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In order to make the labeling change, the agency reviewed retrospective data from seven clinical trials. But this is the exception, according to one official from a diagnostic company who believes FDA's lengthy deliberations have further nudged drug companies to advance diagnostics at the same time as therapeutics in prospective studies.

Navigenics has lowered the price of its full genetic screening service, Health Compass, from $2,500 to $999.

With the ultimate goal of genotyping 100,000 individuals and following them over time, the Center for Applied Genomics at the Children's Hospital of Philadelphia hopes to use its database not only to better inform its own research, but to make eventually all its data available to the public.

The FDA has updated the drugs' labels to note that "retrospective analyses of metastatic colorectal cancer trials have not shown a treatment benefit for the EGFR inhibitors in patients whose tumors had KRAS mutations in codon 12 or 13" and that the use of the drugs is not recommended for the treatment of colorectal cancer patients with these mutations.

Health Canada granted a marketing license for DxS' TheraScreen: K-RAS Mutation Kit as a companion diagnostic for Amgen's colorectal cancer therapy panitumumab (Vectibix).

Decode's shares will return the Nasdaq Global Market just a few months after it was in danger of being delisted from the Capital Market.

The suit, filed by the UI Research Foundation, claims that Abbott has infringed one or more claims of the patents by manufacturing its billion-dollar blockbuster monoclonal antibody Humira, which is used to treat a variety of autoimmune diseases.

A California bill, sponsored by 23andMe, would essentially exempt certain personal genomics firms from having to meet CLIA standards, but would create new requirements for the nascent industry. Privacy groups and members of the personalized medicine community are concerned that the bill doesn't go far enough to protect consumers' genetic information or ensure the accuracy of these tests.

Navigenics' $2,500 Health Compass service, launched in 2007 to screen for the genetic risk of 23 conditions, now screens for 28 conditions. The company also added new SNPs to its service to improve risk screening for various conditions it already tested for, such as Alzheimer's disease.

The company will offer its service for $48,000 through a physician, and will conduct the sequencing at its newly CLIA-certified laboratory in San Diego. Illumina has teamed up with 23andMe, Navigenics, Decode Genetics, and Knome to interpret the data.

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