Scope of Quality Management System extended.
25th July 2016
Abingdon Health announces the registration of its manufacturing facilities as GMP compliant, with the U.S. Food and Drug Administration (FDA), for the design, development and manufacture of lateral flow devices, and device readers for in vitro diagnostic medical use.
In addition, the Company’s Quality Management System certification encompassing ISO 9001:2008, ISO 13485:2003 and ISO 13485:2012, has been further extended to cover the design, development and manufacture of lateral flow devices, ELISA kits, reagents and device readers for in vitro diagnostic medical use.
The first product to benefit from this enhanced regulatory environment is the newly available lateral flow immunoassay reader – ADxLR5® which is now registered with the FDA and CE marked as a Class 1 Medical Device. The ADxLR5® has been developed as a next generation technology designed to offer the user the most up to date features required for the most complex quantitative lateral flow applications as well as the benefit of touch screen technology, barcode scanning and enhanced connectivity features.
The launch of the ADxLR5® will support the growth and expansion of the Abingdon Health multiple myeloma assays: Seralite®-FLC serum and Seralite®-FLC urine. In addition, the ADxLR5® will also be provided as an OEM reader solution for those customers wishing to have a bespoke reader developed alongside the development of lateral flow assays. Using their core expertise Abingdon Health are now able to offer the complete solution to OEM customers to deliver lateral flow assays and customised state of the art readers suitable for sale in USA, European and other markets.
Marsha Leeman, Quality and Regulatory Affairs Director said “The registration of our manufacturing facilities as GMP compliant reaffirms Abingdon Health’s commitment to making the groups Quality Management system integral to the company’s core business principles both for our own assays and also for our OEM customers”
Fiona Kilvington, Head of Sales and Marketing, said: “The availability of the ADxLR5® Reader for our customers will provide improved connectivity and traceability features with unique icon driven software providing workflow solutions for our own assays: Seralite®-FLC serum and Seralite®-FLC urine. Furthermore, we understand that this is an important solution for our OEM customers and GMP compliance will enable the development of lateral flow assays and reader solutions suitable for the USA market.”
Enquiries:
Abingdon Health Ltd +44 1904 406 082
Chris Yates CEO
Fiona Kilvington, Head of Sales and Marketing
About Abingdon Health – www.abingdonhealth.com
Abingdon Health Ltd is a UK-based in-vitro diagnostic group focused on developing a range of rapid testing products in the area of haematology-oncology. The Company launched its first rapid testing product in 2016, Seralite®– FLC, a rapid diagnostic device in multiple myeloma, and is in the process of launching a range of complementary rapid tests.
The Company’s core expertise lies in the development, manufacturing and commercialisation of rapid lateral flow immunoassay diagnostics and reader systems. To support its strategic plan Abingdon is currently working with its partner Sumitomo Chemical Co., Ltd on the development of a multiplexed immunoassay system for the rapid testing market. This device uses printed electronics technology-based components for versatile and quantitative optical detection in a portable and disposable format.