News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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This advanced medical laboratory test looks for 95 genetic mutations associated with cancers of the blood and may provide pathologists with a new diagnostic tool 

Seeking a faster time to answer when diagnosing patients with cancers of the blood, researchers and pathologists at the Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC) in Boston have developed a unique clinical laboratory assay that involves multiple genes and just takes days to perform.

This high-tech genetic diagnostic test is called Rapid Heme Panel. It scans DNA in blood or bone marrow specimens. It uses powerful next-gen sequencing technology that searches for 95 genes that frequently mutate in blood cancers, according to a press release issued by DF/BWCC.

At Dana-Farber/Brigham and Women’s cancer center, this medical laboratory test is used in patients with leukemia, Myelodysplastic syndromes caused by poorly formed or dysfunctional blood cells, and myeloproliferative disorders that fill the bone marrow with abnormal blood cells.

Leukemia cells

New Test Helps Physicians Choose Best Course of Treatment

 

This is possible because cancer DNA contains a unique combination of mutations that drive the cancer’s growth and which make it susceptible to drugs that target those mutations. This test is a major advancement in treating patients with aggressive forms of leukemia. It quickly identifies the right treatment from the start and has been used at the medical center in more than 100 patients since August 2014. It only requires only one tube of blood, rather than six, and returns results in five days or less, rather than two weeks.

The test has also been useful in determining if patients are candidates for clinical trials of experimental drugs that target specific mutations, noted Richard Stone, M.D., Director of the Adult Leukemia Program at DF/BWCC. “This is the best personalized medicine application in hematological oncology,” he said. “Already, we have been able to put patients on clinical trials by knowing the mutational status of their cancers earlier than ever before.”

Novel Test May Indicate Need for Stem Cell or Bone Marrow Transplant

The Rapid Heme Panel may also help specialists determine if bone marrow or stem cell transplant is an option for sick patients, and if it should be done urgently.

“This gives our clinicians information they did not have before,” observed Jeff Golden, M.D., Chair of Pathology at Brigham and Women’s Hospital and Professor at Harvard Medical School (HMS), pointing out that the cost for Rapid Heme Panel testing is less expensive than the cost for separate tests that detect fewer genes.

Test Technology Applies a Modified Sequenom MassARRAY Platform

This new test is based on technology used in DF/BWCC’s Profile research study, which uses next-generation sequencing to scan 305 genes potentially associated with a variety of cancers, explained Jon Aster, M.D., Ph.D., Director of Hematopathology at Brigham and Women’s Hospital, and Professor at HMS.

This comprehensive personalized cancer medicine initiative is aimed at detecting genetic alterations in tumors to potentially target cancers with the most effective drug therapies. The study involves analysis of 471 somatic mutations in 41 genes, using “OncoMap,” a novel screening approach using Sequenom’s [NASDAQ:SQNM] mass spectrometry genotyping platform that is modified to transition to next-generation sequencing.

With the Rapid Heme Panel, however, “we’re looking at 95 genes for blood cancers and returning the results in a timeframe that is actionable for our clinicians,” said Aster, who helped develop this test.

Dana-Farber-Brigham and Women’s Cancer Center Rapid Heme Panel

Dana-Farber/Brigham and Women’s Cancer Center Rapid Heme Panel team members (L-R) Michael Kluk, M.D., Ph.D., Frank Kuo, M.D., Jon Aster, M.D., and Coleman Lindsley, M.D., Ph.D. The team also included: Daniel DeAngelo, M.D., Ph.D., Benjamin Ebert, M.D., Ph.D., and Ilene Galinsky, R.N.P. (Image copyright Dana-Farber/Brigham and Women’s Cancer Center.)

“For many of our patients, it is critical to jump on their cancer quickly with an accurate diagnosis and thorough knowledge of the mutations that are driving their malignancy,” added Robert Soiffer, M.D., Chief, Division of Hematologic Malignancies at DF/BWCC. “Thanks to in-house testing with the Rapid Heme Panel, we can acquire the information we need to make treatment decisions faster than ever before.”

Opportunity for Pathologists and Medical Labs

This test allows caregivers to  quickly make informed decisions on the best therapeutic options for patients with cancers of the blood. It could provide pathologists opportunities to serve as consultants to physicians treating these patients and could offer medical laboratories that are early adopters of advanced genetic diagnostics an advantage over the competition.

—Patricia Kirk

Related Information:

Multidisciplinary Team Brings New Blood Cancer Test to Clinic

New Test Developed at Dana-Farber/Brigham and Women’s Cancer Center Speeds Treatment Decisions For Blood Cancer Patients

Profiling Tumor DNA

New Rapid Heme Panel Screens 95 Gene Mutations for Blood Cancers

Rapid Heme Panel Speeds Treatment Decisions for Blood Cancer Patients

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