Work on directed-donation mandates continues
June 2026—The blood bank community, state pathology societies, and the CAP and Association for the Advancement of Blood and Biotherapies are working to oppose state bills that mandate directed and autologous blood donations.
Most such proposals have failed, but Idaho’s law was enacted on March 16. It will go into effect July 1.
CAP president Qihui “Jim” Zhai, MD, in a March 13 letter, urged Idaho governor Brad Little to veto the legislation. He wrote, “Legislative proposals like House Bill 528, mandating access to autologous or direct blood donations, threaten to reduce blood availability, increase costs, introduce waste, and delay life-saving care—particularly for products like platelets, where timely availability is vital.”
In an April 30 Perspective on “directed donation and the politics of patient choice,” published in the New England Journal of Medicine, Jeremy Jacobs, MD, MHS, of the Vanderbilt University Medical Center Division of Transfusion Medicine, and his Vanderbilt coauthors wrote, “What is emerging is not an expansion of evidence-based patient rights but a distortion of them. The patients’ rights movement of the 1970s—built around informed consent, refusal of treatment, and shared decision making—led to genuinely important protections, but it envisioned those rights operating within the framework of evidence-based medicine, not as mechanisms to compel clinicians to provide interventions that scientific organizations and medical societies have identified as harmful.”
They continue, “Today, the language of patient autonomy is being detached from its ethical foundation in informed, evidence-based decision making and repurposed to justify demands that are unsupported by science” (Jacobs JW, et al. N Engl J Med. 2026;394[17]:1667–1669).
Tennessee House Bill 2166, on autologous and directed donations, was voted down in committee on March 18.
The CAP in July 2025 issued its position statement of opposition to state legislation mandating labeling of blood products based on donor vaccination status for autologous and directed donations (https://bit.ly/CAP_071025). In its statement, the CAP urged policymakers to “consider the overwhelming scientific and logistical evidence and to protect the integrity and safety of the national blood supply.”
ARUP launches infectious disease test positivity trends dashboard
ARUP Laboratories launched in May its National Infectious Disease Test Positivity Trends Dashboard to track laboratory test positivity trends for multiple pathogens.
The dashboard uses deidentified test results to reveal national trends that ARUP says may help clinical laboratories, medical directors, and clinicians detect unusual patterns, seasonal shifts, and emerging infectious disease activity earlier.
“As a national reference laboratory, ARUP sees enough testing volume to identify meaningful trends for certain pathogens. This dashboard was designed to give our clients, other laboratories, and clinicians information they can use to make better decisions for their patients,” Ben Bradley, MD, PhD, ARUP medical director of the Institute for Research and Innovation in Infectious Disease Genomic Technologies, High Consequence Pathogen Response, Virology, and Molecular Infectious Diseases, said in a May 13 press release.
The dashboard (https://bit.ly/49fOp9F) features maps and charts drawn from ARUP’s test results and refreshed weekly, pathogen-specific pages accessible through an expandable navigation menu, and a “key information” box to call out specific data points.
FDA approves companion diagnostic in muscle-invasive bladder cancer
The Food and Drug Administration approved Natera’s Signatera CDx as a companion diagnostic for use with adjuvant atezolizumab (Tecentriq) immunotherapy in muscle-invasive bladder cancer.
FDA approval follows publication last year of the phase three IMvigor011 trial sponsored by Genentech (Powles T, et al. N Engl J Med. 2025;393[24]:2395–2408). The trial found that Signatera measurable residual disease-positive patients treated with immunotherapy achieved significant improvements in disease-free survival and overall survival, while Signatera MRD-negative patients achieved 97 percent two-year overall survival with no adjuvant therapy at all.
“The practice-changing IMvigor011 trial and this approval signal a transformation in cancer care, where MRD is guiding when to treat, whom to treat, and how to treat more precisely,” Thomas Powles, MD, lead principal investigator of IMvigor011 and chair of Barts Cancer Centre at St. Bartholomew’s Hospital, London, said in a May 15 press release.