By Amanda Lyle, Assistant, Managing Editor and Michael J. Harris, Managing Editor
Extracting hope from dire situations
Judging by television's line-up of shows like "CSI" and "Bones," DNA forensics is a current hit. But it's not only TV networks that are realizing the potential of forensics-from governments to private corporations, forensic science is used today in more ways than ever before.
It has only been over the past 10 years, however, that DNA's use in criminal cases and archeology has become widespread. This is due to several factors: New methods of DNA analysis have allowed smaller samples and more degraded samples to be analyzed, and government databases of previous offenders are growing, allowing more crimes to be solved through DNA evidence.
The market for DNA forensics in drug development is young also, but replete with opportunities to ignite fresh, innovative applications such as pharmacogenomics and personalized therapies that have the potential to increase efficacy and reduce side effects associated with traditional therapeutics that are targeted to the same general mass audience with a "one drug fits all" approach.
A brief history of DNA
DNA (deoxyribonucleic acid) was discovered in the middle of the 19th century, although it wasn't until 1943 that Oswald Avery, an American with the Rockefeller Institute, proved that DNA carries genetic information. In the past, it was thought that genetic material was carried in proteins, and even after Avery's discovery, many scientists still believed DNA was too small to carry genetic information.
The work of Cambridge University graduate student Francis Crick and research fellow James Watson left no room for doubt. They had created a failed model of DNA, and were advised by the head of their department to cease their research. Watson and Crick were determined to continue, however, and it was well worth their time. In 1953, they discovered the molecular structure of DNA-the double helix. The finding earned Watson, Crick and Maurice Wilkins a Nobel Prize in 1963. Wilkins, with Rosalind Franklin, had produced the X-ray crystallography data used in deciphering the structure of DNA.
Today it is common knowledge that the sides of the DNA helix are sugar and phosphate molecules and that its four bases-adenine, cytosine, guanine and thymine (also called A, C, G and T)-form "rungs" that connect each side of the helix "ladder."
Technologies for DNA forensics
Each human cell contains a copy of DNA, allowing analysis to be performed on samples from hair, skin, blood, sweat, saliva and semen. Human cells contain two types of DNA-nuclear and mitochondrial. About five percent of DNA contains chromosomes, and the rest is non-coding DNA, or "junk" DNA. Humans have 23 pairs of chromosomes that contain the DNA blueprint. Half of each chromosomal pair is inherited from the mother and the other half from the father.
DNA analysis can be used for identification because about .1 percent of human genomes differ from others. Areas in the genome where there is a high amount of diversity are called polymorphic regions. These regions consist of DNA polymorphisms that can be used for forensic analysis and genetic mapping.
There are two types of repetitive sequences-variable number tandem repeats (VNTRs) and short tandem repeats (STRs), also called microsatellites. While both VNTRs and STRs can be used in DNA analysis, genomes contain more STRs, and they are easier to characterize than VNTRs. The number of repeats at specific points, called loci, will vary from person to person. These are analyzed to determine a person's statistically unique genetic profile. Since people have the same base pairs in their DNA but have different sequences, the Federal Bureau of Investigation (FBI) uses a standard 13 loci to ensure that the probability of finding two individuals with the same DNA profile is roughly one in one billion.
One of the first methods of forensic DNA analysis was restriction fragment length polymorphism, or RFLP (pronounced "rif-lip"). Compared to other methods, RFLP requires a large amount of DNA for analysis and is now rarely used in forensic work.
Its use declined greatly with the advent of polymerase chain reaction (PCR), a DNA amplification process in which millions of copies of DNA can be created from a sample as small as one nanogram. DNA's base pairs will form only between A and T and between G and C. PCR works by splitting DNA strands, which will then produce the missing half. The process was used extensively in the Human Genome Project.
DNA samples can also be analyzed using mitochondrial DNA (mtDNA) analysis. Unlike other methods, which use nuclear DNA (found in the nucleus of a cell and containing a mixture of both parents' genetic codes), mtDNA is found outside the nucleus and is inherited only from one's mother. Compared to methods using nuclear DNA, mtDNA analysis is slow and expensive, but often used in analyzing ancient DNA. Y-chromosome analysis is used for DNA analysis of male-to-male relationships.
A new era in crime scene analysis
In the criminal justice system, DNA is used for two main purposes-to identify criminals and to exonerate the innocent. It was first used for forensic work in 1984 by British scientist Sir Alec Jeffreys. At the University of Leicester, he and his colleagues were tracking genetic variations when they found that maps of DNA sequences were different from person to person. In 1985, DNA was used in an immigration case, and in 1986, DNA evidence exonorated an innocent man and led to the the arrest of a rapist and murderer in the Enderby murders case. About 10 years later, police in Britain created a database of genetic fingerprints to assist in criminal cases.
In the United States, the DNA Identification Act of 1994 gave the FBI the authority to start a national DNA index to assist with solving crimes, and the National DNA Index System (NDIS) began operating in 1998. The NDIS is now the highest level of the three-tiered COmbined DNA Index System (CODIS), the other two being state (SDIS) and local (LDIS) indexes. According to the FBI, CODIS has been installed in more than 100 laboratories nationwide. All 50 states have passed legislation mandating the DNA profiles of particular convicted offenders be sent to CODIS.
There are two components to CODIS-a forensic index which contains DNA profiles from crime scene evidence and an offender index, made up of DNA profiles of individuals convicted of violent crimes or felony sex offenses, depending on each state's law. The database currently has well over a million entries in its Convicted Offender Index and approximately 50,000 DNA profiles collected from crime scenes that have not been matched to any specific criminal.
By December 1999, CODIS had assisted in more than 1,100 investigations. Through June 2005, more than 25,000 investigations had been aided through CODIS. Kirk Bloodsworth was the first person on death row who was exonerated based on DNA evidence. In 1984, when he was 24 years old, he was sentenced to death for rape and murder. After almost nine years behind bars, it was confirmed through scientific testing that the semen at the crime scene was not his.
The Innocence Project (www.innocenceproject.org), a nonprofit group dedicated to post-conviction DNA testing, keeps the number of exonerated people posted on its homepage: As of September 2005, DNA testing had absolved 162 people from wrongful convictions.
Washington power and funding drives the market
The U.S. government has also recognized the need for a greater use of DNA forensics in the courtroom. The Bush administration created an initiative in March 2003 called Advancing Justice Through DNA Technology, which outlines problems and solutions for DNA use in the criminal justice system.
According to the report, the primary issues in the field include a deficiency in up-to-date technology and backlogs of DNA that require analysis. The executive summary of Advancing Justice Through DNA Technology states that President George W. Bush proposed more than $1 billion over five years for DNA technology uses. In addition to eliminating the backlogs of unanalyzed DNA samples, the initiative promotes research and development that will allow more degraded, as well as smaller, samples to be analyzed; cheaper and faster analysis methods; training people in all areas of the criminal justice system; and strengthening the capacity of local, state and federal crime labs in order to prevent backlogs in the future. In addition, the initiative supports the use of post-conviction DNA testing to help protect the innocent from wrongful convictions. More information about the initiative is available at www.dna.gov.
The DNA Initiative, Advancing Justice Through DNA Technology, calls for $232.6 million in federal funding for FY 2004. This includes $100.7 million in new funding. In addition, as part of the $232.6 million, the Department of Justice (DOJ) is targeting $13.5 million in FY 2004 funding from existing programs within the Office of Justice Programs to support the DNA Initiative. (See chart, below)
In a DOJ announcement issued in April 2005, Deputy Attorney General James B. Comey announced, as part of the intiative, awards of $14.2 million to law enforcement agencies nationwide to aid in cracking old, unsolved cases and identifying the missing using DNA evidence. The announcement was made at the inaugural DOJ conference on the missing and unidentified dead, the National Strategy Meeting: Identifying the Missing. For more on this meeting and related information, go to www.ojp.usdoj.gov.
Additionally, a directive was declared to establish a national task force on solving cases of missing persons and unidentified remains. The task force, to consist of law enforcement personnel from all levels of government, the forensic medical community, the crime victims community, and other professionals with applicable experience and proficiency, intends to review and recommend how the DOJ can improve the quantity and quality of information.
Several law enforcement agencies, prosecutor's offices, and crime labs across the country have established innovative programs to review old cases. These programs have enabled criminal justice officials to solve cases that have languished for years without suspects. Increasingly, DNA evidence has been the factor in resolving these cases.
To support such resolution efforts, the National Institute of Justice (NIJ), the research and development agency of the DOJ, released the solicitation "Solving Cold Cases With DNA." From this solicitation, 132 proposals were submitted and 38 awards totaling more than $14 million were issued in FY 2005. Equivalent awards issued in FY 2004 totaled $13.5M.
The need and funding for DNA forensics continue to grow. On September 19, 2005, the DOJ announced $98 million in nationwide grants to be awarded, including more than $84 million in DNA grants nationwide, as part of the DNA Initiative, and $13.6 million awarded to improve criminal justice forensic services.
While DNA technology is helping to solve crimes and exonerate the innocent across the country, many public crime laboratories are not fully equipped to handle the increased demand for DNA testing. This has implications for public companies to consider entering this field to compete for the business of eliminating the huge backlog or addressing the need for more expedient data profiling and storage tools. According to a study funded by the DOJ, approximately 542,700 cases either have biological evidence still waiting to be profiled into the system or backlogged at forensic crime laboratories. That number is projected to increase annually, as crime, conflict and disaster activities and events increase. These grants will help to make it realistic that local jurisdictions with the greatest DNA backlogs can directly benefit from federal funds.
Nationwide, according to NIJ statistics, the agency has awarded $18 million for DNA casework; $30.3 million for DNA capacity building for crime lab improvement; $4 million for DNA training; $7.7 million for DNA research and development; $1.5 million for DNA testing for missing persons; and $20.6 million for convicted offender testing. NIJ will also issue $13.6 million for Paul Coverdell Forensic Science Improvement Grants to be applied to improving non-DNA forensic services. This funding represents the largest amount of money provided by the DOJ to support state and local forensic efforts.
As part of the DNA Initiative, the NIJ awarded $2 million to five jurisdictions in a pilot program to help solve high-volume property crimes. Evidence now suggests that DNA evidence may assist law enforcement in solving these crimes, such as burglary and theft, and can prevent future property crimes and more serious offenses. The DOJ has selected five sites to participate in a $2 million, 18-month pilot project that will assess the cost-effectiveness of expanding the collection of DNA evidence from high volume serious crimes to property crimes, particularly burglary. The five sites are: Denver, CO ($417,207); Orange County, CA ($495,505); Los Angeles, CA ($436,077); Phoenix, AZ ($500,000); and Topeka, KS ($141,500).
Disasters bring additional uses of DNA forensics
Advancing Justice Through DNA Technology also calls for education and outreach for using DNA to identify missing persons. Unfortunately, world disasters such as tsunamis and terrorist attacks kill thousands of people, leaving many unidentified bodies. It helps ease the pain for victims' families, however, when the remains of their loved ones are found and identified.
A recent example is Hurricane Katrina, which struck the Gulf Coast in September 2005. As the death toll neared 500 less than two weeks after the disaster, officials estimated that nearly half of the bodies would need to be identified with DNA matches from the victims' personal items or samples from relatives. Since many of the victims were underwater for days, and with personal items that could be used to obtain DNA underwater as well, officials estimated that identifying all of the bodies could take years. The effort will call for the cooperation of family members of missing persons, who will need to provide DNA samples in order prove kinship through DNA similarities.
Days after the disaster, the DOJ awarded $1.5 million to the University of North Texas to help identify the missing and unidentified dead recovered as a result of Hurricane Katrina. The agency also awarded $4.4 million in DNA Initiative and other forensic service funds to states affected by Hurricane Katrina: Louisiana, Mississippi and Alabama. These funds will be used to assist in the recovery of damaged local and state crime laboratory capacity and identification of remains.
Similarly, more than half of the people killed in the attacks on the World Trade Center on September 11, 2001 were identified using DNA analysis. Many of the DNA samples were difficult to use due to sample degradation caused by extreme heat. There is now a DNA database called the Mass Fatality Identification System, or M-FISys, created by Ann Arbor, MI-based Gene Codes Corporation. The system contains DNA profiles from victims' relatives, profiles created from samples from victims' personal items (such as toothbrushes) and DNA profiles from the site of the disaster. This software was also used by the government of Thailand to standardize its victim identification efforts after the 2004 Sumatra-Andaman earthquake and subsequent tsunami.
Forensic scientists also tried to determine the fate of Osama bin Laden and other al-Qaeda leaders from tissue samples collected from the Tora Bora cave in Afghanistan. DNA evidence will be used by prosecutors of Saddam Hussein, in order to identify victims of his regime.
Due to the events of September 11, the U.S. government placed a high priority on the use of forensics. One example is the Department of Homeland Security National Biodefense Analysis and Countermeasures Center (NBACC), as outlined in accordance with the Homeland Security Act of 2002 and the Homeland Security Presidential Directive "Biodefense for the 21st Century." Located at Fort Detrick, MD, it is managed by Homeland Security's Science and Technology directorate. Part of NBACC will be the National Bioforensic Analysis Center (NBFAC), which will facilitate forensic analysis of evidence from bio-crimes and terrorist attacks in order to identify perpetrators and to discover the methods and origins of attacks. Groundbreaking on the facility is expected in 2006, and the completion of the NBACC is expected in 2008.
Avoiding mishaps, mistakes and misinformation
In May 2005, an independent audit of Virginia's central crime lab prompted the state's governor to order a review of 150 cases handled by the laboratory, which is run by the Division of Forensic Science. The lab twice botched the DNA tests for the capital murder case of Earl Washington Jr., who was only a few days away from execution when his sentence was changed to life in prison due to questions concerning the evidence. After additional DNA analysis, Washington was released in 2001. The auditor's report also recommended that procedures be developed "to insulate the lab from any outside political pressures," an issue during the Washington case. Since DNA evidence is considered virtually fail-proof in so many ways, it can also be dangerous. A mistake in the laboratory could lead to the loss of innocent human lives. Since it is possible to plant DNA at crime scenes, results of analysis could point to an innocent person as a suspect.
Another potential issue in DNA forensics is the degradation of DNA samples, which occurs when a sample breaks into small units due to microbial or environmental causes. Common causes of degradation include temperature, humidity, sunlight and exposure to chemicals. It is a particular issue in bone analysis and archeological DNA analysis.
Ancient DNA is highly susceptible to contamination, even in the confines of a laboratory. Modern DNA exists in higher concentration, and even trace amounts, for example from hair or skin cells, can contaminate more fragile DNA samples.
New approaches such as the MiniSTR test and analyzing single nucleotide polymorphisms, or SNPs, are helping to combat the problems with sample degradation.
The cutting edge of DNA forensics
As DNA analysis is perfected and as methods are simplified, it will continue to be used in more ways. The U.S. military, for example, has started using DNA profiles in place of dog tags: New recruits are required to provide blood and saliva samples to use for identification purposes in the event of personal tragedy.
It is predicted that as new field-testing instruments are developed and analysis duration times are reduced, DNA testing will move from the crime lab to the crime scene. In the future, even smaller and more degraded DNA samples will be able to be analyzed.
Additionally, the types of DNA evidence in the courtroom will become more and more unique as evidence extends to include DNA from animals, plants and insects. A man in Canada was convicted of murder because a hair from his parent's cat was found at the crime scene. Some databases already contain DNA profiles from cat and dog hair samples.
According to an article in New Scientist on March 5, 2005, another novel application of using DNA could be determining the time a rape occurred. A study conducted by Ginger Lucero and Ismail Sebetan at the National University in La Jolla, CA, revealed that the number of viable sperm in condoms with spermicide decrease at a specific rate, which would establish a timeframe.
DNA can also be used to identify sports memorabilia, such as valuable pieces from the Super Bowl and the Olympics. The National Football League uses Newport Beach, CA-based PSA/DNA Authentication Services to help prevent the counterfeiting of Super Bowl footballs. More than 100 footballs used in Super Bowl XXXIX in February 2005 were marked with a synthetic DNA strand that can only be seen when illuminated by a specific laser frequency. The company has also authenticated the bat Babe Ruth used to hit the first home run in Yankee Stadium in 1923, Hank Aaron's 715th homerun baseball and bat, and "Shoeless" Joe Jackson's "Black Betsy" baseball bat.
Since PCR amplification can be used to create a profile from such small DNA samples, DNA can now be gathered from a variety of sources. A glass that a person has sipped from, licked stamps and envelopes, or even bedclothes that contain dead skin cells, can be used to gather samples of DNA.
The current market: opportunities and expectations
Applications for DNA forensics are increasing steadily. In the U.S., more than 100 colleges offer forensic science programs, and programs in other countries are growing as well. One example is the Forensic Laboratory for DNA Research at Leiden University in the Netherlands, which is focused on studies using Y-STRs. The University of Technology, Sydney in Australia boasts the Centre for Forensic Science, and the mission of the University of Maine Molecular Forensics Laboratory (UMMFL) is to process evidence and provide testimony for cases investigated by the Maine Warden Service.
Trent University's Wildlife Forensic DNA Laboratory in Peterborough, Ontario, Canada, provides species, individual and population identification; parentage analysis; and expert testimony and consultation. The Duke University DNA Analysis Facility provides automated DNA sequencing and fragment analysis.
In addition to service-based institutions and businesses that provide DNA analysis, companies are expanding or merging to develop tools and systems for quicker and more accurate DNA analysis.
Affymetrix Inc. (NASDAQ: AFFX), based in Santa Clara, CA, provides arrays, reagents, software and instrument systems, including the popular GeneChip DNA Analysis Platform. Two of the company's GeneChip microarrays were used by researchers at Johns Hopkins School of Medicine and the National Institutes of Health, who discovered mutations in stem cells due to technology that allows for the scanning of the stem cell genome at a very detailed level. In May 2005, Affymetrix entered into a definitive agreement to acquire South San Francisco, CA-based ParAllele BioScience Inc., The combination of Affymetrix' GeneChip technology and ParAllele's proprietary assay effectively gives their researchers a powerful "molecular microscope" for examining the entire genome and performing detailed analyses from tens of thousands of sites within the genome, allowing them the freedom to design virtually any experiment they want.
Los Angeles-based Applied DNA Sciences Inc. (OTC BB: APDN) protects corporate and intellectual property with its line of DNA embedded biotechnology products. With the high level of verification DNA provides, the company can protect against fraud, counterfeiting and piracy. The World Health Organization, in September 2005, announced study results that estimate 10 per cent of all drugs distributed in Europe, 20 per cent in Russia, 40 per cent in Mexico, and up to 80 per cent in Northern Africa, are counterfeit. And that approximately 20 per cent of all drugs ordered over the internet outside of the U.S. and Canada are bogus. Such statistics underscore the challenge and opportunity that characterize this market.
Applied Biosystems Group (NYSE: ABI), one of three businesses of Applera Corp., has formed a strategic marketing and technology agreement with DuPont Qualicon to develop next-generation DNA detection tests and systems for food testing based on Applied Biosystems' PCR technology.
QIAGEN (NASDAQ: QGEN) provides kits that can meet new forensics demands such as RNA and plant, animal and insect samples. Products include the QIAamp DNA Mini Kit and the QIAamp DNA Micro Kit. The company has three automation platforms-the BioRobot EZ1 workstation, the BioRobot M48 workstation and the BioRobot Genetyping System. QIAGEN also offers whole genome amplification, using REPLI-g technology, as well as products for PCR enzymes and kits.
In addition to forensic and family relationship DNA testing services, Orchid Cellmark (NASDAQ: ORCH) provides food safety and selective trait breeding. The company worked with the New York City Medical Examiner's Office to conduct SNP-based genotyping tests in order to identify victims after the September 11 atacks. Orchid Cellmark (formerly Orchid BioSciences Inc.) is focused on global opportunities for immigration DNA testing and agriculture DNA testing services. Currently the company is the world's largest provider of scrapie susceptibility genotyping, which assists farmers in breeding sheep with a reduced risk for the fatal disease.
With more ways to use DNA being discovered and with backlogs of DNA samples that need to be analyzed, the market is primed for launching DNA forensics products and services. Faster methods of analysis are needed, as are products that can analyze genomes in greater detail. One of the most difficult aspects of analyzing DNA is working with degraded samples. Methods that can analyze smaller and more degraded samples will likely do well in the market, and low cost methods of DNA analysis will allow more uses of current technology. As more DNA profiles are added to databases, improved methods of organizing data and ensuring accuracy will be needed, thus further enabling the market for forensics tools.
The Future of Forensics
Most people respond well to medicines for specific indications, but in the U.S., more than 100,000 deaths each year are due to adverse reactions to medications and approximately 2.2 million people each year experience serious reactions to drugs. Others take medicine without responding at all. Scientists say that certain SNPs-genetic changes in DNA sequences-may predispose individuals to disease or influence their response to drugs. These markers are expected to revolutionize disease detection and medicine. If doctors could look at patients' SNP profiles, they could prescribe personalized medicine. Comparative forensics could play a part in developing products that anticipate and address patient susceptibility, response, tolerance and other factors in drug discovery efforts in the future.
Another benefit of genomic data's use in medicine is that it is likely to produce new methods and breakthroughs in target validation, the method used to determine if a molecular target is involved in the disease process. Currently, the majority of drugs are made from approximately 500 molecular targets, but the potential exists for thousands more to be discovered and the analysis of forensics data could be used in the process.
Because DNA can be used to determine individuals' and ethnic groups' propensity to certain diseases, personalized medicine will allow better preventive care, as well as improved treatments that are tailored to individuals. Cancer drugs such as Novartis Pharmaceuticals Corp.'s Gleevec, AstraZeneca Group plc.'s Iressa and Genentech Inc.'s Tarceva have already demonstrated more effectiveness in people with certain genetic profiles. As progress is made in the field, genetic tests will be used to determine individuals' predisposition to specific diseases, which drugs will likely work well, and if any adverse reactions are likely.
A major breakthrough in the field was the approval of Roche Diagnostics' AmpliChip CYP450 Test, now available for in vitro diagnostic use in the U.S. and Europe. The first pharmacogenomic microarray designed for clinical applications, it aids in individualizing treatment doses for therapeutics metabolized through genes that have a role in the metabolism of approximately 25 percent of prescribed medications. The growth in pharmacogenomics is expected to be tremendous in the next five-to-20 years, as new genetic tests are developed and custom treatment plans become more standard. Forensics can likely be a front-end beneficiary of any pharmacogenomics success.
Biodefense and biosurveillance
A main biodefense application for DNA forensics is the development of vaccines. For example, The Dale and Betty Bumpers Vaccine Research Center (VRC) at the National Institutes of Health is currently developing a DNA-based vaccine against West Nile virus in collaboration with San Diego, CA-based Vical Inc. Phase I clinicals for the vaccine began in April 2005. The VRC is also working with Vical on a severe acute respiratory syndrome (SARS) DNA-based vaccine, which entered Phase I clinicals in December 2004.
Currently, biodetection systems which use DNA analysis technologies are not very widespread. They are expensive and complex, as well as time-consuming. Some biodetection technologies that are used are single molecule DNA interrogation and ultra high-throughput DNA sequencing.
In April 2003, DNA samples from plants that lived 400,000 years ago were discovered in Siberia, preserved in ice. It was arguably the oldest DNA ever discovered. Although some people have claimed to have extracted DNA from dinosaur bones, most scientists agree that most DNA cannot survive more than one hundred thousand years. DNA starts to degrade when an organism dies, and the DNA can be contaminated by other environmental factors, such as microorganisms that break down dead plant and animal matter.
An example of ancient DNA analysis is Kennewick Man, whose remains were found in July 1996 in Kennewick, WA. He is thought to have lived in 7,200 B.C. Claims to his remains were made by Native American groups, as well as scientists and the government. Extensive DNA tests were performed to determine his origins.
DNA analysis also ended a more than 200-year-old debate—the fate of the son of French King Louis XVI and Marie Antoinette. DNA analysis confirmed that he died in prison while still a child.
Some scientists hope to learn about other planets through DNA. The Centre for Cellular and Molecular Biology (CCMB) established a facility for Ancient DNA studies in Hyderabad, India, which will investigate the existence of life on Mars.
Many questions have arisen with the advent of DNA forensics. Ethical issues include the possibility of genetic discrimination, such as insurance companies denying coverage based on genetic make-up and discrimination in the workplace. Some issues were portr ayed in the 1997 film Gattaca, set in a future society where a naturally born individual is restricted from opportunities provided to the genetically enhanced. Privacy issues exist in many gray areas, such as in situations in which testing parents can provide information about their children by default. Legislation such as S. 306: Genetic Information Nondiscrimination Act of 2005 will likely become more commonplace as measures are taken to prevent genetic abuse and discrimination. Passed by the Senate in February 2005, the bill is now waiting to be voted on by the House of Representatives. It "prohibits discrimination on the basis of genetic information with respect to health insurance and employment."
Privacy issues are also arising when determining ownership of DNA profiles and to whom they ultimately belong-the person whose DNA was analyzed, the government or the lab that analyzed it. In Virginia, for example, DNA samples are collected from all adults arrested and charged with felony crimes. There is no known provision for discarding or turning the profile over to the individual, even if he or she is proven innocent. The passing of Proposition 69 in California requires that DNA samples be taken from individuals convicted of felonies, as well as adults arrested on suspicion of murder or for some sex crimes. Some argue that the practice violates the presumption of innocence because these databases now include DNA profiles of those not convicted of crimes.
Practices regarding the determination of whom to select for DNA sampling is also a cause for concern. In the United Kingdom, all arrestees can be compelled to submit DNA samples, regardless of the degree of the alleged crime or the possibility that the suspect may later be acquitted. In the U.S., abuse of Fourth Amendment rights against unwarranted search and seizure may come into question if law enforcement officials resort to arresting citizens on less than probable cause just to obtain DNA samples.
Another looming issue regards the approach insurance providers will take as personalized medicines become available. A therapeutic that is created to treat an individual will undoubtedly cost more than a traditional one that was created to treat a general range of patients with no consideration of any specific genetic profile. The costs of prescription medicine would be reflected by classes: generic, brand and customized, and there is concern by advocacy groups that the price of personalized medicine would only be affordable to a limited segment consisting of wealthy patients.
The future of DNA forensics
The potential applications for DNA forensics are myriad. Its commercial applications include authenticating wine, determining the pedigree of livestock and other animals, and marking artwork to prevent fraud. In environmental applications, DNA forensics can be used to identify and track endangered species and detect harmful agents in the air, water and soil.
It is expected that the DNA forensics market will continue to grow for many years, and that new developments will continue to be made. This year, for example, 454 Life Sciences, a company formed in 2000 with a mission to sequence whole genomes in days, not months, reported that it has found a way to sequence a human genome in four hours, as opposed to the standard 36 hours-to-several weeks. With such breakthroughs as that, DNA sequencing technologies will become less expensive and faster, and a new era of pharmacogenomics opportunities would ensue.
Governments have already recognized the importance of DNA forensics in the criminal justice system. Demand, and subsequently funds, for DNA profile databases and crime labs are expected to continue to increase in the quest to administer justice. Due to the threats of biological warfare, DNA use in biodefense and biosurveillance is projected to remain at the forefront of initiatives.
The direct involvement of forensics in biotechnology drug discovery markets is forecasted to mature and grow in value at a more deliberate pace than its criminal justice or identification/authenticity counterpart disciplines, as those applications are currently in heavy use and are expected to continue to experience steady growth over the forecast period. Still, the forensics therapeutics market will eventually equal them, as the science behind pharmacogenomics and personalized medicine validates itself in the clinic, leading to well-received indication- or individual-specific medicines. The capability of forensics to participate in the analysis of unique DNA sequences in order to precisely identify the characteristics of individuals or species will render it a marketable and valuable element in the biotechnology industry.
The DNA forensics market will continue to be led by the sectors with applications in legal, law enforcement and biodefense environments. Gradually, the balance should shift, as therapeutics derived from forensics origins or incorporated into pharmacogenomic medicines assert a more dominant value in a $1.477 billion market by 2014. The worlwide 2006 market, valued at $197.4 million, is forecasted to grow to $366 million in 2008, $736 million in 2010 and $1.010 billion in 2012. The pharmacogenetics market, worth $21.4 million in 2006, will increase to $46.9 million in 2008, $165.1 million in 2010, $243.3 in 2012 and $356.8 million in 2014
Increasing crimes, arrests and the need to stay ahead of counter-technologies which will attempt to legally discredit or criminally circumvent DNA technology will propel the judicial and law enforcement segment to grow from a 103.9 million market in 2006 to a $494.6 million industry in 2014. International conflicts, civil wars and homeland security issues will fuel growth in the biodefense sector. BioWorld concludes that this market, representing $41.3 million in 2006, is forecasted to reach $76.8 million in 2008, $76.8 million in 2010, $243.3 million in 2012 and 356.3 million in 2014.
Corporate and personal security applications are projected to capitalize on the growing concerns of individuals and businesses regarding privacy, safety and protection beyond the level that government provides, according to BioWorld research. The value of this market, estimated at $30.8 million in 2006, is forecasted to grow to $51.8 million in 2008, $111.5 million in 2010, $188.4 million in 2012 and $269.7 million in 2014.
Unfortunately, crime is a permanent element in society, bioterrorism has become an increasingly daily regard worldwide and natural and accidental disasters and catastrophes are unstoppable forces that will create situations that forensics tools and products will best address. This is far from a "feel good" market that can advertise its cures with humorous commercials that appeal to the masses. Nevertheless, there is purpose, inevitability, necessity, fulfillment and reward in addressing the effects of diseases that zero in on genetic targets ranging from one person to entire ethnic groups. The same holds true regarding events such as war, plague and environmental calamity that have the large-scale capability to ruin multiple lives, exterminate species or threaten large areas of Earth.
The issues of privacy, misuse and discrimination will impinge on the DNA forensics sector, attributable to concern over personal data in the hands of unknown private-sector and government entities. Apprehension may especially be high when considering the fact that many of those government agencies were founded, in part, to engage in clandestine activities and are not easily made to be accountable to private citizens. The public is currently tentative over the widespread use of data such as social security numbers and credit reports for identification and profiling purposes by businesses and government. Consider the anxiety that having your entire genetic makeup profile in the hands of similar entities could create.
Even though the primary issues of privacy and potential discrimination associated with DNA forensics were only identified, but not resolved by the Human Genome Project or the DNA Initiative, there is still always the opportunity to legislate those concerns.
Those issues will certainly have to be addressed; however, their impact will stir debate and most likely induce changes on the fly in the industry, but they not projected to severely impede the market.
DNA, or pharmacogenetics, testing for personalized drug development purposes which can pinpoint genetic flaws that contribute to disease, or for the customized prescription of medicines that match DNA with the most efficacious therapeutic dosage or composition will eventually comprise the most substantial segment. Forensics will be a component of the success generated by the gene therapy boom of bioinformatics, pharmacogenomics and molecular diagnostics.
List of related organizations
American Academy of Forensic Sciences www.aafs.org
American Board of Criminalists www.criminalistics.com
American Society of Crime Laboratory Directors www.ascld.org
Association of Forensic DNA Analysts and Administrators www.afdaa.org
British Academy of Forensic Sciences www.bafs.org.uk
British Association for Human Identification www.bahid.org
California Association of Criminalists www.cacnews.org
Canadian Society of Forensic Science www.csfs.ca
European Network of Forensic Science Institutes www.enfsi.org
Forensic Science Society www.forensic-science-society.org.uk
International Association of Bloodstain Pattern Analysts www.iabpa.org
International Association for Identification www.theiai.org
International Association for Microanalysis www.iamaweb.com
International Association of Forensic Sciences www.iafs2002.com
International Association of Forensic Toxicologists www.tiaft.org
International Society for Forensic Genetics www.isfg.org
International Society of Environmental Forensics www.environmentalforensics.org
Mid Western Association of Forensic Scientists www.mafs.net
National Institute of Justice www.ojp.usdoj.gov/nij
National Forensic Science Technology Center www.nfstc.org
National Institute of Forensic Science www.nifs.com.au
National Institute of Standards of Technology www.nist.gov
Northeastern Association of Forensic Scientists www.geocities.com/CapeCanaveral/Lab/ 5122
Southwestern Association of Forensic Scientists www.swafs.org
Southern Association of Forensic Scientists www.southernforensic.org
StaR Base (Short Tandem Repeat DNA Internet DataBase) www.cstl.nist.gov/biotech/ strbase
The American Journal of Forensic Medicine and Pathology www.amjforensicmedicine.com
Environmental Forensics www.environmentalforensics.org
Forensic Magazine www.forensicmag.com
Forensic Science Communications www.fbi.gov/hq/lab/fsc/current/index.htm
Forensic Science International www.elsevier.com/wps/find/journaldescription.cws_home/505512/description...
The International Journal of Legal Medicine http://springerlink.metapress.com
Journal of Clinical Forensic Medicine www.harcourt-international.com/journals/jcfm
Journal of Forensic Sciences www.aafs.org
The Journal of Legal Medicine www.tandf.co.uk/journals/titles/01947648.asp
Science & Justice www.forensic-science-society.org.uk/publications/saj.html
Outside of the US
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Outside the U.S.: +44-203-684-1796
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