TORONTO – Oncocyte Corp. launched Determaio, an immunotherapy response prediction test it said is “the first to comprehensively assess the tumor microenvironment.” This is important because of how smart cancer cells are in that microenvironment, Oncocyte CEO Ronnie Andrews told BioWorld, commandeering natural tissue repair biology and condensing immunological T cells so they back off attacking cancerous tissue.

It has long been known that patients recover more quickly from transcatheter aortic valve replacement (TAVR) than from open-heart surgery for valve replacement (SAVR) and results at two years looked good, too, with very similar outcomes. The question remained what happens in the longer term?

A new study has found that despite the risk, many patients are open to interventional procedures such as renal denervation (RDN) if it can lead to improved blood pressure. RDN is performed under local anesthetic and uses radio frequency ablation to burn the nerves in the renal arteries. The process causes a reduction in nerve activity, which decreases blood pressure.

Despite the morbidity associated with coronary artery bypass graft, this procedure has never been entirely displaced by percutaneous coronary intervention. The results from the latest in a series of studies does not seem to help the case for drug-eluting stents (DES) for patients with three-vessel disease, as the data from this study failed to demonstrate non-inferiority for DES devices implanted with the help of fractional flow reserve measurement to ensure optimal stent placement.

Hot off the heels of a $45 million series B financing raise, Activ Surgical Inc. has completed the first clinical trial evaluating its Activinsights augment reality (AR)-based software suite and Activsight imaging module. The safety and feasibility study, carried out with The University of Texas Health Science Center at Houston (UTHealth Houston) is the first of several trials the Boston-based company is planning in 2021.

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.

Diacarta Inc.’s diagnostic assay, Coloscape, could be the first to meet the Centers for Medicare and Medicaid Service (CMS)’s strict standards for Medicare coverage of a liquid biopsy for colorectal cancer screening if results seen in a Plos One study are borne out in larger trials and the test gets the nod from the FDA. That is a lot of ifs, but the study posted strong results: 100% specificity and 92.2% sensitivity for cancer and 95% specificity and 62.5% sensitivity for precancerous lesions.

To help better utilize real-world data in drug development, the EMA published its final guideline Oct. 26 on the use of registry-based studies to support regulatory decision-making.

Apollo Endosurgery Inc. presented strong results from its endoscopic sleeve gastroplasty study with patients achieving an excess body weight loss of 49.2% at 12 months and the great majority maintaining that loss for two years. Serious adverse events occurred in 2% of patients and all resolved without intensive care or surgical intervention.