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.
You may also be interested in...
California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits
The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.
Kenvue Breaks Ground On New Headquarters, Appoints Chief Corporate Affairs Officer
Firm hosts groundbreaking for 290,000 square-foot global headquarters it’s having built in Summit, NJ, starting with 100,000 square-foot science and innovation and expected to open in 2025. It announced adding Russell Dyer as chief corporate affairs officer starting 13 March.
Xaira Launches With $1bn-Plus And End-To-End AI Strategy
ARCH and Foresite incubated the company and recruited Genentech R&D veteran Marc Tessier-Lavigne to keep data generation, machine learning research and drug development under one roof.