U.S. FDA Approves "Vstrip", IVD for Rapid Diagnosis of H. pylori Infection
Germantown, MD, USA (April 19, 2019) – Amarex Clinical Research, LLC learned that, on March 14, 2019, the US FDA approved a new rapid in vitro diagnostic (IVD) kit, Vstrip, for detection of H. pylori infection. Vstrip is a single use immunochromatographic assay for the qualitative detection of H. pylori antigens developed and produced by Panion & BF Biotech Inc. (PBF), a Taiwan-based biopharmaceutical company. This product successfully completed clinical trials at several medical research centers and sites in the United States and Taiwan, and the data proved to be consistent with the comparator and gold standard.
Amarex’s clinical team designed the trials and managed clinical performance of the studies in the U.S. and Taiwan. In addition, Amarex’s biometrics and regulatory departments worked together on the data analysis and the preparation of the 510(k) application. The President & CEO of Amarex Clinical Research, Dr. Kazem Kazempour stated that, “We worked closely with our client to initiate this development by completing a pre-submission meeting with the U.S. FDA last July, and by adhering to FDA recommendations. As a result, the 510(k) studies preparation and approval application were finished within five months, leading to Vstrip’s rapid 510(k) approval. This accomplishment demonstrates Amarex’s capacity for successful collaboration and highlights our strength in product development.”
Currently, a large U.S. IVD kit manufacturer has developed a similar product with a market value of $60 million. Compared to the available products on the US market, Vstrip enhances the convenience of usage and increases its competitiveness. The approved Vstrip can now be used for clinical applications, in addition to research uses. PBF is looking for U.S. distribution partners to sell the IVD in the U.S. market.
About Panion & BF Biotech Inc.
Panion & BF Tech Inc. is a Taiwan-based biopharmaceutical company focused on three core businesses: Pharmaceuticals, Cosmeceuticals, and Nutraceuticals.
About Amarex Clinical Research
Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services. For more information visit www.amarexcro.com.
Book a meeting or send us a message to talk to one of our experts.