FDA

The company expects the new trials to start this fall, and plans to submit to the FDA next year to get the agency's stamp of approval.

Roche's HbA1c test, along with an immunoassay system from Shenzhen New Industries Biomedical, and a celiac test from Immco also received 510(k) clearance last month. 

The PCR-based test can simultaneously detect for the Zika virus, all serotypes of the dengue virus, the chikungunya virus, the West Nile virus, and a host gene. 

The iC-System is based on on iCubate's amplicon-rescued multiplex PCR technology, which detects multiple pathogens simultaneously.

The US Food and Drug Administration yesterday granted emergency use authorization to Thermo Fisher Scientific's TaqPath Zika Virus Kit.

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 firm anticipates receiving regulatory approval from the CFDA for its first three products by the end of the year, including one for lung cancer.

The new version of the mass spectrometry-based system adds 144 microbial species to its database and includes new tools for sample preparation.

The firm's life science segment grew revenues 8 percent, but revenues from its diagnostics segment saw revenues retreated 4 percent. 

The control, being launched for the immunoassay-based tumor marker testing space, features HE4 and HER-2/neu, and outside the US, proGRP and SCC. 

Pages