IVD

Genomic Health will have exclusive rights to develop and sell its Oncotype DX Genomic Prostate Score test on Biocartis' Idylla platform.

While companies are expected to have their IVDs certified under the new regulation by 2022, manufacturers are frustrated by the slow pace of the certification process.

By ending the agreement, Quanterix regains full control over its Simoa immunoassay technology and its potential use for in vitro diagnostic purposes.

Of the 1,194 Horizon 2020 proposals received between 2014 and 2017, most were related to the development of IVDs, while a third were focused on personalized medicine.

The company highlighted growth in demand for its test , and is now ramping up marketing and focusing on its IVD development plans.

With the NeoLSD MSMS kit, labs can leverage tandem mass spec technology, which reduces sample prep and analysis times, to run hundreds of tests per day. 

Revenues for Roche Diagnostics totaled CHF 6.26 billion for H1, driven primarily by demand for immunodiagnostic solutions.

The Australian firm plans to use the funds for the acquisition of complementary technologies, as well as for working capital.

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.

Pages