FDA says HBsAg testing is not necessary for most blood donations; CMS limits lab fee cuts to 15% a year; ctDNA flags high-risk Ewing sarcoma

• FDA Nov 4, 2026
  FDA final guidance says HBsAg testing is not necessary for blood donations other than Source Plasma but keeps anti-HBc and HBV NAT
  The Food and Drug Administration (FDA) issued final guidance on reducing the risk of transfusion-transmitted hepatitis B virus (HBV), saying that for donations of blood and blood components other than Source Plasma, testing for hepatitis B surface antigen (HBsAg) is not necessary to reduce adequately and appropriately the risk of transmission. Establishments must still test each donation for antibody to hepatitis B core antigen (anti-HBc) and HBV DNA by nucleic acid testing, and the FDA continues to recommend HBsAg and HBV DNA testing for Source Plasma. The guidance supersedes FDA memoranda from December 1987 and September 1991.
  Sources: FDA, FDA guidance document
• Payment Nov 4, 2026
  CMS final 2027 rule limits Clinical Laboratory Fee Schedule cuts to 15% a year through 2029
  The Centers for Medicare & Medicaid Services (CMS) calendar year 2027 physician fee schedule final rule finalizes changes implementing the Consolidated Appropriations Act, 2026, under which Clinical Laboratory Fee Schedule payment reductions based on private payor rate data will be limited to 15% per year through 2029, beginning in 2027. The rule also sets the physician fee schedule conversion factor at $32.63 for clinicians outside qualifying alternative payment models, a 2.31% decrease, according to CMS.
  Source: CMS
• Research Nov 4, 2026
  ctDNA profiling across Ewing sarcoma trials finds TP53, STAG2 and CDKN2A alterations mark high-risk patients in 347-patient study
  A Journal of Clinical Oncology study profiled 991 blood, tumor and bone marrow samples from 347 patients in phase 2 and 3 Ewing sarcoma trials using custom targeted sequencing of circulating tumor DNA and tissue. TP53, STAG2 and CDKN2A alterations defined an independent molecular high-risk subgroup with inferior event-free survival (hazard ratio 3.6, 95% CI 2.2 to 5.8, P < .001) and overall survival (hazard ratio 4.3, 95% CI 2.5 to 7.3, P < .001) in patients from the EE2012 trial.
  Sources: Journal of Clinical Oncology, PubMed
• Research Nov 5, 2026
  LATE-NC found in 7.4% of 1,860 brains and tied to hippocampal sclerosis in population-based autopsy study
  A Brazilian population-based autopsy study of 1,860 participants published in Neurology found LATE-NC in 7.4% (stage 1, 3.0%; stage 2, 4.0%; stage 3, 0.4%). Stages 2 to 3 were associated with hippocampal sclerosis (odds ratio 14.95, 95% CI 7.42 to 30.27, P < .001), and LATE-NC was associated with the CDR-SOB score (beta 4.06, 95% CI 2.95 to 5.18, P < .001).
  Sources: Neurology, PubMed

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