This section highlights FDA-related milestones and regulatory updates for drugs developed by Labcorp (LH).
Over the past two years, Labcorp has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Elecsys, Lumipulse®, and PGDx. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Elecsys pTau181 FDA Regulatory Events
Elecsys pTau181 is a drug developed by Labcorp for the following indication: Amyloid Pathology in Primary Care Settings.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Elecsys pTau181
- Announced Date:
- February 11, 2026
- Indication:
- Amyloid Pathology in Primary Care Settings
Announcement
Labcorp announced today the nationwide availability of the Elecsys® pTau-181 test, the first and only blood test cleared by the U.S. Food and Drug Administration (FDA) to aid in the initial assessment of Alzheimer's disease in the primary care setting.
AI Summary
Labcorp announced nationwide availability of the Elecsys® pTau-181 test, the first and only blood test cleared by the U.S. Food and Drug Administration to aid in the initial assessment of Alzheimer's disease in the primary care setting. The test measures phosphorylated tau‑181, a brain protein linked to Alzheimer’s pathology, from a standard blood draw. As an FDA‑cleared aid, it is meant to support—not replace—clinical judgment, imaging, or cerebrospinal fluid testing when evaluating patients with cognitive concerns.
Key benefits include broader access and convenience: primary care providers can order the test through Labcorp’s network, it is less invasive and faster than PET scans or lumbar punctures, and it may help identify patients who need specialist referral, further testing, or earlier care planning. Making the test widely available aims to support earlier recognition of possible Alzheimer’s and more timely decisions about follow‑up and treatment options.
Read Announcement- Drug:
- Elecsys pTau181
- Announced Date:
- October 23, 2025
- Indication:
- Amyloid Pathology in Primary Care Settings
Announcement
Labcorp announced it will offer the Elecsys pTau181 test, the only blood test cleared by the U.S. Food and Drug Administration (FDA) to aid in the initial assessment for Alzheimer's disease and other causes of cognitive decline in the primary-care setting. Developed by Roche Diagnostics, Labcorp plans to make the test available nationwide by early 2026.
AI Summary
Labcorp announced it will offer the Elecsys® pTau181 test, the only blood test cleared by the U.S. Food and Drug Administration to help primary-care doctors assess Alzheimer’s disease and other causes of cognitive decline. Developed by Roche Diagnostics, the test will be available nationwide by early 2026.
The Elecsys pTau181 test measures phosphorylated Tau 181 protein in plasma, a key biomarker linked to amyloid plaque and tau tangles. Clinical studies show it can rule out Alzheimer’s pathology with a 97.9% negative predictive value, meaning a negative result closely matches a negative amyloid PET scan. Adults ages 55 and older who show signs or complaints of cognitive decline can get the test to help determine if further evaluation is needed.
Performed with a simple blood draw in a doctor’s office or any of Labcorp’s 2,200+ patient service centers, the Elecsys pTau181 test offers a more accessible, affordable, and less invasive alternative to lumbar punctures and PET scans. By expanding access to this FDA-cleared blood test, Labcorp aims to guide timely, appropriate care for patients experiencing memory or thinking problems.
Read Announcement
Lumipulse® FDA Regulatory Events
Lumipulse® is a drug developed by Labcorp for the following indication: Blood Test for Alzheimer's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lumipulse®
- Announced Date:
- August 18, 2025
- Indication:
- Blood Test for Alzheimer's Disease
Announcement
Labcorp announced today the availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first blood-based in-vitro diagnostic (IVD) test cleared by the U.S. Food and Drug Administration (FDA) to aid in the diagnosis of Alzheimer's disease through early detection of the amyloid plaques associated with the disease in appropriate patients.
AI Summary
Labcorp announced the launch of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio test, the first blood-based in vitro diagnostic (IVD) cleared by the U.S. Food and Drug Administration (FDA) to identify amyloid plaques associated with Alzheimer’s disease. By measuring the ratio of phosphorylated tau protein and amyloid beta 42 in blood, this test offers a simpler, less invasive alternative to PET imaging and spinal taps. Clinicians can use the results to support early Alzheimer’s diagnosis in appropriate patients, speeding up treatment decisions and improving care. It is intended for patients showing cognitive symptoms or suspected of early Alzheimer’s, helping doctors decide on further testing or treatment. The blood test is available through Labcorp’s nationwide labs with quick results. This FDA clearance marks a step toward easier, more accessible Alzheimer’s screening and could transform how doctors detect and manage the disease in its early stages.
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PGDx elio™ FDA Regulatory Events
PGDx elio™ is a drug developed by Labcorp for the following indication: For pan-solid tumor liquid biopsy test.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PGDx elio™
- Announced Date:
- April 23, 2025
- Indication:
- For pan-solid tumor liquid biopsy test.
Announcement
Labcorp announced the expansion of its precision oncology portfolio with two solutions: Labcorp Plasma Detect for clinical use to help assess the risk of disease recurrence in stage III colon cancer patients, and the availability of PGDx elio plasma focus Dx, the first and only kitted, pan-solid tumor liquid biopsy test authorized by the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from targeted treatments.
AI Summary
Labcorp has expanded its precision oncology portfolio by introducing two innovative tools. Labcorp Plasma Detect is now available for clinical use to help assess the risk of disease recurrence in stage III colon cancer patients. This blood-based test uses whole-genome sequencing to identify circulating tumor DNA, signaling the presence of molecular residual disease that may indicate a higher risk of cancer returning after treatment.
In addition, Labcorp announced the availability of PGDx elio plasma focus Dx, the first and only FDA-authorized kitted, pan-solid tumor liquid biopsy test. This assay enables clinicians to determine which patients might benefit from targeted treatments based on comprehensive genomic profiling from a simple blood draw. Together, these solutions aim to support more personalized, timely, and accurate treatment decisions in cancer care, ultimately working to improve patient outcomes.
Read Announcement- Drug:
- PGDx elio™
- Announced Date:
- August 2, 2024
- Indication:
- For pan-solid tumor liquid biopsy test.
Announcement
Labcorp announced today it has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for PGDx elio™ plasma focus Dx – the industry's first and only kitted, pan-solid tumor liquid biopsy test.
AI Summary
Labcorp has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for PGDx elio™ plasma focus Dx, the industry’s first and only kitted, pan-solid tumor liquid biopsy test. This groundbreaking diagnostic tool allows for comprehensive tumor mutation profiling from a simple blood draw, providing a new option when tissue samples are limited or unavailable. PGDx elio™ plasma focus Dx utilizes next-generation sequencing with targeted, high-throughput hybridization technology to detect various genetic alterations across multiple key genes. The assay’s ability to efficiently evaluate a wide range of solid tumor types offers laboratories and oncologists a more convenient and cost-effective approach to precision oncology testing. With this FDA approval, Labcorp expands its portfolio of oncology solutions, aiming to deliver critical genetic insights to support personalized treatment decisions for cancer patients.
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