Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

Developers can use the Zika virus samples to ascertain whether their tests can help distinguish Zika infection from similar diseases.

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.