27 Aug 2020 07:00
Immunodiagnostic Systems Holdings plc.
27 August 2020
SARS-CoV-2 manufacturing agreement with The Binding Site
Immunodiagnostic Systems Holdings plc (IDS), a specialty solution provider to the clinical laboratory diagnostic market, is pleased to announce that it will provide contract manufacturing services to The Binding Site (TBS) related to their SARS-CoV-2 Antibody ELISA test, which was launched in Europe and other markets which accept the CE mark today. The test has also been submitted for rapid FDA approval.
The antibody coated ELISA microtiter plates for this test will be produced at the IDS facility in Boldon, UK, where IDS has the capacity to provide up to two million tests per month for TBS. The process involves coating the microtiter plates with the trimeric spike protein developed by TBS and the University of Birmingham (UoB). The plates are then washed and stabilized using proprietary IDS reagents.
About the TBS SARS-COV-2 ELISA test
The SARS-CoV-2 Antibody ELISA assay was developed by TBS and UoB, based on an initial antigen provided by the University of Southampton, with a focus on mild, non-hospitalised patient blood samples. The new test specifically detects antibodies to the SARS-CoV-2 trimeric spike protein, which is an important protein for the virus infectivity. Targeting IgG, IgA and IgM antibodies, the assay will cover all the immunoglobulins which are vital in the body's fight against this virus. These three antibodies appear at different times after infection. The test was designed to detect all three, to increase detection at the earliest possible stage after exposure to the virus. The CE-marked ELISA test is simple to use and provides up to 93 test results in 60-90 minutes.
Jaap Stuut, CEO of IDS commented:
"We are delighted that TBS chose IDS to be their manufacturing partner for this unique SARS-CoV-2 ELISA assay. Leveraging our 30-year experience in producing ELISA tests, we worked with the team at TBS to agree, validate and audit the manufacturing processes in record time. We look forward to supporting TBS through the commercialisation of this project"
Charles de Rohan, CEO of TBS commented:
"We are very excited to bring this antibody test to market. It is really important that we are able to meet the potentially high market demand, and we chose IDS as our manufacturing partner to increase capacity and bring more product to market in such a short time. Collaboration is one pillar of our company values and we are delighted, once again, to work closely with one of the best in the business."
About IDS
IDS is a specialist in-vitro diagnostic provider to the clinical laboratory market. IDS develops, manufactures and markets innovative immunoassays and automated immuno-analyser technologies to provide improved diagnostic outcomes for patients. IDS can provide outsourced manufacturing services covering all areas of ELISA / RIA assay manufacture, for clinical and research use.
IDS is headquartered in Boldon, UK, and listed on the Alternative Investment Market of the London Stock Exchange.
About TBS
Founded in 1986 by a group of former researchers based at UOB, The Binding Site (www.bindingsite.com) is today recognised as a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency. Its product range covers immunoglobulins, subclasses, vaccine response and complement. The Binding Site has a direct presence in over 25 countries and product sales through business partners in more than 100 countries.
For further information:
Immunodiagnostic Systems Holdings plc Tel: +44 (0) 191 519 6111
Jaap Stuut, Chief Executive Officer
Paul Martin, Group Finance Director
Peel Hunt LLP Tel: +44 (0) 20 7418 8900
James Steel
Oliver Jackson