DNA analysis for disease risk isn’t catching on among consumers

Connected to Google by both love and money, 23andMe seems the epitome of a 21st-century company — a cutting-edge merging of biotechnology and the Internet, with a dash of celebrity thrown in.

The scarce ingredient so far is customers.

23andMe is the most prominent of a trio of companies that in 2007 began using the Web to market personal genomics services. The companies scan people’s DNA, promising to tell them their risks of getting dozens of diseases. Propelled by its co-founder Anne Wojcicki, the wife of Google’s billionaire co-founder Sergey Brin, 23andMe attracted attention by holding swanky “spit parties” where people gave saliva samples for DNA analysis. Rich and famous people like Rupert Murdoch, Harvey Weinstein and Ivanka Trump became customers and in some cases investors.

But for the common consumer, 23andMe’s service — and those from its main competitors, Navigenics and DeCode Genetics — have been a much harder sell. Two and a half years after beginning its service, 23andMe has only 35,000 customers. And at least one quarter of them got the service free or for only $25, instead of the hundreds of dollars on which the business model is based. Navigenics and DeCode have even fewer customers.

The low turnout suggest that many people have not yet embraced the genomics age. It does not help, either, that the services cost $300 to $2,000 and have been trying to catch on during a severe recession.

But the services face an even more fundamental problem: In most cases, the current level of DNA scanning technology and science is unable to offer meaningful predictions about the risk that a person will get a disease.

“It is a really wonderful form of recreation,” said Scott R. Diehl, a geneticist at the University of Medicine and Dentistry of New Jersey. But as for applying it to health care, he said, “It’s very premature.”

The companies have been forced to adjust. Named for the 23 pairs of human chromosomes, 23andMe went through two rounds of layoffs last year. The company, which is privately held and based in Mountain View, Calif., has fewer than 40 employees, down from a peak of about 70. Navigenics, based in Foster City, Calif., is on its third chief executive in a year and has also trimmed its workforce. It is now marketing to doctors and corporate wellness programs rather than consumers.

People close to the company estimate that Navigenics has about 20,000 customers, at least 5,000 of whom were given big discounts to be in a study.

And DeCode Genetics, based in Iceland, passed through bankruptcy following heavy spending to develop drugs and diagnostic tests. The DecodeMe personal genomics service, while only one part of the company’s business, apparently attracted fewer than 10,000 customers.

Cheap DNA sequencing will drive a revolution in health care

The dream of personalized medicine was one of the driving forces behind the 13-year, $3 billion Human Genome Project. Researchers hoped that once the genetic blueprint was revealed, they could create DNA tests to gauge individuals' risk for conditions like diabetes and cancer, allowing for targeted screening or preëmptive intervention. Genetic information would help doctors select the right drugs to treat disease in a given patient. Such advances would dramatically improve medicine and simultaneously lower costs by eliminating pointless treatments and reducing adverse drug reactions.

Delivering on these promises has been an uphill struggle. Some diseases, like Huntington's, are caused by mutations in a single gene. But for the most part, when our risk of developing a given condition depends on multiple genes, identifying them is difficult. Even when the genes linked to a condition are identified, using that knowledge to select treatments has proved tough (see "Drowning in Data"). We now have the 1.0 version of personalized medicine, in which relatively simple genetic tests can provide information on whether one patient will benefit from a certain cancer drug or how big a dose of blood thinner another should receive. But there are signs that personalized medicine will soon get more sophisticated. Ever cheaper genetic sequencing means that researchers are getting more and more genomic information, from which they can tease out subtle genetic variations that explain why two otherwise similar people can have very different medical destinies. Within the next few years, it will become cheaper to have your genome sequenced than to get an MRI (see "A Moore's Law for Genetics"). Figuring out how to use that information to improve your medical care is personalized medicine's next great challenge.

Genetic testing for breast or ovarian cancer risk may be greatly underutilized

Although a test for gene mutations known to significantly increase the risk of hereditary breast or ovarian cancer has been available for more than a decade, a new study finds that few women with family histories of these cancers are even discussing genetic testing with their physicians or other health care providers.

In a report in theJournal of General Internal Medicine, which has been released online, investigators from the Massachusetts General Hospital (MGH) Institute of Health Policy and Dana-Farber Cancer Institute note that their findings illustrate the challenges of bringing genetic information into real-world clinical practice. "Testing for BRCA1 and 2 mutations has been around a long time and should be a good indicator of whether genetic testing is making its way into regular medical practice," says Douglas Levy, PhD, of the MGH Institute for Health Policy, the study's lead author. "When a well-established genetic test is not being incorporated into clinical practice when appropriate, we are a long way from meeting the promise of personalized, genetically-tailored medical care.

"Most women's lifetime risk of breast cancer is about 13 percent, and the risk for ovarian cancer is less than 2 percent. But women with mutations in the BRCA1 or BRCA2 genes may be 3 to 7 times more likely to develop breast cancer and 9 to 30 times more likely to develop ovarian cancer than women with unaltered forms of the genes. Several organizations have issued clinical guidelines designating who should be screened for BRCA1/2 mutations, and while there have been discrepancies among the guidelines, all of them include a history of breast or ovarian cancer in close relatives among the criteria indicating elevated risk. The authors note that most U.S. health insurers cover at least part of the cost of BRCA1/2 testing for at-risk women.

New database for gene variations will help diagnosticians

Genetics researchers have unveiled a reference standard of deletions and duplications of DNA found in the human genome. Drawn from over 2,000 healthy persons, the study provides one of the deepest and broadest sets of copy number variations (CNVs) available to date, along with a new research tool for diagnosing and identifying genetic problems in patients.

A team from The Children's Hospital of Philadelphia published its high-resolution map and analysis of CNVs in the human genome in the July 10 online edition of the journal Genome Research.

In contrast to single base alterations of DNA, which are single nucleotide polymorphisms, or SNPs, often referred to as "snips," CNVs are larger variations in DNA structure. As changes to a single DNA letter, SNPs might be considered misspellings or alternate spellings of a word, while CNVs are losses of whole phrases, paragraphs or even pages (deletions), or are repeated sections (duplications). Some CNVs are inserted stretches of DNA from other parts of the genome. Both SNPs and CNVs contribute to genetic diversity and disease by changing the action of genes for which DNA carries coded instructions.

"We all carry a number of these variations in our own genomes," said study co-leader Peter S. White, Ph.D., a molecular geneticist and director of the Center for Biomedical Informatics at Children's Hospital. "Some CNVs contribute to a disorder, but most of them do not, and it is often challenging to determine which are important. One approach is to compare CNVs in healthy individuals to those in patients with a disease, to find those CNVs that seem to occur primarily in people with a certain disease. Our map provides a large and uniform baseline standard to indicate which CNVs represent normal variation."

The investigators analyzed DNA from blood samples taken from 2,026 subjects. The subjects were healthy children and their parents, all of them drawn from primary care and well-child clinics in the Children's Hospital health care network. Of the samples, 65 percent were from Caucasians and 34 percent from African Americans.

The CNV map has a higher resolution than most previous efforts, say the authors, with over 50,000 CNVs cataloged throughout the genome. Three-quarters of these were "non-unique," occurring in multiple unrelated individuals. A majority (51.5 percent) of these non-unique CNVs were newly discovered. On average, the healthy subjects in the study have approximately 27 CNVs each.

The researchers have posted the full CNV database on the Hospital's website, where it is freely available to gene researchers worldwide. The web browser also enables researchers to compare specific CNVs to those collected in public data repositories from other institutions.

"This resource will be very important in enabling rapid and accurate diagnoses of rare diseases resulting from CNVs," said lead author Tamim H. Shaikh, Ph.D., a molecular geneticist at Children's Hospital. These genetic diseases may be individually rare, but collectively occur at frequencies comparable to disorders such as Down syndrome. "In order to pinpoint the one CNV that is the cause of a disease, it is critical to quickly eliminate those that are part of the spectrum of normal variation that exists in the human genome. That's what this CNV data and other similar resources allow us to do," Shaikh added.

The authors went on to analyze DNA from a child with multiple congenital problems, including developmental delay and brain malformations. They found 35 CNVs, of which 32 were previously detected in healthy controls. Two of the patient's three unique CNVs were relatively small in size, but the third CNV was a deletion in chromosome 17 that encompassed 51 genes, including several that are active in early prenatal development. Unlike most of the other CNVs, it did not occur in the child's parents, strongly supporting the conclusion that the chromosome deletion arose spontaneously in the patient and that it caused the child's disease.

To detect CNVs in the thousands of samples, the investigators used automated gene-analyzing technology at the Center for Applied Genomics at Children's Hospital, directed by Hakon Hakonarson, M.D., Ph.D., a co-leader of this study. "Although these CNVs were detected in healthy children, they may have significant disease implications that may not manifest until later in life," said Hakonarson. Hakonarson and colleagues earlier published studies of CNVs in autistic spectrum disorders and attention-deficit hyperactivity disorder. Both studies found CNVs in gene regions involved in neurological development during early childhood.

The new database has another strength, added Shaikh. Because it analyzed large numbers of samples from both Caucasians and African Americans, it measured CNV levels that differ between the two ethnic groups, and enables clinicians to make more precise diagnoses. Shaikh added that the researchers expect to expand the database with larger sample sizes and data from additional ethnic populations.

In addition to its use in diagnosis, said White, the database may also assist researchers studying molecular evolution. For example, those investigating how genetic variations occurred as human populations spread across continents.

Source: Children's Hospital of Philadelphia

Start-Ups Bring Genetic Tests To The Home

By Brian Gormley

What’s in your DNA? Venture capitalists believe you’ll pay to find out.

A few venture firms are funding start-ups that promise to offer consumers insight into what their DNA says about ancestry or disease risks. While most of these services don’t diagnose disease, they say they can spot warning signs.

The latest company seeking to help consumers decode their genetic risk for disease isPathway Genomics Corp., which recently introduced its service to take on venture-funded companies such as Navigenics Inc. and 23andMe Inc., as well as publicly traded companies like deCODE Genetics Inc.

Pathway, based in San Diego, formed in 2008 and closed its most recent venture round in June, though it is not disclosing how much it raised. Investors include technology firm Founders Fund, Western Technology Investment, and Harry Edelson, who has funded several health care and technology companies through Edelson Technology Partners. Navigenics backers include Kleiner Perkins Caufield & Byers, while 23andMe has raised capital from New Enterprise Associates, Genentech Inc. and others.

Pathway Genomics will charge $249 for a service that provides consumers with their genetic risk to more than 90 health conditions by analyzing their genome for genetic markers. Consumers also can order an ancestry test for $199, or both services for $348.

Consumers can learn their genetic risk for several cancers, including those of the prostate and breast, cardiovascular diseases, rheumatoid arthritis, Type 1 and Type 2 diabetes, and many other diseases.

Its prices are in the range of what others charge: 23andMe offers a service that provides disease risk and ancestral information for $399, for example. Pathway Genomics performs its services at its own research lab, so customers’ DNA - taken from saliva samples that they send in after ordering a test from Pathway’s Web site - never leaves the company’s grounds. Its lab has State of California and Clinical Laboratory Improvement Amendments certifications.

For an additional fee, Pathway Genomics customers can also gain access to genetic counselors. The company hasn’t disclosed what it will charge for these services, but James Plante, founder and CEO, said the fees will only cover its expenses and won’t be a moneymaker.

“We think it’s an important service to have available. We don’t anticipate it being a profit center,” Plante said.

Improved understanding of how genetic variations influence health has combined with technological innovation to make such services possible. But since health insurers aren’t covering these offerings - at least not yet - anyone wanting these services will have to pay up for them. It’s as yet unclear how many people will do so.

Personalized Genomic Medicine: Are We and Our Doctors Ready?

Entangled with the national debate about the future of healthcare, there’s a personal debate about the future of medicine. Futuristic medicine will rely on personal genomics, because as consumer-patients, we will demand more integrated – more holistic -- less segmented medical care from our doctors. Personalized genomic medicine is not only our pipe dream for future, it is here, now. But, are we ready? Are our doctors ready? Are healthcare policy makers ready?

In June 2009, I gave a speech at the first Consumer Genetics Conference in Boston, where Dr. Francis S. Collins gave a riveting keynote speech. I was on the panel of speakers because I am a long-term consumer of genomics, having started in 1999, after reading that Dr. Collins and other geneticists were able to use DNA to trace human ancestors. I used DNA to trace ancestors to dozens of ethnic groups in Africa, and confirm my specific ancestral families in Ghana, West Africa. I have always been grateful to Dr. Collins and the other geneticists. This week, President Barack Obama nominated Dr. Francis S. Collins, a physician and genetic researcher, as Director of the National Institutes of Health (NIH), the government’s research laboratory in Maryland. Previously, Dr. Francis Collins directed the publicly-funded team at the National Human Genome Research Institute (NHGRI).

The public team he led brought us the Human Genome Project, which sequenced the human genome in 2000, completing the sequencing in 2003. He was locked in a fierce race to the finish line against J. Craig Venter, CEO of the private venture, Celera Genomics. Venter also sequenced the genome. Medical research, then and now, happens in waves, and is a race to the finish line by leaders and teams in the public, academic and private sectors.

At the Consumer Genetics Conference, the private, academic and public sectors were fully represented. As an author who has written about using DNA, genealogy and American family history to trace my ancestors to Ghana and Scotland, I was one of the few speakers on the panel who was not a MD/Ph.D. or CEO of my own biotechnology company. Other speakers were Kari Stefánnson, CEO of DeCode genetics, Linda Avery, Co-CEO of 23andMe, and CEOs of the country’s leading genetics companies. So today, while consumer-patients and politicians debate the future of healthcare and healthcare funding, biotechnology and pharmaceutical companies race ahead at the speed of light to develop personalized medicine. They race to tailor diagnoses, prescriptions and treatments to the each patient’s DNA.

Dr. Francis Collins’ speech at June’s Consumer Genetics Conference was very forward-looking and inspirational. He focused on how we can make the present and future delivery of medicine more efficient and more effective; how we can respond to what has to be researched and developed in genomic and molecular medicine; how we remain aware of current research and what is neglected or overlooked; and what we must all remember about scientific research and scientific progress. Scientific progress is unique and it explores the unknown.

Personalized medicine, he said, is at the frontier of medical research, it is the future of medicine. Cooperation and collaboration among the government, academic and private sectors must be fostered. Knowledge of the genome will revolutionize medicine, but for preventive medicine to be effective, there has to be usable data from a study that gives a genetic profile of the population. He called such a study, massive.

Now, as the Director of the National Institutes of Health, Dr. Collins will manage a $37 billion research fund, which will distribute grants for medical research and development. But how much will be used to train and retrain doctors in personalized medicine and genomics?

I spoke at the conference about how my use of ancestral DNA, what some at the conference called, “recreational genetics” led to medical genetics. I also highlighted the challenge of educating doctors and patients and finding doctors who are knowledgeable enough about genetics to diagnose and treat rare, unusual genetic-based symptoms or common ailments that have a genetic connection. I echoed and illustrated what Dr. Francis Collins said about integrating family history in genomic research, and how vital it is for doctors to be able to decipher genetic tests and in report genetic results to patients. He said family history must be an integral part of genomic research. I said not only personal and family history but ancestral history must be weighed when developing a patient’s medical profile.

Is it possible that some of us are genetically predisposed to be interested in genetics? From my search in 1999 and 2000, I was able to confirm the specific Ghanaian individuals and families who are my ancestral cousins, and discover others. I was impressed with the diversity in my ancestry. Among the groups in my ancestry, there are dozens of ethnic groups and ancestral cousins in Africa, especially in Ghana, one group in the Middle East, ancestors who were Maroons, escaped slaves in the Caribbean, and nobles in the British Isles. I interviewed elders in New York and in the Caribbean in Jamaica, and corresponded with ancestral cousins in Ghana in West Africa and in Scotland in the British Isles, specifically nobles who are related to the royal families of Scotland and England, including current and retired members of the British Parliament’s House of Lords. (I was granted my Scottish ancestors’ coat of arms in 2005.)

So this week’s report on genomic medicine was fascinating, not only because of its thoroughness, (it covered the American progress better than many American reports), but because of its source. It shows which thinkers and policymakers are preparing for the future of medicine.

A riveting 126-page study and report, “Genomic Medicine,” from Britain’s House of Lords, the upper house of Parliament, echoed Dr. Francis Collins’ statements that genomic medicine must be at the frontier of medical research, because it is the future of preventive medicine and effective treatment, and personalized medicine. The House of Lords’ Science and Technology Committee reported that personalized genomic medicine is not only in our future, it is already here. The committee emphasized that genomic medicine must become an integral part of medical training. Medical schools must instruct doctors, not only about rare single-gene inherited diseases such as cystic fibrosis, Huntington’s disease, hemophilia and sickle cell disease, but they must educate them about the internal and external environments and genetic predispositions that trigger common diseases such as cancers, coronary heart disease, rheumatoid arthritis, diabetes and obesity.

This future wave is called epigenetics – the study of how diseases are influenced not only by changes in one gene but by changes and the interaction of many genes. It’s an examination of the internal and external environments in which our genes are triggered, get turned on, or turned off, unleashing or squashing a predisposition to disease. Doctors must be educated about environmental factors, internal molecular changes, personal family history and ancestry, which are factors in the diagnosis and treatment of diseases.

Doctors must be trained how to tailor individual genetic profiles in prescribing drugs – what is called pharmacogenomics. Given the results of patient’s genomics and molecular tests, they should know which drugs produce a positive response and which produce an adverse reaction.

The House of Lords’ report discusses how genomics will play a vital part in improving the drug development pipeline, how it will result in more effective and safer drugs, and how we will be more prepared to face social, legal, ethical and private genetic challenges. The lords’ report highlights how traditional government-funded and private medical training must recapture the genomic field and get ahead of the commercial front runners. But it also says, the commercial direct-to-consumer companies such as deCODEme and 23andMe should be carefully regulated, not restricted.

The most dramatic statements in the report says, “The new knowledge of these genomic studies is still very fresh.” Genomics-based prevention of disease is in the future. “But the use of many types of genomic tests is increasing rapidly,” and will “have a dramatic impact on disease diagnosis and management.”

The effect of these developments are, “This is already placing strain on the expertise of doctors, nurses and healthcare scientists who at present are poorly equipped to use genomic tests effectively and to interpret them accurately. . . .” (Britain’s House of Lords’ Genomic Medicine Report).

The responses in the press were alarming. The London Times Online reported that the members of the House of Lords’ Science and Technology Committee who did this study is composed of scientists, doctors and philosophers. (Members in the House of Lords inherit their seats as peers or are appointed as leaders in a given field.) And, “It is hard to imagine even a body like the US Senate producing a report of quite this quality and authority.” So all I can say to Dr. Francis Collins is, as the medical research branch of the U.S. Department of Health and Human Services, he has to build the best medical research team possible. His team has made major discoveries about genes and rare and common diseases, from cystic fibrosis to cancers, neurofibromatosis, Huntington's disease and type 2 diabetes. But as he said at the Consumer Genetics Conference, scientific progress means facing the unknown.

The British have laid down the gauntlet. So let the medical research race and the debate begin.

Pearl Duncan

The author is completing a book about she used DNA, genealogy, rare historical records and folk narratives to trace her ancestors.

Our genetic code should be no big secret

We should be less frightened of wider access to our DNA profile — those in the know are offering theirs up for public view

The 1997 movie Gattaca sets out one of the great dystopias of science fiction. Genetic technology has divided humanity. Social class is determined by DNA. The “valids”, with sound genetic profiles, dominate the top jobs and political power. The “in-valids”, with flawed genomes, form a genetic underclass.

The film’s vision highlights a deep concern about the coming genomic age: that as science reveals more about the human genetic code it will not only herald new approaches to medicine but also create new ways to discriminate and invade privacy. Employers might select candidates according to genetic aptitude. Health insurers could refuse cover to people with high-risk genomes. And personal information about our health and personalities might be revealed for all to see.

Such fears have built a consensus that ethical use of genetic information must be founded on strict privacy. If DNA profiles are to improve treatment and prevention of disease without compromising liberty, access must be controlled. They belong to individuals and should not be disclosed without their consent. The prevailing assumption is that we should guard such data closely.

It is far from clear, however, that this assumption is correct. True genetic privacy may be impossible to achieve — and many of the scientists whose work is driving the DNA revolution believe that the costs of trying will outweigh the benefits. Some are even backing their words with action, by publishing their own genetic data on the internet.

The fantasy that it is possible to prevent unauthorised access to a person’s DNA was exposed in March by Peter Aldhous and Michael Reilly, of New Scientist. Aldhous drank from a glass and gave it to Reilly, who used commercial services to extract his colleague’s genetic profile. It is illegal in Britain to test DNA like this without consent. But the process is so cheap and simple, and the chance of detection so slim, that this offers little practical protection. We leave so much DNA wherever we go that we cannot expect to keep it to ourselves. Legislation might be a deterrent, but it will not prevent unauthorised use.

Even if genetic data could be comprehensively protected, it doesn’t automatically follow that it should be. In making a fetish of DNA, we may be limiting its usefulness. If science is to unravel the medical implications of genetic variations between individuals, to personalise and improve healthcare, it will be necessary to compare the DNA sequences of hundreds of thousands of people. A culture of privacy will hold this back while secreting information that may be less sensitive than it seems.

Certainly, the great and the good of human genetics do not feel that they have much to lose by sharing this data. Some are challenging the privacy assumption by example. When the genetics pioneer Craig Venter became the first person to have all six billion DNA letters of his genome sequenced he published the lot. James Watson, the co-discoverer of the double helix, has done likewise, redacting only the status of a gene linked to Alzheimer’s because he did not want to know the information himself. Kari Stefánsson, of deCODE Genetics, which sells personal DNA tests, allows his customers to compare their data with his.

George Church, of Harvard University, has gone a stage further. The founder of the Personal Genome Project (PGP), and its first participant, has published not only his complete genome sequence but also his medical records and other physical details. He aims to recruit 100,000 volunteers to do the same.

The nine other recruits to the PGP’s pilot phase are all people who know their stuff: they include the psychologist Steven Pinker, John Halamka, Dean of Technology at Harvard Medical School, and Misha Angrist, a geneticist at Duke University in North Carolina. Another 13,000 have joined a waiting list to take part. By putting their information in the public domain, participants hope to exploit “crowd-sourcing”, the notion that allowing anyone to work on a problem will lead to it being solved more swiftly. The phenomenon underlies the success of Linux open-source software and Wikipedia. It could soon be driving genetic discoveries as well.

This will have individual benefits as well as social ones. When Church placed his medical records on the internet he was contacted by a doctor who suggested a useful change to his cholesterol medication. Interpretations of open data are more likely to help than harm.

The prophets of open-source genomics are unruffled because the perceived need for absolute secrecy is also based on a misunderstanding of heritability. While most people think of genetics as a deterministic science, this is rarely so. Most genes that influence health have a probabilistic effect, raising or lowering risk by small margins. Most people with the Alzheimer’s risk gene , for example, will not get Alzheimer’s. It would not only be wrong to judge somebody’s intellect, skills or good health by their ownership of particular genetic variations — it would be profoundly misleading.

All of us carry risky variants: there is no such thing as a perfect genome. That should help to prevent discrimination: if insurers were to exclude everyone with a raised genetic risk of this or that they would rapidly go bankrupt. If the market fails, companies can be banned by law from demanding genetic test results; the US has already done this, and the UK has a voluntary moratorium.

Nobody should be forced to reveal genetic data, which should be published only with the informed consent of the owner; the PGP takes the “informed” part so seriously that it requires participants to pass a genetic literacy test. But it is instructive that so many of those who best understand the mechanics of the genome see so little to fear. Given wider understanding of the probabilistic nature of genetics, their choice to go public is one that many more of us could emulate.

How to Fake a DNA Test

by Dr. Hsien-Hsien Lei, originally posted April 13, 2008 in DNA and the Law

Most people who buy DNA test want to know the truth but there are others who want to evade it. In 1992, Dr. John Schneebergerim planted a plastic tube in his arm filled with someone else’s blood. He had been charged with two counts of sexual assault in Saskatchewan, Canada. When ordered to provide a blood sample, Schneeberger drew the blood himself from the plastic tube instead of his vein. He was eventually deported and sent back to South Africa.
In March 2007, four Massachusetts men were charged with attempting to tamper with DNA testing. They apparently tried to trade ID bracelets when having their blood drawn but was caught when their fingerprints didn't match the samples. I’m not sure what became of them but they faced a sentence of up to five years in jail. And in a paper published in the Journal of Forensic Sciences, Dr. Jose Antonio Lorente Acosta at the Laboratory of Genetic Identification of the University of Granada found evidence of fraud in a paternity test case. The suspect had applied another person’s saliva to the inside of his mouth prior to having DNA samples taken with a cotton swab.And what about accurate DNA analyses that are reported inaccurately? I’m sure there are unscrupulous DNA testing services worldwide that will give people any results they want for whatever purposes they need it for, e.g.,immigration. Not to mention people like Simon Mullane, a British businessman who made-up paternity test results rather than actually doing the testing. Makes you think we need to be careful in DNA testing, doesn’t it?