Organoids cultured from patient-derived colorectal cancer cells have been used to demonstrate for the first time that tumors which have developed resistance to the full range of existing treatments, across chemotherapies, targeted therapies and immunotherapies, retain a requirement for Werner helicase (WRN) for survival. WRN has a key role in the maintenance of genome stability, but although loss of WRN is known to initiate synthetic lethality in DNA mismatch repair deficient colorectal cancer, studies into the effect of inhibiting that helicase have to date been limited to a handful of cell lines.
Organoids cultured from patient-derived colorectal cancer cells have been used to demonstrate for the first time that tumors which have developed resistance to the full range of existing treatments, across chemotherapies, targeted therapies and immunotherapies, retain a requirement for Werner helicase (WRN) for survival.
Cosmo Artificial Intelligence Ltd. received the FDA’s nod for its GI Genius intelligent endoscopy system. The device – the first of its kind, according to the agency – uses artificial intelligence (AI)-based on machine learning to improve the detection of lesions during colonoscopy. It will be rolled out in the U.S. by Medtronic plc, which has exclusive worldwide distribution rights.
Following a missed primary endpoint in its phase III study in treating anti-PD-1-refractory advanced melanoma, Idera Pharmaceuticals Inc. is considering stopping the registrational trial of its synthetic Toll-like receptor 9 (TLR9) agonist or pressing on toward the clinical trial’s second primary endpoint.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Rep. Payne resurrects colorectal cancer screening bill; Former Practice Fusion employee enters guilty plea; NICE says Alpha-Stim not ready for anxiety disorder.
The U.S. Centers for Medicare & Medicaid Services (CMS) has determined that the time has come to offer Medicare coverage for blood-based in vitro diagnostics as a screening tool for colorectal cancer (CRC), but there’s one catch: At present, there is no such test approved by the FDA that qualifies under the terms of the coverage memo, making this a null coverage proposition, at least for the time being.
HONG KONG – The third pre-revenue med-tech firm to list on the Hong Kong Stock Exchange in a month, New Horizon Health Technology Co. Ltd. raised HK$1.9 billion (US$245.08 million) in an IPO that began trading Thursday, Feb. 18. New Horizon placed 76.6 million shares at HK$26.66 apiece and said part of the funds will help the company commercialize its FIT-DNA test Coloclear to screen for colorectal cancer.
HONG KONG – Irvine, Calif.-based Trigr Therapeutics Inc. has signed an exclusive licensing deal with Shanghai-based Elpiscience Biopharmaceuticals Co. Ltd., known as Kewang in China. The two companies will develop and commercialize TR-009 in mainland China, Hong Kong, Macau and Taiwan.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Epigenomics out in Medicare NCD for CRC screening; TGA tweaks registration process for class I goods; Global initiative to take on Alzheimer’s; More on EMA cyberattack.
The U.S. Preventive Services Task Force (USPSTF) appears on the verge of expanding colorectal cancer screening to individuals ages 45 to 49, based on its latest draft recommendations. If it does, Exact Sciences Corp. is ready. A study in Cancer Prevention Research demonstrated that the Madison, Wis.-based company's Cologuard multitarget stool DNA test had better than 95% specificity in individuals with nonadvanced precancerous lesions or negative findings on colonoscopy.
