Labcorp To Offer First And FDA-Cleared Test For Monitoring Residual Blood Cancer Cells During And After Treatme

Ad - Bora Pharmaceuticals

Labcorp, a leading global life sciences company, 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.

About Labcorp

Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With more than 70,000 employees, we serve clients in more than 100 countries.

About the clonoSeq Assay

The clonoSEQ Assay is the first and only FDA-cleared assay for MRD in CLL, MM and B-ALL. MRD refers to the small number of cancer cells that can stay in the body during and after treatment. clonoSEQ was initially granted De Novo designation and marketing authorization by the FDA for the detection and monitoring of MRD in patients with MM and B-ALL using DNA from bone marrow samples. In August 2020, clonoSEQ received additional clearance from the FDA to detect and monitor MRD in blood or bone marrow from patients with CLL.

The clonoSEQ Assay leverages Adaptive’s proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and predict potential relapse. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with CLL, MM and ALL.

The clonoSEQ Assay is a single-site test performed at Adaptive Biotechnologies. In addition to its FDA-cleared uses, clonoSEQ is also available as a CLIA-validated laboratory developed test (LDT) service for use in other lymphoid cancers and sample types.

Advertisement