Leumeta™ plasma-based testing for cancer patients

Nichols Institute Innovation

Quest Diagnostics Nichols Institute now offers a novel and proprietary plasma-based technology that is used in the diagnosis and monitoring of patients with leukemia/lymphoma and other cancers. Our suite of Leumeta assays provides detection of specific proteins, DNA, RNA or other molecular targets expressed on or within tumor cells. Studies have shown that in some cases Leumeta is a more sensitive alternative to both cell-based assays and painful bone marrow biopsies allowing for more frequent monitoring and assessment of disease progression.

How Are These Assays Used?

Test
Code

 
Test Name

 
Clinical Use

16031X

ABL Kinase Domain Mutation in CML, Plasma-based, Leumeta

Detect drug-resistant mutations to GleevecŪ' (Imatinib) in patients with chronic myeloid leukemia and identify candidates for alternative therapy

19782X

ABL T315I Mutation in CML, Plasma-based, Leumeta

Early detection of the T315I mutation in CML patients in therapy or pre-therapy could allow alternative treatment before resistance is detected cytogenetically or before disease progression becomes evident.

16119X

B-Cell Gene Rearrangement, Qualitative, PCR, Plasma-based, Leumeta

Useful for establishing clonality of B-cell gene rearrangements for the diagnosis of B-cell neoplasms and for identifying minimal residual disease or early recurrence in those patients with a previous diagnosis of B-cell neoplasm

16118X

B-Cell Gene Rearrangement, Quantitative, PCR, Plasma-based, Leumeta

Useful for establishing clonality of B-cell gene rearrangements for the diagnosis of B-cell neoplasms and for identifying minimal residual disease or early recurrence in those patients with a previous diagnosis of B-cell neoplasm

17853X

bcr/abl Gene Rearrangement, Quantitative PCR, Plasma-based, Leumeta

Diagnose CML; identify acute lymphocytic leukemia (ALL) with t(9;22) bcr/abl rearrangement; assess prognosis in patients with ALL; monitor the effectiveness of therapy and Minimal Residual Disease (MRD); predict early relapse

16104X

c-kit Mutation Analysis, Plasma-based, Leumeta

Diagnose mastocytosis and other hematopoietic malignancies; predict response to therapy

17690X

Follicular Lymphoma, bcl-2/JH t(14;18), Real-time PCR, Plasma-based, Leumeta

Diagnose and monitor follicular lymphoma

16101X

JAK2 Mutation (V617F) Analysis, Plasma-based, Leumeta

Diagnose or confirm the diagnosis of myeloproliferative disease; monitor therapy in patients with myeloproliferative disease

17702X

Lymphocytic Leukemia, Chronic, IgVH Mutation Plasma-based, Leumeta

Determine prognosis of patients with B-cell chronic Status, lymphocytic leukemia (B-CLL)

17679X

Mantle Cell Lymphoma, bcl-1/JH t(11;14), Plasma-based, Leumeta

Diagnose and monitor minimal residual disease in patients Real-time PCR, with mantle cell lymphoma

16159X

NPM (Exon 12) Mutation Analysis, Plasma-based, Leumeta

The NPM exon 12 mutation can serve as predictor of favorable prognosis in AML with normal karyotype, good response to induction chemotherapy and as a marker for monitoring of minimal residual disease.

19800X

p53 Gene Mutation Analysis, Plasma-based, Leumeta

Mutations in p53 gene usually correlate with poor outcome and early recurrence in cancer. This test provides important prognostic and predictive information for patients with B-CLL, breast cancer, or cervical cancer.

16127X

ras Mutation Analysis, Plasma-based, Leumeta

Activating ras mutations can be found in human malignancies with overall frequency of 15-20%. A high incidence of ras gene mutations has been reported in malignant tumors of the pancreas (80-90%, K-ras), in colon rectal carcinomas (30-60%, K-ras), in non-melanoma skin cancer (30-50%, H-ras), in hematopoietic neoplasia of myeloid origin (18-30%, K-ras or N-ras).

17861X

T-Cell Receptor (TCR) Gene Rearrangement, Qualitative PCR, Leumeta

Detect T-cell MRD or early recurrence of T-cell neoplasm

17862X

T-Cell Receptor (TCR) Gene Rearrangement, Quantitative PCR, Leumeta

Diagnose T-cell malignancies and identify MRD or early recurrence of T-cell neoplasm; determine leukemia and lymphoma lineage

Online Resources for Healthcare Professionals

Online Test Information for Your Patients

Your patients can learn about health conditions and laboratory tests in our online Patient Health Library. The library is founded on evidence-based information, provides printer friendly formats, and includes topics such as:

•	Ask-the-Doctor Checklist
•	Work in Partnership with Your Doctor
•	Share in Every Medical Decision
•	Healthwise Self-Care Checklist
•	Making Wise Health Decisions

Contact a Quest Diagnostics Sales Representative, learn more about our testing services, and become a client

This test was developed and its performance characteristics determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

* The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.

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