The California Department of Public Health (CDPH) is cracking down on companies offering direct-to-consumer (DTC) genetic testing, including such Silicon Valley "personal genomics" startups as 23andMe (Mountain View, Calif.), which promises individuals "deeper insights into personal ancestry, genealogy, and inherited traits" in return for $999 and a saliva sample. In June, CDPH sent notices to 13 laboratories to cease and desist performing genetic testing for California residents until the laboratories meet the requirements specified in state laws.

According to California state law, any laboratory offering genetic tests to California residents must be licensed as a clinical laboratory in California. Additionally, tests must be ordered by a licensed physician and validated. Tests for paternity and genealogy are not subject to these laws. Among the companies CDPH notified were 23andMe, Navigenics, deCODE Genetics, Knome, and DNATraits. Since last November, the New York State Department of Health has sent letters to 31 companies notifying them that they need to be licensed by the state in order to solicit DNA samples from New York residents.

August 2008 - Table of Contents

DTTR August 2008 (full PDF issue)

California Cracks Down on DTC Genetic Testing

Monogram Launches Breast Cancer Assay

Invitrogen, Applied Biosystems to Combine in $6.7B Deal

BD’s C. difficile Molecular Test Gets CE Mark

J&J Acquires Swedish IVD Company

DTC Genetic Testing Under Greater Scrutiny

FDA Sends ASR ‘Reminder’ Letters to IVD Manufacturers

Dako Partners With Bristol-Myers Squibb for Companion Diagnostics

Rosetta Genomics Buys Parkway Clinical Labs for $3m+

New Biomarker-Based Test Predicts Prostate Cancer Recurrence

Elevated Fetuin-A Levels Associated With Increased Diabetes Risk

Urinary Albumin Levels Can Predict Hypertension

Boston Researchers Awarded Grant for Breast Cancer Biomarkers

CMS Adds More Waived Tests to Lab Fee Schedule

IVD Stocks Fall 9%; Third Wave Rises on Takeover News

See You at Lab Institute!