Latest news with #bloodTest
The Independent
8 hours ago
- Health
- The Independent
Earliest signs of cancer can be found in the blood
Scientists have developed a highly sensitive blood test that can detect cancerous tumours years before symptoms appear. The study, published in Cancer Discovery, found that genetic mutations caused by cancer can be detected in the blood up to three years in advance for some patients. Researchers from Johns Hopkins University analysed blood samples from a NIH-funded study, using genome sequencing techniques to identify tumour-related mutations. In a sample of 52 participants, the test accurately identified eight individuals who were diagnosed with cancer within four months, and detected tumour DNA in earlier samples of four of those individuals, collected three to three-and-a-half years prior to diagnosis. The findings suggest that multicancer early detection (MCED) tests could lead to more standardised blood screenings, boosting early detection and preventing treatment-resistant tumours, pending validation in larger trials.
The Independent
12 hours ago
- Health
- The Independent
Breakthrough blood test detects cancer years before symptoms appear
Scientists have developed a 'highly sensitive' blood test that could detect signs of cancerous tumours years before the first symptoms appear, an advance that could lead to better treatment outcomes for patients. Researchers from the Johns Hopkins University in the US found that genetic material shed by tumours can be detected in the bloodstream much before patients get their first diagnosis. The study, published in the journal Cancer Discovery, found that these genetic mutations caused by cancer, can be detected in the blood over three years in advance for some patients. 'Three years earlier provides time for intervention. The tumours are likely to be much less advanced and more likely to be curable,' said study co-author Yuxuan Wang. In the research, scientists assessed blood plasma samples collected from participants of a large NIH-funded study to investigate risk factors for heart attack, stroke, heart failure and other cardiovascular diseases. Researchers developed highly accurate and sensitive genome sequencing techniques to analyse blood samples from 52 of the earlier study's participants. Twenty-six of the participants were diagnosed with cancer within six months after sample collection, and 26 who were not diagnosed served as the control group for comparison. Eight of the 52 participants scored positively in a multicancer early detection (MCED) laboratory test conducted at the time their blood samples were taken. The MCED test is designed to detect multiple cancers in their early stages from a single blood sample by analysing cancer-signature molecules in the blood, including DNA and proteins. All eight were diagnosed with cancer within four months following blood collection. For six of these 8 participants, additional blood samples were collected about 3 to 3.5 years before cancer diagnosis. In four of these cases, mutations linked to tumour growth could be identified in their earlier blood samples. The findings point to 'the promise of MCED tests in detecting cancers very early', researchers say. It may lead to more standardised blood tests to screen people either annually or every two years, which could boost early detection and prevent cancers from becoming treatment-resistant tumours. 'These results demonstrate that it is possible to detect circulating tumour DNA more than three years prior to clinical diagnosis, and provide benchmark sensitivities required for this purpose,' scientists wrote. 'Detecting cancers years before their clinical diagnosis could help provide management with a more favourable outcome,' said Nickolas Papadopoulos, another author of the study. Scientists hope the findings can be validated in a larger-scale trial involving more participants.
Yahoo
26-05-2025
- Health
- Yahoo
SeekInCare: New Multi-Omics Blood Test Shows Promise for Early Cancer Detection Across Multiple Cancer Types
SAN DIEGO, May 26, 2025 /PRNewswire/ -- A groundbreaking study published in the Journal of Molecular Diagnostics reports the successful clinical validation of SeekInCare®, a novel, non-invasive multi-omics blood test designed for the early detection of multiple cancer types. Developed by researchers at SeekIn Inc., SeekInCare integrates advanced genomic, epigenetic, and proteomic analyses to identify cancer at its early stage, offering hope for improved outcomes through earlier intervention. Key Findings Comprehensive Cancer Detection: SeekInCare leverages shallow whole-genome sequencing of cell-free DNA (cfDNA) and measures seven protein tumor markers from 8ml peripheral blood. The test analyzes multiple cancer hallmarks, including copy number aberration, fragment size, end motif, and oncogenic virus, combined with artificial intelligence algorithms to distinguish cancer patients from non-cancer individuals and predict the likely tissue of origin. Robust Clinical Validation: In a retrospective study involving 617 cancer patients (across 27 cancer types) and 580 non-cancer individuals, SeekInCare achieved a sensitivity of 60.0% at 98.3% specificity, with an area under the curve (AUC) of 0.899. Sensitivities increased with cancer stage: 37.7% (stage I), 50.4% (stage II), 66.7% (stage III), and 78.1% (stage IV). Real-World Evidence: The test was further validated in a prospective cohort of 1,203 individuals, achieving 70.0% sensitivity at 95.2% specificity over a median follow-up of 753 days. Comparable to Leading Tests: SeekInCare's performance is on par with other multi-cancer early detection (MCED) tests currently in development, demonstrating its potential as a valuable tool for population-level cancer screening, especially in high-risk groups. Addressing Unmet Needs in Cancer Screening Despite advances in cancer therapeutics, most cancers are still diagnosed at advanced stages, where treatment is less effective. Traditional screening methods are limited to specific cancer types and often involve invasive procedures that can deter participation. SeekInCare's blood-based, multi-omics approach addresses these limitations by enabling non-invasive, broad-spectrum cancer detection from a single blood draw. "Our findings demonstrate that integrating multiple molecular signatures from blood can significantly enhance the sensitivity and specificity of early cancer detection," said Dr. Mao Mao, corresponding author and Founder & CEO at SeekIn Inc. "SeekInCare's robust performance in both retrospective and prospective cohorts supports its potential clinical utility as a screening tool, particularly for high-risk populations." The study was a collaborative effort involving leading hospitals in China. The publication can be found at About SeekInCare® With the mission to detect cancer while it is still curable, SeekInCare® has been developed as a pan-cancer detection test that takes a panoramic view of blood cell-free cancer signatures and a multi-omics approach incorporating genomic and epigenetic alterations in conjunction with clinically validated protein biomarkers. Equipped with proprietary AI- and big data-driven CRS algorithm, SeekInCare exhibits superior effectiveness to detect dozens of cancer types at high specificity. SeekInCare is intended for use in individuals with elevated risks of cancer such as smoking, chronic hepatitis, aging, etc., in conjunction with the approved conventional single-cancer type screening tests. SeekInCare received CE-IVD Mark in November 2021. About SeekIn SeekIn Inc. is a biotech company founded in early 2018 in Shenzhen, China, focusing on blood-based pan-cancer early detection utilizing next-generation sequencing and artificial intelligence. Since its creation, SeekIn has been committed to providing cutting-edge and cost-effective solutions for cancer early detection, postoperative recurrence monitoring, and treatment response evaluation. SeekIn has also developed novel molecular tests for leukemia patients and its cancer early detection technology has also successfully been applied to canines. With its proprietary technical advances, SeekIn has launched a number of research and clinical studies in collaboration with top-tier hospitals in China. SeekIn envisions that, by leading a new norm for cancer early detection, the clinical outcomes of mid-/late-stage cancer patients can be reversed, and the cancer mortality rate can be reduced by 15%. For more information about SeekIn's cutting-edge technologies and products, visit View original content: SOURCE SeekIn Inc Sign in to access your portfolio
Yahoo
17-05-2025
- Health
- Yahoo
Fujirebio Receives Marketing Clearance for Lumipulse® G pTau 217/ β-Amyloid 1-42 Plasma Ratio In-vitro Diagnostic Test as an Aid to Identify Patients With Amyloid Pathology Associated With Alzheimer's Disease
—First Blood-Based In-Vitro Diagnostic Test to Receive FDA Clearance for Patients Being Assessed for Alzheimer's Disease. — —Availability of Accurate, Accessible, Blood-Based Diagnostic Tests Will Aid in Development and Availability of More Effective Interventions for Alzheimer's Disease — MALVERN, Pa., & TOKYO, May 17, 2025--(BUSINESS WIRE)--Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer's disease and other causes of cognitive decline. The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA cleared blood-based IVD test in the U.S. to aid to identify patients with amyloid pathology associated with Alzheimer's Disease (AD). Alzheimer's disease currently affects an estimated 7.2 million Americans, a number projected to rise to nearly 14 million by 2060.1 It is a leading cause of disability and death. AD develops over many years, long before symptoms are evident, but the lack of accessible, minimally invasive diagnostics results in many patients remaining undiagnosed until the disease is well advanced, when few effective interventions remain. The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test is an accurate, minimally invasive, accessible measurement of pTau 217 and β-Amyloid 1-42 concentrations in plasma as a proxy for the presence of β-Amyloid plaque pathology in the brain. It is intended for use in adult patients aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline. In a clinical study population of 499 patients, which closely mirrored the US demographics, and when applying a dual cut point, the test demonstrated a positive predicate value (PPV) of 92%, a negative predicate value (NPV) of 97% with only 20% patients who are uncertain to have amyloid pathology, thus requiring further testing. The Lumipulse pTau 217/ β-Amyloid 1-42 Plasma Ratio test uses Fujirebio's fully automated LUMIPULSE® G1200 instrument system, which is widely available in clinical laboratories throughout the U.S. The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), authorized by the FDA for use in CSF in May 2022. "The lack of effective, accessible and minimally invasive diagnostics for AD contributes to its late diagnosis and inadequate treatment," says Monte Wiltse, President and CEO at Fujirebio Diagnostics, Inc. "The Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an AD diagnosis in early stages of the disease, when interventions are more effective. As part of our worldwide commitment to improve the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment." About Fujirebio Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years' accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products. Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio offers a comprehensive line-up of manual and fully automated assays for neurological diseases and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information can be found at About Fujirebio Diagnostics, Inc. Fujirebio Diagnostics, Inc., a wholly-owned subsidiary of Fujirebio Holdings, Inc., is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, over 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us at Reference 1. (2025), 2025 Alzheimer's disease facts and figures. Alzheimer's Dement., 21: e70235. View source version on Contacts MEDIA CONTACT: Chris DagueFujirebio Diagnostics, 484-395-5556daguec@ 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
