Astrazeneca plc has signed an agreement with liquid biopsy testing company Saga Diagnostics AB to develop dPCR assays. Lund, Sweden-based Saga Diagnostics will develop Sagasafe dPCR assays towards undisclosed methylated targets for analysis of tissue samples and liquid biopsies. The assay is part of Saga’s portfolio of “ultrasensitive technologies,” comprising Sagasign for personalized monitoring of cancer burden and minimal residual disease.

LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) is inviting manufacturers to submit electronic cigarettes for approval as medical devices, after drawing up new guidance on the standards that will be required for approval. The move means the U.K. could become the first country in the world where e-cigarettes are available on prescription as smoking cessation aids.

A brighter future awaits radiotherapy if Flash and LIGHT live up to their promise. Announcements made last week by Varian Medical Systems and Advanced Oncotherapy plc indicate results should be seen soon. Varian reported that the first human clinical trial of Flash, Fast-01, completed its treatment phase last week at the Cincinnati Children’s/University of Cincinnati Health Proton Therapy Center. Advanced Oncotherapy plc presented results from a modeling study of Linac for Image Guided Hadron Therapy (LIGHT) technology at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting demonstrating that LIGHT enables both the high, super-quick dose delivery of Flash and good conformality of dose delivery to tumor tissue.

The U.S. Center for Medicare & Medicaid Services (CMS) has made the first award to a product under an add-on payment for treatment of end-stage renal disease (ESRD) as part of the prospective payment schedule for calendar year 2022. Outset Medical Inc., of San Jose, Calif., snared the first of these novel add-on payments for medical technologies under the ESRD prospective payment system, but device makers working the ESRD space can expect to see many similar such awards in the years ahead.

The U.S. Department of Justice (DoJ) reported a new set of policies dealing with federal prosecutions of corporate misconduct that includes a far-reaching policy on disclosure. Deputy attorney general Lisa Monaco announced Oct. 28 that companies will have to disclose all non-privileged information in connection with alleged misconduct rather than just information regarding those who were “substantially involved.”