COMPANY:

Thermo Fisher Scientific

"Biodesix, Inc...announced that the company is designated as a Thermo Fisher Scientific Center of Excellence (COE) as part of Thermo Fisher’s collaborative initiative to advance NGS-based diagnostics. ..Upcoming presentations to learn more about the Thermo Fisher NGS precision oncology solution and how Biodesix will apply the science for its industry clients and healthcare professionals...August 27, 2025 | CAP TODAY | Thermo Fisher Scientific Webinar: Introduction of new FDA approved rapid NGS solution for Companion Diagnostics & tumor profiling in oncology...September 15, 2025 | Orlando, FL | College of American Pathologists (CAP) 2025 Annual Meeting | Thermo Fisher-sponsored Panel: "Introduction of new IVD solution for rapid NGS profiling in Oncology"

"Oncomine Dx Target Test approved to identify patients eligible for HERNEXEOS (zongertinib tablets), the first and only orally administered targeted treatment for HER2 (ERBB2)-mutant NSCLC."

"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."