Why Invitae Stock Popped Today
Shares of Invitae (NYSE: NVTA) roared as much as 37% higher early Monday, then settled to trade up 13% as of 3 p.m. ET after the U.S Food and Drug Administration (FDA) authorized marketing efforts by Invitae for its groundbreaking gene-based test for cancer risk.
In a press release dated Friday, Sept. 29, the FDA announced it has granted De Novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that evaluates DNA extracted from a blood sample to detect hundreds of genetic variants associated with an elevated risk for developing certain cancers. The test was reviewed under the FDA's De Novo premarket review pathway -- a regulatory path for low- to moderate-risk devices of a new type -- and is the first of its kind to be granted FDA marketing authorization.
This is an obvious win for Invitae as it seeks to continue expanding the reach and utilization of its various hereditary cancer panel offerings. But the company still has plenty of work to do; during its most recent earnings conference call in August, Invitae management cited a recent study showing that of 1 million patients diagnosed with cancer in California and Georgia, around 93% did not receive hereditary cancer testing despite guidelines endorsing universal germline testing for several tumor types.
Source Fool.com
