We are looking for a QA/RA Director. Position requires fluent Finnish.
Toimintamme voimakkaasti kasvaessa etsimme joukkoomme laatu- ja regulaatiojohtajaa.
Abacus Diagnostica has developed a SARS-CoV-2 Variants of Concern (VoC) Assay for the GenomEra® CDX platform. In addition to detecting all SARS-CoV-2 strains, the new test detects clinically significant deletions present in the variants first identified in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1). The test is now available as a Research Use Only -product.
For inquiries, please contact firstname.lastname@example.org
We are hiring. Apply by 8th of November 2020.
GenomEra SARS-CoV-2 Assay Kit is now CE IVD approved and development for four-in-one test (FluA, FluB, RSV, SARS-CoV-2) is on-going
GenomEra SARS-CoV-2 Assay Kit is now CE IVD approved and available. Please contact your local distributor or us for more information.
In addition, we are developing a four-in-one test for detecting influenza A, influenza B, RSV and SARS-CoV-2. Targeted release is before winter Flu season 2020-2021.
Finnish regulatory authority Fimea has granted special approval for Abacus to supply the GenomEra RUO SARS-CoV-2 test to Finnish markets.
Press release in Finnish
Our team has been working hard on past weeks and today we shipped first GenomEra SARS-CoV-2 test kits for our customers.
Press-release in Finnish: https://bit.ly/2UvaMC2
Recent publication: GenomEra C. difficile test demonstrates increased reliability for standalone molecular diagnostics
While covid19 is spreading, there are still other worries to deal with. Standalone PCR testing for C. difficile diagnostics is often criticized for overdiagnosis of CDI. In a recent publication (doi:10.1128/JCM.01872-19) GenomEra routine samples were retested with two different toxin immunoassays and discrepant results were confirmed with culture or GeneXpert. Results shows perfect 100% PPV and excellent 99.7% NPV for GenomEra. Study reports insufficient sensitivities of 81.6% and 71.7% for two different toxin immunoassay from ArcDia and TechLab, respectively.
We are proud to announce our new distributor:
-NexGen Molecular Supplies, South Africa.