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
Mpox, nAbCyte, and PGDx. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Mpox PCR Test - FDA Regulatory Timeline and Events
Mpox PCR Test is a drug developed by Labcorp for the following indication: to aid in the diagnosis of infection with non-variola Orthopoxvirus.
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:
- Mpox PCR Test
- Announced Date:
- April 10, 2024
- Indication:
- to aid in the diagnosis of infection with non-variola Orthopoxvirus
Announcement
Labcorp announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox PCR Test Home Collection Kit to aid in the diagnosis of infection with non-variola Orthopoxvirus, including the monkeypox virus that causes monkeypox, also known as mpox.
AI Summary
Labcorp announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization for its Mpox PCR Test Home Collection Kit. This kit, the first of its kind approved for home use, helps diagnose infections caused by non-variola Orthopoxvirus, including the monkeypox virus, also known as mpox. Designed for patients 18 years and older, the kit allows individuals to collect a lesion swab sample at home following clear instructions. After collection, the sample is returned to an authorized laboratory where PCR technology is used to detect the virus’s DNA. The FDA’s emergency authorization will support early detection and management of mpox, providing physicians with a convenient and effective diagnostic tool, while offering patients privacy and ease of testing amid rising mpox cases in the U.S.
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nAbCyte - FDA Regulatory Timeline and Events
nAbCyte is a drug developed by Labcorp for the following indication: for treatment with BEQVEZ™.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- nAbCyte
- Announced Date:
- April 29, 2024
- Indication:
- for treatment with BEQVEZ™
Announcement
Labcorp announced the U.S. Food and Drug Administration (FDA) has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt), Pfizer's recently FDA-approved hemophilia B gene therapy.
AI Summary
Labcorp announced that the U.S. Food and Drug Administration (FDA) has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay. This breakthrough companion diagnostic (CDx) test is designed to determine patient eligibility for BEQVEZ™ (fidanacogene elaparvovec-dzkt), Pfizer’s new gene therapy for hemophilia B. The cell-based assay detects preexisting neutralizing antibodies that could interfere with the delivery and efficacy of the therapy. By identifying whether patients have these antibodies before treatment, the assay helps ensure that only those who are most likely to benefit from BEQVEZ receive it.
This approval marks an important step in precision medicine and cell and gene therapy, as it offers clinicians a reliable method for screening patients. The qualitative test reports results as either negative (no antibodies) or positive (antibodies detected), ultimately guiding safe treatment decisions for those with hemophilia B.
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PGDx elio™ - FDA Regulatory Timeline and 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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