BIVDA has issued a Press Release on the MHRA's decision to grant exceptional use authorisation for NHS Test and Trace's self-testing device.  BIVDA Chief Operating Officer – Helen Dent said; “We welcome the exceptional use authorisation for this self-test device to be used as part of the wider strategy to test for and control COVID-19, but emphasise that this is part of the solution and other methods and laboratory tests remain vital. This technology has a...

A short statement has been released by BIVDA’s Chief Operating Officer Helen Dent on the COVID-19 border closures.  Helen said; “Similarly to pharmaceutical companies, BIVDA members have planned contingencies in place for border emergencies in line with business continuity planning, which includes buffer stock and the ability to re-route supplies. Therefore, the provision of Diagnostic testing supplies will continue. We continue to monitor events and suppliers are working w...

LEX Diagnostics is developing a point-of-care PCR platform that is a major improvement in speed, cost and ease-of-use over all existing molecular diagnostics in the market today. Originally designed as an influenza & RSV platform specifically for use in primary care, LEX is playing its part in getting us through the current Covid pandemic with a combined flu/Covid test providing an answer in around 5 minutes – even for low viral load samples. The entire process from swab elution throug...

New Oxford AHSN study demonstrates how primary care point-of-care testing can avoid unnecessary hospital admissions and improve patient pathways

Alpha Laboratories Ltd. (Eastleigh, UK) and shuttlepac Ltd. (Telford, UK) are delighted to announce that they have established an exclusive distribution partnership, in the UK and Ireland, that will bring new developments in UN3373 sample packaging solutions.

New COVID-SeroKlir SARS-CoV-2 IgG antibody test kit is one of first to detect both the presence and precise levels of COVID-19 neutralizing antibodies

TÜV SÜD Product Service has issued their first In Vitro Medical Device Regulation (IVDR) certificate since receiving notification in June 2020 – and the first IVDR certificate worldwide. The IVDR, which came into force in May 2017, must be implemented by late May 2022.

 BIVDA Chief Executive Doris-Ann Williams has welcomed the confirmation of the first COVID-19 vaccine to be approved by British regulators. Doris-Ann said; “We are delighted that the MHRA have approved the Pfizer/BioNTech coronavirus vaccine for widespread use, meaning it can start its roll out from next week. On behalf of BIVDA and the in vitro diagnostics sector, I would like to congratulate all those involved in this incredible scientific achievement.  An effective v...

Controlled Drug Denature Kits

BIVDA Chief Executive Doris-Ann Williams has commented on the launch of the Medicines and Diagnostic Manufacturing Transformation Fund. “We welcome the announcement of the Medicines and Diagnostic Manufacturing Transformation Fund by the Prime Minister today.  The lessons the country has learned during this difficult year in pandemic response must not be forgotten, and the innovations should be used to improve our diagnostic testing system for non-COVID illnesses including cancer...