Core Insights - Labcorp has launched the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first FDA-cleared blood-based IVD test for aiding in the diagnosis of Alzheimer's disease through early detection of amyloid plaques [1][2] - The test is designed to be more affordable, accessible, and less invasive compared to traditional methods like cerebrospinal fluid testing and PET scans, with a positive predictive value of 92% and a negative predictive value of 97% [2][3] - The launch aligns with new clinical guidelines from the Alzheimer's Association, emphasizing the importance of blood-based biomarkers in evaluating suspected Alzheimer's patients [3] Company Overview - Labcorp is a global leader in laboratory services, providing insights and advancing science to improve health, with nearly 70,000 employees serving clients in approximately 100 countries [5] - The company supports over 75% of new drugs and therapeutic products approved by the FDA in 2024 and performs more than 700 million tests annually [5] Test Details - The Lumipulse pTau-217/Beta Amyloid 42 Ratio is intended for adults aged 50 and older showing cognitive decline symptoms and must be interpreted alongside other clinical information [4] - Patients can have the blood draw done at healthcare provider offices or any of Labcorp's over 2,200 Patient Service Centers nationwide [4]

Core Viewpoint - Roche has received CE Mark for its Elecsys® pTau181 test, which measures phosphorylated Tau (pTau) 181 protein, an indicator of amyloid pathology associated with Alzheimer's disease, enabling clinicians to rule out Alzheimer's as a cause of cognitive decline [1][2][7] Group 1: Product Development and Impact - The Elecsys pTau181 test was developed in collaboration with Eli Lilly and Company and aims to provide clarity for patients and caregivers regarding cognitive decline [2] - The test has the potential to improve patient outcomes and reduce healthcare costs by enabling earlier and less invasive diagnoses [2] - The test's high negative predictive value (NPV) of 93.8% and sensitivity of 83.6% were demonstrated in a study involving 787 patients across the US, Europe, and Australia [4][5] Group 2: Clinical Study and Implementation - The clinical study supporting the Elecsys pTau181 test was the first of its kind to investigate its performance in a diverse patient population aged 55-80 years [5] - The test can be effectively implemented in primary care settings, allowing for earlier identification of Alzheimer's pathology and access to new treatments [3][7] - The test minimizes the need for confirmatory testing, thus streamlining the diagnostic process for Alzheimer's disease [7] Group 3: Future Developments - Roche is also developing the Elecsys pTau217 blood test, which aims to identify amyloid pathology and has shown stability in various conditions [6] - The Elecsys pTau217 test is expected to complement the pTau181 test and could be scaled for broad implementation in clinical practice [6] Group 4: Company Commitment and Vision - Roche has over two decades of research in Alzheimer's disease and aims to detect and treat the disease early to prevent its progression [8] - The company collaborates with various partners to enhance the impact of its Alzheimer's disease portfolio, which includes investigational medicines and diagnostic tools [8]

Elecsys pTau181 is the first In Vitro Diagnostic Regulation (IVDR) certified test to rule out Alzheimer’s associated amyloid pathology.The minimally invasive, blood-based test can serve as a rule out for Alzheimer’s pathology, reducing the need for confirmatory testing with a negative result.Data from clinical study supports use in primary care for people with varying signs of cognitive decline. Basel, 23 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE Mark for its Elecsys® ...

Labcorp's pTau-217/Beta Amyloid 42 Ratio blood test meets the performance criteria to confirm amyloid pathology consistent with Alzheimer's diseaseBURLINGTON, N.C., April 2, 2025 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the nationwide launch of its pTau-217/Beta Amyloid 42 Ratio, a powerful new blood-based biomarker test to aid in the diagnosis of Alzheimer's disease. The new test further expands Labcorp's leading blood-based bi ...