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Labcorp is offering the new blood-based Amyloid-Tau-Neurodegeneration (ATN) pro through physicians for use with patients being evaluated for possible Alzheimer’s disease or other causes of cognitive impairment ATN Pro three blood biomarkers. (Credit: Louis Reed on Unsplash) US-based healthcare company Labcorp has announced the country-wide launch of its new blood-based test, dubbed ATN Profile, to advance the diagnosis of Alzheimer’s disease. ATN Pro three blood biomarkers to identify amyloid plaques, tau tangles and neurodegeneration (ATN), the biological changes associated with Alzheimer’s disease. The new blood-based test is offered through physicians for use with patients evaluated for possible Alzheimer’s disease or other cognitive impairment diseases. It will be offered based on clinical observation and cognitive screenings, said the company. Labcorp chief medical and scientific officer Brian Caveney said: “Many patients experience uncertainty around Alzheimer’s disease risk, which can take months or even years to diagnose. “More definitive testing, including our new ATN profile, can provide objective insights to patients, their loved ones, and treating physicians as they navigate care and treatment.” Alzheimer’s disease is the most common form of dementia that involves a slow build-up of protein plaques and tangles in the brain that eventually cause neurodegeneration, where brain cells stop working properly and die. According to the company, specifically identifying biological changes associated with Alzheimer’s disease has been difficult through widely available methods. The standard approach includes a physical exam, routine blood and urine tests, and cognitive testing, which may not provide definite results, leading to delayed referral to a specialist. Labcorp said that its new ATN Pro physicians with an easily usable blood test to evaluate people with Alzheimer’s disease and other neurodegenerative conditions. Through ATN Profile, the company aims to support better care and outcomes for those impacted by Alzheimer’s disease and other neurodegenerative conditions. In addition, it will continue to conduct studies on ATN testing to help enhance patient care and the development of new drugs to treat and manage the disease, said the healthcare company. Caveney added: “Labcorp’s ATN Pro easier identification of biological changes consistent with Alzheimer’s disease and offers the promise of an accelerated path to diagnosis. “This new blood biomarker test, which is widely available through physicians, will support the diagnostic and referral process for Alzheimer’s disease and other neurodegenerative causes of dementia and impaired cognitive function.”

Test is available through physicians for use with patients being evaluated for possible Alzheimer's disease or other causes of cognitive impairment Labcorp is the first company to deliver a blood-based Amyloid-Tau-Neurodegeneration (ATN) Profile, which uses a trio of blood biomarkers to detect the hallmarks of Alzheimer's disease BURLINGTON, N.C., Oct. 11, 2023 /PRNewswire/ -- LabCorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the launch and national availability of its ATN Profile, a blood-based test that combines three, well-researched blood biomarkers to identify and assess biological changes associated with Alzheimer's disease – amyloid plaques, tau tangles and neurodegeneration (ATN) – which can help accelerate the path to diagnosis and intervention.i The test is available through physicians for use with patients who are being evaluated for possible Alzheimer's disease or other causes of cognitive impairment based on clinical observation and cognitive screenings. "Many patients experience uncertainty around Alzheimer's disease risk, which can take months or even years to diagnose," said Dr. Brian Caveney, Labcorp's chief medical and scientific officer. "More definitive testing, including our new ATN profile, can provide objective insights to patients, their loved ones, and treating physicians as they navigate care and treatment." Alzheimer's disease is the most common form of dementia. According to the U.S. Centers for Disease Control and Prevention (CDC), as many as 6.7 million Americans are living with Alzheimer's disease, a number that is expected to nearly triple to 14 million people by 2060. It involves a slow build-up of protein plaques and tangles in the brain that eventually cause brain cells to stop working properly and die – a process known as neurodegeneration, which may start years before a person experiences symptoms such as memory loss. Until recently, it has been difficult to specifically identify the biological changes consistent with Alzheimer's disease through widely available methods. The standard approach, which includes a physical exam, routine blood and urine tests, and cognitive testing may not provide distinct answers, which can result in delayed referral to a specialist. Labcorp's new ATN Pro physicians an easily accessible and interpretable blood test to assess pathologies associated with Alzheimer's disease and other neurodegenerative conditions in appropriate patients, supporting more informed decision-making and improved personalized patient care. "Labcorp's ATN Pro easier identification of biological changes consistent with Alzheimer's disease and offers the promise of an accelerated path to diagnosis," said Caveney. "This new blood biomarker test, which is widely available through physicians, will support the diagnostic and referral process for Alzheimer's disease and other neurodegenerative causes of dementia and impaired cognitive function." With the release of its ATN Profile, Labcorp is reaffirming its dedication to supporting better care and outcomes for those impacted by Alzheimer's disease and other neurodegenerative conditions. Labcorp is continuing to invest in studies to demonstrate the impact ATN testing can have in enhancing patient care and the continued development of new drugs to treat and manage the disease, as well as in making other key neurological markers widely accessible to physicians. Healthcare providers can now order the ATN Profile, which includes blood Aß42/40, pTau 181 and NfL, or they can order these tests individually. For more information, visit About Labcorp Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's more than 60,000 employees serve clients in over 100 countries, worked on over 80% of the new drugs approved by the FDA in 2022 and performed more than 600 million tests for patients around the world. Learn more about us at . Company Codes: NYSE:LH

Pictured: Red and white Lilly sign on building/Mic Jeff Dage, Ph.D., senior research adviser at Eli Lilly and Company, presented the case for P-tau in blood as an accurate biomarker. Michael Vi/Shutterstock Biomarkers will be critical to developing precision medicine for Alzheimer’s disease. Although a few are out there, phosphorylated tau (P-tau) may enable even earlier and more accurate detection, according to Eli Lilly-associated researchers speaking at the Clinical Trials on Alzheimer’s Disease (CTAD) virtual conference in early November. “They will help researchers mechanistically assess target engagement in clinical trials,” and also will be used in clinical practice to identify the right drugs for the right patients, Howard Fillit, M.D., CSO, Alzheimer’s Drug Discovery Foundation, said, introducing the conference symposium, “ Latest Advances: Blood And Imaging Biomarkers Of Tau In Alzheimer’s Patients .” Jeff Dage, Ph.D., senior research adviser at Eli Lilly and Company, presented the case for P-tau in blood as an accurate biomarker. “Recent literature has demonstrated P-tau levels are elevated many years prior to Alzheimer’s disease (AD) symptom onset and are in line with the detection of amyloid pathology.” Therefore, Eli Lilly is developing an assay that measures P-tau 217 in blood. Results collaborate those of tau PET analysis. “We wanted a tau antibody that would bind to the expressed forms of tau, so we developed a very specific assay,” Dage said. The plasma assay elements include: Capture – a biotin-labeled anti-phosphor-thr217-tau antibody Detection – a ruthenium-labeled isoform-specific anti-tau antibody Calibration – two antigen-specific synthetic peptides coupled with a PEG linker Currently, this early assay is sensitive at 0.08 pg/mL, a measuring range of 0.08 to 2000 pg/mL, but less than 10% precision. Importantly, “It demonstrated a lack of drug interference for each drug studied,” Dage said. In one of the many studies he recounted, a dose-based reduction in plasma P-tau217 levels accompanied the reduction in amyloid. “This is encouraging as a pharmacodynamic biomarker in larger trials,” Dage said. The assay is being explored for applications in clinical research, including new drug trials, based on its capability to identify patients with Alzheimer’s disease and also to predict their risk of progression. “Future work will explore utility as a surrogate efficacy marker,” Dage said. In a related presentation, Mike Devous, M.D., VP of imaging development at Avid Radiopharmaceuticals, a subsidiary of Lilly, compared flortaucipir, a tracer used in imaging studies, to neuropathy in Phase III trials. Results showed an association with the detection of cortical neurofibrillary tangles (NFTs) in a large autopsy study. “We’re exploring whether an early tau region may be sensitive to early pathology and intermediate progression,” he said. Avid’s clinical trials involving tau imaging using flortaucipir show comparable density and distribution of tau pathology when compared to autopsy literature. “Baseline flortaucipir correlates with 18-month cognitive and functional change measures, and tau visual read patterns interact with quantitation to enhance understanding of cognitive decline,” Devous said. “In two pivotal trials, flortaucipir PET imaging had statistically significant sensitivity and specificity for predicting neurofibrillary tangle scores of B3 or Braak V/VI and high levels of Alzheimer’s disease neuropathologic change,” he said. “Despite overall agreement with Braak stages, patients may have widely varying patterns of tau distribution. Those patterns appear in different regions of the brain, and are relevant in progression and decline,” Devous noted. Memory, language, and visuospatial abilities, for example, are affected. Based on these studies, flortaucipir PET imaging appears to identify a therapeutic window. It seems to offer higher sensitivity than MRI imaging, and comparable specificity. Identifying accurate biomarkers and applying them to the clinical treatment of Alzheimer’s patients could have a profound effect on therapeutics and the progression of disease. As Takeshi Iwatsubo, M.D. professor of neuropathology, School of Medicine, University of Tokyo, underscored, “Alzheimer’s disease is a relentless, fatal disease, creating a health crisis for patients, families, and nations. If we can’t stop it, the cost to society will be great. “As researchers, we understand that the hallmark pathologies of Alzheimer’s disease occur 10 to 20 years before clinical symptoms…and we believe that amyloid and tau are both part of a common disease cascade that can trigger neuroinflammation and neuronal death,” Iwatsubo said. “And yet…our research findings are not translating into the realities of community practice and the broader patient experience.” Biomarkers for amyloid, tau, and neuroinflammation already play important roles in stratifying risk for clinical trial populations, but they tend not to be used in clinical practice. Yet, when combined with clinical assessment, family history, and early detection practices, “these latest tau biomarker findings can change the face of clinical practice,” he said. For example, Iwatsubo said this new generation of biomarkers could identify the pathology of Alzheimer’s disease long before symptoms become evident, thus allowing treatment earlier than is common today. That, in turn likely leads to better outcomes. The University of Tokyo conducted a seven-year, 537-patient, Phase III trial sponsored by Eli Lilly, NIA, and AMED, Japan, dubbed the Japanese Alzheimer’s Disease Neuroimaging Initiative (ADNI). The protocol was identical to the U.S. ADNI trial. It found that Japanese and American patients have similar disease pro enabling harmonization of international trials. The trial also found APOE genotyping helpful for predicting ATN (amyloid, tau, neurodegeneration) classification. Building on that, a Japanese trial-ready cohort is ready to study preclinical/prodromal Alzheimer’s disease. More than 4.5 thousand participants are enrolled in what ultimately is expected to be a 15,000- to 20,000-person trial to study variables in amyloid prediction based on A4 screening data. “We are wondering if similar predictions of risk are feasible based on tau biomarkers and this data,” Iwatsubo said. Tau biomarkers are useful in diagnosing Alzheimer’s disease, these researchers agreed. But, as Iwatsubo cautioned, “We are at the early stages. Their potential as efficacy markers of disease-modifying therapies should be further demonstrated.”