Latest news with #CDx
Business Wire
5 days ago
- Business
- Business Wire
Thermo Fisher Receives FDA Approval for NGS-Based Companion Diagnostic for New Non-Small Cell Lung Cancer Treatment
CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. 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), developed by Boehringer Ingelheim. The test allows clinicians and pathologists to assess if non-small cell lung cancer (NSCLC) tumors harbor human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations. 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. 1 Among those diagnosed with NSCLC, approximately 2 to 4 percent of patients present with a HER2 mutation. 2 The FDA approved HERNEXEOS on August 8, 2025 as the first and only orally administered targeted therapy for adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication was approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. More information and full Prescribing Information can be found at "This rare form of non-small cell lung cancer is linked to a poor prognosis and limited treatment options, making HERNEXEOS an important advancement in addressing the unmet needs of patients," said Vicky Brown, Senior Vice President and Head of Immunology, Oncology, and Eye Health, Boehringer Ingelheim. 'Through our collaboration with Thermo Fisher and leveraging the company's proven track record with companion diagnostics, we're pleased that patients have another tool that can be used to identify those with HER2 (ERBB2) tyrosine kinase activating mutations in non-small cell lung cancer.' 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 (availability of these approvals vary per region). The test is reimbursed by government and commercial insurers in the U.S., Europe, Japan, South Korea, and Israel, covering more than 550 million lives globally. In the US 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). "The FDA's approval of HERNEXEOS for previously treated patients living with HER2 (ERBB2)-mutant advanced non-small cell lung cancer signifies continued success in our efforts to develop timely and accessible companion diagnostics," said Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher Scientific. 'We're continuing to expand our solutions for our pharma partners, as this approval quickly follows the recent FDA approval of our latest rapid NGS solution that can deliver results in as little as 24 hours.' For more information on the Oncomine Dx Target Test and Thermo Fisher's leadership in companion diagnostics, please visit About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit
Yahoo
06-06-2025
- Business
- Yahoo
QGEN Stock to Gain From Expanding Oncology Portfolio via New Alliances
QIAGEN N.V. QGEN announced the expansion of its oncology diagnostics portfolio with two strategic partnerships. The new collaborations with Tracer Biotechnologies and Foresight Diagnostics are set to advance the use of minimal residual disease (MRD) testing in clinical trials to support pharma co-development projects for companion diagnostics (CDx). MRD testing is becoming a cornerstone of oncology by enabling early detection of cancer recurrence and guiding timely adjustments to therapy from a blood sample. The latest partnerships support the growing demand for decentralized, non-invasive tools that advance precision medicine and help deliver more personalized care. Following the announcement yesterday, shares of QIAGEN ended the session at $44.90, down 0.5% from the previous close. On a promising note, the company's MRD portfolio spans sample technologies and testing platforms that support workflows from sample to insight. These new partnerships represent an important step in strengthening QIAGEN's leadership in oncology by aiming to bring innovative MRD technologies into clinical practice. The focus is on enhancing scalable, cost-effective solutions based on the QIAcuity digital PCR (dPCR) system, enabling laboratories and healthcare providers worldwide to use MRD insights for guiding personalized treatment decisions for cancer patients. As a result, we expect the developments to positively boost the market sentiment toward QGEN stock. QIAGEN has a market capitalization of $10.03 billion. The company's earnings yield of 5.2% compares favorably to the industry average of -32.1% yield. In the trailing four quarters, it delivered an average earnings surprise of 4.9%. Tracer Biotechnologies, a developer of blood-based molecular diagnostics for cancer, is working with QIAGEN to create CDx for MRD testing in solid tumors. These assays, intended for QIAGEN's QIAcuity dPCR platform, enable the use of minimally invasive blood samples to monitor residual disease with high sensitivity. The approach offers a cost-efficient and quick way to support decentralized implementation in clinical laboratories with results comparable to those generated using next-generation sequencing technologies. Image Source: Zacks Investment Research Foresight Diagnostics is a pioneering cancer diagnostics company focused on developing ultra-sensitive liquid biopsy tests for MRD detection. Together with QIAGEN, both are creating a kit-based version of the Foresight CLARITY assay — a circulating tumor DNA (ctDNA)-based NGS test for certain types of lymphoma. Transitioning the assay from a CLIA central laboratory service to an in-lab kit is designed to allow for broader clinical access and support pharmaceutical-sponsored trials with companion diagnostic applications. Per a research report, the global cancer diagnostics market was valued at $109.61 billion in 2024 and is expected to grow at a compound annual rate of 6.1% through 2030. The growing prevalence of cancer, technological advancements in diagnostics procedures and rising initiatives undertaken by private & public organizations are fueling the market's growth. Last month, QIAGEN announced a new commercial partnership and co-marketing agreement with ID Solutions — a French provider of high-quality dPCR assays and customized molecular testing solutions for oncology and other disease areas — to expand the availability of dPCR assays for oncology research applications. In the past six months, QGEN shares have dropped 0.3% compared with the industry's 11.7% decline. QIAGEN currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the broader medical space are Phibro Animal Health PAHC, Hims & Hers Health HIMS and Cencora COR. While Phibro Animal Health sports a Zacks Rank #1 (Strong Buy) at present, Hims & Hers Health and Cencora each carry a Zacks Rank #2. You can see the complete list of today's Zacks #1 Rank stocks here. Estimates for Phibro Animal Health's fiscal 2025 earnings per share have jumped 3.6% to $2.01 in the past 30 days. Shares of the company have rallied 36.2% in the past year compared with the industry's 10.5% growth. Its earnings yield of 8.7% compares comfortably with the industry's 0.5% yield. PAHC's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 30.6%. Hims & Hers Health shares have surged 176% in the past year. Estimates for the company's 2025 earnings per share have jumped 12.5% to 72 cents in the past 30 days. HIMS' earnings beat estimates twice in the trailing four quarters, matched in one and missed on another occasion, the average surprise being 19.6%. In the last reported quarter, it posted an earnings surprise of 66.7%. Estimates for Cencora's fiscal 2025 earnings per share have increased 2.5% to $15.75 in the past 30 days. Shares of the company have jumped 26.4% in the past year against the industry's 21% fall. COR's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 6%. In the last reported quarter, it delivered an earnings surprise of 8.3%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report QIAGEN N.V. (QGEN) : Free Stock Analysis Report Cencora, Inc. (COR) : Free Stock Analysis Report Phibro Animal Health Corporation (PAHC) : Free Stock Analysis Report Hims & Hers Health, Inc. (HIMS) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
29-05-2025
- Business
- Yahoo
Illumina widens access to cancer tests with Medicare and new CDx
Illumina is expanding access to its oncology range of in vitro diagnostic (IVD) tests, as the company's TruSight Oncology (TSO) Comprehensive IVD is now covered under Medicare. This coverage also extends to most commercial health plans in the US. Preceding the US announcement, Illumina also announced that TSO Comprehensive has been approved by Japan's Ministry of Health, Labour and Welfare (MHLW). TSO uses next-generation sequencing (NGS) to detect variants in more than 500 genes using nucleic acids extracted from tumour tissue samples from cancer patients with solid malignant neoplasms to increase the likelihood that immuno-oncology or clinically actionable biomarkers will be identified. Illumina's chief commercial officer Everett Cunningham said: 'With our growing portfolio of distributable clinical solutions, we are unlocking the next new standard of care for clinicians and their patients.' As part of a 2023 partnership with Pillar Bioscience, Illumina will offer the former's oncoReveal CDx to patients as of mid-2025. Used in sync with Illumina's MiSeq Dx system, oncoReveal detects genetic variations in 22 genes and is intended for previously diagnosed patients with solid tumours. As of last month, the kit is also covered under Medicare. Pillar's chief marketing officer Brian Wright commented: 'With over 66 million people in the US covered by Medicare, reimbursement of oncoReveal CDx will help ensure that highly accurate, actionable, and reimbursable next-generation sequencing testing is available to clinical laboratories and biopharmaceutical companies.' Illumina's TSO Comprehensive test and two companion diagnostic (CDx) indications secured approval from the US Food and Drug Administration (FDA) last year. The CDx indications are for establishing whether adults and paediatric patients will benefit from treatment with Bayer's Vitrakvi (larotrectinib) when neurotrophic tyrosine receptor kinase (NTRK) gene fusions are detected in solid tumours. They also determine adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC). TSO Comprehensive is part of Illumina's broader TSO product portfolio. The company previously announced plans to launch TruSight Oncology 500 v2, a new version of its flagship next-NGS cancer assay for comprehensive genomic profiling (CGP) of solid tumours, by mid-2025. According to GlobalData, the global NGS test devices market is set to reach a valuation of $5.1bn by 2033. Alongside Illumina, other leaders in the space include Thermo Fisher Scientific and Agilent Technologies. "Illumina widens access to cancer tests with Medicare and new CDx" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-05-2025
- Business
- Yahoo
NeoGenomics introduces c-MET companion diagnostic for NSCLC
NeoGenomics has commercially launched the c-MET Companion Diagnostic (CDx) for use in non-small cell lung cancer (NSCLC), offering a 48-hour turnaround for oncologists and pathologists. This new immunohistochemistry (IHC) assay is designed to detect the overexpression of c-Met (mesenchymal-epithelial transition factor) protein, which is found in up to half of individuals with advanced NSCLC. The c-MET CDx for NSCLC assay is intended to detect individuals who may benefit from targeted therapies such as AbbVie's Emrelis (telisotuzumab vedotin-tllv), which was recently approved by the US Food and Drug Administration (FDA). Developed in line with the regulator's guidance, the assay is said to be validated for use with MET-targeted treatments while enabling timely clinical decision-making. NeoGenomics noted that the assay complements the company's PanTracer portfolio, which includes genomic and immuno-oncology markers. It forms part of the company's extensive NSCLC testing offerings, supporting the adoption of MET-directed treatments and the advancement of precision cancer care. Headquartered in the US, NeoGenomics focuses on cancer genetics testing and information services and provides a range of oncology-focused tests. NeoGenomics medical services vice-president Dr Nathan Montgomery said: 'Accurate and timely biomarker testing is critical in lung cancer, where targeted therapies can meaningfully change the course of a patient's treatment. 'The c-MET CDx for NSCLC assay adds an important tool to our testing portfolio, helping oncologists quickly identify patients who may benefit from MET-directed therapies. It also complements our PanTracer suite, enabling comprehensive biomarker profiling for NSCLC.' In October 2024, the company announced the receipt of conditional approval from the New York State Department of Health for two next-generation sequencing (NGS) tests, the Neo Comprehensive Solid Tumor assay and the NeoTYPE DNA & RNA Lung. "NeoGenomics introduces c-MET companion diagnostic for NSCLC" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
