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23andMe Recruiting for Disease Risk Trials

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Personal genetics company 23andMe launched a new online effort in late May to recruit its customers to participate in studies trying to shed additional light on genetic predispositions for certain diseases and adverse drug reactions.

The initiative, called 23andWe, aims to improve the quality of patient data that enter pharmacogenomic-based clinical trials organized by 23andMe; advance the development of tailored drugs; and encourage regulators and medical groups to use genetic information in their medical decision making.

"By directly involving 23andMe customers in the company's research projects, the goal is to conduct large-scale studies powered by a Web-based community of diverse individuals who are willing to share information (on a confidential basis) about their health and other personal traits," the company said in a statement.

The research agenda for 23andWe will be established as 23andMe evaluates proposals submitted to the company. After a proposal is approved, 23andMe researchers will gather phenotypic information from volunteering customers through online surveys. Once they compile these, the researchers will analyze them to determine the genetic underpinnings for certain diseases.

According to the company, all 23andMe customers can participate in the project by filling out the online surveys, and in exchange will have access to the same services offered under the personal genomics program. These give customers the ability to compare their genome to those of populations around the globe, home in on particular genes to learn about their associations to certain traits, trace different inheritance traits, and learn about various genes' associations with certain diseases.

The first 23andWe project will focus on Parkinson's disease through a partnership with the Parkinson's Institute of Sunnyvale in California. The project plans to use Web-based communities to recruit patients for clinical research.

Turna Ray

PGx & Molecular Dx Notes

Invitrogen received US Food and Drug Administration clearance for its new DynaChip Antibody Analysis System, an HLA-based transplant diagnostics system.

AdvanDx filed for 510(k) clearance from FDA for its test for five infectious types of Candida in blood cells. The tool uses an in situ hybridization assay to target species-specific rRNA.

DNAVision will offer Ipsogen's MapQuant Dx Genomic Grade test, a gene expression-based molec-ular diagnostic that measures tumor grade, risk of metastasis, and chemotherapy response in breast cancer patients.

This fall, Duke's Institute for Genome Sciences and Policy will launch a Phase IIb trial of pharmacogenomic-based prognostic model for the treatment of non-small cell lung cancer.

Datapoint

900
More than 900 researchers at Dana-Farber will use HistoRx's biomarker profiling tool in cancer research.

Funded Grants

$193,500/FY2007
Evaluating the Cost Effectiveness of Alternative Sample Designs for Genetic Association Studies
Grantee: Nathan Tintle, Hope College
Began: May 1, 2008; Ends: Apr. 30, 2010

Tintle and colleagues will look at various sample designs for genetic association studies, with the goal of maximizing statistical power for testing genotype-phenotype association. Getting more bang for the buck would allow researchers to quickly and efficiently identify genetic variants predisposing individuals to complex human diseases.

$173,813/FY2007
Prostate Fusion Gene Variants as a Cancer Biomarker
Grantee: Yu-Tsueng Liu, University of California, San Diego
Began: Apr. 1, 2008; Ends: Mar. 31, 2010

Liu's group has established a microarray-based assay to screen fusion variants for the TMPRSS2:ERG gene, in which genomic rearrangement is associated with prostate cancer. Liu believes that TMPRSS2:ERG can be used as a biomarker, and that identifying the specific fusion junction can be used for designing quantitative PCR assays to assess tumor load in urine and blood.

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