By Paul Kleutghen | Posted - Feb 2nd, 2018





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

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.

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 treatment at the division of Cellular Therapy at the Duke University Cancer Institute. My wife, Vicki, and I have two adult children and a grandson who is the ‘light of my life’. 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 and, very specifically, CAR-T therapies, with recent contributions posted by Health affairs, the Institute for Clinical and Economic Review and the Centers for Medicare and Medicaid Services.


Add a Comment



Thanks to our Myeloma Crowd Community sponsors:

.                         .       .