NanoString Technologies ($NSTG) won a coveted 510(k) clearance for its new in vitro breast cancer diagnostic. And as it gears up for a U.S. launch, the Seattle company sees the Prosigna test as a potential game-changer, because the test kits and related hardware can be bought and run by any high-complexity CLIA lab. Typically, these types of diagnostic tests are available only at special centralized labs, Nanostring CEO Brad Gray told FierceDiagnostics. The test is based on the PAM50 gene signature and is designed to profile cells found in breast cancer tissue to assess a patient's risk of future recurrence of the disease. Story