For sponsors requiring support for DNA extractions, we have developed procedures that produce high quality and high yield DNA. ICON Central Laboratories offers two methods for DNA extractions.

Our primary method of extraction is a modified salt precipitation method. This method produces an average yield of 229 µ of DNA and a concentration of 489 µ/ml of DNA. The quality of material rendered from this extraction process is acceptable for PCR, Southern blotting and sequencing downstream testing.

For frozen, archived or older samples, in which DNA extraction can prove more challenging, we utilise GeneCatcher™ technology. This method facilitates rapid and efficient extraction of genomic DNA from blood without the use of centrifugation. Purified DNA extracted using this method is appropriate for the most sensitive downstream applications, including PCR and restriction enzyme digestion.

Upon request, ICON Central Laboratories will send our extracted material to the client’s selected pharmacogenomic laboratory to ensure that the extraction material meets study specific clinical requirements.

Our laboratories also extract high quality RNA with an average yield of 6-10 µ of total RNA, depending upon the source of extracted material. This material is well suited for downstream applications such as Northern analysis, RT-PCR and Gene Chip Sequencing. We utilise the BioRobot Universal System for RNA extractions. This fully automated method utilises a 96-well format and facilitates extraction of highly pure RNA. The material is then quantified on the SpectraMax® Plus. We use the Agilent Bioanalyzer® to determine the quality of the extracted material.

ICON Central Laboratories offers the following sample storage facilities in our wholly-owned laboratories in North America, Europe, Singapore and India:

The Sample Management Department at ICON Central Laboratories has its own team of data coordinators who are responsible for identifying and resolving any missing or discrepant information related to the samples. Our Sample Management Department utilises full Chain of Custody procedures to ensure that the status and location of each specimen are known and documented from the time it is received until its final disposition for the study.

The Challenge: A large, Massachusetts-based biotechnology company often had to wait months to years to lock the PK portion of a study database.

The Solution: By working with ICON Laboratories, they were able to design a PK process flow that would benefit their clinical and data departments, as well as the investigator sites and the CRAs working with those sites. The result of this collaborative effort? The sponsor has been able to perform up to 70 studies a year, many of which are highly PK intensive, and bring every one of them to database lock on time - locking both the clinical and the PK database simultaneously.