Along with an urgent public health challenge, the outbreak of the novel 2019-nCoV coronavirus in Wuhan, China, first reported on Dec. 31, has created a strategic opportunity for makers of lab tests. Lab and diagnostic companies around the globe scrambling to develop and commercialize products capable of rapid and effective 2019-nCoV detection. Here’s a look at the current situation and who might be poised to win the race to market. The CDC Test Because the 2019-nCoV virus is so new, there are no FDA-approved commercial products for it in the US. As it has in responding to previous infectious disease outbreaks, the FDA has called on test makers to seek expedited clearance of investigational products via the Emergency Use Authorization (EUA) pathway. In the meantime, the only test for 2019-nCoV available in the US is the reverse transcriptase real-time PCR (rRT-PCR) assay developed assay Centers for Disease Control and Prevention for respiratory and blood serum samples. On Jan. 27, the CDC published the test formula and announced that it’s using the assay to create kits for distribution to state health departments and public health labs in the next few weeks. Meanwhile, CDC labs are testing all reported US cases in […]