Quest Diagnostics joins the growing number of firms that have developed tests for the coronavirus (COVID-19) in recent weeks.
The Secaucus, NJ-based company said it was launching its COVID-19 test service that aids in the presumptive detection of nucleic acid in respiratory specimens of patients meeting Centers for Disease Control and Prevention clinical criteria. The diagnostics firm said its test is a molecular-based assay that detects viral RNA in respiratory specimens.
Quest said it will be in a position to receive specimens for testing and begin to provide testing Monday, March 9. The company said the new test service will be provided as a laboratory-developed test, pending review by FDA under emergency use authorization (EUA) which the company will submit per the agency’s guidance within 15 days of clinical testing.
"In times of national health crises, quality laboratory testing is absolutely, critical to mobilizing effective public health response," Steve Rusckowski chairman, president and CEO, Quest Diagnostics, said in a release. "Quest's national scale, diagnostic expertise and innovation, and relationships with half the country's physicians and health systems is a vital complement to the efforts of the CDC and other public health labs to contend with a growing number of suspected COVID-19 cases in the U.S. We applaud FDA for providing the flexibility for innovative, quality lab-developed tests to be brought to patients and providers quickly to advance effective response to the coronavirus outbreak."
COVID-19 was identified in the Chinese city of Wuhan in early January. Right now there are at least 129 confirmed COVID-19 cases and at least 11 deaths in the U.S., according to the CDC. There are about 97,873 cases worldwide with 3,353 deaths, according to worldmeter. The website said notes that 54,121 have recovered.
In recent weeks, there has been a strong response from the industry regarding COVID-19 and MD+DI compiled a list in February of eight specific ways companies and agencies were handling the pandemic.
Qiagen, which is in the process of being acquired by Thermo Fisher Scientific, announced in late February that it had shipped its newly developed QIAstat-Dx Respiratory Panel 2019-nCoV test kit to four hospitals in China. The Venlo, Netherlands-based company said it also sent the test kit to public health institutions in other regions, including Europe, South-East Asia, and the Middle East.
Co-Diagnostics has been at the forefront of detection efforts for the pandemic. There isn’t a day that goes by that the Salt Lake City, UT-based company isn’t in the news for its work against the coronavirus. In late February, the firm received CE mark for the Logix Smart COVID-19 Test.
FDA has also gotten out in front of COVID-19 treatment, containment, and detection efforts . In late January, the agency rolled out a strategy that would see it working with the industry and international partners to expedite the development and availability of medical products needed to diagnose, treat, mitigate, and prevent coronavirus outbreaks.
Nearly a week after FDA unveiled its strategy, the agency issued an emergency use authorization (EUA) for the CDC’s Coronavirus detection test. Up until then, the CDC’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel has only been used at CDC laboratories.