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Coriell Informs Handful of Participants of Delays in Risk Results Due to Faulty Reagent

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By Turna Ray

The Coriell Personalized Medicine Collaborative recently informed a small number of study participants that delays in their personalized risk results were caused by a faulty component in the processing kit that analyzes saliva samples.

Courtney Sill, director of communications at Coriell Institute, told Pharmacogenomics Reporter this week that the problem was with a reagent involved in processing samples and only six study participants will experience a delay in receiving results. Sill did not identify the type of reagent that caused the problem.

CPMC informed these participants of the problem and apologized for the delay in providing results via e-mail this week.

"We e-mailed those study participants because we are here as the transparent research study," Sill said. "We are the study that wants to figure out best practices, and work with all the experts that are necessary."

The CPMC has previously said it is working with the US Food and Drug Administration to figure out how to best present genetic risk information to the public in a responsible manner [see PGx Reporter 06-17-2009].

According to the CPMC, the faulty reagent affected operations not just at Coriell's facilities but at a number of labs around the nation. Sill noted that the reagent has been replaced and the processing of participants' samples have now resumed. The reagent problem did not affect participants' samples or the quality of personalized risk results, the CPMC emphasized.

Study participants will be informed via e-mail when their results are ready for viewing. According to Sill, CPMC expects to release the results within the next month.

In February the CPMC launched a web portal through which participants can answer questions about their family medical history and personal lifestyle. Factoring this information along with individuals' genotypes, CPMC will provide study participants with their risk for various actionable medical conditions, approved by its Informed Cohort Oversight Board.

Enrollees were scheduled to receive their personalized risk information through the web portal by the second quarter of 2009, the CPMC states on its web site.

CPMC was launched in December 2007 with the aim of studying the impact of genome-informed treatment on medical care. The project has so far enrolled 4,000 participants, and is hoping to meet its goal of enrolling 10,000 participants by 2010.

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