Quest Diagnostics, Madison, NJ, has received FDA emergency use authorization (EUA) for its Zika virus RNA qualitative real-time, reverse-transcription, polymerase chain reaction (Zika RT-PCR) test.
Developed by the reference laboratory business of Quest’s subsidiary, Focus Diagnostics Inc, Cypress, Calif, the proprietary molecular test is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from certain individuals.
The test is the first from a commercial laboratory provider to be granted an EUA for testing patients for Zika virus RNA. Until now, the only Zika tests authorized by FDA under EUA were available from the US Centers for Disease Control and Prevention (CDC), and were only used in qualified laboratories designated by CDC.
“The availability of our new molecular Zika test provides physicians broad access to a diagnostic tool for managing the Zika outbreak,” says Rick L. Pesano, MD, PhD, vice president of research and development at Quest Diagnostics. “Quest’s expertise in molecular, infectious disease, and women’s health diagnostics, and relationships with half of the country’s physicians and hospitals, allow us to quickly make useful tests widely available for clinical use. This capability uniquely positions Quest to complement the response of public health laboratories for Zika outbreaks, where access to FDA authorized diagnostic tests can potentially influence the quality of patient management.”
The EUA authorizes qualified laboratories designated by Focus Diagnostics and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests, to perform the Zika RT-PCR test. The test can potentially be performed at any CLIA high-complexity laboratory in the Quest Diagnostics network. For now, the test will be performed only at the company’s Focus Diagnostics reference laboratory in San Juan Capistrano, Calif, which developed and validated the test.
International and US health officials have confirmed Zika infection during pregnancy can cause fetal microcephaly and other birth defects, and warn that local outbreaks in the United States are possible. Symptoms of Zika include fever, rash, joint pain, and conjunctivitis. CDC recommends RT-PCR testing during approximately the first 7 days of symptoms onset for certain patients. A negative result does not preclude infection, and additional serological testing to evaluate the body’s immune response to infection may be considered within 2–12 weeks after symptom onset.
Complementing its new molecular Zika test service, Quest Diagnostics plans to offer serological testing capabilities that have received EUA from FDA.
The EUA is the second that Focus Diagnostics has received for an emerging infectious disease diagnostic test. In 2009, the company was granted the first EUA for a commercial lab test for the 2009 H1N1 influenza pandemic virus.
Focus Diagnostics includes reference laboratory and product manufacturing businesses. Quest expects to complete the sale of the product manufacturing business to Diasorin in the second quarter of 2016, but will continue to wholly own the Focus reference laboratory business that developed the Zika RT-PCR test, as well as intellectual property related to the test.
The test has not been FDA cleared or approved.
For more information, visit Quest Diagnostics.