Roche's Ebola Virus Test Could Be Fast-Tracked by FDA

Laboratories who want to handle Ebola samples would have to meet specific safety requirements.

Oct 16, 2014

Roche Holding AG wants their Ebola virus test approved for emergency use in the United States, according to Reuters.

Roland Diggelman, the company’s head of diagnostics, said Roche is in discussions for an emergency use application by the FDA, and that they also filed for CE mark approval by the European Union.

According to the report, it takes about two hours for their test to detect Ebola, and using their Roche LightCycler 480 machine, it is possible to run about 480 samples per day.

Laboratories that want to handle the samples will be required to fulfill specific safety requirements. It was not immediately clear what those safety requirements would be.

Pharmaceutical Innovations Report

Experience a breakthrough in life sciences packaging. Register now!

Triumphs and Challenges in Sustainability

Currently more than half of US drugs are manufactured overseas and only 11% of APIs are produced in the U.S.

FDA Launches PreCheck to Accelerate Domestic Drug Facility Approvals

The two-phase program is designed to expedite the approval of new pharmaceutical manufacturing facilities in the U.S. by providing enhanced regulatory guidance and communication to manufacturers.

Pharmaceutical Packaging Innovations Report Video Interview

Through the Line: Packaging and Processing

Through the Line Podcast: Improving DSCSA Data Exchange Accuracy

2025 Packaging State of the Industry: U.S. Expands, Canada Maintains

Ullrich Mayeski, director of customer success- healthcare GS1 US shares why supply chain visibility is more critical now than ever before.

Why Is Supply Chain Visibility and Transparency More Critical Now Than Ever Before?

Medical Device Innovations Report

Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.

Learn More

Break out of the ordinary: see what’s new in life sciences packaging

At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us this month to experience a breakthrough for life sciences products.