Fujirebio mesothelioma blood test:
This article was originally published in Clinica
The US FDA has cleared for sale under its Humanitarian Device Exemption (HDE) programme what is claimed to be the first in vitro test for monitoring patients confirmed as having mesothelioma, a form of cancer linked to asbestos exposure. The Mesomark test, made by Fujirebio Diagnostics, enables doctors to more accurately detect disease recurrence and monitor treatment of patients, via a simple blood test, said the company, a subsidiary of Japan's Fujirebio. The company plans to collect more data to support the test's use for detecting mesothelioma. HDE approvals are intended to allow companies to show safety and probable benefit for products designed to treat a defined group of patients - fewer than 4,000 individuals in the US per year.