Quest Diagnostics Introduces Flow Cytometry Blood Cancer Test

Quest Diagnostics has launched a blood test that uses advanced flow cytometry methods to detect the blood cancer myeloma (also known as multiple myeloma). The Quest Flow Cytometry MRD for Myeloma provides comparable sensitivity as next-generation sequencing methods in finding residual myeloma,* but at a fraction of the cost, supporting better care and outcomes, according to the company.

“Our Flow Cytometry MRD for Myeloma test harnesses cutting-edge science and technology to deliver ultrasensitive insights from a noninvasive blood test, thereby improving care and value for patients and the healthcare system,” said board-certified oncologist and hematologist Yuri Fesko, M.D., senior vice president and chief medical officer, Quest Diagnostics. “This new test merges this elite performance with improved access, given Quest’s approximately 7,000 phlebotomy sites across the United States, helping to illuminate a path to better health for more patients.”

Myeloma is a cancer of plasma cells, a type of white blood cell, in which dysregulated growth triggers the creation of abnormal antibodies affecting the blood and bones. About 36,000 new cases of myeloma are diagnosed every year in the United States, and nearly 11,000 patients die of the disease annually, according to the American Cancer Society, making it one of the most common types of plasma cell cancers. While incurable, myeloma can often be treated as a chronic condition using chemotherapy and other personalized treatments and guided by MRD monitoring during and after treatment. Physicians typically assess MRD using flow cytometry methods that detect abnormal cells in bone marrow aspirates, a type of biopsy. In recent years, next-generation sequencing has been deployed on both blood and bone marrow aspirate specimens, improving sensitivity 10-fold compared to conventional flow cytometry, but at a higher price point.

Quest Diagnostics’ new test uses next-generation flow cytometry techniques with a detection level comparable to next-generation sequencing but on noninvasive blood specimens instead of bone marrow aspirates. The test can also be used in situations where a baseline aspirate sample is not available, unlike NGS methods, which require a pre-treatment baseline sample to provide a reference for ongoing monitoring. Moreover, the test features five-day specimen stability, compared to three or fewer days by conventional flow cytometry, supporting access when specimen transport to the lab takes several days.

“The enthusiastic response received at the American Society of Hematology (ASH) Annual Meeting and Exposition upon educating the medical community about the Quest Flow Cytometry MRD for Myeloma test made it clear to me that this assay has the potential to greatly improve the treatment paradigm,” said Timothy Looney, Ph.D., senior director, Immuno-Oncology, Quest Diagnostics. “The sensitivity, cost, and sample stability that we can now offer to patients and their care team will help those suffering from this condition.”

In addition to supporting clinical care, the Quest Flow Cytometry MRD for Myeloma test is expected to be used as a response monitoring tool in clinical trials. In January, the U.S. Food and Drug Administration provided draft guidance on using MRD as a primary endpoint in trials evaluating drug and biological products to treat patients with multiple myeloma to support accelerated approval.

Quest Diagnostics provide diagnostic insights from laboratory test results to empower people, physicians, and organizations to improve health outcomes. Derived from one of the world’s largest databases of de-identifiable clinical lab results, Quest’s diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors, and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States.