Clinical Diagnostics

Clinical diagnostics are still largely conducted manually. In the case of image interpretation, many studies have demonstrated the high degree of inter and intra-observer variaton which results in problems of accuracy and consistency. These problems, in turn, lead to late or incorrect diagnosis, poor treatment, severe side effects and low patient satisfaction. In addition, the rising amount of image data and the falling number of expert pathologists and radiologists is causing a major bottleneck in both the clinic and in research studies. Finally, critical opportunities to gather valuable insights are lost because human observers only provide qualitative results or a limited number of measurements.

Definiens’ technology can help healthcare service providers to increase the speed and accuracy of image analysis and drive personalized healthcare:

  • Improving the quality and consistency of grading and scoring standards

  • Developing new predictive, prognostic, and companion diagnoses of tissue biopsies, thereby improving patient stratification for targeted therapies

  • Providing accurate 3D volumetric measurements in medical imaging

  • Facilitating the convergence of pathology and radiology, supporting the development of translational research

In pathology, Definiens is successfully being used to analyze H&E, IHC, and ISH stains. There is strong evidence that multiplexing yields better predictive and prognostic insight. Similarly, studies in medical imaging reveal that 3D volumetric measurement of tumor lesions and lymph nodes is more sensitive than the existing RECIST standard.

Customers and partners are deploying Definiens’ technology for diagnostic decision support. These include commercial Clinical Laboratory Improvement Amendments (CLIA) laboratories analyzing thousands of tissue samples per day and medical system providers selling integrated imaging solutions based on Definiens.

Quality Assurance

Definiens products are developed and manufactured using a quality management system subject to the requirements of DIN EN ISO 9001:2008, DIN EN ISO 13485:2007, MDD 93/42/EEC Annex II, and IVDD 98/79/EC (depending on the respective product and legal requirements).

This allows Definiens’ customers and partners to validate new diagnostic solutions in a CLIA or a 510(k) certified environment.