Johnson and Johnson 2006 Annual Report Download - page 33

Veridex, LLC Introduces Second Novel Diagnostic Platform in Two Years;
Ortho-Clinical Diagnostics, Inc. Adds 23 New Assays to Menu
Ortho-Clinical Diagnostics, Inc. Receives FDA Approval
for First Blood-Screening Test for Chagas’ Disease
Y E A R I N R E V I E W
DePuy Orthopaedics, Inc.
Broadens Leadership
Through Acquisitions and
Portfolio Development
Through strategic acquisitions and
internally developed innovations,
the DePuy franchise has become
a comprehensive orthopaedics
business spanning the entire
lifetime continuum of orthopaedic
care—from sports medicine and
early intervention through joint
replacement and spinal fusions.
Three strategic acquisitions in 2006
will continue to broaden DePuy’s
leadership in this important category
and impact future development of
meaningful innovations for an aging
population.
· Hand Innovations, LLC, a privately
held manufacturer of widely used
fracture fixation products for the
upper extremities, provides leading
technology in plating, the fastest-
growing and most underpenetrated
segment of the trauma market.
· Future Medical Systems, SA,
a privately held company that
primarily develops, manufactures
and markets arthroscopic fluid
management systems, positions
DePuy at the forefront of rapidly
evolving minimally invasive
techniques in sports medicine.
· OrthoMedics, a South African
distributor, expands the company’s
presence in that region.
In addition, DePuy capitalized
on learnings from the CHARITE™
Artificial Disc and extended the
spine portfolio with introduction
of the DISCOVER™ Cervical Disc
(below) in Europe in late 2006.
The first patients were enrolled in
U.S. clinical trials in July.
Last year two new innovations
in hip replacement were introduced:
the DEPUY PROXIMA™ bone-
preserving hip implant in Europe
for younger and more demanding
patients, and the DEPUY ASR™ XL
metal-on-metal “large head”
hip bearings, which launched in
the U.S. and continue to gain usage.
(See story on page 20.)
Also in 2006, DePuy Mitek saw
use of the MILAGRO™ Bioreplacable
Screw rapidly expand one year
post-launch, an important indicator
that physicians are adopting
this technology.
VISTAKON
Introduces
New Advances
in Vision Care
VISTAKON, a division of
Johnson & Johnson Vision
Care, Inc., continues to perform
strongly around the globe with
new products introduced in
2006 including 1-DAY ACUVUE®
MOIST™ Brand Contact Lenses
and 1-DAY ACUVUE® DEFINE™
Vivid Style Cosmetic Contact
Lenses in Asian markets.
(See story on page 12.)
Veridex, LLC recently
launched the second of two
novel diagnostic platforms
in two years. GENESEARCH™,
the world’s first gene-based
diagnostic test designed to
detect the spread of breast
cancer into the lymph nodes,
uses molecular technology
to diagnose, stage and more
accurately characterize tumors
and can be used during surgery
to guide the procedure.
GENESEARCH™ entered the
European market in mid-2006
in compliance with EU in vitro
medical device regulations.
It received a favorable FDA
advisory panel review in
December 2006.
The first platform,
the CELLSEARCH™ System,
identifies and enumerates
circulating tumor cells (CTCs)
directly from whole blood
in breast cancer patients.
Approved in the U.S. in
January 2004 as a diagnostic
tool for identifying and
counting CTCs in a blood
sample to predict progression-
free survival and overall
survival in patients with
metastatic breast cancer,
CELLSEARCH™ was granted
expanded FDA-approved
claims in 2006 as an aid in
the monitoring of metastatic
breast cancer. CELLSEARCH™
and the new GENESEARCH™
Breast Lymph Node diagnostic
test represent the next
chapter in in-vitro diagnostics.
(See story on page 14.)
In 2006, Ortho-Clinical
Diagnostics, Inc. expanded
its diagnostics menus with
23 new FDA-approved
assays, including five assays
for the VITROS® ECiQ
Immunodiagnostic System
and 11 new MicroTip™
assays for the VITROS® 5.1 FS
Chemistry System. The new
VITROS® ECiQ assays include
tests to aid in the diagnosis
of congestive heart failure,
determine whether a patient
has a previous or ongoing
infection from hepatitis A
virus (HAV), quantify levels
of an oncology marker and
aid in assessment of
metabolism. The new VITROS®
MicroTip Chemistry Products
include tests to detect the
presence of drugs of abuse,
measure homocysteine
concentration in blood
plasma, measure the extent
of red-blood destruction
and manage diabetes.
31
Chagas’ disease, also called
American trypanosomiasis,
is an infection caused by the
parasite Trypanosoma cruzi
(T. cruzi) that can damage
heart tissue and cause death.
The disease is endemic to
most countries in Central
and South America, as well
as Mexico. Transmission
occurs through insect bites,
blood transfusions and
organ transplants, and via
infected pregnant women
to children in utero. A new
test by Ortho-Clinical
Diagnostics, Inc., called the
ORTHO® T. cruzi ELISA Test
System, is designed to screen
blood donors for exposure
to Chagas’ disease and is the
first such test approved by
the FDA for use in the U.S.
The Centers for Disease
Control and Prevention
(CDC) estimates that 10 to
12 million people worldwide
are infected with Chagas’
disease; of those, 50,000 will
die each year. Chagas’ disease
can be treated successfully
if detected soon after the
infection occurs, but there
is no cure once the disease
has entered the chronic
stage. The test is being
implemented in the U.S. due
to an increased prevalence
in blood donors and will
improve transfusion safety.