Australian researchers say they have developed a simple cytokine assay for the early detection of breast implant-associated anaplastic large cell lymphoma, potentially paving the way for point-of-care testing.

With the most robust ALCL biomarker able to detected by a lateral flow assay similar to COVID detection, any potential test could be performed by unspecialised personnel at low cost, they say.

This biomarker, IL-10, was identified by an analysis of cytokines in the seroma (fluid) around the textured breast implants of 61 patients, 27 of whom had been diagnosed with BIA-ALCL.

Results showed this biomarker was elevated 671-fold in BIA-ALCL compared with benign infusions. Two other cytokines, IL-9 and IL-13 were also elevated in the malignant samples, although to a lesser extent.

In addition, IL-10 exceeded 100 pg/mL in 88% of malignant seromas but not in any benign effusion, enabling the Australian and US research team to develop a lateral flow assay.

“These findings potentially enable future rapid point-of-care testing for BIA-ALCL by unspecialised personnel at low cost,” they reported in American Journal of Hematology (link here).

“The amount of fluid (1 mL) is far less than used or required for current practice of histology, immunohistochemistry and/or flow cytometry and clonal analysis.”

“The ability to detect BIA-ALCL in 1 mL of fluid will reduce the number of patients exposed to disease progression and death due to financial barriers.”

“Early detection of ALCL in seromas before infiltration may avoid need for cytotoxic or immunotherapy and is possibly life-saving,” they added.

Besides its predictive potential, the study also provided insight into the pathogenesis of BIA-ALCL, according to the team.

“IL-10 is an immunosuppressive/anti-inflammatory cytokine that may contribute to the long delay (median 9 years) in development of BIA-ALCL following implant,” they added.

“IL-9 and IL-13 are important mediators of allergic inflammation consistent with eosinophils frequently found in BIA-ALCL.”