FDA flags most serious recall of HemosIL HIT antibody assay lots; claudin 18.2 ADC doubles later-line survival at 25% staining cutoff

• FDA Oct 30, 2026
  FDA rates recall of four HemosIL AcuStar HIT-IgG(PF4-H) lots as most serious type over 20% to 35% negative bias
  The Food and Drug Administration (FDA) on Oct. 30 posted a recall of Instrumentation Laboratories (Werfen) HemosIL AcuStar HIT-IgG(PF4-H) lots B40005, B40006, B38062 and B38063, which it identified as the most serious type. Werfen confirmed performance variability with a negative bias of 20% to 35%, and a falsely negative result may delay recognition of heparin-induced thrombocytopenia, according to the FDA. The FDA said users should destroy affected lots and identify an alternative method for HIT antibody testing because a supply interruption is expected. No serious injuries or deaths had been reported as of Sept. 3.
  Source: FDA
• Research Oct 25, 2026
  Claudin 18.2 ADC trial selecting tumors at 25% membranous staining doubles later-line gastroesophageal cancer survival
  The phase 3 CLARITY-Gastric01 trial enrolled patients with previously treated advanced gastroesophageal carcinoma with claudin 18.2 expression on at least 25% of tumor cells, by membranous staining with the Ventana SP455 assay, according to AstraZeneca. Among 594 randomly assigned patients, sonesitatug vedotin improved median overall survival in the third-line or later population, a dual primary end point, to 10.0 from 5.0 months with investigator's choice (hazard ratio 0.47, 95% CI 0.36 to 0.62). The other primary end point, progression-free survival, was not statistically significant (P = .053). Results were presented Oct. 25 at the European Society for Medical Oncology Congress.
  Sources: AstraZeneca, Targeted Oncology

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