FDA Grants Breakthrough Device Designation to Liquid Biopsy Liver Cancer Detection Test
| Onco'Zine

The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device designation to a Liquid Biopsy Liver Cancer Detection Test being developed by Laboratory for Advanced Medicine (LAM), a commercial-stage medical technology company. The blood-based liquid biopsy test analyzes the DNA methylation pattern of cell-free DNA (cfDNA) indicating the presence of hepatocellular carcinoma (HCC; liver cancer) as early as Stage I.

Athersys Advances Off-the-Shelf Stem Cell Therapy for Stroke
| The Bio Report

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 […]

LAM Gets FDA Breakthrough Designation for Liver Cancer Liquid Biopsy
| ClinicalOMICs

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 […]