Owkin Inc. has secured CE marking for two first-in-class artificial intelligence (AI)-based diagnostics, marking a move from research use only and towards the mainstream for AI in enabling faster and more efficient analysis of digital pathology slides.
Guardant Health Inc. tripled the number of cancers that can be monitored for minimal residual disease (MRD) or risk of recurrence using its Reveal liquid biopsy, adding breast and lung cancers. The test is currently used to detect circulating tumor DNA in blood for patients treated for stage II or III colorectal cancer (CRC).
It’s an august August for Hutchmed Ltd. as it reported positive business results and a number of trial developments, including results from its pivotal global phase III FRESCO-2 trial evaluating the investigational use of fruquintinib in patients with advanced, refractory metastatic colorectal cancer, which met its primary endpoint of overall survival.
Isofol Medical AB’s slow reveal of data from its phase III registration trial of arfolitixorin in first-line metastatic colorectal cancer (mCRC) will not reach a conclusion until the fourth quarter of this year. The news follows a December 2021 warning to investors that an unexplained level of therapy switches occurring in the absence of disease progression would impair its analysis of a key secondary endpoint, the rate of progression-free survival.
A 2,000-patient U.K. study has been set up to generate real-world evidence of the value of using AI technology to detect bowel polyps (adenomas) during colonoscopy procedures. The aim is to show whether Medtronic plc’s GI Genius system improves the detection of polyps when deployed in both expert centers and non-specialist units, in the routine diagnostic screening of patients referred from primary care or through the national fecal immunochemical testing program.
With FDA clearance of its Endoscreener that uses artificial intelligence (AI) to detect polyps during coloscopy procedures, Wision AI Ltd. is expanding its product portfolio to include colorectal histopathology tools.
Treatment-emergent adverse events (TEAEs) may have soured investors on otherwise-positive new data from Cardiff Oncology Inc.’s phase Ib/II study with PLK1 inhibitor onvansertib in second-line, KRAS-mutated metastatic colorectal cancer (mCRC). Cardiff, however, is forging ahead with a pivotal experiment.
Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
Shares in Isofol Medical AB dropped by 27% on Dec. 6 as the company informed investors that its ongoing phase III trial of arfolitixorin in metastatic colorectal cancer would not reach the predefined number of events needed to demonstrate a statistically significant effect on progression-free survival (PFS) based on the study’s present statistical plan.
