Luminex Corporation today* announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a multiplex nucleic acid test designed to detect Zika virus RNA in potentially infected patients using their blood serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen).
Designed by Luminex partner, GenArraytion, Inc., the xMAP® MultiFLEX™ Zika RNA Assay detects Zika viral RNA in serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen). In July 2016, the Centers for Disease Control and Prevention (CDC) updated its guidance to clinicians to recommend serum and urine testing for specimens collected <14 days after symptom onset.
The xMAP® MultiFLEX™ Zika RNA Assay is available for purchase by certain authorized laboratories. The multi-target assay uses the Luminex® 100/200™ or MAGPIX® instrument, or other authorized instruments, to simultaneously test for six genetic targets of the Zika virus.
Per Dr. Amy Altman, Vice President of Biodefense and Protein Diagnostics, “…and guidance continues to change as we see things evolve. For instance, it was just (initially) recommended that you test serum, blood. Now, they’ve discovered that the virus can last longer in urine so they’ve added that recommendation.” Just like the flu, Zika is prone to mutation, and this test will still be able to detect it, even if it changes genetically.
Press release: “Luminex Corporation Receives FDA Emergency Use Authorization for Zika Virus Molecular Detection Assay: Commercially available xMAP® MultiFLEX™ Zika RNA Assay, designed by GenArraytion, Inc., detects 6 genetic targets of Zika virus”
Luminex Corp., an Austin-based biotech company that develops diagnostic technology to identify diseases, is seeing its MAGPIX® technology used by scientists in the U.S. Army Medical Research Institute of Infectious Diseases in Africa to identify strains of the deadly Ebola virus that has killed nearly 800 people in recent weeks.
Government scientists have been using the MAGPIX system since at least the late 2000s to develop assays that are used to test for the presence of viral proteins as well as antibodies directed at these antigens.
Results of the assays provide information about replication of the virus and the immune response of the host. After training the field workers on how to maintain the MAGPIX equipment after the platform was purchased, Luminex has continued to remotely advise Army and medical personnel on how to address technical and repair issues in the field.
Amy Altman, vice president of biodefense at Luminex, said the company is also four years into work funded by the National Institutes of Health to generate antibodies that can be used to detect different variants of the disease, which can help in studying its patterns of virality.
In the fall of 2010, a massive Cholera epidemic broke out in Haiti in the aftermath of the devastating earthquake that struck in early 2010. Luminex officials realized we could help. After getting in touch with GHESKIO (Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections, a non governmental organization), our Director of Scientific Affairs, Dr. Sherry Dunbar and Jim Griffin, Senior Director, Global Technical Operations, along with two of our MAGPIX multiplexing systems and our xTAG® GPP (Gastrointestinal Pathogen Panel) were sent to the GHESKIO Institute in Haiti. Sherry and Jim made a total of four trips to Haiti to train technologists and engineers at the GHESKIO lab on performing the test, interpreting the results and troubleshooting the equipment. The introduction of MAGPIX and GPP assists in speeding the diagnosis and stemming the spread of cholera in Haiti. They also worked with Haiti’s national laboratory, the Laboratoire National de Santé Publique (LNSP), who used GPP to study the epidemiology of gastrointestinal infections in Haiti.
According to Macarthur Charles, GHESKIO IMIS Director, and Associate Professor of Medicine at Weill Cornell Medical College. “We think the Luminex assay will significantly change the way we look at the causes of infectious diarrhoea in Haiti. In addition, it will allow us to better predict and react to outbreaks of acute diarrhoeal illness in Haiti.”1
While Haiti has seen a significant decrease in the number of Cholera cases since 2010, thanks in part to Luminex Technology, Haiti still hosts the largest number of suspected cholera cases worldwide with more than 707,000 infected and 8,600 deaths since October 2010, according to the U.N.2 Despite severe infrastructure and financial constraints, important strides have been made in combating cholera in Haiti. There has been a drastic reduction in the number of suspected cases and deaths from cholera starting from 2013. The overall incidence of the disease has been reduced by half and fatality rates are below 1 per cent, the target rate set by the World Health Organization (WHO) globally. These results confirm that efforts to tackle the epidemic are working.3