The company anticipates launching an in vitro diagnostic version of the 10-gene ThyroidPrint assay in South America and Europe after receiving regulatory clearance by Q2 2021.
The tests performed well, with researchers suggested they could be used for diagnosis in the future, rather than just screening.
Newly discovered biomarkers of preterm birth risk — D-lactic acid and TIMP-1 — may lead to a simple ELISA test at the point of care, its developers said.
Isothermal molecular assays to diagnose a parasitic infection that afflicts approximately 300 million people are moving closer to commercialization.
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 study showed that the Zeesan test kit and qPCR instrument could be used for near-patient HPV typing of 94 samples in 2.5 hours.
The firm said it has multiple point-of-care tests available in Brazil and anticipates soon fulfilling an order for its dengue, chikungunya, and Zika tests.
The test for P. vivax-associated malaria was developed with support from FIND and will be distributed by Human Diagnostics Worldwide.