| R. Lewis Dark:
New Technologies Bring New Issues for Pathologists
TECHNOLOGICAL IMPROVEMENTS ARE MOVING through the lab industry like a
buzz saw through balsa. Three briefings in this issue provide examples. In
two briefings, we address the topic of false positive results generated in part
because of innovations in molecular testing. In the third briefing, we explain
how more sophisticated automation and complex new diagnostic technologies
are outrunning the ability of legacy laboratory information systems
(LIS) to keep pace.
Another factor that can outdate legacy lab information systems is a
dynamic, fast-growing hospital laboratory outreach program. As you will
read on pages 11-14, Gilbert Hakim, CEO of SCC Soft Computer in
Clearwater, Florida, explains how the newest generation of technologies in
automation, analyzers, molecular diagnostics, and informatics integration
is pushing laboratories to adopt increasingly sophisticated computer software
solutions.
Newly recognized problems with false positives in certain types of molecular
assays are tackled in two briefings. The first, on pages 15-16, deals with
whooping cough outbreaks in several hospitals in recent months that
received wide media attention. Our expert pathologist comments on the
challenges of improving the sensitivity and specificity of molecular assays
for Bordetella pertussis, along with insights on how individual laboratories
can improve the performance of these assays.
Our second briefing on this subject, on pages 17-18, deals with concerns
about variation in sensitivity and specificity in testing for the HER2/neu gene
across different laboratories performing this test. To improve this situation, the
American Society of Clinical Oncology (ASCO) and the College of American
Pathologists (CAP) made news in December when they jointly recommended
practice guidelines for HER2 testing for breast cancer.
Each of these developments illustrates how the pace of technology change
is accelerating, not just in laboratory medicine and laboratory operations, but
across the entire American healthcare system. Lab administrators and pathologists
will be challenged to keep up with this knowledge explosion. On the
other hand, effective deployment of new technology is something that proactive
laboratory organizations can use to stay ahead of their competitors.
Quest Acknowledges
Loss of United Business
Company tells investors that, during January,
it lost 50% of its existing UnitedHealth business
CEO SUMMARY: In the boxing world, prize fights between
heavyweight contenders always grab the world’s attention.
The same is true in the lab industry, where the current fight
between the industry’s two heavyweights has the potential to
reshape several important aspects of the national market for
lab testing services. This boxing match started on January 1,
when the exclusive national contract between UnitedHealth
and LabCorp became effective.
New Competive Forces
Alter Market Status Quo
Quest Diagnostics announces plans
to expand internationally and enter POCT
CEO SUMMARY: January was not kind to Quest
Diagnostics, as the company disclosed that it was likely to lose
all its UnitedHealth business by year end. It also found itself
excluded from the Horizon Blue Cross Blue Shield of New
Jersey program. By February 1, however, Quest Diagnostics
had acquired HemoCue, a point-of-care testing company with
international distribution and annual revenue of $90 million.
LabCorp Uses United
As a “Growth Driver”
Company reports positive progress from
the first six weeks of its United Contract
CEO SUMMARY: In the first six weeks since its exclusive
national contract with UnitedHealth became effective,
Laboratory Corporation of America has made major gains in
several key markets. It has also begun to share the details of
its three-phase strategic plan to maximize the leverage it gets
from its 10-year pact with UnitedHealth.
UK Laboratories Pushed
To Serve Primary Care
National Health Service shifts emphasis
to early detection and active intervention
CEO SUMMARY: At the fifth annual Frontiers in Laboratory
Medicine (FiLM) meeting in Birmingham, England, lab administrators
and pathologists from the United Kingdom and the United
States gathered to share knowledge about innovations in the
management of clinical laboratories. The event sold out for the
second consecutive year, demonstrating the keen interest in the
United Kingdom for improving laboratory testing services.
LIS As Productivity Tool
Throughout the Laboratory
Laboratories are becoming sophisticated
in their approach to lab information systems
CEO SUMMARY: Is the classic laboratory information
system (LIS) morphing into a different information technology
product? That’s the observation of one laboratory IT
expert, who says that “best of breed” LIS products are
becoming productivity tools that support improved clinical
performance and give lab managers the comprehensive, real
time information they need to closely manage laboratory
work flow, including genetic and molecular testing.
Whooping Cough Cases
Reveal Test Deficiencies
Molecular tests called into question as hospitals
research outbreaks of Bordetella pertussis
CEO SUMMARY: Doctors rely on labs for the definitive
diagnosis of the bacterium that causes whooping cough. Yet in
several recent cases, the use of a molecular test for a definitive
diagnosis led to questions about the effectiveness of the
test. Molecular pathologists recommend labs may need to do a
second test to confirm initial findings and labs may need to be
diligent about any equivocal findings to avoid reporting false
positive results.
New Rules to Boost
Cancer Test Accuracy
Breaking new ground, oncodiagnostics are
changing how pathologists test for breast cancer
CEO SUMMARY: Recent developments in breast cancer
testing are leading to changes in pathology. Oncologists and
pathologists have issued new guidelines regarding HER2 testing
and new research suggests changes may be coming for
estrogen-receptor testing as well. For the first time, the new
guidelines require a certain level of testing and new procedures
for pre-analytical processing.
INTELLIGENCE: Late & Latent
KAISER PERMANENTE
TO CREATE DATABASE
WITH GENETIC INFO GENETIC DISCRIMINATION
LAW MOVES TO VOTE | 
