Developing Biodefense Ivds Is Still a Priority John Conroy
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Beyond Clinical Applications Developing biodefense IVDs is still a priority John Conroy In a scary world, nonclinical diagnostic testing spies a few challenges and many opportunities. s anthrax scares go, this one had that false alerts have become a fact of 1 Environmental and biowarfare. The as benign a beginning and ending life for lawmakers and their staffs. "We report noted that new technologies A as possible in today's terror- get a few of these a day," the spokesman have emerged since the 9/11 attacks to obsessed world. A New York City mu- told the Houston Chronicle. improve the detection, prevention, and sician who returned from Africa in As these stories attest, challenges and surveillance of bioterrorist attacks. February with unprocessed animal skins opportunities abound for IVD firms in a These technologies include rapid tests tested positive for anthrax. The 44-year- world where infectious diseases and for smallpox, anthrax, and salmonella, old man bought the skins, which con- bioterrorism agents are just a plane as well as improved vaccines and in- tained anthrax spores, to make tradi- flight, mail drop, cargo dock, or car ride formation-awareness networks to ex- tional African drums, authorities said. away. Market applications include tests pedite tracking the symptoms of chem- Complaining of flu-like symptoms, the for biodefense, avian flu, West Nile ical and biological events. musician collapsed while on tour with virus, food, animals and pets, water qual- his dance troupe in Pennsylvania, where ity, and genetically modified food. Test- • Food microbiology. In 2003, the glob- he was hospitalized. ing formats include ELISA, rapid later- al market for food microbiology tests Notable for their slightly more prosa- al-flow technology, and real-time was an estimated $864 million with an ic origins, similar stories of viral, toxic, polymerase chain reaction (PCR). annual 9% growth rate. A worldwide or bacterial misadventures have made emphasis on production of safer foods news of late. In France, government au- Market Analysis has sparked a sharp increase in the thorities reported finding cases of a pos- In a report on the IVD market, Kalo- number of tests performed, according sibly deadly strain of H5N1 bird flu on rama Information (New York City) pro- to Kalorama. In 1999, users ran 440 a turkey farm. In the United States, 60% vided an in-depth look at three of these million tests. The 2003 report estimat- of Americans are worried about the nonclinical market segments. Among ed that by 2005, the numbers of tests spread of the virus, according to a new the highlights are the following: run would reach 625 million, a 7% poll. A cat in Germany died after re- portedly eating an infected bird. And in early February, at least a dozen U.S. sen- ators and 200 staff members were quar- antined in a parking garage of a Senate office building after a nerve gas alarm sounded. They were permitted to leave three hours later when tests proved negative. A routine cleaning substance may have triggered the attic sensor that set off the alarm at the Russell Senate Of- fice Building. However, the false alarm points to just one of several challenges facing nonclinical diagnostic testing: Researchers at the California Animal Health and Food Safety Laboratory and Lawrence getting the right reading in a rough, un- Livermore National Laboratory demonstrated that the Newcastle disease virus could controlled environment. By the same be detected using an environmental air sampling system, which is much less labor- token, a senator's spokesman mentioned intensive and time-consuming than conventional swab sampling. in a newspaper account of the evacuation devicelink.com/ivdt IVD Technology • April 2006 37 Applications annual increase. Listeria monocyto- test kits from Bio-Rad Laboratories for highly sensitive, field-type tech- genes, Escherichia coli, and Vibrio (Hercules, CA), Idexx Laboratories niques for pathogens that are likely to parahaemolyticus are among the (Westbrook, ME), and other IVD spill over into clinical testing in micro- microorganisms that can cause food- manufacturers. biology and virology." related illnesses. In addition, no rapid assays to test in- Given the state of the world these dividuals for infection by biowarfare • Veterinary medicine. Global concern days, the environmental and biowarfare agents or other similar pathogens are on about the spread of bovine spongiform sphere presents a world of business op- the market, Kalorama said in the 2004 encephalopathy (BSE), or mad cow portunities. In its report, Kalorama cited report. Many IVD companies have been disease, has increased the market for the U.S. Project BioShield program, a working with various U.S. federal agen- BSE test kits, the research firm says. In $5.6 billion program featuring expedit- cies to develop rapid-response diagnos- 2003, the market in Europe and Japan ed approvals and government procure- tics and environmental sensors in order for postmortem kits stood at approxi- ment. The goal of the 10-year program to detect biological or chemical agents at mately $140 million. Kalorama fore- is to create "a medical arsenal to combat very low concentrations. However, the casts the market will double between bioterrorism." The United States spent research firm said that such tests or de- 2007 and 2009. More than 1500 cases $890 million in 2004 and authorized an vices have not reached the market, and were detected in Europe in 2002. Cana- outlay of $2.5 billion in 2005 for prod- no such products are expected to be da, which exports more than 70% of ucts such as vaccines, therapeutics, and commercially available before 2009. its beef to the United States, performed testing devices. IVD companies working with U.S. BSE tests on approximately 900 of Since the 9/11 attacks, demand has government agencies to develop rapid 11 million cows in 2003. The United increased for tests that can detect an- tests for biowarfare agents include States tested 19,900 of 96 million cows thrax, botulism, malaria, ebola virus, Invitrogen (Carlsbad, CA) and Micro- in the same year. In March 2004, the ricin, and other bioterrorist agents, Kalo- Fluidic Systems (Pleasanton, CA). The U.S. Department of Agriculture rama noted. However, few tests are avail- former company launched Biologi- (USDA) said it plans to expand its able for these pathogens. The critical cal Defense Systems (BDS) in July 2004 BSE surveillance program with rapid- need for new tests has spurred "research to further explore biosecurity applica- tions based on the company's pathogen research, according to Kalorama. MicroFluidic Systems received a $4.5 million contract from the Ad- vanced Research Projects Agency at the U.S. Department of Homeland Security (DHS) to develop an automated system for identifying airborne bacteria, virus- es, and toxins. Kalorama said the market for bio- warfare-based molecular tests, which reached approximately $31 million in 2003, will grow 2% annually and reach $34 million in 2008. The tests are being used by the U.S. government at post offices and federal buildings to detect anthrax. Preparing for Bioterrorism Although no rapid assays exist for biowarfare agents, other such tests to de- tect anthrax, ricin, and other bacteria have been developed by a number of IVD companies. Cepheid (Sunnyvale, CA) is the main supplier of tests for the U.S. post offices. Genelex (Seattle), Ocean Optics (Dunedin, FL), and Re- A lab technician using the GeneXpert system by Cepheid (Sunnyvale, CA). sponse Biomedical (Vancouver, BC, Canada) also offer rapid tests. 38 IVD Technology'April 2006 devicelink.com/ivdt Increased demand for its point-of-care business development at Response, says lumped in with their laboratory- and Ramp system, test cartridges for West it is difficult to track the growth of non- hospital-based counterparts. Nile virus, and on-site detection of an- clinical diagnostic tests because "it's Although market numbers may be thrax, smallpox, ricin, and botulism such a segmented industry," and point- hard to differentiate, the market for non- toxin has bumped Response Biomedi- of-care and rapid field tests tend to get clinical testing products is definitely cal's revenues to $1.4 million in 2003, according to Kalorama's 2004 market report. Response sold more than 125 Ramp systems in 2003. More than 70 of the biological field detection kits have been sold to the U.S. Marine Corps, South Korea, the University of Califor- nia at Los Angeles, the New Jersey state government, and the city of Philadel- phia, as well as other public health and first-responder agencies throughout the United States. Response Biomedical says the hand- held system is 100% reliable at detecting anthrax at the 4000-spore level with no false positives. Results are available in 15 minutes instead of the two days it takes to receive results from culture- based tests, according to the company. The Ramp biodetection field testing system by Response Biomedical Corp. (Vancouver, Joanne Stephenson, vice president of BC, Canada). The voice of . in vitro diagnostics for over a decade. "IVD Technology is the premier publication for the IVD industry. Its focus on a wide breadth of subjects of high interest to those who work in this industry, and the use of subject matter experts to write articles makes reading IVD Technology the best way to keep current with important issues in the diagnostics field." Emily Winn-Dean, PhD (vice president of strategic planning and business development, Cepheid) For more information please visit: www.ivdtechnology.com jyww -Ine.com into®abionllne,com )784(us&CN) devicelink.com/ivdt IVD Technology • April 2006 39 Clinical Applications sample in 30 minutes or less in the field, according to the company. The GeneXpert uses 13-chamber car- tridges for sample preparation, com- bined with amplification and detection in an automated instrument with a rapid nucleic acid analysis capability, the com- pany says.