Latest news with #NCCNClinicalPracticeGuidelinesinOncology
Business Wire
6 days ago
- Business
- Business Wire
Artera Achieves Nationwide Access for its ArteraAI Prostate Test with New York State License
SAN FRANCISCO--(BUSINESS WIRE)-- Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today it has received its New York laboratory permit from its Department of Health. This licensure allows Artera to offer the award-winning ArteraAI Prostate Test to one of the largest healthcare markets and makes the test available to all patients across the United States. This milestone comes on the heels of Artera's recent announcement that its test is now updated with new insights to help higher-risk patients optimize treatment decisions. This advancement was supported by newly presented validation data, which was selected for Best of ASCO 2025. The ArteraAI Prostate Test is the only test in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) that can both predict therapy benefit and forecast long-term outcomes in localized prostate cancer. Starting on June 4th, clinicians and patients in New York can access data-backed insights to personalize cancer treatment decisions. 'Receiving the New York lab license is a significant milestone for Artera,' said Andre Esteva, CEO and co-founder of Artera. 'Prostate cancer is one of the most common cancers, with the NY State Department of Health estimating that more than 15,000 men are diagnosed each year in New York alone. One of my founding goals was to increase access to AI-enabled precision medicine tools, and I'm proud our team has accomplished this in record time.' New York State inspectors examined laboratory staff qualifications, equipment, facilities, safety program, record, and overall management to ensure the highest standard of care for all laboratory patients. This license follows the College of American Pathologists (CAP) accreditation Artera received in August and the State of California license in October of last year. Together, these certifications underscore Artera's commitment to quality and patient safety. 'We are thrilled that the ArteraAI Prostate Test is now available in New York,' said Himanshu Nagar, MD, Director of Genitourinary Cancer, Department of Radiation Oncology at Memorial Sloan Kettering Cancer Center. 'This test complements existing biomarkers by integrating multimodal AI analysis of both digital pathology and clinical data, providing an additional layer of precision in risk stratification. By leveraging AI-driven insights, it enhances our ability to personalize treatment decisions, ensuring that patients receive the most appropriate therapy while minimizing unnecessary interventions.' About Artera Artera is a leading precision medicine company developing AI tests to personalize cancer therapy. Artera offers an AI-enabled test that is the first of its kind to provide both prognostic and predictive results for patients with localized prostate cancer: ArteraAI Prostate Test. Artera's multimodal artificial intelligence (MMAI) biomarker test leverages a unique algorithm that assesses digital images from a patient's biopsy and their clinical data. The AI combines this information to determine their prognosis and predict whether a patient will benefit from a particular therapy and has been validated using many Phase 3 randomized trials. Artera's laboratory is CLIA-certified and College of American Pathologists (CAP) accredited. The ArteraAI Prostate Test is clinically available through Artera's laboratory in Jacksonville, Florida, and can be ordered online at
Business Wire
6 days ago
- Business
- Business Wire
Artera Launches Registry Trial to Measure Real-World Impact and Outcomes of its Prostate Test
SAN FRANCISCO--(BUSINESS WIRE)-- Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced the launch of its DIRECT-AI registry study. This study will assess how the ArteraAI Prostate Test influences treatment decision-making between clinicians and patients with localized prostate cancer. Additionally, the study will monitor participants to evaluate their long-term cancer outcomes, reinforcing Artera's commitment to advancing personalized cancer treatment and identifying future opportunities for test optimization. The DIRECT-AI study centers on the award-winning ArteraAI Prostate Test—the only test included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) for localized prostate cancer that can both predict therapy benefit and prognosticate long-term outcomes. "Harnessing the power of AI, the ArteraAI Prostate Test marks a significant advancement in the personalized treatment of localized prostate cancer. Through the DIRECT-AI registry, we are rigorously evaluating how this technology can enhance clinical decision-making and improve patient outcomes, providing clinicians and patients with the most accurate, tailored insights available," said Dr. Tim Showalter, Chief Medical Officer at Artera. The study is structured into two phases. The initial phase captures real-world insights into how the Artera Prostate Test informs clinical decision-making, with feedback collected from participating clinicians and patients. The second phase will monitor long-term health outcomes at key intervals of 2 and 5 years, looking at endpoints such as distant metastasis, survival rates, and treatment effectiveness. This research will help Artera understand how its test impacts cancer outcomes and monitor its performance so that it can be improved for patients in the future. Any patient receiving the commercial ArteraAI Prostate Test and whose ordering physician is associated with an enrolling clinic is eligible to participate in the study. Patients must have localized prostate cancer and must not have started or received treatment for their condition. The study is non-interventional, meaning it does not require additional procedures or tests, and there will be no changes to the care participants receive, regardless of their participation. For clinics participating in the DIRECT-AI Registry, physicians can enroll all patients for whom they order an ArteraAI Prostate Test in the study. For more information and to sign up, visit the website or contact direct-ai@ About Artera Artera is a leading precision medicine company developing AI tests to personalize cancer therapy. Artera offers an AI-enabled test that is the first of its kind to provide both prognostic and predictive results for patients with localized prostate cancer: ArteraAI Prostate Test. Artera's multimodal artificial intelligence (MMAI) biomarker test leverages a unique algorithm that assesses digital images from a patient's biopsy and their clinical data. The AI combines this information to determine their prognosis and predict whether a patient will benefit from a particular therapy and has been validated using many Phase 3 randomized trials. Artera's laboratory is CLIA-certified and College of American Pathologists (CAP) accredited. The ArteraAI Prostate Test is clinically available through Artera's laboratory in Jacksonville, Florida, and can be ordered online at
Yahoo
7 days ago
- Business
- Yahoo
GEHC Stock Declines Despite Expansion in Precision Care Capabilities
GE HealthCare Technologies Inc. GEHC, on Thursday, announced the combination of its proprietary features and algorithms with MIM Encore. Per management, the software solution has been designed to handle key healthcare challenges like improving efficiency, streamlining cross-departmental communication and reducing manual workloads. GE HealthCare acquired MIM Software in 2024. The latest move is expected to be a significant milestone for GE HealthCare with respect to delivering precision care through advanced digital solutions. This, in turn, is likely to boost its Molecular Imaging & Computed Tomography (CT) business and strengthen its foothold in the niche space. Following the announcement, shares of the company lost nearly 1.6% till Friday's trading. Historically, the company has gained a high level of synergies from its partnerships. Although the latest announcement is likely to be beneficial for GEHC's top-line growth going forward, the stock declined overall. GE HealthCare currently has a market capitalization of $33.08 billion. It has an earnings yield of 5.6%, better than the industry's 0.5%. In the last reported quarter, GEHC delivered an earnings surprise of 10.9%. Per GE HealthCare, its first combined software release with MIM Encore will likely aid in enhancing digital imaging and workflow solutions across oncology, cardiology and neurology. MIM Encore, now equipped with additional GE HealthCare features and algorithms, is expected to deliver an integrated reporting experience for both positron emission tomography (PET) and SPECT (single-photon emission CT) imaging. Also, GE HealthCare's Effortless Workflow seamlessly integrates with MIM Encore, enabling clinicians to manage rising caseloads with intuitive interfaces, customizable displays and automation that can help bridge experience gaps and reduce burnout. Per a report by Grand View Research, the global molecular imaging market was valued at $8.8 billion in 2024 and is anticipated to witness a CAGR of 4.6% between 2025 and 2030. Factors like the increasing prevalence of chronic diseases, such as cancer, the therapeutic sectors, and the development of hybrid imaging systems are likely to drive the market. Given the market potential, the latest advancement in precision care is expected to provide a significant boost to GE HealthCare's business. This month, GE HealthCare and PT Kalbe Farma Tbk (Kalbe) have officially inaugurated Indonesia's first production facility dedicated to manufacturing technologically advanced CT scanners. Last month, GE HealthCare announced that the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for clinicians now recommend considering fluoroestradiol (FES) PET for systemic staging in patients with recurrent or metastatic lobular breast cancer. The same month, GE HealthCare received the FDA's 510(k) clearance for its Aurora nuclear medicine system and Clarify DL. Shares of the company have lost 6.8% in the past year against the industry's 10.1% rise and the S&P 500's gain of 9.4%. Image Source: Zacks Investment Research Currently, GEHC carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the broader medical space are Hims & Hers Health, Inc. HIMS, Cencora, Inc. COR and Integer Holdings Corporation ITGR. Hims & Hers, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 36.5%. HIMS's earnings surpassed estimates in two of the trailing four quarters, missed once and broke even in the other, the average surprise being 19.6%. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Hims & Hers' shares have surged 129.7% compared with the industry's 36.1% gain in the past year. Cencora, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.8%. COR's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 6%. Cencora has rallied 25.9% against the industry's 16% decline in the past year. Integer Holdings, sporting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 18.4%. ITGR's earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 2.8%. Integer Holdings' shares have gained 0.9% against the industry's 14.2% decline in the past year. 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 Cencora, Inc. (COR) : Free Stock Analysis Report Integer Holdings Corporation (ITGR) : Free Stock Analysis Report Hims & Hers Health, Inc. (HIMS) : Free Stock Analysis Report GE HealthCare Technologies Inc. (GEHC) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
10-06-2025
- Health
- Yahoo
International Oncology Experts Meet in Kenya to Address Regional Cancer Needs
National Comprehensive Cancer Network and African Cancer Coalition take part in American Cancer Society Global Academy Regional Workshop to improve cancer care in Sub-Saharan Africa. NAIROBI, Kenya, June 10, 2025 /PRNewswire/ -- The National Comprehensive Cancer Network® (NCCN®)—an alliance of leading cancer centers in the United States—is joining the African Cancer Coalition (ACC) to update cancer treatment recommendations during the American Cancer Society (ACS) 2025 Global Academy Regional Workshop: Sub-Saharan Africa, in Nairobi, Kenya, June 9-11. The ACS Global Academy Regional Workshop brings together oncology specialists from around the world to improve treatment and support for people with cancer. The three-day workshop includes two days devoted to updating NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) adapted specifically for the Sub-Saharan Africa region. Additional workshops will focus on improving utilization of those guidelines, navigation programs, and provider tools. "The ACS Global Academy Regional Meetings aim to provide a productive and dedicated space for providers to learn from one another, engage in discourse, and reach consensus on regional needs," said Anu Agrawal, MD, Vice President, Global Cancer Support, American Cancer Society. "Continuing the collaboration with ACC and NCCN on the development and update of NCCN Harmonized Guidelines™ provides an essential framework to better understand localized needs and priorities, a key part of this regional meeting in Nairobi." NCCN Guidelines® contain the latest evidence-based, expert consensus-driven recommendations for cancer prevention, screening, treatment, and supportive care. They are the most thorough and frequently updated clinical practice guidelines available in any area of medicine. Approximately half of the two million registered users are from outside the United States, across 190 different countries. The NCCN Global Program oversees adapting and translating the original recommendations to be more accessible for care providers worldwide. During the meeting, the following NCCN Harmonized Guidelines™ for Sub-Saharan will be updated: Anal Carcinoma Biliary Tract Cancers Bladder Cancer Cervical Cancer Colon Cancer Colorectal Cancer Screening Gestational Trophoblastic Neoplasia (GTN) Hepatocellular Carcinoma Kidney Cancer Ovarian Cancer Penile Cancer Rectal Cancer Testicular Cancer Uterine Neoplasms Vulvar Cancer "We have been working in collaboration with experts from ACC across the Sub-Saharan Africa area and ACS for many years to share guidelines that are both aspirational and pragmatic," said Crystal S. Denlinger, MD, Chief Executive Officer, NCCN. "In that time, we have seen improved capacity in cancer-related resources and care, but we have also seen increased cancer rates for the people who live in this region. Our commitment to collaborate with leading experts in the region to maintain and update treatment recommendations, based on the latest research and local circumstances, is more important than ever." Dr. Denlinger is representing NCCN at the meeting, along with Nadeem R. Abu-Rustum, MD, Memorial Sloan Kettering Cancer Center, Chair, NCCN Guidelines Panel for Cervical/Uterine Cancers; Al Benson, MD, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chair, NCCN Guidelines Panels for Colon/Rectal/Anal Cancers and Hepatobiliary Cancers; Thomas Flaig, MD, University of Colorado Cancer Center, Chair, NCCN Guidelines Panel for Bladder/Penile Cancers; Lisa Gurski, PhD, Manager, Licensed Clinical Content, NCCN; Vaishnavi Sambandam, PhD, Oncology Scientist/Medical Writer, NCCN; and Katy Winckworth-Prejsnar, MPH, Director, Global Program, NCCN. Visit to learn more about free resources for improving cancer treatment around the world. About the National Comprehensive Cancer NetworkThe National Comprehensive Cancer Network® (NCCN®) is marking 30 years as a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to defining and advancing quality, effective, equitable, and accessible cancer care and prevention so all people can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) provide transparent, evidence-based, expert consensus-driven recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients® provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation®. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit for more information. Media Contact: Rachel Darwin267-622-6624darwin@ View original content to download multimedia: SOURCE National Comprehensive Cancer Network Error al recuperar los datos Inicia sesión para acceder a tu cartera de valores Error al recuperar los datos Error al recuperar los datos Error al recuperar los datos Error al recuperar los datos
Business Wire
30-05-2025
- Health
- Business Wire
Updated NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) Recommend Use of FES PET Imaging for Lobular Breast Cancer
ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced that the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) for clinicians now recommend considering fluoroestradiol (FES) positron emission tomography (PET) for systemic staging in patients with recurrent or metastatic lobular breast cancer. GE HealthCare's Cerianna™ (fluoroestradiol F18) injection, available in the United States, is the only FDA-approved imaging agent for the detection of estrogen receptor positive (ER+) breast cancer metastases, including lobular breast cancer. The updated NCCN Guidelines ® expand the recommendation for the use of FES PET imaging in ER+ disease. In 2023, FES PET was included in the NCCN Guidelines for systemic staging of recurrent/stage IV ER+ breast cancer. According to the Breast Cancer Research Foundation, 95% of invasive lobular cancer (ILC) tumors are ER+. i ILC is the second most common type of breast cancer in the U.S., accounting for 10-15% of all breast cancers and an estimated 43,000 new cases each year. ii iii iv Lobular tumors typically do not form lumps which makes the cancer harder to detect with self-exams, mammography, ultrasound and magnetic resonance imaging (MRI). ILC can also recur more than a decade v after initial diagnosis and metastasize to unusual places such as the bones, brain, liver, lungs, gynecological organs, and others. vivii Once recurrent or metastatic lobular breast cancer is suspected, the new guidelines recommend considering FES PET imaging of the whole body to assess whether ER+ lobular tumors are present. 'Lobular cancers are often missed during routine screening, which can result in larger, more advanced tumors when they are finally detected and diagnosed,' said Jit Saini, MD, Chief Medical Officer of the Pharmaceutical Diagnostics (PDx) division of GE HealthCare. 'This NCCN Guidelines update is significant because it will give more oncologists the confidence to use Cerianna PET imaging for patients with lobular breast cancer. It may also facilitate broader insurance coverage so more patients with this common, but hard-to-detect cancer will have an opportunity to receive a comprehensive diagnosis that accelerates clinical decisions and early intervention.' Cerianna is a molecular imaging agent indicated for use with PET imaging for the detection of ER+ lesions as an adjunct to biopsy in patients with known or suspected recurrent or metastatic breast cancer. Cerianna works by binding to functional ER lesions and then the whole body is imaged by PET scan to help doctors assess and treat lobular breast cancer appropriately. With its diffuse growth patterns, detection and biopsy of ILC can be more difficult. Cerianna provides an alternative method to assess ER status across the whole body. The recommendation that FES PET may be appropriate in lobular histology was established by an expert working group convened by the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and included breast care specialists from the SNMMI, Lobular Breast Cancer Alliance, American College of Nuclear Medicine and Korean Society of Nuclear Medicine. The SNMMI is a nonprofit organization that promotes the science, technology and practical application of nuclear medicine and molecular imaging. The National Comprehensive Cancer Network (NCCN ®) is a not-for-profit alliance of 33 leading U.S. cancer centers devoted to patient care, research, and education. The NCCN Guidelines are the recognized standard for clinical direction and policy in cancer care and the most thorough and frequently updated clinical practice guidelines available in any area of medicine. GE HealthCare's Pharmaceutical Diagnostics segment is a global leader in imaging agents used to support around 130 million procedures per year globally, equivalent to four patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology, with an innovative pipeline, all aimed at enabling better informed diagnosis and monitoring for improved therapy decision making and clinical outcomes. Learn more about Cerianna here: About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient's journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. GE HealthCare is proud to be among 2025 Fortune World's Most Admired Companies™. Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website for more information. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. IMPORTANT SAFETY INFORMATION FOR CERIANNA™ (FLUORESTRADIOL F18) INJECTION INDICATIONS AND USAGE: CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Limitations of Use: Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR). Important Safety Information CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Risk of Misdiagnosis Inadequate Tumor Characterization and Other ER-Positive Pathology Breast cancer may be heterogeneous within patients and across time. CERIANNA images ER and is not useful for imaging other receptors such as HER2 and PR. The uptake of fluoroestradiol F 18 is not specific for breast cancer and may occur in a variety of ER-positive tumors that arise outside of the breast, including from the uterus and ovaries. Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer. False Negative CERIANNA Scan A negative CERIANNA scan does not rule out ER-positive breast cancer. Pathology or clinical characteristics that suggest a patient may benefit from systemic hormone therapy should take precedence over a discordant negative CERIANNA scan. Radiation Risks Diagnostic radiopharmaceuticals, including CERIANNA, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe drug handling and patient preparation procedures (including adequate hydration and voiding) to protect patients and health care providers from unintentional radiation exposure. Pregnancy Status Assessment of pregnancy status is recommended in females of reproductive potential before administering CERIANNA. ADVERSE REACTIONS In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary All radiopharmaceuticals, including CERIANNA, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. Advise a pregnant woman of the potential risks of fetal exposure to radiation from administration of CERIANNA. There are no available data on CERIANNA use in pregnant women. No animal reproduction studies using fluoroestradiol F 18 have been conducted to evaluate its effect on female reproduction and embryo-fetal development. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Lactation Risk Summary There are no data on the presence of fluoroestradiol F 18 in human milk, or its effects on the breastfed infant or milk production. Lactation studies have not been conducted in animals. Advise a lactating woman to avoid breastfeeding for 4 hours after CERIANNA administration in order to minimize radiation exposure to a breastfed infant. Pediatric Use The safety and effectiveness of CERIANNA in pediatric patients have not been established. Geriatric Use Clinical studies of fluoroestradiol F 18 injection did not reveal any difference in pharmacokinetics or biodistribution in patients aged 65 and over. DRUG INTERACTIONS Systemic Endocrine Therapies that Bind to ER Drugs that bind to the ER, including SERMs and SERDs, may compete with the binding of fluoroestradiol F18 and may reduce detection of ER-positive lesions with CERIANNA. Before administration of CERIANNA, discontinue drugs that bind to the ER, such as SERMs and SERDs, for at least 5 biological half-lives: (e.g. elacestrant for 11 days, tamoxifen for 8 weeks and fulvestrant for 28 weeks). Prior to Cerianna administration, please read the full Prescribing Information and additional Important Safety Information here. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2 then option 1) or by email at or FDA at 800 FDA 1088 or JB11825US 2025
