Africa

The test, which detects antibodies to Ebola virus from whole-blood samples and cadaveric oral fluid, was also granted breakthrough device designation.

Erada Technology Alliance said the Global Health Innovative Technology Fund grant facilitates production, testing, and validation trials for the rapid test for malaria.

The appointment of a former Roche executive as the firm's new COO is viewed as a significant event for a firm still in the early stages of driving adoption of its Pheno system.

The company will market Inivata's InVision liquid biopsy assays to insured and self-pay patients across the region.

The new list comprises 122 test categories — 46 general IVDs, 69 IVDs for specific diseases, and seven test categories for screening blood donations.

Using a fingerstick, the Mylan HIV Self Test can be completed at home and detects whether HIV antibodies are present in about 15 minutes.

The project, called Seq&Treat, will be implemented in Brazil, China, Georgia, India, and South Africa starting in October.

The firm's CEO said it is continuing to develop its distributor network to make its tests available in centralized and decentralized settings globally.