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Having recently won prequalification status from the World Health Organization the British Columbia-based firm is also considering US regulatory options.
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 test, called Fujifilm SILVAMP TB LAM, was found to be about 30 percent more sensitive than the Alere Determine TB LAM Ag test from Abbott.
The mass spec-based assay can detect viral proteins eight days after the onset of symptoms, compared to four to five days with PCR tests, its developers said.
Along with WHO, Mologic, and Leiden University Medical Center, FIND is developing two rapid diagnostic tests to detect circulating anodic antigen in blood or urine.
Researchers at Washington University in Saint Louis will use new funds to confirm preliminary findings on malaria-infected kids in a second location in Africa.
Backed by the UK and Swiss governments, FIND's Diagnostics Use Accelerator will support studies that could lead to improved use of antibiotics, as well as new diagnostics.
Developers claim the immunochromatographic assay has advantages over other tests on the market for diagnosing TB in HIV patients, as well as the conventional approach.