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.

Smart Medical Systems Ltd. has released positive data showing its FDA-cleared G-eye balloon endoscope has a higher adenoma detection rate (ADR) compared to Olympus’ Endocuff Vision (ECV) technology in patients undergoing screening or surveillance colonoscopy.

Natera Inc. added its Prospera assessment for lung transplant patients to its portfolio, joining the company’s tests for rejection of kidney and heart transplants. The test uses donor-derived cell-free DNA (dd-cfDNA) to detect acute rejection as well as chronic rejection and infection in stable patients. Results of the VALID study presented at CHEST 2021 demonstrated that the Prospera Lung test had a negative predictive value of 97.33%, sensitivity of 89.06% and area under the curve of 0.91.

LONDON – Inivata Ltd. is extending efforts to bring its liquid biopsies into routine use, in two new clinical trials in lung cancer. The first will attempt to show increased speed in getting advanced non-small-cell lung cancer (NSCLC) patients on to the most appropriate therapies. The second study aims to demonstrate that detecting circulating tumor DNA (ctDNA) will single out those early-stage lung cancer patients who have residual or recurring disease after surgery and need further treatment with chemo- or immuno-therapies.

A genetic biomarker-based diagnostic test developed by Inbiomotion SL to identify treatment for early-stage breast cancer could significantly improve patient survival, a study has found. Data from the phase III NSABP-B34 study published in the Journal of the National Cancer Institute Cancer Spectrum, showed that in patients with MAF-negative (mutation biomarker) tumors – determined with Inbiomotion’s MAF Test – adjuvant treatment with clodronate was associated as having the greatest benefit compared to placebo-treated control patients receiving the same standard of care.

Fabric Genomics Inc.’s Gem artificial intelligence algorithm plus whole genome and whole exome data detected more than 90% of disease-causing variants in infants with rare diseases, a study in Genome Medicine demonstrated. The full process from blood sample to shortlist of causative variants and likely diseases takes just a matter of hours and the time to interpret whole genomes is condensed to about 15 minutes.