Latest news with #OncomineDx
Yahoo
a day ago
- Business
- Yahoo
Biodesix Recognized as a Thermo Fisher Scientific Center of Excellence (COE) for NGS Diagnostics
Biodesix recently validated Thermo Fisher's tissue-based Oncomine Dx Express Test for solid tumors on the Genexus Dx Integrated Sequencer LOUISVILLE, Colo., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Nasdaq: BDSX), a leader in personalized diagnostics, 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. The services provided to Thermo Fisher are an example of Biodesix Development Services offerings, including customizable options that enable the world's leading life sciences companies, biopharmaceutical, and medical research institutions with scientific, technological, and operational capabilities. As Thermo Fisher announced in July 2025, Biodesix was an instrumental partner in the validation of the Oncomine Dx Express Test leading to the FDA approval of the Genexus Dx Integrated Sequencer. Biodesix Development Services conducted validation studies utilizing its design-controlled laboratory processes, quality management systems, and contributed data generation in support of regulatory submission. 'Working with Thermo Fisher, we continue to forge a path to conquer cancer, and we are delighted to expand our molecular diagnostic and NGS testing capabilities in tissue-based profiling,' said Scott Hutton, CEO at Biodesix. "Being a member of Thermo Fisher's COE network puts us in excellent company with other global groups committed to transforming cancer diagnosis and care. We are excited about the potential to offer the Oncomine Dx Express Test in the future.' 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. Speakers: David Chi, PhD, Thermo Fisher Scientific, Bence Sipos, MD, and Gary Pestano, PhD, Chief Development Officer, Biodesix 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". Speakers: Mahmoud Elsayad, MD, FCAP, University of Texas Health, Alison Roos, Thermo Fisher Scientific, and Gary Pestano, PhD, Chief Development Officer, Biodesix About Biodesix:Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests, marketed as Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance, support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world's leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. For more information, visit About the Thermo Fisher COE Network: Thermo Fisher's NGS COE Network partners with leading global institutions to develop, validate, and refine its Ion Torrent™ Oncomine™ solutions portfolio. Through these COEs, Thermo Fisher collaborates with experts to accelerate oncology research, foster strategic alliances, and advance precision medicine. Biodesix Contacts: Media:Natalie St. Denis, Director Corporate Communications, 925-9285 Investors:Chris Brinzey, Partner, 970-2843
WebMD
09-07-2025
- 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@
