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Business Wire
3 days ago
- 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
10-02-2025
- Health
- Yahoo
NCCN Strengthens Guidance on ctDNA in Colon Cancer, Rectal Cancer, and Merkel Cell Carcinoma
National Comprehensive Cancer Network® (NCCN®) Guidelines for colon and rectal cancer were updated to include ctDNA as a prognostic marker and high risk factor for recurrence NCCN guideline for merkel cell carcinoma cites SignateraTM data and now includes positive recommendation for ctDNA monitoring in surveillance AUSTIN, Texas, February 10, 2025--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today commented on recent updates by the NCCN on circulating tumor DNA (ctDNA) molecular residual disease (MRD) testing in the Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for colon cancer, rectal cancer, and merkel cell carcinoma (MCC). In its updated guidelines for colon cancer1 and for rectal cancer2, NCCN now includes ctDNA as a high risk factor for recurrence in the adjuvant setting, recognizing its prognostic value. This represents a significant step forward as it's the first time the committee has formally recognized ctDNA as being prognostic. The guidelines remain cautious about ctDNA for surveillance, as expected. The NCCN finalized these updates before data from the phase III CALGB (Alliance) / SWOG 80702 study were presented at ASCO GI in January, supporting the predictive nature of Signatera in the adjuvant setting. For MCC, the updated NCCN guidelines state that "ctDNA can assess disease burden in both virus-positive and virus-negative MCC and typically becomes positive prior to or at the time of a clinically evident recurrence. For surveillance, this test is often obtained every 3 months."3 In addition, the guideline specifically references a Signatera publication with data from a prospective multicenter study published in 2024 in the Journal of Clinical Oncology (JCO). The study demonstrated excellent performance of Signatera, with 95% detection at time of enrollment and 20x higher risk of recurrence among patients who were persistently Signatera positive. Natera believes this positive update on MCC can set a precedent for the important role of ctDNA testing across other indications. "Signatera tumor-informed ctDNA testing is a highly accurate and prognostic biomarker for surveillance of high- and low-risk patients with MCC to help determine imaging frequency," said Lisa Zaba, M.D., Ph.D., associate professor of dermatology, director of the MCC multi-disciplinary clinic and member of the supportive oncodermatology group at the Stanford Cancer Center. MCC is a rare skin cancer (~3,000 patients diagnosed annually) which disproportionately affects the elderly with most patients diagnosed above age 70.4 MCC has high mortality and a recurrence rate of 40% within 5 years.5 "These guideline changes came faster than expected given the typical timelines to be included," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology for Natera. "The inclusion of ctDNA testing in NCCN guidelines for these histologies is another step toward more personalized care for patients with cancer." About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, coverage and reimbursement determinations from third-party payers, or our expectations or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at and References NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer Version 1.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed February 7, 2025. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Rectal Cancer Version 1.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed February 7, 2025. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Merkel Cell Carcinoma Version 1.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed January 17, 2025. American Cancer Society. Key statistics for Merkel Cell Carcinoma. McEvoy AM, Lachance K, Hippe DS, et al. Recurrence and Mortality Risk of Merkel Cell Carcinoma by Cancer Stage and Time From Diagnosis. JAMA Dermatol. 2022;158(4):382-389. View source version on Contacts Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@ Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@ Sign in to access your portfolio
