Gen-Probe suffers US setback for fully automated NAT (Nucleic Acid Test) blood screening tech
This article was originally published in Clinica
Executive Summary
Shares in Gen-Probe fell by almost 10% last week after the US FDA decided not to approve what could have been the first fully automated, high-throughput nucleic acid test (NAT) system for blood screening in the US. Moreover, the company's failure to gain 510(k) marketing clearance for its Procleix TIGRIS laboratory system for screening donated blood samples meant that it also forfeited, temporarily, on a $10m milestone payout from marketing partner Chiron.