Nonagen Bioscience Corp. received FDA breakthrough device designation for its liquid biopsy assay designed to predict response to treatment for bladder cancer. The test, Oncuria, measures 10 protein biomarkers in a urine sample and uses an algorithm to predict whether patients will respond to Bacillus Calmette-Guerin (BCG), the first-line treatment for bladder cancer, or should proceed to another treatment option.
The FDA has granted Anchordx Medical Co. Ltd.’s Urifind, an early detection test for bladder cancer, a breakthrough device designation (BTD). This marks the first BTD given to a liquid biopsy test for bladder cancer detection in China, putting it in good stead as it gears up for an IPO.
New evidence about the role of the RSK family of protein kinases in cancer has cut through conflicting experimental data to demonstrate they have different functions and that the RSK4 isoform is a promoter of drug resistance and metastasis in lung and bladder cancer.
TORONTO – Ambu Inc. has won Health Canada clearance for a flexible, single-use cystoscope for diagnosing, managing, and treating lower urinary disorders such as incontinence and bladder cancer. The disposable Ascope 4 Cysto system goes head-to-head with reusable urology scopes that must be reprocessed after each use, diminishing image quality and mechanical performance, said Jens Kemp, Ambu’s vice president of marketing for North America.
Gilead Sciences Inc.’s recent decision to acquire Immunomedics Inc. looks even smarter now in light of the full data in a phase III study of Trodelvy (sacituzumab govitecan-hziy) released at the European Society for Medical Oncology (ESMO) over the weekend.
Vessi Medical Ltd. has scooped up $1.7 million in series A funding to move forward with a first-in-human study of its minimally invasive bladder cancer device. The trial is set to launch in the first quarter of 2021. Leading the funding round are the Trendlines Group Ltd. and Agriline Ltd. The Trendlines Group already counts Misgav, Israel-based Vessi Medical as part of its portfolio of medical startups.
CAPS Medical, of Netanya, Israel, closed a $3.5 million series A round led by Chasing Value Asset Management and the Los Angeles-based Israel Investment Fund Group. The new funds will be used to enable CAPS to undertake its first clinical trial for its minimally invasive, nonthermal plasma device for cancer treatment and further develop its portfolio for the treatment of solid tumors.
In a setback for Astrazeneca plc's plans to tackle previously untreated cases of advanced bladder cancer, neither its immune checkpoint inhibitor, Imfinzi (durvalumab), nor a pairing of it with the investigational drug tremelimumab beat standard-of-care (SOC) chemotherapy in improving overall survival (OS) during a phase III trial evaluating the treatments as first-line (1L) care for patients with advanced disease.
TORONTO – Imagin Medical Inc., which has a presence near Boston and in Vancouver, British Columbia, will have verified and built a device in early January that meets all functional, electrical safety and radiated emission requirements for a new way of visualizing bladder cancer. Jim Hutchens, Imagin Medical’s president and CEO, said the i/blue imaging system should dramatically improve surgeons’ ability to visualize cancerous bladder cells by producing higher quality images more quickly compared with current methods.