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In Brief This Week: Fusion Pharmaceuticals, Mainz Biomed, FDA, Medial EarlySign

NEW YORK – Fusion Pharmaceuticals this week opened a radiopharmaceutical manufacturing facility to produce its radiopharmaceuticals that meet good manufacturing practices (GMP) requirements. The facility will help the firm scale production of its pipeline of targeted alpha therapies, which includes FPI-2265 for prostate cancer, FPI-1434 for tumors expressing IGF-1R, FPI-1966 for FGFR3-expressing tumors, and FPI-2059 for gastric cancers expressing NTSR1. At full capacity, the manufacturing facility can produce 100,000 doses of its targeted alpha therapies per year, the firm said. 


German cancer early detection firm Mainz Biomed said this week that Eurofins GeLaMed has joined its network of laboratory partners and will process its ColoAlert stool PCR test for colorectal cancer screening. Eurofins GeLaMed has four locations in Germany and is part of Eurofins Scientific. It will offer Mainz Biomed's assay at all of its testing sites. 


The US Food and Drug Administration this week released a draft guidance document providing recommendations on the implementation of decentralized clinical trials. The guidance has suggestions for trial design, use of digital health technologies and telehealth, and which types of drugs and medical devices are best suited to decentralized studies. The public can submit comments on the guidance through Aug. 1. 


Medial EarlySign announced this week that it has entered an agreement with Roche to include the EarlySign ColonFlag algorithm in Roche's Navify algorithm suite. The ColonFlag algorithm is a computational clinical software model that aims to help healthcare providers identify those at increased risk for colon cancer who warrant further evaluation, EarlySign said in a statement. In the US, the algorithm is marketed as LGI-Flag with an indication for lower gastrointestinal disorders. EarlySign and Roche have existing development agreements to support the early detection of gastric and lung cancers, the company noted. 


In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Medicine Online.