Quest Diagnostics launches genomic test service that aids in diagnosis for myeloid neoplasms

Genomic service detects 30 gene mutations to aid in the diagnosis, prognosis, monitoring and treatment selection for several myeloid neoplasms

Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, today announced LeukoVantage™, an evidence-based genomic test service that aids in the diagnosis, prognosis, monitoring and selection of treatment for myeloid neoplasms, a group of hematologic malignancies that includes acute myeloid leukemia (AML), the most common form of adult acute leukemia, as well as myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPNs).

“LeukoVantage is an outgrowth of Quest’s commitment to advancing oncology care based on actionable molecular insights,” said Frederick K. Racke, M.D., medical director, hematology oncology, Quest Diagnostics. “There is growing evidence that several genetic alterations involved in myeloid neoplasms not only provide significant diagnostic and prognostic value, but may also help guide treatment decisions. LeukoVantage builds from the latest science and Quest’s deep experience in genomics and hematology to deliver insights that can help the physician potentially diagnose the patient more quickly and reliably and establish an appropriate treatment plan.”

A wide range of gene mutations are associated with myeloid neoplasms, which occur when the bone marrow makes too many blood cells or platelets. Next-generation sequencing technologies can simultaneously test for mutations in multiple genes associated with myeloid neoplasms to diagnose, subclassify, monitor and predict the course of disease. LeukoVantage is a lab-developed test that uses next-generation sequencing, polymerase chain reaction (PCR) and other techniques to interrogate DNA from leukocytes (white blood cells) in blood or bone marrow specimens for the presence of mutations in 30 genes most frequently associated with myeloid neoplasms.

For MDS, LeukoVantage may detect certain molecular markers to help identify early stages of the disease, complementing conventional diagnostic techniques. MDS is typically diagnosed through a series of tests that include complete blood count (CBC), morphology, and cytogenetic (chromosomal) analysis. For MPN, LeukoVantage may identify molecular markers that can aid the selection of certain targeted therapies, such as JAK2 inhibitors, and establishing a prognosis.

LeukoVantage has also been shown to detect gene mutations in greater than 95% of newly diagnosed cases of AML. Physicians may use this information to aid in disease diagnosis and subclassification as well as to establish a treatment plan with induction chemotherapy. In addition, Leukovantage may aid in establishing a prognosis and in monitoring for minimal residual disease and recurring disease. In the case of both AML and MDS, LeukoVantage may also provide information for selecting epigenetic modifying drugs, which may be less toxic than inpatient chemotherapies.

In addition to LeukoVantage, Quest Diagnostics provides an industry-leading menu of hematologic test services, including morphology, flow cytometry, cytogenetics, FISH, and molecular services for blood and bone marrow specimens and other tissues and body fluids as necessary. Because patients with hematological cancers often require multiple services, clinicians may prefer a single provider that can coordinate, perform and interpret all necessary testing services as well as split bone, blood and other samples to simplify test ordering and reporting.

“LeukoVantage is an innovative and clinically useful lab test – but that is only part of its value. Quest Diagnostics provides a broad suite of accompanying services for diagnosing and managing patients with myeloid neoplasms. Those larger capabilities can be most useful for these and other diseases in which continuous monitoring, supported by lab tests, is vital to promote quality patient care,” said Frederic Waldman M.D., Ph.D., medical director, cancer diagnostics, Quest Diagnostics.

LeukoVantage extends Quest’s growing menu of genomic oncology services. In June 2014, Quest Diagnostics launched OncoVantage™ in collaboration with Memorial Sloan Kettering Cancer Center, as a new molecular test for selecting chemotherapy based on somatic mutations of solid tumors, such as colon and breast cancer. Quest Diagnostics also provides genetic (germline) cancer services for assessing inherited risk of cancers, including BRCAvantage™ for breast and ovarian cancers, and genetic testing for Lynch Syndrome, which can cause colorectal and endometrial cancers. LeukoVantage builds on this expertise as well as precursor molecular panel sequencing services for MDS and MPN, which were among the first available to clinicians when introduced in the United States in 2013.