assays target multiple parts of the B- and T-cell immune receptors using a single reaction with ultra-high sensitivity, thereby increasing the probability of malignant clone detection and decreasing the time to results."

"Thermo Fisher Scientific today announced that submissions are now open for the Oncomine Clinical Research Grant program to support clinical research projects in oncology. This grant aims to provide funding for high-quality molecular profiling studies focusing on the impact of immune-based treatments for cancer patients...Since its launch in 2020, the Oncomine Clinical Research Grant has been awarded to eight projects worldwide, supporting research in areas including fusion genes detection in solid cancer and hemato-oncology."

"Thermo Fisher Scientific Inc...and PPD, Inc...today announced that their boards of directors have approved a definitive agreement under which Thermo Fisher will acquire PPD for $47.50 per share for a total cash purchase price of $17.4 billion plus the assumption of approximately $3.5 billion of net debt."

"Thermo Fisher Scientific...today announced new collaborations of the Thermo Fisher Precision Medicine Science Center (PMSC) with AstraZeneca and the University of Nebraska Medical Center as part of its ongoing development of innovative solutions for unmet needs in clinical biomarker discovery. The new alliances strengthen the PMSC's mission of creating standardized workflows with pharma and academic partners to streamline the transition from biomarker research to clinical implementation, creating new opportunities for precision medicine."

"The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify RET fusion-positive, metastatic non-small cell lung cancer (NSCLC) patients who are candidates for GAVRETO™ (pralsetinib), a targeted therapy developed by Blueprint Medicines….It is now also the first and only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC. Thermo Fisher will update the Oncomine Dx Target Test to enable it to report RET fusions in the U.S. before the end of the year."

"Today, Thermo Fisher Scientific announces a new portfolio of hematology-oncology assays for the Ion Torrent Genexus System designed to enable a future in which turnaround times for next-generation sequencing (NGS) results can be reduced to less than 24 hours…The Oncomine Myeloid Assay GX is the first in a series of clinical research assays available from the new suite of hematology-oncology solutions."

"Thermo Fisher Scientific has signed a companion diagnostic (CDx) agreement with Hengrui Therapeutics, Inc. (HTI), a U.S. subsidiary of Chinese pharmaceutical company Jiangsu Hengrui Medicine Co., Ltd. (JHM), to develop a CDx that will leverage the Oncomine Precision Assay, which runs on the new Ion Torrent Genexus System. Once commercialized, the CDx will be used to identify non-small cell lung cancer (NSCLC) patients who may be eligible for pyrotinib, JHM's novel, irreversible pan-HER2 tyrosine kinase inhibitor…Under the terms of the agreement, Thermo Fisher will retain rights to commercialize the test globally and will seek approval from regulatory agencies."

"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."

“Thermo Fisher Scientific and First Genetics JCS…today announced a strategic partnership focused on commercializing next-generation sequencing (NGS)–based diagnostics in Russia. The agreement enables First Genetics to market its F-Genetics NGS System and IVD assays to Russian labs for reproductive health testing and cancer diagnostics….First Genetics has already received its first registration certificate for an IVD kit by Roszdravnadzor, the Russian medical device regulatory agency.”

"Thermo Fisher Scientific...inks an agreement with Roche...unit Chugai Pharmaceutical Co., Ltd. to expand the use of TMO's Oncomine Dx Target Test as a companion diagnostic to identify ROS1-positive non-small cell lung cancer patients who may be suitable for Roche's Rozlytrek (entrectinib)...Chugai has submitted an application to Japan's Ministry of Health, Labor and Welfare seeking approval for the expanded use of the test....TMO says that Oncomine Dx Target Test is currently reimbursed by both private insurers and governments in the U.S., Europe, Japan and South Korea."

"Thermo Fisher Scientific and Daiichi Sankyo have expanded their partnership by signing a new agreement to co-develop a companion diagnostic (CDx) that will utilize Thermo Fisher's next-generation sequencing (NGS)-based Oncomine Dx Target Test. The CDx will be designed to identify non-small cell lung cancer (NSCLC) patients with human epidermal growth factor receptor 2 (HER2) mutations who may be eligible for Enhertu, a HER2 directed antibody drug conjugate (ADC), which is currently in global phase 2 development for HER2 mutated or HER2 overexpressing NSCLC….Under the terms of the agreement, Thermo Fisher will retain rights to commercialize the test globally and will seek approval from regulatory agencies."

"The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Thermo Fisher Scientific's Oncomine Precision Assay to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881)."