New test beats biopsy for transplant rejection
The U.S. National Institutes of Health said a new donor-derived, cell-free DNA liquid biopsy test may allow clinicians to prevent or impeded acute heart transplant rejection, and possibly eliminate as many as 4 in 5 heart tissue biopsies. The underlying study of 171 heart transplant recipients demonstrated that this test outperformed biopsy, and diagnosed tissue rejection prior to the onset of symptoms. The test also detects types of rejection often missed by biopsy, such as antibody-mediated rejection, and can pick up the related biomarkers as early as 28 days post-implant. The agency said these findings call for a randomized, controlled trial for confirmation.
NICE eyes digital health HTAs
The U.K. National Institute for Health and Care Excellence (NICE) said it is ramping up an effort to evaluate digital health technologies as part of an effort to evaluate the agency’s current health technology assessment (HTA) procedures are useful for digital health offerings. The agency said it is encouraged by the successful assessment of the Zio XT system by Irhythm Technologies Inc., of San Francisco, an ambulatory cardiac rhythm monitoring system. NICE said part of this effort is to develop a set of standards on data quality and utility for the National Health Service, and that the Zio is recommended “as an option” for these patients while additional data are collected to address gaps in the evidence.
MHRA moves on the hazards of bedrails
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) posted a guidance for the safe use of bedrails, prompted by reports of incidents that have led to patient injury or death, principally from entrapment in the rails. Entrapment is often encountered between two rails, between rails and mattresses, or between rails and the bed frame. Patient disorientation has led to attempts to climb over the rails to get out of the bed, leading to a more hazardous fall than would have been incurred without the rails. The guidance lists several recommended parameters for bedrail dimensions.
TGA zeroes in on tests for COVID-19
Australia’s Therapeutic Goods Administration (TGA) said it is undertaking a postmarket review of all lab and point-of-care tests for the SARS-CoV-2 virus to establish whether these tests can pick up the most recent variants of the SARS-CoV-2 virus. At present, the agency’s focus is on the strains identified in the U.K. (B.1.1.7) and South Africa (B.1.351), the latter of which is said to present some mutational overlap with the former. The higher viral load associated with these variants may result in lower cycle threshold (CT) values, TGA advised.
HHS posts rule for agency enforcement action
The U.S. Department of Health and Human Services released a final rule that spells out the appropriate use of HHS agency guidance documents in connection with legal proceedings. HHS said the rule prohibits the use of non-compliance with guidance documents as the sole source of allegations of violation of the law. The rule further disallows the use of any compliance standards that have not been publicly disclosed to thwart “unfair surprise” in agency enforcement actions. The rule would also require written notice and opportunity for response when taking any civil enforcement action with the potential for legal consequences.