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.

CEO Mark McKenna told BioWorld MedTech that San Diego-based Prometheus Biosciences Inc. has "cracked the code" in inflammatory bowel disease (IBD) – progress underscored by the firm's deal with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, which brings an undisclosed up-front payment and as much as $420 million more if development, regulatory and commercial milestones are reached in three programs.

HONG KONG – In vitro diagnostic company Cube Bio Co. Ltd., of Seoul, South Korea, has inked an agreement worth KRW3 trillion (US$2.5 billion) with Moscow-based Standart-Biotest LLC to export its cancer self-diagnostic kits for five years to Russia and the Commonwealth of Independent States (CIS).

PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is seeking comments from stakeholders on whether certain self-testing in vitro diagnostics (IVDs) should be prohibited from being sold to consumers.

A large-scale U.K. clinical trial of a portable electronic nose device has shown it is possible to distinguish bacterial from viral infection in an unselected population of patients presenting with a respiratory tract infection (RTI) symptoms, at the point of care.