PARIS – The French National Authority for Health (HAS) is expanding the available range of novel autologous technologies reimbursed in the context of breast reconstruction following ablative surgery. In doing so, the HAS is paving the way towards reimbursement for novel autologous techniques in general.
The Menarini Group and Radius Health Inc.’s phase III Emerald study of oral elacestrant as a monotherapy vs. standard of care in treating estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer hit its two primary endpoints. The study’s top-line data, according to the companies, showed statistically significant progression-free survival in both the overall population and in patients with tumors harboring estrogen receptor 1 mutations.
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.
TORONTO – Radialis Medical Inc. has submitted FDA premarket notification for a positron emission tomography system (PET) that targets specific organs for low dose imaging and may be flexible enough to assess many different diseases. The Radialis PET camera is under clinical investigation at Toronto’s University Health Network and Princess Margaret Cancer Center for its ability to assess anomalies in breast cancer.
The French Cosegregation Variant study, a collaboration by cancer genetics clinics and laboratories led by geneticists at the Curie Institute in Paris, has demonstrated that cosegregation analysis represents a powerful tool for classifying variants in BRCA1 and BRCA2 breast-ovarian cancer predisposition genes.
Monoclonal antibodies are already a pillar of cancer therapy, and cancer makes up the largest indication of FDA-approved antibodies, with almost 40% of the total. At the 2021 European Society of Medical Oncology (ESMO) Congress, Elena Garralda predicted that engineered versions of classical antibodies will soon join them on their pedestal.
Lunit Inc. won an innovative medical device designation from South Korea’s Ministry of Food and Drug Safety (MFDS). The designation was for Lunit Insight MMG, its commercial artificial intelligence (AI) solution for breast cancer detection from mammography images. The company said that Lunit Insight MMG is now the first medical device of its type to receive the designation, and the company now has its second innovative medical device designation. “All of our commercialized products are now designated innovative medical devices by the MFDS. We will ensure that our Lunit Insight AI products allow medical staff to rapidly and accurately diagnose patients,” said Beomseok Suh, CEO at Lunit.
In a recent study, researchers led by Beth Weaver from the University of Wisconsin, Madison (UW-M) show that paclitaxel treatment in breast cancer patients increased cell division with chromosome missegregation to induce cytotoxicity.
LONDON – Ibex Medical Analytics Ltd. has claimed a further advance in applying artificial intelligence (AI) to the interpretation of digitized pathology slides, reporting that the first commercial system in the world using AI to detect gastric cancers has gone live. The Galen Gastric system has been deployed at the pathology lab of Maccabi Healthcare Services, one of Israel’s leading HMOs, where it is now operational alongside Ibex’s breast and prostate cancer AI systems.
LONDON – Endomag Ltd. has received endorsement from the U.K. health technology assessment body NICE, opening the way to broader adoption of its Magtrace non-radioactive cancer staging technology in the National Health Service, and providing backing for commercialization of the system in other markets.