Latest news with #NCCNGuidelines
Yahoo
5 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
Associated Press
03-06-2025
- Business
- Associated Press
Geneoscopy's RNA-Based ColoSense Test Included in Latest National Comprehensive Cancer Network (NCCN) Guidelines
ST. LOUIS--(BUSINESS WIRE)--Jun 3, 2025-- Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that its ColoSense® test has been included in the National Comprehensive Cancer Network® (NCCN) Guidelines for Colorectal Cancer (CRC) Screening as a first-line test for average-risk patients, supporting its role as a screening alternative for individuals aged 45 years and older. ColoSense is a noninvasive stool-based test for detecting CRC and advanced adenomas, and is the only FDA-approved screening test utilizing stool RNA biomarkers, which are not subject to age-related methylation. 1,2 The NCCN Guidelines are comprehensive, evidence-based recommendations to support the prevention, diagnosis, and treatment of more than 97% of cancers affecting patients in the United States. They are regularly updated to reflect the latest scientific evidence and improve the quality and consistency of cancer care. 'The NCCN Guidelines are among the most trusted clinical resources in oncology, and the addition of ColoSense is a powerful validation of its clinical performance,' said Erica Barnell, M.D., Ph.D., Chief Science and Medical Officer of Geneoscopy. 'As the first and only FDA-approved stool RNA screening test for colorectal cancer, this affirms the scientific rigor behind our technology and reinforces the importance of noninvasive modalities in expanding access and improving screening compliance, especially among populations less likely to undergo colonoscopy.' ColoSense's inclusion in the NCCN Guidelines is based on data from Geneoscopy's CRC-PREVENT pivotal study, which was published in the Journal of the American Medical Association (JAMA). 3 Unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs, nearly two-thirds of CRC-PREVENT participants had never undergone CRC screening or scheduled a colonoscopy at the time of enrollment. The study demonstrated ColoSense's ability to detect CRC with 94% sensitivity, identifying 100% of CRC in Stage I. Additionally, ColoSense detected 46% of advanced adenomas, when the disease is most preventable. 'The NCCN Guidelines heavily impact both the clinical adoption and insurance coverage of screening tests,' said Matt Sargent, Chief Commercial Officer of Geneoscopy. 'Achieving this milestone as a first-line test marks a pivotal step forward in our mission to bring ColoSense to market as an accurate, accessible screening solution for millions of Americans. NCCN guideline inclusion also positions ColoSense for future inclusion in other major guidelines.' About ColoSense ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. Results from Geneoscopy's pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit About Geneoscopy, Inc. Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy's mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The company's FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit and follow the company on LinkedIn. References View source version on CONTACT: Media Contact Andrea Sampson Sampson Public Relations Group [email protected] KEYWORD: MISSOURI UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: SCIENCE OTHER SCIENCE BIOTECHNOLOGY RESEARCH MANAGED CARE ONCOLOGY HEALTH GENETICS SOURCE: Geneoscopy, Inc. Copyright Business Wire 2025. PUB: 06/03/2025 07:50 AM/DISC: 06/03/2025 07:50 AM
Business Wire
03-06-2025
- Business
- Business Wire
Geneoscopy's RNA-Based ColoSense Test Included in Latest National Comprehensive Cancer Network (NCCN) Guidelines
ST. LOUIS--(BUSINESS WIRE)-- Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that its ColoSense® test has been included in the National Comprehensive Cancer Network® (NCCN) Guidelines for Colorectal Cancer (CRC) Screening as a first-line test for average-risk patients, supporting its role as a screening alternative for individuals aged 45 years and older. ColoSense is a noninvasive stool-based test for detecting CRC and advanced adenomas, and is the only FDA-approved screening test utilizing stool RNA biomarkers, which are not subject to age-related methylation. 1,2 The NCCN Guidelines are comprehensive, evidence-based recommendations to support the prevention, diagnosis, and treatment of more than 97% of cancers affecting patients in the United States. They are regularly updated to reflect the latest scientific evidence and improve the quality and consistency of cancer care. 'The NCCN Guidelines are among the most trusted clinical resources in oncology, and the addition of ColoSense is a powerful validation of its clinical performance,' said Erica Barnell, M.D., Ph.D., Chief Science and Medical Officer of Geneoscopy. 'As the first and only FDA-approved stool RNA screening test for colorectal cancer, this affirms the scientific rigor behind our technology and reinforces the importance of noninvasive modalities in expanding access and improving screening compliance, especially among populations less likely to undergo colonoscopy.' ColoSense's inclusion in the NCCN Guidelines is based on data from Geneoscopy's CRC-PREVENT pivotal study, which was published in the Journal of the American Medical Association (JAMA). 3 Unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs, nearly two-thirds of CRC-PREVENT participants had never undergone CRC screening or scheduled a colonoscopy at the time of enrollment. The study demonstrated ColoSense's ability to detect CRC with 94% sensitivity, identifying 100% of CRC in Stage I. Additionally, ColoSense detected 46% of advanced adenomas, when the disease is most preventable. 'The NCCN Guidelines heavily impact both the clinical adoption and insurance coverage of screening tests,' said Matt Sargent, Chief Commercial Officer of Geneoscopy. 'Achieving this milestone as a first-line test marks a pivotal step forward in our mission to bring ColoSense to market as an accurate, accessible screening solution for millions of Americans. NCCN guideline inclusion also positions ColoSense for future inclusion in other major guidelines.' About ColoSense ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. Results from Geneoscopy's pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit About Geneoscopy, Inc. Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy's mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The company's FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit and follow the company on LinkedIn. References Ahlquist, D. A., Taylor, W. R., Yab, T. C., Devens, M. E., Mahoney, D. W., Boardman, L. A., Thibodeau, S. N., Zou, H., Michael, D., Berger, B. M., & Lidgard, G. P. (2012). Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research, 72(8_Supplement), 3572–3572. Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. (2012) Aberrantly Methylated Gene Marker Levels in Stool: Effects of Demographic, Exposure, Body Mass, and Other Patient Characteristics. J Mol Biomark Diagn 3:133. doi:10.4172/2155-9929.1000133 Barnell EK, Wurtzler EM, La Rocca J, et al. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023;330(18):1760–1768. doi:10.1001/jama.2023.22231
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
Yahoo
30-05-2025
- Business
- Yahoo
Updated NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Recommend Use of FES PET Imaging for Lobular Breast Cancer
NCCN Guidelines® recommend FES PET for systemic staging in certain patients with invasive lobular cancer (ILC), which could facilitate greater diagnostic accuracy, earlier interventions, better clinical decision-making and broader insurance coverage for breast cancer patients. GE HealthCare's Cerianna (fluoroestradiol F18) injection is the first and only U.S. Food and Drug Administration (FDA) approved imaging agent to help clinicians assess estrogen receptor positive (ER+) lesion status in recurrent or metastatic breast cancer. ARLINGTON HEIGHTS, Ill., May 30, 2025--(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 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 decadev after initial diagnosis and metastasize to unusual places such as the bones, brain, liver, lungs, gynecological organs, and 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 ______________________________ i Rubio M, et al. Invasive lobular carcinoma: symptoms, treatment, research. Breast Cancer Res. 2025 May 20. Available from: ii McCart Reed AE, et al. Invasive lobular carcinoma of the breast: the increasing importance of this special subtype. Breast Cancer Res. 2021 Jan 7;23(1):6. PMID: 33413533 iii Ciriello G, et al. Comprehensive Molecular Portraits of Invasive Lobular Breast Cancer. Cell. 2015 Oct 8;163(2):506-19. PMID: 26451490 iv 2021 Projected Incidence from ACS Surveillance Research (Source: SEER data) v Pestalozzi BC, et al. International Breast Cancer Study Group. Distinct clinical and prognostic features of infiltrating lobular carcinoma of the breast: combined results of 15 International Breast Cancer Study Group clinical trials. J Clin Oncol. 2008 Jun 20;26(18):3006-14. PMID: 18458044 vi Franzoi MA, et al. Leptomeningeal carcinomatosis in patients with breast cancer. Crit Rev Oncol Hematol. 2019 Mar;135:85-94. PMID: 30819451 vii Blohmer M, et al. Patient treatment and outcome after breast cancer orbital and periorbital metastases: a comprehensive case series including analysis of lobular versus ductal tumor histology. Breast Cancer Res. 2020 Jun 26;22(1):70. PMID: 32586354 JB11825US 2025 View source version on Contacts GE HealthCare Media Contact: Emmy ElguizaouiCommunications Director – 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
