THE SLEUTH? YOU CAN'T HANDLE THE SLEUTH (GENETICALLY SPEAKING): THE ETHICAL AND MORAL CONSIDERATIONS OF COMMERCIAL DNA MATCHING AND DNA PRIVACY.

• Author: Knight-Walker, Keani

1. INTRODUCTION 333 II. THE EVOLUTION OF DNA MATCHING COMPANIES AND THE LEGAL BATTLES THAT ENSUED 337 A. Inception of Direct-to-Consumer DNA Testing 337 B. IP Battles Amongst Genetic Giants 340 III. GENETIC DATA PRIVACY CONCERNS IN DIRECT-TO- CONSUMER DNA TESTING 343 A. The Parameters of Your Genetic Privacy 343 B. Your DNA Disclosure May Unknowingly Impact Others 348 IV. CONSUMER AWARENESS AND ETHICAL CONCERNS PLAGUING DIRECT-TO-CONSUMER DNA TESTING 353 A. Consumers May Not Understand the Dangers of Consenting to the Terms and Conditions Presented by DNA Matching Companies 353 B. The Risk of Genetic Discrimination and Other Limitations are Unknown by Consumers 359 V. LEGISLATIVE RESPONSE TO DIRECT-TO-CONSUMER TESTING PRIVACY CONCERNS 363 VI. CONCLUSION 366 I. INTRODUCTION

   Society has always had an obsession with the past. Whether we're scouting to find vintage and retro clothing (1) or throwing Great Gatsby themed parties to imagine what it was like to have lived in the Jazz Age, (2) humans seem to appreciate experiencing a connection to the past. The science behind using direct-to-consumer DNA kits allows one to travel back in time and discover one's ancestral roots. By doing so, this technology has afforded many people the opportunity to discover who they are and to connect to family members they never knew existed. (3) However, there is a price for these revelations that could be more than consumers anticipated. (4)

   In order to understand the significance of at-home DNA kits, as well as their function and implications, we must understand the significance of DNA itself. DNA, or deoxyribonucleic acid, is the hereditary material in humans and almost all other organisms. (5) The order, or sequence, of the four chemical bases that make up the DNA code determines the information available for building and maintaining an organism, similar to the way in which letters of the alphabet appear in a certain order to form words and sentences. (6) Simply put: DNA codes genetic information for the transmission of inherited traits. (7) DNA is often referred to as the blueprint or the foundation which holds the information required for encoding the proteins and other cell components. (8)

   This blueprint function of DNA allows companies such as Ancestry.com (9) and 23 and Me (10) to calculate ethnicity estimates, trace ancestors back in time, and find family connections. As the DNA is run through testing systems, if a genetic anthropologist has a DNA sample and a very large library of other samples to compare it against, that anthropologist can quickly figure out which groups in the library that DNA is most closely related to. (11) Researchers can track paternal ancestry by looking at the Y chromosome, which fathers pass to their male children. (12) Maternal ancestry, similarly, can be found in mitochondrial DNA, which mothers pass to all of their children. (13) The richest and most detailed ancestry information, however, comes from comparing everything else--the 22 non-sex chromosomes--against the massive libraries DNA testing companies possess. (14)

   Companies like Ancestry.com also enable consumers to locate genetic cousin matches. (15) Your genetic cousin matches are listed from closest to most distant. (16) Each company has a different algorithm for classification, but typically matches are sorted from highest to lowest number of centimorgans (cM) shared. (17) Centimorgans are the unit of measurement used to describe the amount of DNA shared between two people. (18) The more you share with a match, the more likely you are to be closely related and for each match on your match list, the total number of cM is given, along with a predicted relationship. (19)

   This method for analyzing consumer DNA and producing genetic results has also been the subject of repeated IP lawsuits. (20) Eventually, such legal issues simmered, but a newer problem has emerged. This time, the consumers have been put in a perilous position, rather than the testing companies themselves. Legal questions began to arise regarding the ownership of a person's DNA. (21) Consumers began to allege that DNA-matching websites were releasing their private health information to unknown persons and entities without their expressed permission. (22) In addition to this, the acquisition of consumer DNA from these DNA testing companies presented the very likely possibility of discrimination based on information gleaned from DNA results. (23) These pressing concerns demonstrate a need for increasing legislation to regulate DNA data privacy once consumers release it to direct-to-consumer DNA matching companies. (24)

   While various statutes and congressional acts have been passed to address some of the prevalent issues within this scope, (25) problems remain regarding: HIPAA loopholes, educational discrimination, and economic discrimination. (26) It seems that society may need to take a step back and reevaluate its priorities regarding genetic privacy. (27) While some are willing to sacrifice this privacy to learn more about their roots, others are potentially put in harm's way due to the vast amounts of genetic connection that expose genetic relatives to the prying eyes of entities with various motives. (28) Additionally, as genetic testing companies are partnering with billionaires and facilitating in the acquisition of millions of customers' genetic data, (29) we are confronted with the very real possibility that, if solutions to the de-identification of genetic data are not presented, (30) we run the risk of losing privacy for multiple generations. (31)

2. THE EVOLUTION OF DNA MATCHING COMPANIES AND THE LEGAL BATTLES THAT ENSUED

   1. Inception of Direct-to-Consumer DNA Testing

      The first company to offer direct-to-consumer genetic DNA testing services was GreenTree, a family history website that enabled account users to order DNA tests, enter results from other testing companies, search the DNA database, create an online family tree, and correspond with family members by sharing pictures. (32) Founded in 1997 by a molecular biologist, GreenTree DNA Testing Center quickly grew into a multi-million dollar enterprise by allowing customers to send swab samples discreetly in the mail to GeneTree analysts who provided prompt, accurate results. (33) GeneTree's initial offerings did not include multi-generational genealogy tests, but it did offer genetic counseling and predisposition assessments. (34) This was a revolutionary concept that opened the door to allow companies such as Family Tree DNA, (35) 23 and Me, (36) Ancestry.com, (37) and My Heritage (38) to become leaders in the direct-to-consumer DNA testing market.

      In addition to the allure of the technological benefits of direct-to-consumer testing, the financial alternative offered by these companies provided consumers with a way to take genealogical discovery into their own hands at an affordable price. While professional genealogy services have the potential to range from $600 to $2800 dollars for specific services and may additionally incur a hefty hourly rate, (39) the leading direct-to-consumer DNA testing companies offer quick and convenient results at attainable prices with Ancestry.com and 23andMe offering heritage and family testing kits for $99 (40) and MyHeritage offering testing kits for as low as $79. (41) Originally priced at $1,000, 23andMe didn't initially make waves in the market, (42) but in 2009, 23andMe lowered prices, and its customer base began to grow. Around 2012, Ancestry combined with AncestryDNA, and by 2015, over one million people had been tested through the major companies. (43) Within a year, that number had nearly doubled. (44)

      The science behind these services explains how large companies are able to collect genetic information from consumers to produce results that can shed light on ethnic backgrounds, familial connections, and predispositions to health risks. (45) A genealogical DNA test is performed on a DNA sample. (46) This DNA sample can be obtained by a cheek-scraping and using spit-cups. (47) After following the kit instructions on how to collect the sample, it is returned to the supplier for analysis. The sample is then processed using a technology known as DNA microarray to obtain the genetic information. (48) There are three main types of genealogical DNA tests: autosomal, Y-DNA, and mtDNA. (49) Autosomal tests look at chromosomes 1-22 and X. (50) The autosomes (chromosomes 1-22) are inherited from both parents and all recent ancestors. (51) The X-chromosome follows a special inheritance pattern. Ethnicity estimates are often included with this type of testing. (52) Y-DNA looks at the Y-chromosome, which is inherited father to son, and so can only be taken by males to explore their direct paternal line. (53) The final method, mtDNA, looks at the mitochondria, which is inherited from mother to child and so can be used to explore one's direct maternal line. (54) Y-DNA and mtDNA cannot be used for ethnicity estimates, but can be used to find a consumer's haplogroup, which is unevenly distributed geographically. (55) Direct-to-consumer DNA test companies have often labeled haplogroups by continent or ethnicity, (56) however, these labels have been revealed to be overall misleading. (57)

   2. IP Battles Amongst Genetic Giants

      The methods that direct-to-consumer DNA testing companies use to create their tests and enable their products to appeal to consumers are extremely valuable. As a result, DNA testing companies have fought for strict intellectual property rights and will enforce such rights in instances where their IP rights have been encroached. (58) The legal battles that ensue tend to revolve around the technology used to collect consumer DNA and connect individuals to distant relatives with matching DNA components. (59) In order to understand how important this technology is to the foundation of the direct-to-consumer DNA testing business, it is helpful to analyze...