At Congenica the quality of our software and the insights that it provides for patients is paramount.
What does this mean for my lab?
Using Congenica for clinical diagnosis means more life-changing answers for patients with rare or inherited genetic disorders.
As a CE Marked In Vitro Diagnostic (IVD), you can now use Congenica for the clinical diagnosis of patients with rare or hereditary genomic disorders.
On average, laboratories analysing genetic data with Congenica achieve a 30% higher diagnostic yield in heterogeneous rare disease cases compared to their previous clinical workflows.
Why is quality important?
Regulatory compliance is essential for patient safety and the effective application of genomic medicine for clinical use.
Congenica is now the only CE Marked IVD software for clinical diagnosis of rare and inherited genetic disorders that is available globally in both cloud and on-premise deployments and can fully integrate with your systems for seamless transfer of patient data and reports.
This enables you to use Congenica for diagnosing heritable genetic diseases as part of routine medical care.
”Obtaining the CE mark is testament to the quality of Congenica’s software platform. As the regulatory landscape continues to evolve, we are committed to remaining ahead of the game with regards to meeting the strong requirements in our industry.Jonathan DaySenior Director of Regulatory Affairs and Quality Assurance, Congenica