Category: In the News

With the help of Bio-Rad’s ultra-sensitive, multiplexed digital PCR system, Biodesix and its research partners are pursuing novel blood tests for the early detection and targeted treatment of lung cancer. Dr. Gary Pestano, chief development officer at Biodesix, discusses how his team is leveraging Bio-Rad’s advanced Droplet Digital™ PCR (ddPCR™) technology to develop novel blood tests…

The unique event brought together patients, researchers, clinicians, and other stakeholders to discuss new and emerging research on metastatic breast cancer with a focus on patient priorities for better, more effective therapies. There are over 42,000 deaths due to breast cancer in the U.S. each year and nearly 700,000 globally. But it is not disease…

A year ago, when applied biologist Renee Wegrzyn took the helm of the Advanced Research Projects Agency for Health (ARPA-H), questions swirled around the brand-new agency, which was created by President Joe Biden to fund daring, cutting-edge biomedical research. Would the new organization be sufficiently different from the sluggish, risk-averse National Institutes of Health (NIH)?…

The growth in cell and gene therapy development will force industry and health technology providers to “get smart” about combining prospective clinical trial data with real-world data sources and addressing the “data quality mismatches” that will inevitably result, said Amy Abernethy, Verily clinical studies platforms president. Abernethy, the former US Food and Drug Administration principal deputy commissioner…

Beaconcure Technologies, a leader in AI-enabled clinical data validation and automation, announces enhancements to its leadership team, emphasizing its dedication to innovation in drug delivery and clinical data science. The company empowers healthcare professionals with groundbreaking tools, reducing the time and cost of delivering therapies to patients. Beaconcure is pleased to introduce the following professionals…

Fulfills agency promise after bill failed to pass last year Move faces opposition from lab groups, academic centers The FDA would have clear authority to regulate medical tests that come from a single laboratory under a proposal released by the agency Friday. The proposed rule (RIN: 0910-AI85) marks a pivotal step in the Food and…

Brittany Avin McKelvey noticed something was wrong when she had trouble yelling plays to her teammates during middle school basketball games. Eventually, she could not raise her voice so friends could hear her in the school cafeteria. Her doctor told her to rest her voice. When her voice didn’t return after months of rest, an…

The biomarker-driven Lung Cancer Master Protocol (Lung-MAP) may have enrolled a higher percentage of patients who are older, are from rural or socioeconomically deprived areas, and have Medicaid or no insurance compared with conventional, standalone clinical trials in advanced non–small cell lung cancer (NSCLC), according to a study published by Vaidya et al in JCO Precision Oncology.…

During this week’s Friends of Cancer Research (FOCR) meeting on the use of real-world data to support oncology drug development, FDA Commissioner Robert Califf shared his take on the barriers preventing the collection and utilization of high-quality real-world data (RWD) and pondered what lessons the U.S. healthcare system could stand to learn from others. The…

The “biggest area” where FDA Commissioner Rob Califf believes real-world evidence will “make a difference” is in the post-market phase, “where there are all kinds of issues that often involve other parts of the ecosystem.” He pointed to drug developers’ new focus on Alzheimer’s disease and obesity: “we’ve got these enormous markets” and significant patient…