TruSight Oncology assay
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ILMN Stock Gains Following Expanded Collaboration With Labcorp
ZACKS· 2026-03-19 18:21
Core Insights - Illumina, Inc. (ILMN) and Labcorp (LH) have expanded their collaboration to enhance precision oncology through next-generation sequencing (NGS) solutions, which is expected to solidify Illumina's position in the oncology market [1][3] Company Developments - Following the collaboration announcement, ILMN's shares increased by 1.8%, closing at $122.95, indicating positive market sentiment [2][10] - Illumina's TruSight Oncology assay, TSO 500, is experiencing increased utilization and broader adoption, contributing to the company's growth in cancer genomics [2] - The collaboration aims to co-commercialize Labcorp's FDA-authorized liquid biopsy assay PGDx elio plasma focus Dx alongside Illumina's FDA-approved TruSight Oncology Comprehensive for solid tumor profiling, expanding access to both tissue and liquid biopsy testing [5] Research and Clinical Utility - The collaboration will focus on developing new tests for advanced oncology research, including comprehensive genomic profiling (CGP) and whole-genome sequencing (WGS) [6] - A study published in Frontiers of Oncology demonstrated that CGP identified variants associated with targeted therapies in over 72% of non-small cell lung cancer (NSCLC) patients, showcasing the clinical utility of CGP [7][8] Market Outlook - The global oncology market is projected to reach $866.1 billion by 2034, growing at a compound annual growth rate (CAGR) of 10.8% from 2024 to 2034, driven by rising cancer incidence and technological advancements [9] - Illumina currently has a market capitalization of $18.48 billion and an earnings yield of 4.25%, significantly outperforming the industry's -15.13% [4]
TMO Receives FDA Approval for Oncomine Dx Target Test
ZACKS· 2025-08-15 14:15
Company Overview - Thermo Fisher Scientific (TMO) received FDA approval for its Oncomine Dx Target Test as a companion diagnostic for identifying patients eligible for HERNEXEOS (zongertinib tablets), a tyrosine kinase inhibitor [1][2] - The Oncomine Dx Target Test enables multi-biomarker analysis from a single tissue sample, providing results in as little as four days, and is fully reimbursed by Medicare and top commercial payers in the U.S. [3] Product Details - The Oncomine Dx Target Test checks for HER2/ERBB2 tyrosine kinase domain activating mutations in NSCLC tumors, reducing the need for second biopsies and avoiding suboptimal therapy selection [3] - The test has received global approvals, including its first FDA approval in 2017, and is reimbursed by insurers covering over 550 million lives globally [4] Market Insights - Lung cancer is the second most common cancer in the U.S., with NSCLC accounting for 85-90% of cases, and approximately 2-4% of NSCLC patients carry a HER2 mutation [5] - The global market for NSCLC treatments is projected to reach $66.04 billion by 2032, growing at a CAGR of 10.3% from 2024 to 2032 [5] Competitive Landscape - Thermo Fisher faces competition from MedTech players like Illumina, which is expanding its NGS oncology portfolio, and Guardant Health, which is enhancing its liquid biopsy and NGS-based testing offerings [7][9] - Illumina's TruSight Oncology assay continues to gain utilization, while Guardant Health's Guardant360 test provides comprehensive tumor profiling from a single blood draw [7][9] Recent Developments - Thermo Fisher also announced FDA approval for the Oncomine Dx Express Test as an in vitro diagnostic assay for use as a companion diagnostic for Dizal's ZEGFROVY (sunvozertinib) [6]