![handle is hein.journals/appndx14 and id is 1 raw text is:
FILLING IN THE CRACKS:
IMPROVING THE REGULATION
OF DIRECT-TO-CONSUMER
GENETIC TESTS
SERRAJ. SCHLANGER*
Advances in genetic technology and the increased acceptance of
genetic testing by the general public have led to the development and sale
of direct-to-consumer (DTC) genetic tests.' Genetic testing is one of the
fastest growing areas of laboratory testing.2 A recent survey found more
than thirty different DTC genetic testing companies offering genetic tests
for both health and non-health related purposes.3 These tests range in cost
from $78 to $68,500.4 The DTC genetic testing companies advertise that an
Copyright © 2011 by Serra J. Schlanger.
* J.D. Candidate, 2011, University of Maryland School of Law (Baltimore, MD); B.A., 2005,
Science, Technology, and Society, Vassar College (Poughkeepsie, NY). The author wishes to
thank Professor Leslie Meltzer Henry for her guidance in developing this Comment and the
editorial staff of the Journal of Health Care Law & Policy. She would also like to thank Saul
Ehrenpreis and her family for their encouragement and support.
1. Andrew S. Robertson, Taking Responsibility: Regulations and Protections in Direct-to-
Consumer Genetic Testing, 24 BERKELEY TECH. L.J. 213, 214-15 (2009).
2. See BIN CHEN ET AL., DEP'T OF HEALTH & HUMAN SERVS., CTRS. FOR DISEASE
CONTROL & PREVENTION, GOOD LABORATORY PRACTICES FOR MOLECULAR GENETIC TESTING
FOR HERITABLE DISEASES AND CONDITIONS, 58 MORBIDITY & MORTALITY WKLY. REP. 3
(2009) [hereinafter LABORATORY PRACTICES], available at
http://www.cdc.gov/mmwr/PDF/rr/rr5806.pdf (describing the rapid growth in the number of
available genetic tests and the number of laboratories performing genetic testing).
3. See GENETICS & PUB. POL'Y CTR., DTC GENETIC TESTING COMPANIES (Feb. 26, 2010)
[hereinafter DTC GENETIC TESTING COMPANIES], available at
http://www.dnapolicy.org/news.release.php?action=detail&pressrelease id=137 (compiling a list
of DTC genetic testing companies and information on what tests each company offers).
4. See e.g., Low Cost At Home DNA Paternity Test, HOMEDNA, https://www.homedna.com
(last visited Mar. 1, 2011) (advertising a $78 DNA Home Paternity Testing System); Ryan
McBride, Knome Challenged to Keep in Step With Falling Genetic Sequencing Prices,
XCONOMY, Jan. 1, 2010, http://www.xconomy.com/boston/2010/01/20/knome-challenged-to-
keep-in- step-with- falling-genetic- sequencing-prices/?singlejpage-true (detailing Knome's
complete genetic sequence service price decrease from $350,000 in 2008 to the current price of
$68,500).](ViewImageLocal?handle=hein.journals/appndx14&div=1&collection=&method=preview&ext=.png&size=3)
What Is HeinOnline?
Contact us for annual subscription options:
Already a HeinOnline Subscriber?
profiles profiles most
Contact us for annual subscription options:
Already a HeinOnline Subscriber?
profiles profiles most
Contact us for annual subscription options:
Already a HeinOnline Subscriber?
profiles profiles most