A new test developed by the US Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses has been cleared by the FDA.
A new test developed by the US Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses has been cleared by the FDA.
The device, called the Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel), uses a molecular biology technique to detect the flu virus and differentiate between seasonal and novel influenza.
The device is used to isolate and amplify viral genetic material present in secretions taken from a patient’s nose or throat. The viral genetic material is labeled with fluorescent molecules, which are then detected and analyzed by a diagnostic instrument called the Applied Biosystems 7500 Fast Dx.
The test panel and diagnostic system can detect and identify commonly circulating human influenza viruses as well as influenza A (H5N1) viruses. Results can be available within four hours and the system can test multiple samples at once.
The test will be available to CDC-qualified laboratories for diagnosing influenza this fall, and some laboratories will be able to obtain reagents (certain substances used in the testing process) at no cost. This test should help ensure the accuracy of influenza testing results among the different qualified laboratories that conduct influenza subtype testing.
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.