Labcorp to Offer First and Only FDA-Cleared Test for Monitoring Residual Blood Cancer Cells During and After Treatment

clonoSEQ® Assay Expands Labcorp’s Comprehensive Oncology Offerings; Helps Oncologists Screen, Diagnose, Monitor and Treat Various Blood Cancers

BURLINGTON, N.C., July 14, 2021 — Labcorp (NYSE: LH), a leading global life sciences company, today announced that it is now offering clonoSEQ®, the first U.S. Food and Drug Administration (FDA)-cleared test that can identify whether cancer cells remain in a patient’s body during and after treatment for lymphoid cancers, which develop within immune system cells. Labcorp is only U.S. commercial reference lab to offer clonoSEQ testing, expanding Labcorp’s capabilities for diagnosing and detecting blood cancers. 

“Labcorp’s goal is to bring precision medicine within reach for all cancer patients by expanding breakthrough science and providing access to more tests throughout the patient care continuum,” said Prasanth Reddy, M.D., MPH, senior vice president and head of enterprise oncology at Labcorp and a triple board-certified oncologist. “Adding clonoSEQ moves us closer to achieving this goal as the test enables the detection of a single cancer cell among a million healthy cells. This gives physicians and their patients a powerful tool that can help predict long-term outcomes, assess treatment responses, monitor disease burden over time, and detect a potential relapse.”

Developed by Adaptive Biotechnologies, clonoSEQ uses next-generation sequencing technology and proprietary bioinformatics to provide powerful insights from diagnosis, through treatment, and into survivorship. The test analyzes specific DNA sequences associated with malignant B-cells in the blood or bone marrow of patients with lymphoid cancers such as multiple myeloma (MM), chronic lymphocytic leukemia (CLL) and B-cell acute lymphoblastic leukemia (B-ALL). In patients with blood cancers, the presence of cancer cells after treatment—known as measurable (or minimal) residual disease (MRD)—is among the strongest predictors of long-term disease outcomes. 

According to the National Foundation for Cancer Research, someone in the United States is diagnosed with a blood cancer every three minutes. This accounts for almost 10% of new cancer cases each year. Of those diagnosed, one-third will be diagnosed with a form of leukemia, approximately half with lymphoma, and 18% with myeloma. The collaboration between Labcorp and Adaptive Biotechnologies expands access to new testing options that provide doctors with the resources and data they need to better treat lymphoid cancers. Labcorp’s suite of comprehensive blood cancer tests allows oncologists to screen, diagnose, monitor and make treatment decisions that will contribute to improved outcomes in blood cancer patients. 

“Following clonoSEQ’s FDA clearance in 2018, Adaptive’s vision has been to make clonoSEQ as widely available to blood cancer patients as possible,” said Chad Robins, co-founder and CEO of Adaptive. “We are proud to expand our collaboration with Labcorp and make clonoSEQ more broadly accessible to clinicians across the country who can use it to help guide patient care decisions.” 

Labcorp offers an extensive menu of diagnostic tests for blood cancers, including clonoSEQ, IntelliGEN® Myeloid, and the Comprehensive Hematopathology Analysis for complete assessment and diagnosis by one of Labcorp’s expert hematopathologists. 

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