IVD

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MHRA has also published a draft guidance for institutions that offer such tests so that they can gain compliance with the new directive.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.

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