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Privacy Groups Challenge Calif. Bill Pushing Regulatory Exemptions for 'Post-CLIA Bioinformatics Services'

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.

Monogram Acquisition Bolsters LabCorp's PGx Test Portfolio, Companion Dx Know-how

LabCorp's $107 million offer to acquire Monogram gives it access to molecular diagnostics and pharmacogenomic tests that are clinically validated and are free of regulatory challenges. Although Monogram wasn't looking to be acquired, the deal would allow broader marketing of its tests by using LabCorp's national infrastructure.

DxS Hoping to Invite Companion Dx Opportunities by Developing Blood-based Genetic Tests with Exosome

Under the partnership announced this week, DxS' RT-PCR technology will be joined with Exosome Dx's xOSO technology — which collects nucleic acids from blood exosomes — to develop blood-based companion diagnostics for detecting cancer gene mutations.

Pairings

Anat Cohen-Dayag, Martin Gerstel

FDA Updates Plavix Label with PGx Data, but Does Not Provide Dosing Recommendations

Without PGx-guided dosing information, it is unclear whether genetic testing to gauge Plavix response will go the same way as genetic testing for warfarin. At least one national insurer, Aetna, feels that the FDA did not provide enough information in the updated label to warrant coverage for the intervention.

Eyeing 10K Enrollees by 2010, Coriell Institute Refines Personalized Med Portal for End Users

A Coriell Institute official said that the personalized medicine project has so far enrolled 4,000 participants, and at this rate is hoping to meet its goal of 10,000 participants by 2010.

Q&A: Boyd Discusses How Fox Chase Plans to 'Operationalize' Personalized Medicine

Jeff Boyd, Fox Chase's chief scientific officer, shared with Pharmacogenomics Reporter the center's plans to leverage its biorepositories and Phase I clinical trial expertise to woo pharma companies and advance personalized cancer drugs.

Navigenics Adds New Health Conditions to Health Compass

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.

AHRQ Report Finds 'Insufficient Evidence' Supporting Genetic Testing To Prevent Deep-Vein Thrombosis

The authors of the report recommend conducting randomized trials with "sufficiently large sample sizes and long-term follow-up," in addition to other types of research to determine whether genetic testing in patients with a history of blood clots improves outcomes and whether physicians should alter current treatment practices to adopt genetic testing for the prevention of deep-vein thrombosis.

Pairings

Ron Long

New Releases

Clarient's EGFR Mutation Test

Illumina's New DTC Sequencing Service Addresses Ethical Quandary by Requiring Prescription

Unlike most DTC genomic-firms, which allow customers to order gene scans over the Internet and receive sample collection kits in the mail, Illumina’s service will require a prescription from their doctor or from a physician in its Personal Genome Network.