Among the many challenges to developing stem cell therapies is the need to match donors to recipients and the risk of graft vs. host disease that requires the use of immunosuppressants. Athersys has developed a stem cell therapy platform known as MultiStem that makes use of a type of stem cell that doesn’t carry the […]
Bringing it closer to one of the world’s fastest-growing diagnostic market places, the Laboratory for Advanced Medicine (LAM)’s blood-based liver cancer test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). The test analyzes the DNA methylation pattern of cell-free DNA (cfDNA) non-invasively, and can indicate the presence of hepatocellular […]
FDA has granted breakthrough status to Laboratory for Advanced Medicine’s liver cancer liquid biopsy, the Irvine, California-based company said in a statement Tuesday. LAM secured the regulatory status after generating preliminary clinical data showing the test detects liver cancer with a specificity and sensitivity in excess of 95%. Like a rival test in development at Exact Sciences, […]