The U.S. Food and Drug Administration (FDA) has approved the first test to screen blood donors for Chagas disease, also known as American trypanosomiasis, a potentially fatal parasitic infection. The ORTHO T. cruzi ELISA test system, manufactured by Johnson & Johnson subsidiary Ortho-Clinical Diagnostics (Raritan, NJ), qualitatively detects antibodies to the Trypanosoma cruzi parasite in serum and plasma. The test is not yet approved to diagnose the disease.

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February 2007 - Table of Contents

DTTR February 2007 (full PDF issue)

Siemens, GE Build Diagnostic Powerhouses

FDA to Hold Meeting on IVDMIA Draft Guidance

Pfizer Buys Diagnostic Rights for Genizon’s Disease Markers

New ACOG Guidelines Urge Earlier Screening for Down Syndrome

FDA Approves Ortho-Clinical’s Chagas Disease Screening Test

Initiative Seeks Routine SCID Screening for Newborns

Genomic Health Gets United, Aetna Reimbursement for Oncotype DX

Pharmacogenomics: Are Labs Believing the Hype?

JAMA Study Links Expanded Medicare Reimbursement With Increased Colon Cancer Screening, Earlier Diagnosis

Epigenomics Chooses New CEO, Contracts With Centocor for Cancer Biomarkers

Luminex to Buy Tm Bioscience for $37.9M

BD Closes on $350m TriPath Acquisition

IVD Stocks Rose 20% in 2006 Led by Immucor, Cholestech, Digene

Molecular Diagnostics: The Conference