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TMO Receives FDA Approval for Oncomine Dx Target Test
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Key Takeaways
TMO gains FDA nod for Oncomine Dx Target Test as a CDx for NSCLC patients eligible for HERNEXEOS.
TMO's test detects HER2 TKD mutations, delivering multi-biomarker results in as little as four days.
TMO's Oncomine Dx Target Test holds global approvals and coverage for over 550 million lives.
Thermo Fisher Scientific (TMO - Free Report) recently received approval from the Food and Drug Administration (“FDA”) for its Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients who may be candidates for HERNEXEOS (zongertinib tablets), a tyrosine kinase inhibitor (TKI).
The HERNEXEOS, developed by Boehringer Ingelheim, is the first and only FDA-approved orally administered targeted therapy for adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).
The recent approval is expected to bolster Thermo Fisher’s Specialty Diagnostics arm.
About TMO’s Oncomine Dx Target Test
The Oncomine Dx Target Test checks if NSCLC tumors harbor human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations. It enables multi-biomarker analysis from a single tissue sample to aid treatment decisions in as little as four days. This reduces the need for second biopsies and avoids suboptimal therapy selection in the absence of a complete biomarker report. The test is fully reimbursed by Medicare, as well as by the top 20 commercial payers in the United States.
Oncomine Dx Target Test’s Global Approvals
The Oncomine Dx Target Test received its first approval by the FDA as an NGS CDx in 2017, followed by regulatory approvals in 20 countries for 11 biomarkers and over 20 targeted therapies. The test is reimbursed by government and commercial insurers in the United States, Europe, Japan, South Korea and Israel, covering more than 550 million lives globally. In the United States alone, it is approved for targeted therapies in NSCLC, cholangiocarcinoma (CC), astrocytoma (AC) and oligodendroglioma (OG), anaplastic thyroid cancer (ATC), medullary thyroid cancer (MTC) and thyroid cancer (TC).
Industry Prospects Favor TMO
According to the American Cancer Society, lung cancer is the second most common cancer in both men and women in the United States, with NSCLC accounting for about 85-90% of all lung cancer cases. Research further indicates that roughly 2-4% of NSCLC patients carry a HER2 mutation. With lung cancer cases continuing to rise, the global market for NSCLC treatments is expected to expand significantly, reaching $66.04 billion by 2032 at a CAGR of 10.3% from 2024 to 2032 (per Fortune Business Insights).
Another Development by TMO
Thermo Fisher recently announced the FDA approval for Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer as an in vitro diagnostic (IVD) assay for use as a companion diagnostic (CDx) for Dizal’s ZEGFROVY (sunvozertinib) and in tumor profiling.
Offerings by TMO’s Competitors
In the oncology space, Thermo Fisher faces competition from some prominent MedTech players. These companies are also making notable developments in their respective businesses.
An expanding NGS oncology portfolio is helping Illumina (ILMN - Free Report) drive the revolution in cancer genomics. The company’s market-leading TruSight Oncology assay, TSO 500, continues to see increased utilization and broader adoption. In February, the company announced a new single-cell offering for CRISPR research with applications in oncology, immunology and drug target discovery. In 2024, the FDA approved its in vitro diagnostic (IVD) TSO Comprehensive test and its first two companion diagnostic (CDx) indications to rapidly match patients to targeted therapies. This year, Illumina is set to roll out TSO 500 v2, a new version that includes hundreds of genes across all variant classes and immuno-oncology biomarkers in a single assay from one sample, to facilitate therapy selection research.
A rapidly expanding liquid biopsy and NGS-based testing portfolio is positioning Guardant Health (GH - Free Report) as a leader in precision oncology. The company’s flagship Guardant360 test has been recently enhanced with the Guardant Infinity platform, enabling a single blood draw to provide comprehensive tumor profiling, confirm the absence of actionable mutations and determine ER/PR/HER2 status. Regulatory milestones include approvals for Guardant360 CDx as a companion diagnostic in the United States, Japan and Singapore, covering multiple cancer targets such as EGFR and HER2 mutations. Its pipeline also includes the FDA-approved Shield blood test for colorectal cancer screening, offering a non-invasive alternative to colonoscopy.
Exact Sciences’ (EXAS - Free Report) flagship screening product, the Cologuard test, is a non-invasive, stool-based DNA (sDNA) screening test that utilizes a multitarget approach to detect DNA and hemoglobin biomarkers associated with colorectal cancer and pre-cancer. The company’s precision oncology portfolio also offers the Oncotype DX Breast Recurrence Score test to identify patients who are most likely to benefit from chemotherapy, as well as those who may receive no clinical benefit from chemotherapy. Its Oncotype DX Colon Recurrence Score test is a multi-gene test for predicting recurrence risk in patients with stage II and stage III A/B colon cancer to enable an individualized approach to treatment planning.
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TMO Receives FDA Approval for Oncomine Dx Target Test
Key Takeaways
Thermo Fisher Scientific (TMO - Free Report) recently received approval from the Food and Drug Administration (“FDA”) for its Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients who may be candidates for HERNEXEOS (zongertinib tablets), a tyrosine kinase inhibitor (TKI).
The HERNEXEOS, developed by Boehringer Ingelheim, is the first and only FDA-approved orally administered targeted therapy for adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).
The recent approval is expected to bolster Thermo Fisher’s Specialty Diagnostics arm.
About TMO’s Oncomine Dx Target Test
The Oncomine Dx Target Test checks if NSCLC tumors harbor human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations. It enables multi-biomarker analysis from a single tissue sample to aid treatment decisions in as little as four days. This reduces the need for second biopsies and avoids suboptimal therapy selection in the absence of a complete biomarker report. The test is fully reimbursed by Medicare, as well as by the top 20 commercial payers in the United States.
Oncomine Dx Target Test’s Global Approvals
The Oncomine Dx Target Test received its first approval by the FDA as an NGS CDx in 2017, followed by regulatory approvals in 20 countries for 11 biomarkers and over 20 targeted therapies. The test is reimbursed by government and commercial insurers in the United States, Europe, Japan, South Korea and Israel, covering more than 550 million lives globally. In the United States alone, it is approved for targeted therapies in NSCLC, cholangiocarcinoma (CC), astrocytoma (AC) and oligodendroglioma (OG), anaplastic thyroid cancer (ATC), medullary thyroid cancer (MTC) and thyroid cancer (TC).
Industry Prospects Favor TMO
According to the American Cancer Society, lung cancer is the second most common cancer in both men and women in the United States, with NSCLC accounting for about 85-90% of all lung cancer cases. Research further indicates that roughly 2-4% of NSCLC patients carry a HER2 mutation. With lung cancer cases continuing to rise, the global market for NSCLC treatments is expected to expand significantly, reaching $66.04 billion by 2032 at a CAGR of 10.3% from 2024 to 2032 (per Fortune Business Insights).
Another Development by TMO
Thermo Fisher recently announced the FDA approval for Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer as an in vitro diagnostic (IVD) assay for use as a companion diagnostic (CDx) for Dizal’s ZEGFROVY (sunvozertinib) and in tumor profiling.
Offerings by TMO’s Competitors
In the oncology space, Thermo Fisher faces competition from some prominent MedTech players. These companies are also making notable developments in their respective businesses.
An expanding NGS oncology portfolio is helping Illumina (ILMN - Free Report) drive the revolution in cancer genomics. The company’s market-leading TruSight Oncology assay, TSO 500, continues to see increased utilization and broader adoption. In February, the company announced a new single-cell offering for CRISPR research with applications in oncology, immunology and drug target discovery. In 2024, the FDA approved its in vitro diagnostic (IVD) TSO Comprehensive test and its first two companion diagnostic (CDx) indications to rapidly match patients to targeted therapies. This year, Illumina is set to roll out TSO 500 v2, a new version that includes hundreds of genes across all variant classes and immuno-oncology biomarkers in a single assay from one sample, to facilitate therapy selection research.
A rapidly expanding liquid biopsy and NGS-based testing portfolio is positioning Guardant Health (GH - Free Report) as a leader in precision oncology. The company’s flagship Guardant360 test has been recently enhanced with the Guardant Infinity platform, enabling a single blood draw to provide comprehensive tumor profiling, confirm the absence of actionable mutations and determine ER/PR/HER2 status. Regulatory milestones include approvals for Guardant360 CDx as a companion diagnostic in the United States, Japan and Singapore, covering multiple cancer targets such as EGFR and HER2 mutations. Its pipeline also includes the FDA-approved Shield blood test for colorectal cancer screening, offering a non-invasive alternative to colonoscopy.
Exact Sciences’ (EXAS - Free Report) flagship screening product, the Cologuard test, is a non-invasive, stool-based DNA (sDNA) screening test that utilizes a multitarget approach to detect DNA and hemoglobin biomarkers associated with colorectal cancer and pre-cancer. The company’s precision oncology portfolio also offers the Oncotype DX Breast Recurrence Score test to identify patients who are most likely to benefit from chemotherapy, as well as those who may receive no clinical benefit from chemotherapy. Its Oncotype DX Colon Recurrence Score test is a multi-gene test for predicting recurrence risk in patients with stage II and stage III A/B colon cancer to enable an individualized approach to treatment planning.