In a new guidance, the US regulatory agency encouraged voluntary inclusion of LOINC codes with IVDs as a means to promote data interoperability.
Clinicians are using Roche's Cobas Omni Utility Channel to run lab-developed PCR tests alongside in vitro diagnostic kits, freeing valuable resources for labs.
BacterioScan has signed a sales and distribution agreement for the system with Fisher Healthcare.
The agency finalized recommendations for developing and validating NGS tests, and proposed a submission process for investigational IVDs in cancer Rx trials.
Randox is using the funding, which includes £23 million from Invest NI, to create three centers in Northern Ireland to develop new diagnostic technologies.
MHRA has also published a draft guidance for institutions that offer such tests so that they can gain compliance with the new directive.
The group of regulatory authorities from around the world has proposed a new guidance for harmonizing the procedures for assessing medical devices, including IVDs.
The agency cleared the company's C-reactive protein, which is based on its Multi-Array technology used by life science researchers for 20 years.
The base term for the contract, which is for medical surgical products, is 14 months with eight one-year and one 10-month option periods.
The hospital will run Agendia's new NGS test kit in its lab, comparing results with the firm's existing centralized MammaPrint test.