IVD Technology

May/June 2000
Selected Contents

EDITOR'S PAGE:
Just a few words of introduction . . .

REGULATIONS AND STANDARDS:
FDA takes over CLIA complexity determinations
by Joseph L. Hackett

Industry consortium developing standards for POC device connectivity
by Dirk Boecker, Emery J. Stephans
members of the IVD industry and the users of POC devices have formed a new group, called the POC Connectivity Industry Consortium (CIC), whose purpose is to develop a base-level standard for POC connectivity.

COVER STORY:
Lyophilization processing: Freeze-dried microspheres offer new IVD packaging and product opportunities
by Timothy E. Pearcy

A refined technology promises new flexibility in the processing and packaging of lyophilized IVD reagents.

In-line manufacturing for rapid-flow diagnostic devices
by Thomas C. Tisone

Advanced manufacturing technologies are helping IVD manufacturers achieve quantitative testing in lateral-flow formats.

SPECIAL SUPPLEMENT ON MOLECULAR DIAGNOSTICS

EDITOR'S PAGE
Wanted: A room with a viewpoint

Advanced manufacturing technologies are helping IVD manufacturers achieve quantitative testing in lateral-flow formats.

Solid-phase nucleic acid extraction, amplification, and detection
by Roy R. Mondesire, Diane L. Kozwich, Kristine A. Johansen, John C. Gerdes, and Shannon E. Beard

The use of molecular technologies for clinical diagnostics doesn't have to be synonymous with high-cost, high-complexity instrumented systems.

Technologies for mutation detection
by Angela Ryan, Richard Schifreen, John Shultz, Isobel MacIver, and Dan Kephart

Methods used to detect genetic mutations linked to various diseases will be the bases of a myriad of new molecular diagnostic tests. Manufacturers must consider many factors when deciding which of these technologies to use.

TECHNOLOGY ROUNDTABLE
Technology Roundtable: Intellectual properties in the molecular age
with Daniel H. Farkas, PhD, Debra G. B. Leonard, MD, PhD, and Peter R. Shearer

Is gene patenting a threat to the commercial development of molecular diagnostics? To find out, IVD Technology turns to a panel of experts in the field.

DNA-chip makers build strategies to break into diagnostics
by Cliff Henke

To fund the development of DNA-chip products for the clinical diagnostics marketplace, manufacturers are turning to alliances with powerhouse corporations.