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New Test for Daratumumab (Darzalex) Patients Helps With M-Protein Accuracy

Posted: Feb 02, 2018
New Test for Daratumumab (Darzalex) Patients Helps With M-Protein Accuracy image

All myeloma patients are familiar with immunofixation tests (typically abbreviated as IFE, for Immmuno Fixation Electrophoresis), which are tests that looks for the presence of monoclonal cells in the blood (serum). A patient being treated with Darzalex (daratmumab) is infused with monoclonal antibodies and, therefore, the IFE test will show the presence of monoclonals which may lead to an erroneous interpretation of the test results. Some patients think they still have residual disease when in fact they don't. This problem has now been solved and gives a little bit of good news for Darzalex patients. The marketer of Darzalex, Janssen Biotech, has collaborated with the company Sebia to develop a new test that mitigates the daratumumab-mediated interference seen with IFE test results.  The US FDA has approved this new test, called Hydrashift 2/4, over the past week for use in multiple myeloma patients being treated with Darzalex. Ask your doctor about the new test if you are being treated with Darzalex.

All myeloma patients are familiar with immunofixation tests (typically abbreviated as IFE, for Immmuno Fixation Electrophoresis), which are tests that looks for the presence of monoclonal cells in the blood (serum). A patient being treated with Darzalex (daratmumab) is infused with monoclonal antibodies and, therefore, the IFE test will show the presence of monoclonals which may lead to an erroneous interpretation of the test results. Some patients think they still have residual disease when in fact they don't. This problem has now been solved and gives a little bit of good news for Darzalex patients. The marketer of Darzalex, Janssen Biotech, has collaborated with the company Sebia to develop a new test that mitigates the daratumumab-mediated interference seen with IFE test results.  The US FDA has approved this new test, called Hydrashift 2/4, over the past week for use in multiple myeloma patients being treated with Darzalex. Ask your doctor about the new test if you are being treated with Darzalex.

The author Paul Kleutghen

about the author
Paul Kleutghen

I am a patient diagnosed in 2014 with primary plasma cell leukemia (pPCL), a rare and aggressive variant of multiple myeloma and have been very fortunate to find successful treatment at the division of Cellular Therapy at the Duke University Cancer Institute. My wife, Vicki, and I have two adult children and two grandsons who are the ‘lights of our lives’. Successful treatment has allowed Vicki and I to do what we love best : traveling the world, albeit it with some extra precautions to keep infections away. My career in the pharmaceutical industry has given me insights that I am currently putting to use as an advocate to lower drug pricing, especially prices for anti-cancer drugs. I am a firm believer that staying mentally active, physically fit, compliant to our treatment regimen and taking an active interest in our disease are keys to successful treatment outcomes.

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