IVD Technology

July/August 1999
Selected Contents

Editor's Page

Hot . . . Or not?

COVER STORY:

The future of automation in clinical laboratories
by Jack Zakowski and Diane Powell

With economic forces creating ever more intense competition, clinical labs see automation as a key to survival.

COMMENTARY:
Negotiated rule making for medicare coverage: What have we learned?
by Ted Mannen

The negotiated rule making that has attempted to craft national Medicare coverage policies for IVD tests will prove to be one of the most significant policy developments for years to come.

Regulations and standards:
Labeling for IVDs:Issues and recommendations
by Patricia B. Shrader

Of the issues of greatest significance to the IVD industry, few have received more attention in recent years than labeling.

Streamlining the IVD software development process
By Nelson Holton

Complexities in diagnostic instruments pose challenges for software engineers and product developers. Communication and thorough planning can make the process a smooth one.

A multisystem approach to cytokine research
By Daniel P. Collins

Multiplexed flow cytometry offers an innovative tool for monitoring and quantitating cytokine levels in biological samples

Breaking the home-use barrier for tumor markers
By Glen Freiberg and Alicia Moffat

Even for a low-risk test, the path to FDA clearance can be a tangled one. But a new spirit of cooperation at DCLD could make the road a little smoother for manufacturers.

News Update:

DoD takes delivery of biowarfare analyzer
A new weapon in the battle against biowarfare and bioterrorism was recently delivered to the Department of Defense in the form of a rapid DNA analyzer by Cepheid Inc.

Free speech at stake for IVDs
IVD manufacturers could be drawn into an ongoing First Amendment battle with FDA if the agency's draft compliance policy guide for RUOs and IUOs takes effect in its current form.

Healthcare 2000 highlights opportunities for new diagnostics
Manufacturers seeking targets for new products need only listen to what users say about the current generation of tests.

Less painful glucose monitor hits the market
A system that allows diabetics to accurately monitor their blood sugar levels without the pain usually associated with finger sticking has received FDA approval.

ODE to get complexity ratings duty
FDA will "soon" take over responsibility for determining the complexity level of laboratory tests from the CDC.

Diagnostic devices win design awards
Seven diagnostic products took home gold and silver awards at the second annual Medical Design Excellence Awards ceremony.