Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite.
Prostate cancer affects roughly 1 in 9 American men in their lifetime, with 174,650 new cases reported each year. However, current prostate specific antigen (PSA) tests lack specificity, leading to overdiagnosis and overtreatment of inconsequential cancers. Cleveland Diagnostics Inc. is looking to change that with its IsoPSA assay, which just received a breakthrough device designation from the U.S. FDA. In clinical studies, the noninvasive, blood-based test has been shown to have higher accuracy than standard PSA tests.
Foundation Medicine Inc., of Cambridge, Mass., has had a busy fall, and it is showing no signs of letting up. For example, in the next 12 to 18 months, the company has high hopes for its Foundationone Liquid test, David Fabrizio, VP, product development, told BioWorld MedTech during a visit to its headquarters last month as the Medtech Conference wrapped up in Boston. "This is one that we are actively engaged in with FDA and planning to submit and hopefully get approval and launch mid-next year," he added.