In This Issue:
Engineered Baculovirus to Be Field
Tested
Green Fluorescent Protein - A New Reporter Gene in Transgenic Research
Patent Office Views DNA as a Chemical
What's in the Pipeline?
Gene Flow in Brassica
Preparations for Plum Pox Prevention
Sheep Cloning by Nuclear Transfer
Assays for Seafood Safety
Bt Germplasm Reserves
Diagnostics: A Growing Business in Food and Agriculture
Upcoming Meetings
American Cyanamid Company (Princeton, NJ) has filed with EPA's Office of Pesticide Programs a notification of intent to conduct small-scale field testing of a genetically-engineered isolate of the baculovirus Autographa californica Multiple Nuclear Polyhedrosis Virus (AcMNPV). EPA has determined that the application may be of regional and national significance, and therefore is soliciting public comments. Following review of American Cyanamid Company's application and any comments received in response to this notice, EPA will decide whether or not an experimental use permit is required.
The proposed small-scale field trial involves the introduction of a baculovirus strain that has been genetically modified with approximately 1 kilobase internal deletion in the ecdysteroid UDP-glucosyltransferase gene and an inserted gene which encodes an insect-specific toxin protein from the venom of the scorpion Androctonus australis. The purpose of the proposed testing will be to evaluate the efficacy of this genetically-altered AcMNPV, relative to the gene-deleted construct and a commercial Bacillus thuringiensis insecticide, against lepidopteran species Trichoplusia ni (cabbage looper) and Heliothis virescens (tobacco budworm) on tobacco, cotton and leafy vegetables.
The proposed program consists of a total of 20 field trials to be conducted in spring 1996 thru fall 1996. Testing will occur in 12 states: Alabama, Arkansas, California, Florida, Georgia, Illinois, Louisiana, Mississippi, New Jersey, North Carolina, Texas, and Virginia. For each crop to be treated, the following number of trials and treatments are proposed:
There will be a maximum of four plots per treatment and six applications per treatment. The maximum size of a given treatment plot in each test will be 0.02 acres (4 rows wide x 75 ft. long). The total acreage treated with the genetically modified construct will consist of 7.4 acres. The total amount of active ingredient to be used will be 98.25g. Treated plots will be buffered on either side by an untreated row.
Alleyways (6') will be cut between replicates. Entire trials will be surrounded by a 10' crop-free buffer zone. Small-scale ground-based spray equipment will be used. Equipment will be cleaned with hypochlorite after applications with the construct. Upon completion of the trials, crops will remain standing for at least 2 weeks to maximize the natural degradation of the remaining Polyhedral Inclusion Bodies (PIBs) before being shredded and interred into the soil. Weekly monitoring of target insects and non-target insects will take place within treated plots.
Written comments in triplicate should be submitted to EPA by April 22, 1996. Comments must bear the docket control number OPP-50816 and be submitted to: Public Docket and Freedom of Information Section, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW, Washington DC 20460.
Comments and data may also be submitted electronically by sending electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic comments must be submitted in ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on disks in WordPerfect in 5.1 or ASCII file format. All comments and data in electronic form must be identified by docket number OPP-50816.
For further information contact: Linda Hollis, Biopesticides and Pollution Prevention Division (7501W), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone number, and e-mail address: 5th Floor, CS #1, 2805 Jefferson Davis Hwy., Arlington, VA, (703)308-8733; e-mail: hollis.linda@epamail.epa.gov.
Reporter genes or screenable markers have proven very useful in biotechnology research as they provide a visual means to identify genetically engineered cells. Transgenic plants, animals and microorganisms are now routinely identified using such genes. Currently the most popular reporter genes are GUS (-glucuronidase; uidA) and lacZ (-galactosidase) from E. coli which confer blue color to the transformed cells, and the luciferase gene from firefly or bacteria which produces luminescence. Detection of these gene products, however, often necessitates an assay that results in the destruction of the sample and requires the addition of substrates. A new reporter gene obtained from the jelly fish (Aequorea victoria) called Green Fluorescent Protein (GFP) is thus attracting considerable attention because it can be detected without destroying the tissue. Cells transformed with the GFP gene exhibit bright fluorescence under ultraviolet or blue light, and this luminescence requires only oxygen but no other substrates. The GFP is a highly stable protein with a small molecular weight and shows very little photobleaching.
Douglas Prasher of USDA/APHIS first cloned the GFP gene in 1992. Along with Martin Chalfie and associates at Columbia University in 1994, he showed that E. coli and C. elegans exhibit bright green fluorescence when transformed with the GFP gene. Since then, GFP has been expressed in many organisms including yeast, Drosophila, vertebrate (including human) cell lines and plant cells (1). Because it can be detected non-invasively and with little disruption of the cell ultrastructure, GFP gene has many potential applications in molecular biology research and commercial biotechnology: measuring gene expression in vitro, selecting transgenic cells, studying fusion proteins, studying intracellular protein traffic (and thus identifying signal sequences), determining cell lineage, assessing promoter activity, developing cell- and tissue-specific markers, investigating pathogen movement and disease development, biomonitoring of organisms released into the environment, developing bioindicators for detecting environmental pollutants, ensuring the containment of genetically modified organisms and in evolutionary and ecological studies of transgenic organisms (2).
Several variations and improvements have now been made in the GFP gene sequence. By substituting amino acids in the chromophore, proteins which yield blue and red fluorescence have been developed (3). As the GFP mRNA is spliced into smaller fragments after transcription in certain plant species, Jim Haseloff at MRC Laboratories in the U.K. has created an improved GFP by removing the cryptic intron splice sites from the coding region. Jen Sheen and Brian Seed at Massachusetts General Hospital have developed a completely synthetic GFP based on the optimum codon usage for plants, and this new gene results in an impressive 120-fold brighter fluorescence than the original GFP (4). A similar 'humanized' GFP gene has also been developed at Florida State University. David Galbraith and associates at University of Arizona along with Jen Sheen have developed protocols for the identification and sorting of GFP-expressing cells using flow cytometry equipment.
Roger Beachy and colleagues at the Scripps Research Institute have recently employed the GFP gene fused with the tobacco mosaic virus movement protein gene to conduct some very innovative studies on the cell-to-cell movement of this virus in plants and to show that the movement protein interacts with the microtubules of the plant cytoskeleton (5). Baulcombe and coworkers also employed the GFP gene fusion to confirm the role of viral coat protein in the intercellular movement of potato virus X (6).
A few potential problems in the use of GFP marker include its weak expression as it is not an enzyme and thus its signal is not amplified; green autofluorescence of certain samples (e.g. lignin in plants); potential toxicity to cells from excited GFP (GFP may inhibit plant cell regeneration and growth); and the variability in the intensity of fluorescence.
A biotechnology company in the U.K. is now developing transgenic plants with the GFP gene fused to various stress-promoters to eventually market such indicator plants for farmers to help them detect heat, pathogen, drought and other stress situations on the farm. In the not so distant future, Santa Clause may find himself placing a gift under Christmas trees 'glowing-in-the-dark'!
Several GFP gene clones, antibodies and a bibliography are available from Clontech Laboratories (http://www.clontech.com). The optical filters for GFP detection are available from Chroma Technology Corporation ( sales@chroma.com). An electronic newsgroup 'Fluorescent Proteins', devoted to discussion on research issues related to GFP, is on the Internet (http://www.bio.net). Send an email message to biosci@net.bio.net to receive information on accessing this and other newsgroups.
References
1. Kain, et al., 1995. BioTechniques 19: 650-655.
2. Prasher, 1995. Trends in Genetics 11: 320-323.
3. Heim, et al., 1994. PNAS 91:12501-12504; Delagrave, et al., 1995 Bio/Technology
13:151-154.
4. Sheen and Seed, 1995. The Plant Journal 8:777-784.
5. Heinlein, et al., 1995. Science 270:1983-1985.
6. Baulcomb, et al., 1995. The Plant Journal 7:1045-1053.
C. S. Prakash
Center for Plant Biotechnology Research
Tuskegee University
prakash@acd.tusk.edu
For some time, patent applicants and the U.S. Patent and Trademark Office (PTO) have been debating the appropriate standard for determining whether a DNA molecule meets the requirements for patentability. In a recently published decision on claims to tomato genomic markers, the PTO's Board of Patent Appeals and Interferences indicates that the PTO may apply the same rules for determining patentability of DNA molecules as it applies to smaller organic molecules.
Under U.S. patent law, any invention must meet the requirements of novelty and nonobviousness. The requirement of novelty means that an invention must differ from the "prior art," which is the sum of publicly known information. In contrast, the requirement of nonobviousness means that an invention would not have been obvious at the time the invention was made to a person with ordinary skill in the art. While a determination of novelty (i.e., lack of identity between the claimed invention and the prior art) is usually straightforward, the question of obviousness is more complex, since it requires a determination of the degree of difference between the invention and the prior art.
For traditional chemical inventions, a case of obviousness requires that cited references disclose a compound related to the claimed compound and a suggestion to modify the known compound to obtain the claimed compound. When it comes to DNA molecules, however, overcoming the obviousness hurdle has been problematic. For example, the PTO may consider an isolated gene to be obvious in view of a reference that describes a related gene (such as a homologous gene) and a reference that teaches general cloning methods (e.g., the Maniatis manual). That is, the PTO's determination of obviousness may center on the question of whether it would have been obvious to try to isolate the claimed DNA molecule.
In 1993, the Court of Appeals for the Federal Circuit (CAFC) rejected this approach for examining DNA claims. The court found that the PTO's obviousness rejection of claims to human insulin-like growth factor (IGF)-encoding DNA molecules was not supported by a combination of references that disclosed IGF amino acid sequences and general methods for isolating a gene that encodes a protein with a known amino acid sequence (1). The court recognized that the degeneracy of the genetic code invalidated the PTO's theory that the "correspondent link" between a gene and its encoded protein renders the gene obvious when the amino acid sequence is known.
Two years later, the CAFC reversed a similar obviousness rejection, emphasizing that, in the absence of prior art that suggests the claimed DNAs, the existence of a general method of isolating DNA molecules is irrelevant to the question of whether the claimed DNA molecule itself would have been obvious (2). Even after this decision, however, the PTO seemed inclined to reject DNA claims on the basis that one skilled in the art could have isolated the molecule using standard techniques. Still, there is reason to hope that this may change.
In a decision published in February, the PTO's Board decided that known tomato cDNA libraries did not render obvious certain tomato cDNA probes claimed in a patent application of Steven D. Tanksley and Robert Bernatzky (3). First, the Board considered an affidavit of an expert, whose statistical analysis led to the conclusion that it is "virtually impossible" for the prior art cDNA libraries to contain exact duplicates of Tanksley's and Bernatzky's clones. The prior art libraries, therefore, did not defeat the novelty of the claimed cDNA molecules.
The novel cDNA molecules also were found to be nonobvious. The Board explained that the mere fact that the prior art libraries could have been modified to arrive at the claimed clones is not sufficient to make the modification obvious. Rather, the prior art must suggest the desirability of the modification.
Accordingly, the question of obviousness hinged on whether the prior art suggested the modification of a known composition to obtain the claimed composition, which is the standard for determining whether a traditional chemical invention would have been obvious. The Tanksley decision, therefore, indicates that the PTO may now follow its own observation that "a gene is a chemical compound, albeit a complex one" (4).
References
1. In re Bell, 26 USPQ2d 1529 (Fed. Cir. 1993).
2. In re Deuel, 34 USPQ2d 1210, 1215 (Fed. Cir.1995).
3. Ex parte Tanksley, 37 USPQ2d 1382 (BPAI 1994).
4. Ex parte D, 27 USPQ2d 1067, 1069 (BPAI 1993).
Phillip B.C. Jones
Foley & Lardner, Washington, D.C.
pbcj@ari.net
Field Tests Permit Requests
The latest crop of field test permit applications under review by APHIS's Biotechnology Permits staff
includes almost 20 from academic and public sector institutions. Applications have been submitted
by:
Biotech companies continue to expand and diversify their product lines. In addition to numerous permit requests for insect resistant potatoes, virus resistant melons and squash, rapeseed with altered oil profiles and other staples of the industry, applications from the private sector have been submitted by:
In August, USDA/APHIS published a proposed rule that would allow most genetically engineered plants to be field tested under the notification procedure, provided they meet eligibility criteria and performance standards. Under the proposed rule, a permit would be required only when the transgenic plant is a noxious weed, or if the introduced gene encodes a functional viral movement protein, or is from a nonendemic virus. All other tests could be conducted after filing a simple notification with the Agency. A final rule, together with an updated Users Guide, is expected to be published later this year in time for next year's trials.
Pat Traynor
Information Systems for Biotechnology
One of the concerns raised by large scale cultivation of some genetically engineered crops is the potential for transgene movement into related weedy species. If the introduced gene confers a selective advantage or enhances the fitness of the recipient, it may make it a 'better' weed that is more difficult to control. Results from a study to evaluate this risk in a particular combination of crop-transgene-environment were reported by a group of Danish researchers in the March 7 issue of Nature.
The study examined introgression of a gene conferring herbicide (glufosinate) tolerance from transgenic oilseed rape, Brassica napus, into nontransgenic Brassica campestris, a weedy relative. The two species are know to hybridize spontaneously, and hybrids can be found in natural populations. The report did not state whether the transgenic line contained a single copy of the herbicide tolerance gene or if there were multiple, possibly unlinked insertions.
In the experiment, interspecific Brassica napus x B. campestris hybrid plants resistant to the herbicide BASTA were backcrossed to B. campestris. Four thousand seeds of the first backcross generation were germinated and screened for herbicide tolerance. Of the 865 herbicide tolerant seedlings grown to flowering, 44 showing B. campestris-like morphology were analyzed. Five of these had highly fertile pollen and a B. campestris-like number of chromosomes. A second backcross was made with four of this group; of the resulting 416 progeny, 42% were found to be herbicide tolerant.
Only two generations of hybridization and backcrossing, coupled with selection for herbicide tolerance and B. campestris-like morphology, pollen fertility, and chromosome number, were needed to recover weedy BASTA-resistant plants. The results demonstrate that engineered traits, like any traits, can be transferred from crops to sexually compatible weed species. The authors note that this "should be taken into account when considering the consequences of transferring new traits to oilseed rape."
Pat Traynor
U.S. fruit growers worried about the spread of plum pox virus, which has not yet appeared in North America, have been looking over their shoulders as the pathogen invaded orchards throughout Europe and then was reported in South America in 1994. The virus causes severe damage and crop loss in plums, peaches, and apricots, where it is transmitted by aphids and by grafting.
Plum pox disease causes fruit to drop from affected trees 20 to 40 days before maturity, and leaves the remaining fruit unmarketable. There is no remedy once a tree is infected. The devastation caused by this virus can be seen in the numbers - plum orchards in the Czech Republic, once numbering 18 million trees, have dwindled down to 5 million. More than 16 million trees in Europe are now thought to be infected.
A five year effort to combat the disease by genetically engineering virus resistance now shows some promise of paying off. In 1990, USDA/Agricultural Research Service (ARS) scientists began their efforts with a papaya ringspot virus coat protein gene obtained from Cornell University plant pathologist Dennis Gonsalves. This gene shows 70% homology to the plum pox gene and has been used to control other viruses similarly related to papaya ringspot. Hypocotyl slices from seeds of a plum germplasm stock were transformed by Agrobacterium and 36 plants of four transgenic clones were produced.
The plants were grown in greenhouses at the Appalachian Fruit Research Station (Kearneysville, WV) before being moved to the ARS Foreign Disease-Weed Science Research Laboratory in Frederick, Maryland. There, under very strict quarantine, the transgenic trees were inoculated with plum pox virus to test their resistance. One plant remained virus free for 19 months before it, too, succumbed. While insertion of the papaya ringspot gene delayed symptoms, in a perennial crop such as fruit trees, disease resistance needs to hold up for years.
A more direct approach was used in a collaborative effort between the ARS and its equivalent in France, which brought together horticulturist Ralph Scorza and collaborator Michel Ravelonandro, from the INRA Centre de Recherche Agronomique in Bordeaux, France. This time, the researchers used a coat protein gene from plum pox virus and transgenic seedlings were sent to France to be tested. After 2 years one clone tree appears to have complete immunity to both highly virulent and less virulent isolates of plum pox virus. These results were confirmed in inoculation trials undertaken in the US in collaboration with ARS plant pathologist Vern Damsgeet and APHIS plant pathologist Laureen Levy. This immune line will now be tested in Central European countries where the virus is rampant.
Further work is still needed to produce virus resistant fruit trees that are commercially useful. The next phase is to breed the transgenic trees for fruit quality, while simultaneously working to optimize the transformation technology so that cultivars having desirable qualities can be transformed directly. With a little luck, U.S. growers will have some control strategies ready if plum pox ever hits their orchards.
Pat Traynor
SHEEP CLONING BY NUCLEAR TRANSFER
In the March 7, 1996 issue of Nature, scientists from the Roslin Institute (Edinburgh) have reported the first successful cloning of sheep by nuclear transfer from a cultured cell line. This technique allows the production of genetically identical sheep, potentially of great benefit to researchers interested in generating a large flock of identical transgenic or "elite" animals.
The process involves the transfer of a nucleus from a donor cell to an enucleated egg via electrofusion. Previously only nuclei from embryo-derived sheep primary cells have successfully been used as nuclear donors. In this report, nuclei transferred from embryonic disk cells cultured up to and including passage three resulted in the birth of lambs. An embryo-derived epithelial cell line was established upon further passage of these embryonic disk cells. However, no development to term was obtained following nuclear transfer with this cell line unless the cells were first induced to enter a quiescent phase.
Five phenotypically normal lambs were born after nuclear transfer of passage 11 or 13 cells, however two died minutes after birth and a third 10 days later. It is not clear why success was obtained only after the cultured sheep cells were allowed to quiesce. Perhaps, the induction of quiescence is a necessary event to allow sufficient time for nuclear reprogramming and normal development. Errors in gene reprogramming or reactivation, or in interactions between egg cytoplasm factors and the transferred nucleus, are among possible explanations for the deaths of some of the lambs.
Currently the efficiency of producing lambs by nuclear transfer is not high, however the success rate is likely to improve with further research. One of the first applications of this technology may be sheep engineered to produce a human pharmaceutical compound in milk. Once reviewed and approved by the FDA, scaling up production of the drug by generating genetically identical animals would be more straightforward than by making additional transgenic animals that would not be identical.
The development of nuclear transfer from cultured cells in a livestock species affords the opportunity to utilize the elegant genetic manipulation techniques now available for mouse embryonic stem (ES) cells. Mouse ES cells maintain their totipotency in culture and are capable of recolonizing embryos and contributing to the germ line. Thus it is possible to isolate mouse ES cells that contain precise alterations of chromosomal genes (gene targeting) and to use these cells to generate a mouse with any desired genotype. The ability to engineer precise chromosomal mutations has represented a major development in mouse genetics.
Over 250 different mice carrying genes inactivated by gene targeting ("knockouts") have been isolated. A database of mouse knockout mutants has been established on the Internet. Visitors to http://www.cursci.co.uk can access the library. Hopefully, there will soon be a similar knockout database for livestock.
Eric Wong
Dept. of Animal and Poultry Sciences
Virginia Tech
Many new assays are being developed for detection of toxins and pathogens in seafood. The next decade will see many of these tests become available in kit form, allowing processors, clinicians, and public health authorities to rapidly and accurately assess the safety of foods and to diagnose food-borne disease.
One of the major concerns among seafood-borne pathogens is Vibrio vulnificus. This Gram-negative bacterium is common in the coastal marine environment, and during warmer months of the year can be found in nearly every oyster harvested, particularly from the Gulf of Mexico. It is prevalent enough that some restaurants on the Gulf Coast have routinely included in their menus a warning against eating raw oysters without due consideration of the risks.
While regulatory and industry personnel wrangle over the tolerance limits for V. vulnificus and other seafood-borne pathogens, researchers are making progress on detection of the organism by fluorescent or alkaline phosphatase-labeled oligonucleotide probes, and labeled monoclonal antibodies directed against flagellar antigens.
Probes and other sensitive methods continue to be developed for detection of other pathogens, as well. One method for detection of Salmonella sp. in food is by colony hybridization with a 32P-labeled probes derived from chromosomal sequences specific to this organism. At least two probes have been reported that reliably detect various Salmonella species and serovars but do not hybridize with DNA from other enteric and nonenteric bacteria.
To develop a probe for the detection of E. coli O157:H7 (enterohemorrhagic E. coli, or EHEC), restriction fragments of plasmid DNA obtained from multiple strains of E. coli were screened to locate those which were unique to EHEC strains of serogroup 0157. A 2 kilobase fragment was found to be both sensitive and specific in identifying isolates of O157:H7. When applied to nearly 150 E. coli strains from humans, animals, and foods, the probe hybridized to 100% of O157 EHEC strains, but none of eight enterotoxigenic E. coli strains nor any non-E. coli culture. The probe did hybridize with 10% of non-O157 E. coli strains which were positive when examined with a probe for the verotoxin gene, a potential problem which was apparently eliminated by increasing the stringency of conditions.
For detection of Campylobacter jejuni, a procedure based on solution hybridization has been developed. Contaminating bacteria negatively affected the assay's sensitivity, but detection was still possible when C. jejuni were outnumbered by 10,000:1. A study of fourteen artificially-contaminated food samples demonstrated that both the amplification-based and standard cultural procedures were subject to a small number of false negatives, but enrichment culture and nucleic acid amplification shortened time to result from 6 days to little more than 24 hours.
J. Glenn Songer
University of Arizona
Over the past decade, scientists at the ARS Insect Biocontrol Laboratory in Beltsville, Maryland have accumulated an impressive collection of Bacillus thuringiensis (Bt) strains and isolates. Under the direction of Phyllis Martin, the Bt germplasm bank has grown from 500 isolates in 1983 to more than 12,000. This collection, and others being built by research groups around the world, may hold as-yet uncharacterized strains that produce unique insecticidal endotoxins.
The search for new Bt isolates shifted into high gear with the discovery in the late 1980's that a simple lab procedure could greatly speed the screening of samples. In a reverse selection step, soil samples are treated with sodium acetate; spores of most contaminating fungi and other bacteria germinate and the unwanted microbes are killed by heat treatment. Bt spores do not germinate in the presence of acetate, and thus are protected. This fast and simple selection procedure allows samples to be processed in quantity. As a result, microbe hunters now know that Bt is not the rare organism it was once thought to be, but is in fact widely distributed in the environment.
Bt isolates are identified by a biochemical profile that is stored in a database; researchers can search the collection for isolates fitting particular criteria. Candidates are first selected by subtype, then by the crystal structure of their endotoxin. Those fitting the desired profile are then tested for toxicity to insects.
The screening is tedious and labor intensive, but the reward can be a potentially significant discovery. For example, Martin's group at ARS, collaborating with entomologist D. Wes Watson at Cornell University, recently identified Bt isolates that kill house fly larvae. Out of 4,000 isolates collected from oak, maple, pine, tulip poplar, and straw used as calf pen bedding, they tested 200 and found 49 that have activity against flies. Stable flies, which are related to house flies, can be serious barnyard pests that draw blood meals from animals and cause significant stress and reduced weight gain in calves that are being weaned. The newly identified Bt isolates will be further characterized to evaluate their biocontrol potential against these fly pests.
The Beltsville Bt germplasm bank is probably the largest available to other researchers, however funding and personnel shortages have made it nearly impossible to accommodate requests. The collection currently is being replicated at the National Regional Research Laboratory, a national repository of agriculturally important microbial strains located in Peoria, Illinois. Once the NRRL has the bank established, they will be a source for Bt strains and isolates in the ARS collection.
Pat Traynor
DIAGNOSTICS: A GROWING BUSINESS IN FOOD AND AGRICULTURE
The growing concern over food safety is having a positive impact on biotechnology. A recent article in Genetic Engineering News describes the increasing contribution of immunoassays and other biotechnology-related technologies to the estimated annual $1 billion food safety business (1). Biotechnology-based diagnostic systems offer more rapid and lower cost alternatives to slower and more costly traditional methods. Given that the large majority of food samples yield negative results when tested for contaminants, it is more cost effective to utilize these diagnostics tests for initial on-site monitoring, and use the more conventional methods for the smaller number of positives and controls.
Estimates of the current market for immunoassays and other biotechnology-based food safety diagnostics are $150 to $200 million and growing to between $400 and $500 million by the middle of the next decade. One major driver of this market is expected to be the toughening of food safety standards by the USDA. Applications include detection of disease, pesticides, natural toxins, and microbes in plants, livestock, seafood and diary products. It is hoped that biotech-based diagnostics tests will help decrease the estimated 80 million annual U.S. cases of food-related sickness, and the resulting 9,000 annual deaths.
Given the expanding nature of these markets, a growing number of companies are developing biotechnology-based diagnostics for food and agriculture. A list of sample companies includes Agdia, BioControl Systems, Chromagen, Diagnostix, Editek, Gene-Trak Systems, Idetek, IDEXX Laboratories, International Diagnostics Systems, ImmunoSystems, Neogen, Organon Teknika, Promega Corporation, and Vicam.
As the industry matures, some people believe that competition will thin out the sector, resulting in larger companies, but fewer of them. Survival will likely be based on traditional pillars of successful commercialization including effective innovation, collaboration, and globalization. The Durham, North Carolina company Editek is working on all these fronts to advance its cause. Editek is developing and marketing diagnostics products for substance abuse and food safety, and recently completed agreements with companies in the United Kingdom and Germany to distribute diagnostics test for food and agriculture.
Many believe that the desire for rapid and cost effective biotechnology-based diagnostic testing processes will offer the largest challenge to the industry in terms of its ability to manage growth and the transition from providers of qualitative to quantitative results.
References:
1. Larkin, M. Genetic Engineering News, Vol. 16, No. 6, March 15, 1996.
William O. Bullock
Institute for Biotechnology Information LLC
Research Triangle Park, NC
June 5-7: Agricultural Biotechnology: Novel Products and New Partnerships, Rutgers University, New Brunswick, NJ. The food industry, chemical and pharmaceutical industries, and environmental and energy industries are poised on the brink of bringing new agricultural products to the marketplace. The eighth annual NABC meeting will focus debate on the multiple social, ethical, economic, research, development, and commercialization issues and opportunities that these new products pose for consumers, farmers, industry, public interest groups, government, and academe. Contact Jill Braun, 908-932-9271; braunj@gandalf.rutgers.edu.
August 25-30: 10th International Biotechnology Symposium, Sydney Australia. Held every four years, this major conference covers all areas of biotechnology. This year's program has invited papers arranged in 12 symposia, including Frontiers in Polypeptide Production, Genetically Engineered Vaccines, Agriculture and Food Biotechnology, Frontiers in Production of Metabolites, Environmental Biotechnology, Downstream Processing, and Policy Issues in Biotechnology. Online information is available at http://acsusun.acsu.unsw.edu.au, or contact the 10th IBS '96 Symposium Secretariat, GPO Box 128, Sydney, NSW 2001 Australia; tel: 61-2-262 2277; fax: 61-2-262 2323; email: tourhosts@tourhosts.com.au.
September 1-7: Society for Invertebrate Pathology and Colloquium on Bacillus Thuringiensis, Cordoba, Spain. Topics ranging from Bt mode of action and resistance management, baculoviruses as control agents, pathology of marine invertebrates and microbial control of soil dwelling pests will be dealt with in submitted paper sessions, poster presentations, symposia, plenary sessions and workshops. For information on program and abstract submissions, contact Wendy Gelernter, Secretary, Society for Invertebrate Pathology, 619-272-9897; pacenet@delphi.com.
The material in this News Report is compiled by NBIAP's Information Systems for Biotechnology, a joint project of USDA/CSREES and the Virginia Polytechnic Institute and State University. It does not necessarily reflect the views of the U.S. Department of Agriculture or of Virginia Tech. The News Report may be freely photocopied or otherwise distributed without charge. P.L. Traynor, Editor.
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