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The California Department of Public Health (CDPH) is following the lead of the New York State Department of Health in cracking down on companies that offer genetic tests directly to consumers (DTC). In June, CDPH sent notices to 13 companies (listed below) ordering them to cease and desist performing genetic testing for California residents until they meet state laws that 1) require that all clinical laboratories in California or receiving biological specimens originating in California for the purpose of performing a clinical laboratory test or examination possess a clinical laboratory license or registration; and 2) prohibit the offering of a clinical laboratory test directly to the consumer without a physician order, unless specifically exempt.

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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!