The FDA cited Euro Diagnostica for at least five violations stemming from an inspection of its facility in January, as well as inadequate responses to those violations.
The PCR-based test, run on Roche's Liat platform, was among several other assays that was cleared by the agency last month.
Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.
Eleven sites have been established across Britain to enable the development of new tests and technologies within the UK National Health Service, as well as to evaluate commercial IVD kits.
Genomic Health will gain exclusive worldwide rights to develop and sell an IVD version of its Oncotype DX breast cancer test on Biocartis' Idylla platform.
The test is intended to detect FLT3 mutations in order to select patients for treatment with Novartis' Rydapt, and has also been approved by the US FDA.
The IVD Industry Connectivity Consortium's new LIVD standard promises to support data interoperability by mapping test results directly to LOINC procedure codes.
PSS, which develops tools for the IVD space, will supply to Hitachi its nucleic acid isolation system, fully automated diagnostic instruments, and reagents.
A set of rules for IVDs will take effect in 2022, and another for medical devices will take effect in 2020.
Ahead of a longer-term goal to develop IVD kits, the company has a plan this year to allow early-access customers to take on one aspect of testing in their own labs.