Stockholm, Sweden – April 12, 2021 - iCellate Medical AB, a Swedish cancer diagnostics company receives news of Swedac’s decision to certify according to ISO 15189:2012, Medical laboratories – Requirements for quality and competence. iCellate’s certification indicates that the company has demonstrated a high standard of quality in its laboratory work and that the company can now move forward with offering its services to the public healthcare system.
iCellate is continuously committed to the improvement of the quality of its services. The company now has something to show for it: Swedacs certification symbol can now be found on iCellate’s website and clinical reports.
- It is an essential milestone for our work to achieve this goal, says Francisca Lameiras, Quality Director. It is very validating to have the authorities confirm that we meet their expectations.
Swedac’s decision to award ISO 15189 certification is grounded in a thorough investigation of iCellate’s quality system and its service GeneMate® – a test for hereditary cancer risk. The ISO standard demands that the laboratory continuously maintain a high-quality operation, the right competencies and continued education of its employees, and a robust and correctly documented process. It follows that high demands are placed on suppliers, IT security, and management.
- We see this as an important step in our work to deliver high-quality genomic services, says CEO Pelle Redare. We believe that this will open doors not only commercially, but even within the continued research and development of precision medicine, which we see as a major opportunity.
With this decision, iCellate becomes one of just six private companies in Sweden to hold an ISO 15189 certification, alongside Unilabs and Synlab. iCellate is the only ISO 15189-certified laboratory within cancer genomics in Sweden.
About iCellate Medical
iCellate is a spin-off of the Karolinska Institute in Sweden. The life-science company is headquartered in Solna where all of its cancer diagnostic services are performed. iCellate has been the recipient of several awards and research grants from, among others, Roche, Eurostars, Vinnova, and Horizon 2020.
View the press release here.