MedicQuant: A Danish university spin-out developed a novel point-of-care technology for rapid quantification of Direct Oral Anticoagulants (DOACs).
Generation of analytical and clinical evidence aligned with future regulatory submission requirements and clinical adoption pathways.
ISOCHECKS designed and conducted a clinical study evaluating the utility of ADAMTS13 Open-Close CLIA technology for relapse-risk prediction in immune TTP patients.
Production of clinically meaningful evidence supporting the use of ADAMTS13 testing in patient monitoring and relapse-risk assessment
ISOCHECKS coordinated and designed a comprehensive evaluation programme investigating methodologies used for the diagnosis and monitoring of congenital TTP (cTTP).
Provision of robust clinical evidence demonstrating suitability of multiple methodologies for patient monitoring programmes.
An NHS laboratory in London, Royal Brompton has a long standing project of verifying a full range of specialized coagulation assays on their ACL Top analyzer (Werfen).
Staffing constraints to conduct verification work.
Site referring specialist tests out to another laboratory resulting loss of revenue and delayed turn around times.
ISOCHECKS team delivered a full verification compliant to ISO15189 requirements within 7 days of commencing study.
An NHS laboratory in London, Royal Brompton has a long standing project of verifying a full range of specialized coagulation assays on their ACL Top analyzer (Werfen).
Staffing constraints to conduct verification work.
Site referring specialist tests out to another laboratory resulting loss of revenue and delayed turn around times.
ISOCHECKS team delivered a full verification compliant to ISO15189 requirements within 7 days of commencing study.
Enzyre B.V., The Netherlands a company developing a new novel POCT device to measure ADAMTS13, required clinical relevant sample to conduct feasibility studies.
Sample availability of rare conditions.
Delays in development & investor concerns.
The ISOCHECKS team discussed, planned & delivered a validation pack for a clinical feasibility study together with ETHICS, customs and other regulatory documentation. Assay validations successfully published in JTH.