The U.S. Food and Drug Administration (FDA) has given Roche an Emergency Use Authorization (EUA) for the LightMix Zika rRT-PCR Test.
According to an announcement made by Roche, the product is to be used on patients who meet the Zika virus clinical and or epidemiological criteria set by the U.S. Centers for Disease Control and Prevention. To detect the virus in samples of EDTA plasma or serum, the LightMix Zika test is to be used with Roche's cobas z 480 analyzer or the LightCycler 480 instrument.
"The LightMix Zika test is an easy-to-use molecular diagnostic test that enables health care professionals to quickly detect the virus," said Uwe Oberlaender, Roche Molecular Diagnostics Head, adding that the release of the EUA supports Roche's commitment to aiding health care professionals in fighting the serious disease.
But while the EUA does facilitate the use of Roche's Zika test, this does not mean that the product has been approved or cleared by the FDA. Rather, LightMix may be used by laboratories that have been certified through the Clinical Laboratory Improvement Amendments of 1988 or facilities with similar qualifications not in the United States. Additionally, the Zika test has only been authorized to detect the virus' RNA and not for other pathogens or viruses.
By using LightMix with compatible instruments, laboratories can test up to 96 samples and produce needed results within 2.5 hours.
The Zika virus has been largely linked to microcephaly and other brain defects in babies but a new study suggests that it can also be as severely damaging to the brains of full-grown adults.
According to researchers from the La Jolla Institute for Allergy and Immunology and the Rockefeller University, the virus also attacks a particular brain cell that has been associated with a person's learning and memory.
In a mice model, the researchers were able to show that the Zika virus took hold of a group of brain cells called neural progenitor cells, which left the subjects not only with relatively smaller brains but also mental impairment.
Neural progenitor cells are typically found in the brains of developing fetuses, acting like stem cells. In adults, some of the cells remain, tasked with the responsibility of replenishing brain neurons. When the Zika virus strikes, brain neurons are not replenished, leading to retarded brain growth.
The researchers pointed out that adults have better resistance against the virus but the presence of neural progenitor cells in their brains makes them still at risk of brain damage caused by Zika.
Further research, however, is needed to determine if brain damage due to Zika will result in long-term negative effects on neurons.
