Core Insights - The Quest AD-Detect® blood tests demonstrate high accuracy in identifying Alzheimer's disease pathology, potentially reducing the need for PET imaging confirmation [1][2][3] Test Performance - The study evaluated two blood tests with 91% sensitivity and 91% specificity in a population of 215 patients with mild cognitive impairment or Alzheimer's disease, where 46% were amyloid PET-positive [4][5] - The test combining AB 42/40, p-tau217, and ApoE4 had a positive predictive value (PPV) of 88% and a negative predictive value (NPV) of 91%, while the test without ApoE4 had a PPV of 87% and the same NPV [4] Indeterminate Results - The indeterminate rate was found to be 10% for the test with all three biomarkers and 15% for the test without ApoE4, aligning with recommendations that no more than 15%-20% of individuals should have indeterminate results [5] Market Context - Nearly 7 million Americans are diagnosed with Alzheimer's disease, projected to reach 14 million by 2060, highlighting the growing need for effective diagnostic tools [7] - Blood tests are considered more cost-effective compared to invasive methods like CSF lumbar puncture and PET imaging, which could benefit the healthcare system [8] Company Commitment - Quest Diagnostics is focused on developing innovative diagnostics for Alzheimer's disease and other brain diseases, aiming to improve patient care and health outcomes [8][9]

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]

Core Insights - 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 [1][7] - The test aims to assist clinicians in ruling out Alzheimer's disease as a cause of cognitive decline, potentially reducing the need for further confirmatory investigations for patients testing negative [1][2] Company Developments - The Elecsys pTau181 test was developed in collaboration with Eli Lilly and Company and is designed to provide clarity for patients and caregivers regarding cognitive decline [2][3] - The test has shown a high negative predictive value (NPV) of 93.8% and 83.6% sensitivity based on a study involving 787 patients across the US, Europe, and Australia [4][5] Industry Context - Alzheimer's disease poses a growing burden on healthcare systems globally, with up to 75% of individuals with symptoms remaining undiagnosed [2][3] - Current diagnostic methods for confirming amyloid pathology, such as PET scans and cerebrospinal fluid assessments, are often expensive and invasive, highlighting the need for less invasive alternatives like the Elecsys pTau181 test [2][4] Clinical Implications - The Elecsys pTau181 test can be effectively implemented in primary care settings, allowing for earlier identification of Alzheimer's pathology and enabling access to new treatments [3][4] - Roche is also developing the Elecsys pTau217 blood test, which aims to provide an accurate standalone test for identifying amyloid pathology [6][7]

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 ...