COMPANY:

Thermo Fisher Scientific

"Thermo Fisher Scientific...has received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals, LLC’s VORANIGO (vorasidenib) tablets. VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection or gross total resection...Today’s approval expands clinical indications for the Oncomine Dx Target Test, which is currently approved and reimbursed by government and commercial insurers in 19 countries, including the U.S., Japan, South Korea and countries across Europe and the Middle East, covering more than 550 million lives globally."

"At the 36th annual European Congress of Pathology in Florence, Italy, Thermo Fisher Scientific...announced the latest recipients of the Oncomine Clinical Research Grant, designed to support emerging research on molecular profiling in oncology and to help democratize the future of precision medicine. Now in its fourth year, the grant recognizes research from Tata Memorial Centre in India; Leiden University Center in The Netherlands; Western University in Canada; and Fred Hutch Cancer Center in the U.S."

"Thermo Fisher Scientific Inc...announced that its SeCore CDx HLA A Sequencing System has been granted 510(k) clearance by the United States Food and Drug Administration (FDA) for use as a companion diagnostic with TECELRA (afamitresgene autoleucel), Adaptimmune’s newly approved T-cell receptor (TCR) therapy for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. Synovial sarcoma is a rare, soft tissue cancer that most commonly impacts young adults."

"Thermo Fisher Scientific Inc...announced it has been 510k cleared, following US Food and Drug Administration (FDA) requirements, to market its Optilite® Freelite® assays’ claim for the evaluation of monoclonal gammopathy of undetermined significance (MGUS)."

"The Applied BiosystemsTM OncoScanTM CNV Plus Assay for Research offers a reliable and cost-effective alternative to NGS-based approaches for detection of HRD and can contribute to expanding access to HRD testing for cancer research."

"To help accelerate research into new treatments for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), Thermo Fisher Scientific Inc...is partnering with the National Cancer Institute (NCI) – part of the National Institutes of Health – on the myeloMATCH (Molecular Analysis for Therapy Choice) precision medicine umbrella trial. By testing patients’ bone marrow and blood for certain genetic biomarkers using Thermo Fisher’s next-generation sequencing (NGS) technology, clinical sites can more quickly match patients with an appropriate clinical trial that tests a treatment designed to target specific mutations present in the samples."

"Thermo Fisher Scientific Inc...the National University Hospital, Singapore (NU- H), and Mirxes, a Singapore-headquartered RNA technology company, signed a Memorandum of Understanding (MoU) agreement on Friday, 14 June 2024. The agreement formalizes the commitment to collaborate, develop and clinically validate advanced, next-generation sequencing (NGS) genomic testing solutions and cancer research tailored specifically to address the needs of the Southeast Asian population."

"Bayer AG and Thermo Fisher Scientific Inc...announced to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx) together. These will help identify patients who may benefit from Bayer’s growing portfolio of precision cancer therapies by offering decentralized genomic testing and rapid turnaround time...The CDx will be developed using Thermo Fisher’s Oncomine Dx Express Test on the Ion Torrent Genexus Dx System, a fully integrated NGS platform that can deliver results on a patient’s tumor or liquid biopsy sample in as little as 24 hours."

"Thermo Fisher Scientific, Pfizer Canada, and Colorectal Cancer Canada have awarded a total of C$300,000 ($221,081) to two Canadian healthcare providers to study the use of next-generation sequencing-based testing in colorectal cancer care."

"To support emerging precision therapies and improve patient outcomes by increasing access to reliable genomic testing needed to match patients with targeted cancer treatments, Thermo Fisher Scientific today announced a companion diagnostic (CDx) partnership with Boehringer Ingelheim. Through this collaboration, the companies will work to develop CDx tests to help identify patients with non-small cell lung cancer (NSCLC) with specific genomic mutations....The collaboration will leverage the Oncomine Dx Express Test on the Ion Torrent Genexus Dx System as well as the Oncomine Dx Target Test."

"Swedish molecular diagnostics firm Devyser Diagnostics said on Wednesday that it has entered an agreement with Thermo Fisher Scientific to promote its laboratory services to pharmaceutical companies."

"Pfizer and Thermo Fisher Scientific Inc...announced they have entered into a collaboration agreement to help increase local access to next-generation sequencing (NGS)-based testing for lung and breast cancer patients in more than 30 countries across Latin America, Africa, the Middle East and Asia where advanced genomic testing has previously been limited or unavailable. Access to local NGS testing can help to provide faster analysis of associated genes, empowering healthcare providers to select the right therapy for that individual patient."

"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."