Subscribe to Newsletter
Outside the Lab Oncology, Clinical care, Regulation and standards

Battling Blood Cancer

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.

Receive content, products, events as well as relevant industry updates from The Pathologist and its sponsors.
Stay up to date with our other newsletters and sponsors information, tailored specifically to the fields you are interested in

When you click “Subscribe” we will email you a link, which you must click to verify the email address above and activate your subscription. If you do not receive this email, please contact us at [email protected].
If you wish to unsubscribe, you can update your preferences at any point.

  1. US Food and Drug Administration, “FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas” (2017). Available at: Accessed July 18, 2017.
About the Author
Michael Schubert

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.

Related Application Notes
Tumor Genomic Profiling with SureSelect Cancer Tumor-Specific Assays

| Contributed by Agilent

Comprehensive Genomic Profiling with SureSelect Cancer CGP Assay

| Contributed by Agilent

Preventing Bias in scRNAseq Performed on Solid Tumors

| Contributed by Revvity

Related Product Profile
Diagnostics Genetics and epigenetics
QIAseq® Pan Cancer Multimodal cuts user interventions by 50%

| Contributed by QIAGEN

Most Popular
Register to The Pathologist

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:
  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Pathologist magazine