Syncthink Inc. is preparing to launch its neurological impairment and disease diagnostic in Europe, after securing CE marking for the ocular biomarker device. The company is raising a new round of funding to support commercialization of the Eye-Sync system and has two projects exemplifying applications of the device running with academic collaborators in the U.K.
Two Israeli companies aiming to improve in vitro fertilization (IVF) success rates received good news recently, with Aivf Ltd. hauling in $25 million in a series A round for Ema, its IVF software platform, and Fairtility Ltd. gaining CE mark for its CHLOE EQ embryo quality decision-support tool.
Biocartis Group NV received CE-marking of its Idylla Gene Fusion lung cancer biomarker test. The automated panel is designed to detect chromosomal translocations that generate fusion genes and cause non-small-lung cancer (NSCLC). Mechelen, Belgium-based diagnostics company Biocartis recently reported results from a study that found the assay enables rapid screening with quicker turnaround and lower tissue requirements compared to standard methods.
Los Angeles-based cancer diagnostics company Nonagen Bioscience Corp. obtained CE marking for its Oncuria immunoassay for bladder cancer. The multiplex urine test is designed to detect the concentration of 10 proteins that are associated with bladder cancer in urine samples. Clinical studies found the test has a 93% sensitivity and 93% specificity for detecting bladder cancer. The test is also designed to predict whether people are more likely to respond to bacillus Calmette-Guérin (BCG) therapy, a first-line treatment for bladder cancer.
Ibex Medical Analytics Ltd. extended the reach of its artificial intelligence (AI) powered pathology system, adding gastric cancer to existing CE mark approvals in prostate and breast cancer.
Stratipath AB gained CE-IVD mark for its artificial intelligence (AI)-based software for prognostic risk stratification of breast cancers, clearing the path for introduction of the solution in the EU. Stratipath Breast analyzes digital histopathology whole slide images generated from surgically resected breast cancer tissue to identify patients with increased risk of disease progression. The system provides clearer guidance on the best treatment path for the 50% of women whose breast cancer is categorized as intermediate risk.
Volitionrx Ltd. won the CE mark for its Nu.Q NETs test for the detection, evaluation and management of NETosis, a type of cell death characterized by the release of neutrophil extracellular traps, or NETs. The test – the first biomarker approved for the measurement of NETs for patient management – will soon be available for clinical use across the E.U.’s 27 member states.
Lumiradx Ltd. has secured CE marking for its HbA1c test for diabetes. The point-of-care (POC), automated fingerstick assay is run on the Lumiradx portable platform and designed to provide connected results in under seven minutes, with a reportable range of 20-130 mmol/mol HbA1c (4.0% to 14.0% HbA1c).
Organ transplant diagnostic company Caredx Inc. has received CE marking for its Alloseq HCT chimerism testing kit and Alloseq HCT interpretation software for use in patients who have received hematopoietic cell transplantation (HCT). The NGS-based solution is used to monitor engraftment and evaluate the success of a hematopoietic stem cell transplant by measuring the relative ratio of the recipient and the donor cell population post-transplantation.
Venus Medtech (Hangzhou) Inc.’s Venusp-Valve, a transcatheter pulmonic valve replacement (TPVR) system, has gained the CE mark in Europe. The system is used to treat moderate to severe pulmonary regurgitation with or without right ventricular outflow tract stenosis. The TPVR provides an alternative for those not eligible for open-chest operations because of the risks such as large trauma, and slow recovery, a spokesperson of Venus Medtech told BioWorld.
