Battling Blood Cancer
The FDA has authorized a new diagnostic test for hematological malignancies – and simultaneously established “special controls” for future tests
Blood cancers are complex; the symptoms are often vague and general, leading to late diagnoses – and with well over 100 different types of hematological malignancies, it’s not always easy to zero in on a conclusive diagnosis. When leukemia (or a similar disease) is suspected, attempts at diagnosis are painful and invasive for the patient, and time-consuming and labor-intensive for physicians. In June 2017, the FDA authorized a new test (Beckman Coulter’s ClearLLab LS) that aims to provide a simpler, more consistent way of detecting cancer-specific cell surface markers in blood, bone marrow, or lymph node samples (1).
The test becomes the first FDA-authorized product that works with flow cytometry to detect and differentiate between several different types of blood malignancies, including acute and chronic leukemias, non-Hodgkin lymphoma, myeloma, myelodysplastic syndromes, and myeloproliferative neoplasms. But the test isn’t the only unique aspect of the new authorization; the FDA also established new criteria for leukemia and lymphoma tests: “special controls.” Special controls work alongside the existing general controls to assure the safety and effectiveness of such tests and also lay out the least burdensome regulatory pathway for others to follow when developing similar products. With these new special controls – and an existing test already pioneering their use – the blood cancer diagnostic space looks set for change.
- US Food and Drug Administration, “FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas” (2017). Available at: bit.ly/2tBmZEr. Accessed July 18, 2017.
While obtaining degrees in biology from the University of Alberta and biochemistry from Penn State College of Medicine, I worked as a freelance science and medical writer. I was able to hone my skills in research, presentation and scientific writing by assembling grants and journal articles, speaking at international conferences, and consulting on topics ranging from medical education to comic book science. As much as I’ve enjoyed designing new bacteria and plausible superheroes, though, I’m more pleased than ever to be at Texere, using my writing and editing skills to create great content for a professional audience.