Performance of high quality genotyping in clinical trials requires careful handling of biological specimen, as the source for DNA in successful genetic testing trials. Epidauros has established validated methods for extraction of DNA from different sources, such as:

• Potassium-EDTA Blood Samples
• Lithium-Heparin Blood Cell Pellets
• PAXgene™ DNA Blood System
• Isohelix™ T-Swabs (Buccal Swabs)
• Others
• New Methods can be validated on demand

 

The portfolio of validated methods underlines Epidauros’ solution-driven approach for various customer requirements. Whereas DNA extraction from Potassium-EDTA or Lithium-Heparin blood samples are state-of-the-art techniques, the company has also developed and validated DNA extraction based on alternative sampling methods or procedures as cost-efficient solutions in particular for use in multicenter trials.

 

For example, a reliable Buccal Swab sampling protocol using Isohelix™ T-Swabs (Cell Projects Ltd) has been developed and validated. With this protocol sufficient DNA yields (up to 4 µg human DNA) with high quality can be obtained and there is only a very low risk of unwanted DNA degradation and microbial contamination. DNA extracted from T-Swabs at Epidauros is suitable to obtain high quality genotyping results. Such methodology is ideally applicable for a cost-efficient and fast sampling process because samples can be sent individually at ambient temperature. This is of special interest if screening for specific genetic inclusion or exclusion criteria in multicentre trials is needed. By using T-Swabs, Epidauros was able to realize cost savings of a factor of more than five, by using buccal swab sampling instead of standard blood sampling and dry ice shipments, thus reducing logistical costs.

 

A limitation of buccal swab sampling is the relatively small amount of DNA per swab. The advantage of shipments at ambient temperature combined with large amounts of DNA per sample can be exploited by sampling with the PAXgene™ DNA Blood System (PreAnalytiX GmbH). By using PAXgene™ and cost-efficient shipping procedures high quality DNA can be obtained in large quantities, which makes this approach ideal for biobanking or whole genome association applications.

Epidauros is well prepared to quickly establish new procedures and protocols for sampling and DNA extraction based on specific customer requirements.