Molecular diagnostics company Monogram Biosciences (South San Francisco, Calif.) is launching its first oncology product. Beginning July 15, the company will offer HERmark, a test that quantifies HER2 protein expression in patients with breast cancer to determine whether each can benefit from the drug Herceptin (trastuzumab). The HERmark test will be marketed to physicians nationwide and performed at Monogram’s College of American Pathologists (CAP)-certified clinical laboratory. List price for the test is $3,350, and turnaround time is seven days.

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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!