Posted: 14th May 2019
Seralite®– FLC Serum granted registration by the Brazilian Health Regulatory Agency (ANVISA)
Abingdon Health is pleased to announce Seralite® – FLC Serum has been granted registration by the Brazilian Health Regulatory Agency (ANVISA)
Seralite® – FLC is a rapid lateral flow test for the quantitative measurement of kappa (K) and lambda (λ) immunoglobulin free light chains (FLCs) in serum. The format of this rapid test enables a free light chain service to be offered in all clinical laboratories. This enables the provision of FLC results in ~10 minutes rather than days or weeks. With this simple to use, compact, rapid test, clinicians are able to monitor patients in “real time” supporting faster decision making.
This is a key registration for Seralite® – FLC and underpins the regional strategy for Latin America. In conjunction with Seralite® – FLC Serum, Seralite® – FLC LFD Controls and the ADxLR5® Reader System have also been granted registration. Latin America has a population of 606 million people and with a market size of more than US$2.4bn is a key emerging IVD market.
With this registration in Brazil, Seralite® – FLC is now available in 73 countries worldwide. Seralite® – FLC is distributed globally (with the exception of Benelux), by Sebia, the world leader in medical diagnostics for electrophoresis.
Fiona Smith, Sales and Marketing Director, Abingdon Health commented;
“The registration of Seralite® – FLC in Brazil is a milestone registration in South America and supports the global expansion Seralite® – FLC. Our aim is to make free light chain testing available to all clinical laboratories in all areas of the world thus improving patient access to this important diagnostic and monitoring tool for Multiple Myeloma.”
About Abingdon Health
Abingdon is a UK-based developer and manufacturer of lateral flow immunoassay tests and readers.
Abingdon offers development and manufacturing services for customers looking to develop new assays or looking to transfer existing laboratory-based assays to a lateral flow format. Abingdon takes projects from initial concept through to routine and large-scale manufacturing. Abingdon’s patented lateral flow reader, the ADxLR5®, is CE marked and FDA registered and can be fully customised to meet the needs of clients looking for a quantitative solution for a lateral flow assay. Internally Abingdon is focused on developing lateral flow assays in partnership with key opinion leaders that meet significant unmet needs.
In January 2019 Abingdon closed a growth capital funding round NPIF – Mercia Equity Finance, which is managed by Mercia Fund Managers and part of the Northern Powerhouse Investment Fund.
Abingdon is headquartered in York, England.
© Abingdon Health 2019