Ionpath Inc., a developer of high-definition spatial proteomics, scored $18 million in a series B funding round led by Samsara Biocapital. The round also included global mass spectrometry leader Bruker Corp. as a new investor. Menlo Park, Calif.-based Ionpath plans to use the investment for continued development and deployment of the company’s Multiplexed Ion Beam Imaging (MIBI) technology, which provides quantitative protein imaging at a subcellular level. Read More
Dexcom Inc. has partnered with the University of Virginia (U.Va.) to accelerate development of next generation continuous glucose monitoring (CGM) and automated insulin delivery technology. The five-year agreement will focus on expanding CGM use in type 2 diabetes, gestational diabetes and in-hospital settings. Read More
An independent analysis of studies of Nucleix Ltd.’s Bladder Epicheck demonstrate high diagnostic accuracy and performance in monitoring for disease recurrence in patients with non-muscle invasive bladder cancer (NMIBC). Read More
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program is intended to foster med-tech regulatory harmonization, but stakeholders saw a number of issues with the September 2019 ASCA draft guidance. Read More
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has submitted its first new drug application to the FDA for TLX591-CDx, a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for imaging prostate cancer using positron emission tomography (PET). Read More
As Johnson & Johnson (J&J) made public the launch of a phase III trial with its COVID-19 vaccine, officials from the company and others at the virtual Biopharm America meeting discussed modes of innovation in the pandemic era. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 2Morrow, Nucleix, Rarecells Diagnostics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alafair Biosciences, Assure Tech, Quadrant Biosciences, Vela Diagnostics. Read More
Keeping you up to date on recent developments in diagnostics, including: Distinguishing metastatic SLNs in breast cancer; MRS method reveals insights into Alzheimer’s disease; SARS-CoV-2 multiplex assay allows 3x as many patients per run. Read More
