The U.S. Food and Drug Administration (FDA) has granted waived status under CLIA regulations for two additional analytes, creatine kinase (CK) and phosphorus (Phos), used with the Piccolo and Piccolo Xpress point-of-care analyzers manufactured by Abaxis (Union City, Calif.). The waivers affect Abaxis’s Renal Function and MetLyte 8 test panels.

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January 2009 - Table of Contents

DTTR January 2009 (full PDF issue)

Genentech Files Petition with FDA Urging Regulation of Lab-Developed Tests

Rosetta Genomics Launches First Test

Invitrogen, Applied Biosystems Close on $6.7 Billion Merger Deal

HHS Report Examines Potential of Molecular Medicine

LabCorp, National Jewish Health to Collaborate on Molecular Diagnostics

American College of Physicians Releases Guidance on HIV Screening

New Study Findings May Aid in Breast Cancer Diagnosis, Treatment Selection

Gene Networks May Predict Leukemia Growth Rate

BD Receives FDA Approval for Cervical Cancer Screening System

Protein Levels Indicate Risk of Death in Colorectal Cancer Patients

Clarient Introduces Second Genetic Test for Colorectal Cancer

Esoteric Testing Fuels 11% Q3 Revenue Growth at LabCorp

Roche Gets CE Mark for New HIV, HBV Viral Load Tests

Tom Daschle Nominated for HHS Secretary

Abaxis Gets CLIA Waiver for Point-of-Care Test Panels

Gene Express, BioTrove to Co-Market Lung Cancer Test

Diagnoplex, Generation Health Close on Funding Rounds

IVD Stocks Down 12%; Affymetrix Falls 30%

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