The Food and Drug Administration (FDA) Office of In Vitro Diagnostic Evaluation and Safety (OIVD) will hold a public meeting on In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) on February 8 at 8:00 a.m. at the Hilton Washington, DC/Gaithersburg Hotel. The meeting is intended to provide a public forum during which OIVD will hear presentations and comments from interested stakeholders, regarding the draft guidance issued late last year, which is intended to provide clarification on FDA’s approach to regulation of in vitro diagnostic multivariate index assays.

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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FDA to Hold Meeting on IVDMIA Draft Guidance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