The AdnaGen system for isolation and detection of CTC is called AdnaTest and is presently CE-certified for diagnostic use for breast, colon and prostate cancer within Europe.  The Company's tumor diagnostics are complete kits consisting of reagents for immunomagnetic selection, mRNA isolation and multiplex RT-PCR, and can be performed on standard technology platforms.  The products have high analytical sensitivity (2 cells in 5 ml blood) and high specificity (>90%) achieved through the combination of multi-marker tumor cell enrichment and multiplex gene expression profiling. The whole procedure is divided into two main steps, Select and Detect:

1.       Select

In this first step, tumor cells are enriched from peripheral blood of cancer patients by means of antibody-linked magnetic particles in vitro. The antibody combination has been particularly adapted to the respective type of tumor. Subsequently, the RNA is isolated from the selected tumor cells.

2.       Detect

The isolated RNA is purified to mRNA and transcribed into cDNA and a multiplex PCR for the detection of tumor associated gene expression is carried out. Due to the combination of different selection and tumor markers, both the heterogeneity of the tumor cells and possible individual or therapy induced deviations in the expression patterns are taken into account.

Expanded detection andanalysis

All the AdnaTest kits are standardized and use a predetermined set of markers to detect CTC. These markers have all been carefully selected to maximize the probability of finding CTC in a sample and there is a growing body of scientific literature and publications based on these kits, which makes comparisons between studies relatively easy. In certain cases though, the predetermined markers are not enough and more genes need to be tested.

Tataa Biocenter can offer expanded detection and analysis services where AdnaTest CancerSelect is used for the CTC isolation, while the detection is performed by Tataa using custom designed probes and assays based on the customers need.