March 2004
IVD Technology
Selected Contents
EDITOR'S PAGE
Tapping
into academia
Richard Park
INDUSTRY NEWS
- USDA to expand its BSE surveillance program
- Reports anticipate growth in molecular diagnostics
- FDA’s new guidance on drug tests
- Notable
- Notable
- Notable
ASSAY
DEVELOPMENT
A
new brain marker for laboratory assessment of TIA and stroke
Svetlana A. Dambinova
Assays
based on autoantibodies generated by NMDA receptors can provide highly sensitive
and specific results quickly.
Sidebar: Ischemia
and Stroke
ASSAY
DEVELOPMENT
Genotype
assay for the genetic determination of osteoporosis
Ken Milne
A molecular test
may allow both earlier identification of, and more effective intervention for,
individuals with osteoporosis.
MOLECULAR DIAGNOSTICS
The past, present, and future of microarray technology
Andy McShea, Ali Arjormand,
Amit Kumar, and Stephen Schmechel
While DNA
microarrays have the potential of developing into powerful molecular diagnostic
tools, more work needs to be done before this potential is reached
COMMENTARY
The
IVAT solution
Bradley Merrill Thompson
The IVD industry has the potential to develop the most effective biodefense technologies for use in defense against threats of
bioterrorism.
Sidebar: The
contents of an IVAT submission
REGULATIONS & STANDARDS
Employing good clinical practice in IVD
clinical studies
Debra M. Foster and Anastasia N. Derzko
Conducting clinical research in the IVD
industry is challenging. It encompasses a broad range of activities, from
consumer preference studies to fully regulated pivotal studies.
IN PERSON
Putting
new assays to the test
Creating new and successful assays requires business savvy, an eye for innovation, and flexibility when acting as a technological development partner.
Expanded version
of this article.
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