Direct-to-consumer genetic testing: Learning from the past and looking toward the future

Food and Drug Law Journal

Volumn 67, Issue 4, 2012, Pages

  Bair, Stephanie ^a,b,c  

^a UNIVERSITY OF PRINCE EDWARD ISLAND   (Canada)

^b UNIVERSITY OF UTAH   (United States)

^c HARVARD LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450 2C9; DNA; WARFARIN;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ALZHEIMER DISEASE; CHROMOSOME; CONSUMER HEALTH INFORMATION; DIRECT TO CONSUMER; DISEASE SEVERITY; ETHNICITY; EYE COLOR; FOOD AND DRUG ADMINISTRATION; GENE EXPRESSION PROFILING; GENE SEQUENCE; GENETIC ASSOCIATION; GENETIC RISK; GENETIC SCREENING; GENETIC VARIABILITY; GENETICS; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; HEPATITIS C; HUMAN; HUMAN GENOME PROJECT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HUNTINGTON CHOREA; INFORMED CONSENT; LABORATORY TEST; MEDICAL LIABILITY; MEDICAL RESEARCH; PHARMACOGENETICS; PHYSICIAN; PRODUCT DEVELOPMENT; PUBLIC HEALTH; REVIEW; SINGLE NUCLEOTIDE POLYMORPHISM;

CONSUMER PARTICIPATION; GENETIC PRIVACY; GENETIC TESTING; GOVERNMENT REGULATION; HUMANS; INFORMED CONSENT; PERSONAL AUTONOMY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84873140602     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (178)

1. Francis S. Collins et al., The Human Genome Project: Lessons from Large-Scale Biology, 300 Science 286 (2003).
2. Wired.com, Human Genome Complete, http://www.wired.com/medtech/health/ news/2003/04/58471, last visited on Nov. 18, 2012.
3. Id.
4. See, e.g., Justin P. Annes et al., Risks of Presymptomatic Direct-to-Consumer Genetic Testing, 363 NEW ENG. J. MED. 1100, 1100 (2010).
5. Id.
6. For example, the genetic testing service 23andMe provides information for both of these purposes with the purchase of a 23andMe genetic "health kit." 23andMe.com, Health Reports: Complete List, https://www.23andme.com/ health/all/, last visited on Nov. 18, 2012.
7. See, e.g., Rebecca Andar Novick, One Step at a Time: Ethical Barriers to Home Genetic Testing and Why the U.S. Health Care System is Not Ready, 11 N.Y.U. J. INT'L L. & POL. 621, 624-631 (2008).
8. In September 2010, FDA sent letters to five DTC genetic testing companies, requesting that these companies submit premarket approval applications for their products. See FDA.gov, Medical Devices Letters to Industry, http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm111104. htm, last visited on Nov. 18, 2012.
9. For example, the company Ancestry.com offers a genetic test to "help you find genetic cousins and expand your family tree." Ancestry.com, DNA Testing by Ancestry.com, http://dna.ancestry.com/welcome.aspx., last visited on Nov. 18, 2012.
10. This article will focus on the health-related tests.
11. See, e.g., Gail H. Javitt & Kathy Hudson, Public Health at Risk: Failures in Oversight of Genetic Testing Laboratories 5 (2006), available at http://www.dnapolicy.org/images/reportpdfs/PublicHealthAtRiskFinalWithCover.pdf [hereinafter Public Health at Risk].
12. Novick, supra note 7, at 633-34.
13. Id. at 632.
14. For example, the genetic testing service Navigenics will "analyze[] your DNA for genetic risk markers associated with a wide variety of health conditions and medication responses," so that a consumer can "personalize [his] health strategies." Navigenics.com, Conditions and Medication Responses, http://www.navigenics.com/visitor/what-we-offer/ conditions-we-cover/. Since the first writing of this article, Navigenics has been acquired by Life Technologies. It appears that Navigenics will not continue to offer genetic testing services.
15. ELDRA PEARL SOLOMON ET AL., BIOLOGY G-16 (4th ed. 1996).
16. Id. at 272-77.
17. Id.
18. Id. at 303-309.
19. Id.
20. Id.
21. JOHN M. BUTLER, FORENSIC DNA TYPING: BIOLOGY, TECHNOLOGY, AND GENETICS OF STR MARKERS 182 (2d ed. 2005).
22. Id.
23. R. RAPLEY R. & S. HARBRON, MOLECULAR ANALYSIS AND GENOME DISCOVERY (2004).
24. 23andMe, for example, states that their DNA chip "genotypes hundreds of thousands of SNPs at one time," and the company also "hand-pick[s] tens of thousands of additional SNPs of particular interest from the scientific literature and adds their corresponding probes to the DNA chip... to provide personal genetic information." 23andMe.com, How Does 23andMe Genotype my DNA?, https://www.23andme.com/you/faqwin/chip/, last visited on Nov. 18, 2012.
25. See, e.g., Javitt & Hudson, Public Health at Risk, supra note 11.
26. See, e.g., Wadelius et al., Association of Warfarin Dose with Genes Involved in its Action and Metabolism, 121 Hum. Genet. 23, 23-34 (2004).
27. FDA.gov, http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/ CriticalPathInitiative/CriticalPathOpporrunitiesReports/UCM077254.pdf, R10, last visited on Nov. 18, 2012.
28. 23andMe.com, Warfarin Sensitivity-Sample Report, https://www.23andme.com/ health/Warfarin-Coumadin-Sensitivity/. last visited on Nov. 18, 2012.
29. 23andMe.com, Health Reports: Complete List, https://www.23andme.com/ health/all/, last visited on Nov. 18, 2012.
30. For example, 23andMe's association between genetics and response to a subset of antidepressant drugs is based on a single study. 23andMe.com, Antidepressant Response-Sample Report, https://www.23andme.com/health/ Antidepressant-Response/, last visited on Nov. 18, 2012. A single study, without at least a confirmation trial, is insufficient to establish the association on which 23andMe relies.
31. See, e.g., Novick, supra note 7, at 633-34.
32. MICHAEL WINK, AN INTRODUCTION TO MOLECULAR BIOTECHNOLOGY 456 (2006).
33. Id.
34. MUIN J. KHOURY ET AL., HUMAN GENOME EPIDEMIOLOGY 38 (2d ed. 2010).
35. Id.
36. Wink, supra note 32.
37. D.J. Galton & G.A.A. Ferns, Genetic Markers to Predict Polygenic Disease: a New Problem for Social Genetics, 92 Quart. J. Med. 223 (1999).
38. Id.
39. Galton & Feras, supra note 37.
40. 23andMe.com, Health Reports: Complete List, https://www.23andme.com/ health/all/, last visited on Nov. 18, 2012.
41. See, e.g., Novick, supra note 7, at 632.
42. See, e.g., A.L. Maguire et al., Personal Genome Testing, 330 Science 181-82 (2010).
43. Id. The strongest call for increases regulation of DTC genetic tests comes from the scientific and medical community.
44. See, e.g., Id.
45. Id. Those who oppose increased regulation of DTC genetic tests include, unsurprisingly, the companies that offer such services, as well as various consumer groups.
46. See, e.g., Id.
47. See, e.g., Dorothy C. Wertz & John C. Fletcher, Communicating Genetic Risks, Sci, Tech., & Human Values, Jun. 1988, at 60.
48. See, e.g., L.B.Andrews, The Rationale Behind the Informed Consent Doctrine, 1 J. Med. Prac. Mgmt. 59-65 (1985).
49. This concept is also referred to as the "learned intermediary doctrine." See, e.g., Jeffrey J. Wiseman, Another Factor in the Decisional Calculus," The Learned Intermediary Doctrine, The Physician Patient Relationship, And Direct-To-Consumer Marketing, 52 S.C. L.R. 993 (2001).
50. Id.
51. Id.
52. Id.
53. Id.
54. Novick, supra note 7, at 636.
55. For example, the genetic testing service deCodeme's website exclaims the health benefits of using its service and prominently includes patient testimonials on its webpage; the only disclaimer is found at the very bottom of the page in 8-point font of an almost illegible light grey against a white background. It states that deCodeme is for informational purposes only and "should NOT be used for medical decision making without consulting your physician." deCodeme.com, Genes and Health, http://www.decodeme.com/genes- and-health, last visited Nov. 18, 2012.
56. Of the major testing companies 23andMe, deCodeme, and Navigenics, there is no mention on the companies' respective websites of the option of not testing.
57. See Gregory Kutz, Direct to Consumer Genetic Tests: Misleading Test Results are Further Complicated by Deceptive Marketing and Other Questionable Practices, GAO 10-847T, at 15 (2010).
58. See, e.g., Alberto Gutierrez, FDA official, Interview with the New York Times, (http://www.nytimes.com/2010/06/12/health/12genome.html?-r=1&scp= 1&sq=gutierrez%20FDA%20genetic%20testing&st=cse (June 11, 2010), last visited Nov. 18, 2012.
59. Id.
60. None of the three major genetic testing services companies (23andMe, deCodeme and Navigenics) requires mandatory genetic counseling, although they all offer these services to varying degrees.
61. See infra page 424-426, for a discussion of the potential benefits of home genetic testing.
62. 23andMe.com, 23andMe Enlists Informed Medical Decisions to Make Independent Genetic Counseling Services Available to Customers, https://www.23andme.com/about/press/20100603/, last visited Nov. 18, 2012.
63. Novick, supra note 7, at 640.
64. See, e.g., David Altshuter et al., Genetic Mapping in Human Disease, 322 Science 881, 881 (2008).
65. Id.
66. Id. at 885, 886.
67. Id. at 887.
68. Ten A. Manolio, Genomewide Association Studies and Assessment of the Risk of Disease, 363 New Eng. J. Med. 166, 173 (2010).
69. Id. at 173-74.
70. Carla G. van El & Martina C. Cornel, Genetic Testing and Common Disorders in a Public Health Framework: Recommendations of the European Society of Human Genetics, 176 Eu. J. Hum. Genetics 1, 3 (2011).
71. Although 23andMe's website makes clear that smoker status is the best predictor of lung cancer, similar situations could arise in which research has not yet revealed external risk factors whose predictive value is significantly greater than known genetic contributors.
72. van El & Cornel, supra note 67.
73. Altshuter et al., supra note 61, at 884.
74. Id.
75. Of the major testing companies 23andMe, deCodeme, and Navigenics, only 23andMe mentions ethnicity. It does so in the context of specific tests. For example, it states on the prostate cancer information page that because a study including Japanese Americans was inconclusive, "the exact association in populations with Asian ancestry still needs to be confirmed." Presumably, this was only mentioned because a study in Asian Americans was in fact performed. There is no mention of ethnicity for other studies performed in only a single ethnic group. 23andMe.com, Prostate Cancer Sample Report, https://www.23andme.com/health/Prostate-Cancer/, last visited Nov. 18, 2012.
76. Kutz, supra note 54, at 5.
77. Id.
78. Id.
79. Annes et al., supra note 4, at 1100.
80. Kutz, supra note 54, at 15.
81. Manolio, supra note 65, at 173.
82. McAlindon T.E. at al., Glucosamine and Chondroitin for Treatment of Osteoarthritis: a Systematic Quality Assessment and Mela-Analysis, 283 J. Am. Med. Ass'n, 1469 (2000).
83. Joseph G. Yu et al., The Effect of Oral Glucosamine Sulfate on Insulin Sensitivity in Human Subjects, 26 Diabetes Care 1941 (2003). This study found that insulin sensitivity was reduced in obese patients, although it did not find an effect in overall populations.
84. Manolio, supra note 65, at 173.
85. Altshuter et al., supra note 62.
86. See, e.g., Shelly Cummings, The Genetic Testing Process: How Much Counseling Is Needed?, 18 J. Clinical Oncology 60, 62 (2000).
87. Cinnamon S. Bloss et al., Effect of Direct-to-Consumer Genomewide Profiling to Assess Disease Risk, 364 New Eng. J. Med. 524 (2011).
88. Id.
89. Id. at 531.
90. See, e.g., Alberto Gutierrez, FDA official, Interview with the New York Times, http://www.nytimes.com/2010/06/12/health/12genome.html?-r=1&scp= 1&sq=gutierrez%20FDA%20genetic%20testing&st=cse (June 11, 2010), last visited Nov. 18, 2012.
91. 23andMe.com, Health Reports: Complete List, https://www.23andme.com/ health/all/, last visited Nov. 12, 2012.
92. 23andMe.com, Health Reports: Complete List, https://www.23andme.com/ health/all/, last visited Nov. 12, 2012.
93. See, e.g., Maguire et al., supra note 42.
94. S. Chao et al., Health Behavior Changes After Genetic Risk Assessment for Alzheimer Disease: the REVEAL Study, 22 Alzheimer Dis. Assoc. Disord. 94 (2008).
95. Kutz, supra note 54.
96. 23andMe charges $200 for their service, while deCodeMe charges $2000. Navigenics does not include pricing information on its website.
97. Manolio, supra note 65, at 174.
98. Bloss et al., supra note 84.
99. Annes et al., supra note 5, at 1101.
100. See, e.g., Kathleen A. Mahoney, Malpractice Claims Resulting from Negligent Preconception Genetic Testing: Do These Claims Present a Strain of Wrongful Birth or Wrongful Conception, and Does the Categorization Even Matter, 39 Suffolk L. Rev. 773 (2006) for a discussion of physician liability for negligence in the context of preconception genetic testing.
101. Novick, supra note 7, at 641.
102. Id.
103. Id.
104. Bloss et al., supra note 84 at 529.
105. Id. at 531.
106. van El & Cornel, supra note 67.
107. Id.
108. Id.
109. Novick, supra note 7, at 641.
110. Id.
111. National Human Genome Research Institute, Genetic Discrimination Fact Sheet, http://www.genome.gov/10002328, last visited Nov. 18, 2012.
112. Id.
113. National Human Genome Research Institute, Genetic Information Nondiscrimination Act of 2008, http://www.genome.gov/10002328#3, last visited Nov. 18, 2012.
114. Id.
115. Amy Harmon, Congress Passes Bill to Bar Bias Based on Genes, N.Y. Times, May 2, 2008, at A1.
116. For example, the Navigenics website reassures customers with the rather disturbing statement that "unlike some other companies, we do not sell or share your genetic information," implying that some companies do in fact engage in these activities. Navigenics.com, What we Offer, http://www. navigenics.com/visitor/what-we-offer.
117. See Health Insurance Portability & Accountability Act of 1996, 29 U.S.C.A. §1181 et. seq.
118. See James P. Evans et al., Preparing for a Consumer-Driven Genomic Age, 363 New Eng. J. Med. 1099 (2010).
119. Providing a prime example of this situation is the case of Navigenics, which, since the first writing of this article, has been acquired by Life Technologies, Inc., a "global biotechnology company." Navigenics assures its customers that the company "remains committed to our founding principle of protecting the privacy and security of our members' genetic information." http://www.navigenics.com/.
120. Navigenics also states that "all customer information will be protected and handled according to regulatory guidelines." http://www.navigenics.com/visitor/about-us/acquisition-faqs//, last visited Nov. 18, 2012.
121. See, e.g., Maguire et al., supra note 42.
122. Id.
123. See, e.g., Altshuter et al., supra note 61.
124. The correlations between SNPs and health measures on which these tests rely are all performed by outside parties. Further, the DNA chip on which these services rely is a technology that was first developed and used by researchers in a medical college. Leonard H. Augenlicht & D. Kobrin, Cloning and Screening of Sequences Expressed in a Mouse Colon Tumor, 42 Cancer Research, 1088-1093 (1982).
125. van El & Cornel, supra note 67.
126. In September 2010, FDA sent letters to five DTC genetic testing companies, requesting that these companies submit premarket approval applications for their products. See FDA.gov, Medical Devices Letters to Industry, http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm111104. htm, last visited Nov. 18, 2012.
127. Ctrs. for Medicare & Medicaid Servs., CMS Initiatives to Improve Quality of Lab. Testing under the CLIA Program 1 (2006), available at http://www.cms.hhs.gov/CLIA/downloads/060630.Backgrounder.r1EG.pdf.
128. Id. A laboratory is defined under CLIA as "a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings." 42 C.F.R. § 493.2 (2007). DTC genetic testing companies, which collect "materials derived from the human body" of consumers "for the purpose of providing" health assessment information arguably fall under this definition, and are thus subject to CLIA.
129. 42 C.F.R. § 493.5 (2007).
130. 42 C.F.R. § 493.15 (2007).
131. See Am. Soc'y of Human Genetics Bd. of Dirs., ASHG Statement on Direct-to-Consumer Genetic Testing in the United States, 81 Am. J. Human Genetics 635, 636 (2007), available at http://www.dnapolicy.org/resources/ ASHGDTCstatement.pdf.
132. Novick, supra note 7, at 625.
133. 42 C.F.R. § 493.801 (2007).
134. See 42 C.F.R. § 493.17 (2007).
135. See Am. Soc'y of Human Genetics Bd. of Dirs., ASHG Statement on Direct-to-Consumer Genetic Testing in the United States, supra note 126.
136. Id.
137. 42 C.F.R. § 493.801(a)(2)(ii).
138. http://www.genome.gov, Promoting Safe and Effective Genetic Testing in the United States, http://www.genome.gov/10002402, last visited Nov. 8, 2012.
139. Federal Trade Commission, FTC Facts for Consumers, At-Home Genetic Tests: A Healthy Dose of Skepticism May Be the Best Prescription 1 (July 2006), http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea02.pdf, last visited Nov. 18, 2012.
140. Id.
141. Javett & Hudson, supra note 11.
142. Centers for Medicare and Medicaid Services, CMS Initiatives to Improve Quality of Laboratory Testing Under the CLIA Program 2 (July 2006), http://www.cms.hhs.gov/CLIA, last visited Nov. 18, 2012;
143. Centers for Medicare and Medicaid Services, List of Exempt States Under the Clinical Laboratory Improvement Amendments (CLIA), http://www.cms.hhs.gov/ CLIA/, last visited Nov. 18, 2012.
144. Gail H. Javitt, Erica Stanley & Kathy Hudson, Direct-to-Consumer Genetic Tests, Government Oversight, and the First Amendment: What the Government Can (and Can't) Do to Protect the Public's Health, 57 Okla. L. Rev. 251, 258 (2004).
145. For example, although DTC genetic tests are banned in some states, the genetic testing service Navigenics makes no mention on their website of these state restrictions. Navigenics.com, http://www.navigenics.com/, last visited Nov. 18, 2012. In its Terms of Service, 23andMe places the burden on the customer by stating that an agreement to the Terms of Service includes a representation that "you are [not] a person barred from receiving the Services under the laws of the jurisdiction in which you are resident or from which you use the Services."
146. 23andMe.com, Terms of Service, https://www.23andme.com/about/tos/, last visited Nov. 18, 2012.
147. Only deCodeMe explains that it will omit certain genetic information for customers in states where dissemination of this information is illegal; however, this information is buried in the fine print and customers in these states will likely be surprised when they do not receive full testing information. deCodeMe.com, deCodeMe Genetic Scan Service Agreement and Informed Consent, http://www.decodeme.com/service-agreement, last visited Nov. 18, 2012.
148. Steve Gutman, The Role of Food and Drug Administration Regulation of In Vitro Diagnostic Devices-Applications to Genetics Testing, 45:5 Clin. Chem. 746 (1999).
149. See 21 U.S.C.A. §360.
150. See id. at §360(a)(A)(i).
151. See id. at §360(a)(B)(ii).
152. See id. at §360(a)(C)(ii).
153. Anny Huang, FDA Regulation of Genetic Testing: Institutional Reluctance and Public Guardianship, 53 Food & Drug L.J. 555, 562 (1998).
154. See Gutman, supra note 140, at 746.
155. Id.
156. Oversight of Laboratory Developed Tests; Public Meeting; Request for Comments, 75 Fed. Reg. 34,464 (June 17, 2010);
157. see also Council for Responsible Genetics, FDA Investigation into Direct to Consumer Genetic Testing Companies: An Analysis (2010).
158. Due to resource constraints, administrative agencies may utilize what is known as enforcement discretion to set priorities for enforcement, or to choose not to institute enforcement proceedings in certain circumstances. The Supreme Court has found that these decisions are generally not subject to judicial review under the Administrative Procedure Act. Heckler v. Chaney, 470 U.S. 821 (1985).
159. Gutman, supra note 140, at 746. The active ingredients of DTC genetic tests fall within FDA's definition of ASRs, which includes "antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reactions with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens." 21 CFR 864.4020(a).
160. Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents, 62 Fed. Reg. 62,243 (Nov. 1997).
161. See, e.g., 21 CFR 807.20(a) (requiring registration of devices); 21 CFR 809.10(e) (specifying labeling requirements); 21 CFR 809.30 (restricting the sale and use of ASR tests but not test results).
162. See FDA.gov, Medical Devices Letters to Industry, http://www.fda.gov/ MedicalDevices/ResourcesforYou/Industry/ucm111104.htm. Last visited Nov. 18, 2012. The five companies included Knome, Inc., 23andMe, Inc., deCode Genetics, Ilumina, Inc., and Navigenics.
163. Council for Responsible Genetics, supra note 148.
164. FDA.gov, Medical Devices Letters to Industry, supra note 152. An LDT is a subset of the category of medical devices referred to as in vitro diagnostics. In vitro diagnostics are defined as "those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of state of health, in order to cure, mitigate, prevent, or treat disease or its sequelae." An LDT is an in vitro diagnostic that is developed and used by a single laboratory. 21 CFR 809.3(a).
165. Council for Responsible Genetics, supra note 148.
166. This narrower definition of an LDT would result in some non-DTC genetic tests that have historically fallen within the LDT exception to be excluded; for example, in cases in which a hospital outsources its diagnostic testing to an outside laboratory. FDA could use its enforcement discretion, however, to exempt such a subset of tests that do not present the same concerns as DTC genetic tests from the full regulatory approval process.
167. It would also present a simple means to future DTC genetic testing companies of circumventing more comprehensive regulatory review - these companies would simply need to ensure that test development and test execution were carried out in the same lab.
168. 42 C.F.R. § 493.801 (2007).
169. See Genetics and Public Policy Center, Direct-to-Consumer Genetic Testing: Empowering or Endangering the Public? (July 25, 2006), http://www.dnapolicy.org/policy.issue.php?action=detail&issuebriefid=32, last visited Nov. 18, 2012.
170. Javitt & Hudson, supra note 11.
171. See 21 U.S.C.A. §360.
172. Alberto Gutierrez, interview with the New York Times, supra note 87.
173. A diagnostic test diagnoses the absolute presence or absence of a given condition, while a predictive test predicts susceptibility (or resistance) to a specific condition. Although many of the concerns discussed in this article are general to both types of tests, each type raises specific concerns to varying degrees. For example, while diagnostic tests primarily raise concerns of adverse psychological reactions, predictive tests primarily raise concerns of ensuring that patients understand the meaning of the test results. Each should therefore be considered separately when making decisions about the appropriate degree of regulation.
174. See 21 U.S.C.A. §360(a)(B)(ii).
175. Turna Ray, Genomewe.com, Seeking 510(k) Clearance for Genomic Testing Service, 23andMe Maintains Direct-to-Consumer Ethos, http://www.genomeweb.com/ mdx/seeking-510k-clearance-genomic-testing-service-23andme-maintains-direct- consumer, last visited Nov. 18 2012.
176. Draft Guidance for Industry and Food and Drug Administration Staff - De Novo Classification Process (Evaluation of Automatic Class III Designation) (Oct. 3 2011), available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm273902.htm.
177. Id.
178. A draft guidance issued in 2011 suggests that FDA intends to do just this, with three guidance documents for LDTs planned for the coming years. Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices (Jul. 12 2011), available at http://www.fda.gov/ downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ UCM262327.pdf.