The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health emergencies and another on software assurance in computer and data processing systems for medical device production.
Professor Alexander Star and researchers from the University of Pittsburgh have filed for protection of their development of a rapid, affordable, and reliable tuberculosis diagnostic tool.
The EU’s Medical Device Coordination Group issued a guidance on the types of products that qualify as in vitro diagnostics (IVDs), including some important distinctions even in instances in which a given analyte is the subject of two tests.
Continuing its aggressive buying spree, Bruker Corp. entered into a definitive share purchase agreement with Tecfin S.à r.l. to acquire molecular diagnostics (MDx) company Elitechgroup SAS for €870 million (US$943.5 million), excluding the Elitech clinical chemistry business. The deal is expected to close in the second quarter of 2024 and will be funded with a mix of cash on hand and debt financing.
The U.S. FDA has announced the next stage in its program to down-classify a series of in vitro diagnostics (IVDs) from class III to class II, a change that would significantly ease the premarket requirements for these test types. Much of the emphasis here is on companion diagnostic (CDx) tests, a category of products that is the focus of a separate FDA imperative, but there are those who view this down-classification regime as little more than a meager attempt to paste over a massive impending regulatory overhang.
Oxford Nanopore Technologies plc secured a £70 million (US$85 million) investment from Biomérieux SA. The investment comes on the back of a partnership formed between the two companies earlier in the year. The funds will support the development of products in Oxford Nanopore’s portfolio to serve in vitro diagnostics (IVD) markets.
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR.
Infandx AG has had an abrupt change of strategy after discontinuing development of an umbilical cord blood biomarker test, which was intended to diagnose brain injury in newborns caused by a lack of oxygen before or shortly after birth.
Numares Health AG received $21.2 million from the European Investment Bank (EIB) in support to its automated and software based IVD platform for obtaining high-quality nuclear magnetic resonance metabolomics data from blood or urine biopsy samples.
The first home pregnancy test to analyze saliva rather than urine is due to be on the shelves in Europe at the start of 2023, following CE approval of Salistick, developed by saliva diagnostic specialist Salignostics Ltd.
