Olsen D.,Dako Denmark |
Jorgensen J.T.,Dx Rx Institute
Frontiers in Oncology | Year: 2014
Companion diagnostics (CDx) holds the promise of improving the predictability of the oncology drug development process and become an important tool for the oncologist in relation to the choice of treatment for the individual patient. A number of drug-diagnostic co-development programs have already been completed successfully, and in the clinic, the use of several targeted cancer drugs is now guided by a CDx. This central role of the CDx assays has attracted the attention of the regulators, and especially the US Food and Drug Administration has been at the forefront in relation to developing regulatory strategies for CDx and the drug-diagnostic co-development project. For an increasing number of cancer patients the treatment selection will depend on the result generated by a CDx assay, and consequently this type of assay has become critical for the care and safety of the patients. In order to secure that the CDx assays have a high degree of analytical and clinical validity, they must undergo an extensive non-clinical and clinical testing before release for routine patient management. This review will give a brief introduction to some of the scientific and medical challenges related to the CDx development with specific emphasis on the regulatory requirements in different regions of the world. © 2014 Olsen and Jørgensen.
Dako Denmark | Date: 2015-10-14
Dako Denmark | Date: 2014-06-17
A sample processing system that may be automated and methods are disclosed where samples are arranged on a carrier element and a process operation control system automatically processes the samples perhaps robotically with an operationally-influential exteriorly-consequential information monitor or a data capture element. Significant process details as well as operationally-influential exteriorly-consequential information may be monitored and an automatic notice element may cause notification of a person at some display that may be remote. Various people may be notified, such as an administrator, a supplier, or a manufacturer of an opportunity for some action such as reagent reordering or the like. A simulated motion display may be included to watch simulated operation in real time or long after completion of the actual processing.
Dako Denmark | Date: 2015-08-04
Methods and systems for image scoring and analysis are provided. Scored and analyzed images may include digital pathology images. Image scoring and analysis methods may include techniques to identify nuclei and determine membrane staining extent through the use of a priori models. Image scoring and analysis methods may include techniques for membrane intensity determination. Images may be scored based on an extent of membrane staining and membrane intensity.
Dako Denmark | Date: 2014-10-01
An apparatus for processing a biological sample is provided. The biological sample being arranged on a first planar surface of a carrier, the apparatus having a second planar surface arranged substantially parallel to said first planar surface and at a first distance from said first planar surface. The first planar surface and said second planar surface are arranged at an angle (A) greater than zero degree from the horizontal plane (HP). The apparatus having a supply for supplying an amount of a liquid that is to be applied to said biological sample. The first planar surface and said second planar surface are configured to be arranged at a second distance from each other, said second distance being such that said supplied amount of liquid is distributed over said biological sample when said first planar surface and said second planar surface are brought to said second distance from each other.