Originally Published IVD Technology January 2002
INDUSTRY NEWS
Industry joins the battle against bioterrorism
The
bioterrorism scare that has terrified much of the nation during the past several
months has caused a flurry of activity in the IVD industry. Such activity includes
companies coming up with better and faster tests for anthrax as well as forming
partnerships with government agencies to develop systems that could aid in combating
bioterrorism.
Roche Diagnostics
(Basel, Switzerland) is planning to produce a DNA test that has been developed
by the Mayo Clinic (Rochester, MN) and can rapidly identify anthrax in human
and environmental samples. Roche officials claim that the new test can detect
the presence of anthrax in less than one hour instead of days.
"This rapid
identification will enable doctors to begin more timely treatment of patients
who have been exposed to anthrax, and it will more quickly alleviate undue anxiety
for people who haven’t been exposed," says Franklin R. Cockerill III,
the Mayo Clinic microbiologist who led the team that developed the new test.
Cockerill and his team developed the test using Roche’s LightCycler instrument
for polymerase chain reaction (PCR)–based assays.
According to Roche
officials, about two dozen geographically dispersed LightCycler-equipped laboratories
in the United States will be able to conduct the anthrax test. While the Mayo
Clinic has been working with the federal government to make the test formula
available to any federal agency, Roche has been working with FDA to determine
requirements for expedited regulatory approval of the test.
Other companies
are working on anthrax tests that can produce even faster results. Response
Biomedical Corp. (Burnaby, BC, Canada) is developing an on-site test that can
detect anthrax within minutes. Using Response’s RAMP diagnostic system,
the environmental test will be designed to identify anthrax spores within 15
minutes, according to company officials.
"Our RAMP
system has demonstrated the ability to detect immunogenic substances to a level
of analytical sensitivity found in lab-based systems," says Bill Radvak,
president and CEO at Response Biomedical. "After considerable research,
we are confident there will be a sustained market for rapid, sensitive on-site
tests."
Response officials
add that the company has had discussions with U.S. government security agencies
about the RAMP system’s ability to meet security needs in the United States.
At the same time,
Cepheid (Sunnyvale, CA) has granted Environmental Technologies Group (ETG; Baltimore)
a worldwide, nonexclusive sublicense to key patents for the development of a
rapid, handheld DNA analysis system for bioagent detection. ETG is preparing
to commercialize its Handheld Advanced Nucleic Acid Analyzer, which is designed
to rapidly test samples for the unique DNA sequences of bioagents and other
pathogens. According to ETG officials, the device is designed for military use
and emergency response and may be utilized for a variety of field-testing applications
where speed and portability are critical.
Cepheid also announced
that the Centers for Disease Control and Prevention (CDC; Atlanta) have developed
and validated test kits for several biothreat agents for use on the company’s
Smart Cycler DNA detection systems. The CDC is developing such validated detection
assays for biothreat agents and providing these approved testing reagents to
the Laboratory Response Network (LRN), enabling public-health laboratories to
identify anthrax bacteria and other potential bioterrorism agents. Cepheid officials
said that the Smart Cycler is designed for both laboratory and field testing
and enables rapid sample analysis by real-time PCR with results in as little
as 20 minutes.
"The availability
of these assays will strengthen our ability to make a rapid identification of
a biothreat agent," says Stephen Morse, associate director for science
at the CDC’s bioterrorism preparedness and response program. "The
LRN is bringing advanced technology to the public health effort to combat bioterrorism."
Other companies
are also working in conjunction with the government to develop systems that
could help in the fight against bioterrorism. Ibis Therapeutics (Carlsbad, CA),
a division of Isis Pharmaceuticals, received an additional two-year contract
from the Defense Advanced Research Projects Agency (Arlington, VA) to develop
a sensor that can detect infectious agents used in biological warfare attacks.
The two-year contract from the triangulation identification genetic evaluation
of biological risks (TIGER) research program is currently valued at $7.1 million.
Isis had previously received a $1.8 million award from the TIGER program, bringing
the total of the company’s TIGER contracts to $8.9 million.
Another company,
Nanogen Inc. (San Diego), was awarded a three-year grant from the U.S. Army
to continue developing miniaturized electronic devices that can isolate and
detect biological warfare and infectious-disease agents in human blood samples.
The U.S. Army Medical Research Institute of Infectious Disease (Fort Detrick,
MD) will supervise the research. This $1.5 million grant is the second dual-use
science and technology grant that has been awarded to Nanogen by the U.S. Army
Medical Research Acquisition Activity.
Industry analysts
believe that the anthrax scare has drawn attention to the need for better testing
for biowarfare agents and could provide opportunities for IVD companies.
"Bioterrorism
testing has been an industry that has pretty much been ignored because the ability
to make a good business has not really been there in the past," says Response
Biomedical’s Radvak. "Recent events have driven urgency which has
produced a market where there will be a good profit for a number of companies."
Analysts also contend
that the technologies that emerge from companies developing new tests for bioterrorism
should directly affect advances in other clinical areas.
"Lots of other
people are obviously trying to jump on the bandwagon," says Randy White,
CEO at Nanogen. "What that means is it will pay a dividend because the
things that we learn on the bioterror side directly apply to the human side,
producing smaller, faster, and more-accurate instruments."
Industry groups
are also getting involved in fighting bioterrorism. AdvaMed (Washington, DC)
has formed a Medical Technology Preparedness Council to help ensure that America’s
public-health system and military are prepared to make use of the latest advanced
medical technologies in times of national crisis.
"The council
is working closely with government officials to address issues related to availability
of new technology, rapid distribution of products, and coordination with our
partners in the healthcare community," says William H. Longfield, current
chairman of AdvaMed’s board of directors.
Specifically, AdvaMed’s
council is working with FDA to identify and accelerate the development of needed
medical technologies, such as new rapid tests for diagnosing diseases caused
by bioterrorism, and expedite their review.
"Medical technologies, such as rapid diagnostic tests, are perfect examples of how makers of medical devices and diagnostics can help combat bioterrorism," says Susan Alpert, MD, PhD, who serves as medical advisor to the council.
Richard Park
Photo By Lester Lefkowitz/Corbis Stock Market
Copyright ©2002 IVD Technology
