Author: edinburghgenetics

Regulatory Approval in Argentina

Edinburgh Genetics is pleased to announce that our immunoassay products have received regulatory approval by Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Food and Medical Technology) in Argentina.  ‘We are grateful for the work our local partners and the ministry in Argentina have done to improve local access to high […]

Regulatory approval in India

Edinburgh Genetics is pleased to announce that our immunoassay products have received regulatory approval in India. The Indian Council of Medical Research (ICMR) validated 600 tests with highly encouraging results. “We are grateful for the hard work our local partners have done to make this happen. We believe our easy to use and cost-effective products […]

Edinburgh Genetics COVID Antigen Rapid Diagnostic Test

At Edinburgh Genetics, we have been working on developing a COVID antigen rapid diagnostic test that can accurately detect active infection in under 20 minutes with no instrument required. A preliminary validation study involving 42 positive samples and 143 negative samples yielded sensitivity of 88.1% and specificity of 100% with no cross-reactivity with Human coronavirus […]

ISO 13485 Quality Management Audit

After a busy couple weeks at our quality and regulatory team, we have passed with flying colours in our annual ISO 13485 audit, the medical device industry’s most widely recognised quality management standard globally. ‘At Edinburgh Genetics, we constantly work to maintain a robust quality management system. I want to thank our quality and regulatory […]

Donation to a local charity

Edinburgh Genetics is pleased to donate COVID test kits to Autism Anglia, an independent charity which provides care and support to autistic children, adults and their families in East Anglia. ‘As a UK company working globally, we are always keen to support local charities serving those within our communities. We want to ensure that vulnerable children […]

Regulatory approval in Peru

Edinburgh Genetics is pleased to announce that our COVID immunoassay products have received regulatory approval by the Ministerio de Salud in Peru. ‘We are grateful for the work our local partners and the ministry in Peru have done over the past couple months to improve local access to high quality COVID testing products. The approval […]

COFEPRIS Approval in Mexico

On June 11th, the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) of Mexico issued an approval for the Edinburgh Genetics COVID-19 Immunoassay Antibodies Testing Kits, a high precision, rapid diagnostic test that enables the qualitative detection of novel coronavirus 2019-nCoV IgM/IgG antibodies. After a rigorous evaluation process involving 1,500 samples, COFEPRIS selected Edinburgh […]