Latest news with #NCCN


Medscape
a day ago
- Health
- Medscape
Fast Five Quiz: B-Cell Acute Lymphoblastic Leukemia
Though more common in pediatric populations, B-cell acute lymphoblastic leukemia (B-ALL) affects both children and adults, and it has several genetic subtypes that significantly affect prognosis and treatment decisions. Despite advances in treatment protocols, resistance mechanisms remain a significant challenge. However, some genetic subtypes are associated with more favorable prognosis, and the nuances of this disease are evident in the cascading treatment algorithm recommended by the National Comprehensive Cancer Network (NCCN) for pediatric and adult cases. What do you know about B-ALL? Check your knowledge with this quick quiz. The treatment of B-ALL involves a complex and intensive series of steps. In the induction phase, glucocorticoids are typically used to reduce tumor burden by clearing leukemic cells from the bone marrow. However, point mutations in the NR3C1 gene generally cause resistance to glucocorticoid therapy, which can significantly affect prognosis. Mutations in the CREBBP gene also cause resistance to glucocorticoids DHFR , FPGS , and TYMS genes have been shown to generally cause resistance to methotrexate, not glucocorticoids. Learn more about corticosteroids in B-ALL. In risk stratification for B-ALL, the NCCN notes that having a white blood cell count of > 30 x 109/L is considered a high-risk feature. This is consistent with European guidelines. The NCCN also states that age over 35 years is another high-risk feature for B-ALL. ETP phenotype is a high-risk feature for T-cell acute lymphoblastic leukemia rather than the B-ALL subtype. Hyperdiploidy (a molecular subtype of B-ALL with 51-65 chromosomes) is considered standard risk by the NCCN; data have shown better prognosis for pediatric patients with this subtype. Learn more about risk stratification for B-ALL. TKIs are an important component of induction, consolidation, and maintenance treatment for Ph+ B-ALL. They are recommended by the NCCN for use in conjunction with other drugs, such as corticosteroids, blinatumomab, and inotuzumab ozogamicin (depending on treatment phase and disease severity) and as a treatment post-HCT. They recommend continuing TKI therapy for at least 2 years after HCT, although they note that the 'optimal duration' is unknown for this population. A recent review, however, notes that despite their success in patients with Ph+ B-ALL, approximately 25% of cases will develop resistance to TKIs. Given this possibility, the NCCN notes that clinicians should consider prior TKI intolerance, dose used, BCR::ABL1 mutations, and disease-related features when choosing a specific TKI; they specifically recommend bosutinib, dasatinib, imatinib, nilotinib, or ponatinib as options for TKI therapy. Learn more about Ph+ B-ALL treatments. The DUX4-rearranged subtype of B-ALL is considered to have a favorable prognosis in adolescents and young adults, compared with MEF2D-rearranged, CDX2/UBTF, and IDH1/2; these subtypes generally have inferior prognosis in the same populations (although MEF2D-rearranged has intermediate prognosis in adults). Specifically, DUX4-rearranged B-ALL has been associated with 93% event-free survival and overall survival in pediatric patients, and adolescent and young-adult patients also see longer disease-free survival after complete remission is achieved. Learn more about B-ALL genomics. Several genetic subtypes of B-ALL are associated with varying prognoses, and the outcomes differences seen between pediatric and adult patients can be partly explained by the different subtypes expressed by these populations. Further, new therapies have enabled high survival rates among pediatric patients with B-ALL, with long-term survival of up to 90% in this population. Prognosis for B-ALL in adolescents and adults is comparatively poor. For example, a population-based study reported the following declining survival rates with age: 74% for patients 15-19 years old, 59% for patients 20-39 years old, and 43% for those 40-59 years old. However, the researchers explained that these percentages still demonstrate improvements, as survival rates were overall lower in the 1980s and 1990s. Learn more about B-ALL prognosis.


Medscape
a day ago
- Health
- Medscape
Rapid Review Quiz: Ovarian Cancer Screening and Prevention
Reliably screening for ovarian cancer in the general population remains a challenge. Common tools such as CA-125 testing and transvaginal ultrasound have shown limited sensitivity and specificity, leading to unnecessary surgeries and false reassurance. However, advances in genetic testing and molecular pathology have reshaped prevention strategies, particularly in individuals at elevated hereditary risk such as BRCA mutation carriers. Risk-reducing salpingo-oophorectomy remains the cornerstone of prevention for high-risk patients, while oral contraceptives offer a risk-reducing effect in the general population. Additionally, genetic counseling has become an essential step in identifying at-risk individuals who may benefit from tailored interventions. How much do you know about recent developments in ovarian cancer screening and prevention? Test your knowledge with this updated review. Despite significant research efforts, no screening strategy has yet demonstrated a mortality benefit in average-risk female patients. As noted in the National Comprehensive Cancer Network (NCCN) guidelines, landmark clinical trials — including the PLCO (Prostate, Lung, Colorectal, and Ovarian) cancer screening trial — failed to show a survival benefit from annual CA-125 testing or transvaginal ultrasound alone or in combination. The risk of ovarian cancer algorithm (ROCA) — which evaluates CA-125 trends over time — did improve early-stage detection rates but did not ultimately reduce mortality. As a result, current guidelines from the United States Preventive Services Task Force and other expert bodies, including the NCCN, recommend against routine screening for ovarian cancer in asymptomatic, average-risk females. Instead, attention has shifted toward identifying and managing high-risk individuals through genetic counseling and risk-reducing strategies. Routine screening in the general population is considered ineffective and may result in harms from false-positive tests and unnecessary surgical interventions. Learn more about the workup for ovarian cancer. Risk-reducing salpingo-oophorectomy (RRSO) remains the most effective strategy for preventing ovarian and fallopian tube cancer in individuals with BRCA1 or BRCA2 mutations. Guidelines recommend RRSO typically between ages 35 and 45, depending on the specific mutation and family history. This surgery significantly lowers the risk of high-grade serous carcinoma, the most common and aggressive subtype. Studies have shown that RRSO can reduce ovarian cancer risk significantly also confer a survival benefit, particularly in BRCA1 carriers. While oral contraceptives also reduce risk, they do not offer the same degree of protection as surgical removal of at-risk tissue. Annual pelvic exams and imaging have not demonstrated efficacy in early detection or mortality reduction in this population. Patients considering RRSO should be counseled about surgical menopause and may require hormone therapy depending on age and symptom burden. The procedure is essential in the preventive care of high-risk individuals. Learn more more about ovarian cancer deterrence and prevention. Emerging evidence over the past decade suggests that the fallopian tube epithelium — not the ovary — is the origin of many high-grade serous ovarian carcinomas. As a result, the practice of opportunistic salpingectomy — removing the fallopian tubes during hysterectomy or tubal sterilization procedures — has gained traction as a preventive strategy, even in females at average risk. Major gynecologic societies now endorse this practice as a safe and effective risk-reducing option during pelvic surgery for benign indications. The rationale is grounded in the theory of serous tubal intraepithelial carcinoma as a precursor lesion to high-grade serous cancer. Unlike endometrial cancer, whose origin lies in the uterine lining, salpingectomy directly targets the tissue where most serous carcinomas are thought to begin. Learn more about ovarian cancer and surgical considerations. Current guidelines recommend genetic counseling and consideration of BRCA and multigene panel testing in females with a personal or strong family history of breast, ovarian, fallopian tube, or peritoneal cancer. Identifying carriers of pathogenic variants enables implementation of life-saving risk-reducing strategies, including salpingo-oophorectomy or enhanced surveillance. Importantly, such testing is also offered to individuals with male relatives who have had breast cancer, early-onset cancers, or known mutations in cancer susceptibility genes. Genetic testing should ideally be preceded by counseling to interpret results accurately and discuss implications for family members. Patients with unrelated gynecologic conditions like endometriosis or abnormal uterine bleeding, and those without relevant family history, are not routinely offered genetic testing unless other risk factors emerge. Early identification of mutation carriers is essential for tailored management, timely preventive interventions, and cascade testing of at-risk relatives. Learn more about risk assessment and genetic counseling in ovarian cancer. Multiple large observational studies and meta-analyses have consistently demonstrated a protective effect of combined oral contraceptives (COCs) against ovarian cancer. The reduction in risk is observed with long-term use, typically over 5 years, and persists for decades after discontinuation. The proposed mechanism involves suppression of ovulation, thereby reducing the repetitive trauma and repair cycles to the ovarian epithelium, which may underlie carcinogenesis. The protective effect spans multiple histologic subtypes, including high-grade serous, endometrioid, and clear cell carcinomas. While other agents such as NSAIDs have been evaluated, their protective role is less well established and not considered standard for chemoprevention. Aromatase inhibitors and bisphosphonates are not used for ovarian cancer prevention. As with any medication, the decision to use oral contraceptives must consider individual risk profiles, including thromboembolic and cardiovascular risks, and be guided by patient preferences and shared decision-making. Learn more about ovarian cancer and the impact of oral contraceptives.


Associated Press
2 days ago
- 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
2 days ago
- 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


Associated Press
3 days ago
- Business
- Associated Press
National Comprehensive Cancer Network (NCCN) Updates Colorectal Cancer Screening Guidelines to Include Shield Blood-Based Screening
PALO ALTO, Calif.--(BUSINESS WIRE)--Jun 2, 2025-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the National Comprehensive Cancer Network (NCCN) has included the Shield blood test in its updated colorectal cancer (CRC) screening guidelines. The Shield test detects CRC signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA). The updated NCCN CRC Screening Guidelines reflect the addition of Shield with a recommendation for testing every three years. 'With a simple blood draw, Shield provides a more convenient and pleasant screening option for the millions of eligible Americans who are forgoing their recommended screening for colorectal cancer,' said AmirAli Talasaz, Guardant Health co-CEO. 'This major guideline inclusion from the National Comprehensive Cancer Network is just the first for Shield, and we believe a pivotal step for more patients to benefit from this test.' In its guideline update, the NCCN pointed to Guardant's landmark ECLIPSE (Evaluation of ctDNA LUNAR Assay in an Average Patient Screening Episode) study evaluating the performance of Shield compared to a screening colonoscopy. One of the largest studies of its kind and published in the New England Journal of Medicine (NEJM), ECLIPSE demonstrated that the Shield blood test is highly effective in detecting CRC, with a sensitivity of 83 percent. About Shield Shield is a non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit and follow the company on LinkedIn, X (Twitter) and Facebook. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health's liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operation' and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health's views as of any date subsequent to the date of this press release. View source version on CONTACT: Investor Contact: Zarak Khurshid [email protected] Contact: Meaghan Smith [email protected] KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH ONCOLOGY OTHER HEALTH SOURCE: Guardant Health, Inc. Copyright Business Wire 2025. PUB: 06/02/2025 08:05 AM/DISC: 06/02/2025 08:03 AM