Latest news with #OncomineDx
WebMD
6 days ago
- Health
- WebMD
FDA OKs First-of-Its-Kind Lung Cancer Pill
approval to a first-of-its-kind pill for a type of lung cancer known as non-small-cell lung cancer (NSCLC). The drug, called sunvozertinib and sold as Zegfrovy, is for adults with advanced non-small-cell lung cancer (NSCLC). It works for people whose cancer has a certain genetic change, called an EGFR exon 20 insertion mutation. This drug is used when the cancer has gotten worse during or after chemotherapy. It is taken by mouth once a day, making it easier for patients to stick to their treatment, which can go on for a long time. The FDA also approved a test called the Oncomine Dx Express Test. This test helps find the EGFR exon 20 insertion mutation in people with NSCLC who might get Zegfrovy. The test gives results in just 24 hours, so doctors can find the mutation fast and start treatment sooner. NSCLC is the most common type of lung cancer, accounting for about 80% to 85% of all cases. Among these, EGFR exon 20 insertions are the third most common type of EGFR mutation and play a key role in helping cancer cells grow and spread. These cancers are often hard to treat because the mutations can vary from person to person, making it difficult to find effective treatment options. The FDA's approval was based on a clinical trial involving 85 people with advanced NSCLC and EGFR exon 20 insertion mutations whose cancer had worsened despite chemotherapy. They received oral Zegfrovy once daily until their cancer got worse or side effects became too severe. Results showed about 46% of them responded to the treatment, with benefits lasting for more than 11 months. Zegfrovy works by blocking bad EGFR proteins that help cancer cells grow. It is made to target many kinds of EGFR changes, including exon 20 insertion mutations, but it mostly leaves healthy cells alone. It may also help treat other rare EGFR changes and HER2 exon 20 insertion mutations. Ongoing approval may depend on confirming how well the drug works in further studies, according to a news release from Dizal, the drug's maker. In a statement, Pasi A. Jänne, MD, PhD, of the Dana-Farber Cancer Institute of Harvard Medical School and lead principal investigator of the clinical trial, said results from the study show that Zegfrovy works well for patients of different backgrounds. He noted that it's easy to take because it's just one pill a day, which helps people stick to their treatment – something that's really important as lung cancer care becomes more like managing a long-term illness. People taking Zegfrovy should know that the drug may cause serious side effects, including lung inflammation, stomach and skin problems, eye issues, and harm to an unborn baby.
Yahoo
06-07-2025
- Business
- Yahoo
FDA Approved Thermo Fisher Scientific's (TMO) Oncomine Dx Express Test
Thermo Fisher Scientific Inc. (NYSE:TMO) is one of the . On July 3, Thermo Fisher Scientific Inc. (NYSE:TMO) announced receiving FDA approval for its Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer. After the approval, this test is now authorized as an in vitro diagnostic and as a companion diagnostic for Dizal's ZEGFROVY. ZEGFROVY is a targeted therapy for non-small cell lung cancer patients with EGFR exon 20 insertion mutations. The test is also approved for broader tumor profiling in solid tumors, detecting mutations across 46 genes with clinical or potential clinical significance. A workstation in a research lab stocked with laboratory products and services. This is a significant achievement as it brings rapid next-generation sequencing closer to patients. The technology can deliver crucial genomic results in as little as 24 hours. This speed is important for cancer care, as delays in obtaining tumor profiles can prevent patients from receiving timely treatments. Thermo Fisher Scientific Inc. (NYSE:TMO) is a healthcare company that is focused on accelerating research, solving complex analytical problems, boosting laboratory efficiency, and improving patient health. While we acknowledge the potential of TMO as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Yahoo
04-07-2025
- Business
- Yahoo
Thermo Fisher Scientific (NYSE:TMO) Gains FDA Approval for Rapid Cancer Diagnostic Tool
Thermo Fisher Scientific recently achieved a 7% price increase following the FDA approval of its Oncomine™ Dx Express Test. This approval, enabling rapid genomic testing, bolsters the company's position in precision oncology and positively impacts investor sentiment. The FDA's decision in early July underscored Thermo Fisher's commitment to advancing diagnostic solutions, which aligns with industry trends toward expedited drug development. Additionally, its strategic collaborations and new contracts, such as with the U.S. Department of Defense, provide further support to its market performance. Despite a broader market dip earlier this year, Thermo Fisher's recent achievements contributed to its stock recovery. Every company has risks, and we've spotted 1 risk for Thermo Fisher Scientific you should know about. Find companies with promising cash flow potential yet trading below their fair value. The FDA approval of Thermo Fisher's Oncomine™ Dx Express Test may bolster its long-term revenue prospects by enhancing its precision oncology portfolio. This is expected to propel Thermo Fisher's market position within the fast-growing biopharma services sector. The company's revenue and earnings forecasts might see positive adjustments as this product gains market traction, aligning with its focus on innovative diagnostic solutions. The integration of these advancements could support further share price increases toward the consensus price target of US$554.04, representing a potential appreciation from the current share price. Over a five-year period, Thermo Fisher's total shareholder return, including dividends, amounted to 12.13%. This shows moderate growth compared to the challenging conditions experienced by the broader market, particularly over the past year when Thermo Fisher underperformed the US Life Sciences industry, which recorded a 15.6% decline. Analyzing this context, the recent uptick in share price highlights a rebound from earlier market pressures, as investors respond positively to decisive company actions and innovations. Thermo Fisher's recent initiatives and developments aim to counter macroeconomic challenges, although potential risks from tariffs and policy changes remain. Gain insights into Thermo Fisher Scientific's historical outcomes by reviewing our past performance report. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:TMO. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ 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
Medscape
03-07-2025
- Health
- Medscape
Sunvozertinib Wins Approval for EGFR-Mutated NSCLC
The FDA has granted accelerated approval to sunvozertinib (Zegfrovy, Dizal Pharmaceutical) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor ( EGFR) exon 20 insertion mutations that's progressed on or after platinum-based chemotherapy. The agency also approved Oncomine Dx Express Test (Life Technologies Corporation) as a companion diagnostic to detect the mutations. The oral EGFR inhibitor is the first small molecule approved in the US for the indication; it was previously approved in China. The intravenous bispecific antibody amivantamab-vmjw (Rybrevant, Johnson & Johnson) also carries a second-line indication for EGFR exon 20 insertion mutated advanced/metastatic NSCLC, as well as a first-line indication with carboplatin and pemetrexed. Dizal is going for a first-line indication, too. The company recently announced completion of enrolment in a phase 3 trial pitting sunvozertinib against platinum-based chemotherapy for the upfront treatment of EGFR exon 20 insertion mutated NSCLC. The new second-line approval was based on WU-KONG1B, a multinational dose finding trial. All subjects had previous platinum-based chemotherapy and 43.4% had also received immunotherapy; 13.3% had been on amivantamab. Among 85 patients on 200 mg sunvozertinib daily, the overall response rate was 46% and the duration of response was 11.1 months. Labelling warns of the possibility of interstitial lung disease/pneumonitis, gastrointestinal adverse reactions, dermatologic issues, ocular toxicity, and embryo-fetal toxicity. Diarrhea, skin rash, and creatine phosphokinase increase were the most common drug-related treatment emergent adverse events in the trial, with most events being grade 1 or 2. The recommended dose is 200 mg orally once daily with food until disease progression or unacceptable toxicity. M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@
Yahoo
03-07-2025
- Business
- Yahoo
Thermo Fisher's NGS Assay Receives FDA Approval as a Companion Diagnostic for ZEGFROVY and for Tumor Profiling
Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer generates results in as little as 24 hours to support timely therapy decisions CARLSBAD, Calif., July 03, 2025--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, today announced the U.S. Food and Drug Administration (FDA) has approved the 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. This approval brings rapid next-generation sequencing (NGS) to decentralized clinical settings closer to where patients receive care. With the ability to deliver essential genomic insights in as little as 24 hours*, this approval helps advance the accessibility of precision oncology tools and enables more timely decision making. A patient's tumor profile has the potential to guide precision oncology care. However, delays in obtaining results can hinder clinicians' ability to make informed decisions, potentially causing patients to miss out on targeted therapies, which can impact treatment efficacy and patient outcomes. Furthermore, a significant number of patients miss out on targeted therapies due to inefficiencies or lack of access to testing, highlighting the critical role of timely genomic profiling. The Oncomine Dx Express Test was designed to simplify the NGS workflow and connect patients everywhere to precision oncology. Now with the Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer, laboratories across a variety of clinical settings can deliver rapid genomic profiling with exceptional accuracy and ease, helping to ensure patients can benefit from the latest advancements in precision oncology. The Oncomine Dx Express Test is intended for use as a companion diagnostic for ZEGFROVY (sunvozertinib), a targeted therapy from Dizal, to identify patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. In addition, the test has been approved for tumor profiling in solid tumors and detects cancer mutations with evidence of clinical significance and potential clinical significance across 46 genes. Accelerating informed precision oncology care The Genexus Dx Integrated Sequencer automates the NGS workflow — from sample preparation to data analysis and reporting — making the technology accessible to more laboratories, including those that are smaller and without previous NGS expertise. It also enables laboratories to generate timely CDx results as well as tumor profiling reports in as little as 24 hours, helping accelerate insights and access to precision oncology. "NGS has been instrumental in advancing precision oncology, but these insights often aren't available early enough to inform real-world care," said Kathy Davy, president of Clinical Next-Generation Sequencing at Thermo Fisher Scientific. "With our rapid NGS solutions, we aim to deliver timely results to clinicians and their patients prior to the initiation of treatment. We've been leading companion diagnostics in collaboration with our pharma partners for a decade, and this approval signifies the next step in our journey bringing rapid, decentralized NGS CDx to drug development. We are proud of our collaboration with Dizal to bring ZEGFROVY to the US market." Biodesix, one of Thermo Fisher's collaborators in the validation of Oncomine Dx Express Test on the Genexus Dx Integrated Sequencer, will be the first lab to launch testing services. "The Biodesix team is excited at the prospect of using the newly FDA approved Genexus Dx Integrated Sequencer for clinical testing using the Oncomine Dx Express test and for supporting our biopharma client projects," said Gary Pestano, Ph.D., chief development officer at Biodesix. "Automation of the systems for nucleic acid purification, library preparation, sequencing and report generation has the potential to significantly improve our NGS laboratory workflows by reducing hands-on time and by delivering rapid turnaround times - from sample receipt to results." ZEGFROVY (sunvozertinib) CDx approval ZEGFROVY, developed by Dizal, was granted FDA accelerated approval following Breakthrough Therapy designation and Priority Review for the treatment of NSCLC patients with EGFR exon 20 insertion mutations. With the approval of the Oncomine Dx Express Test on the Genexus Dx Integrated Sequencer as a companion diagnostic for this therapy, clinicians can now quickly identify eligible patients – supporting earlier intervention and expanding access to targeted therapy. "ZEGFROVY is a highly effective and currently the only approved EGFR TKI targeting EGFR exon 20 insertion mutations. The approval of ZEGFROVY will have a significant impact on platinum-pretreated patients with NSCLC harboring EGFR exon 20 insertion mutations, a difficult-to-treat lung cancer subtype," said Susan Chen, senior vice president, head of clinical operation at Dizal. "Today's FDA approval of the Oncomine Dx Express Test offers access to ZEGFROVY through decentralized companion diagnostic testing. The ability to match patients to our therapy quickly and accurately, regardless of mutation location, can improve outcomes for this patient population." To learn more about today's approval, please visit * Timing varies by number of samples and type of run. About Thermo Fisher ScientificThermo 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 View source version on Contacts Media Contact Information:Jen CarrollPhone: (760) 583-8898Email: Jessika ParryPhone: (419) 266-4016Email: jparry@
