23andMe is a genomics and biotechnology company that was founded in 2006 and backed by Google. Their primary product is a DNA-testing kit and service that informs customers about traits related to their DNA. The company got into hot water with the FDA, but the CEO successfully navigated this and re-launched the product with FDA backing. This is their story.

After completing the case you should be able to:

  • Write your own “claim” statements about the ethics of founders, c-level executives, investors, and other stakeholders with respect to the 23andMe case.
  • Explain, according to Wojcicki, the role of the consumer in regards to the information in their own genome?
  • Explain the FDA’s concern in their warning letter regarding the BRCA gene test from 23andMe.
  • Explain why “user comprehension” is important to the 23andMe genetic reports.
  • Explain why bioethicists and doctors were concerned about 23andMe directly providing gene-testing results to consumers.
  • Explain the privacy concerns about 23andMe. What makes DNA sensitive information?
  • Describe the GINA Act and its implication.
  • Identify the type of CSR Initiative when 23andMe co-creates a course on “Genetic Testing” to inform consumers.
  • Discuss how 23andMe proactively used the time between the cease-and-desist letter and the re-launch of the product.
  • Explain, according to Wojcicki in her second TEDMed talk, why you are not really the decision-maker about your own health.
  • Be able to discuss how both caveat emptor and caveat venditor apply to the case of 23andMe.

Be able to argue the affirmative or negative for the following claims:

Claim: Because of closed adoption laws, companies like 23andMe should not be allowed to disclose information about relatives that they find during testing.
Claim: A life insurance provider should be able to require a DNA test before deciding on pricing for a new customer.
Claim: Any parent-to-be should be able to get genetic tests on an embryo prior to the birth of a baby.

Learn about 23andMe

The first two videos will help you understand the mission of 23andMe and the time at the company prior to the FDA shut-down.

Anne Wojcicki, CEO of 23andMe | TEDMED 2009 (March 19, 2010)

23andMe CEO Anne Wojcicki talks genetic testing, her company’s goals | CBS This Morning (Nov 7, 2013)

FDA Recalls: 23andme Must Stop Selling At-Home DNA Tests | ABC News (Nov 26, 2013)

Why the FDA cracked down on 23andMe | Washington Post (Dec 20, 2013)

Assessing Direct-to-Consumer Genetic Testing | The Mayo Clinic (May 28, 2014)

23andMe CEO on genetic testing relaunch, protecting privacy | CBS This Morning (Oct 21, 2015)

Anne Wojcicki on the FDA and future of 23andMe | Fortune Magazine (Dec 1, 2015)

Taking health into our own hands | TEDMed (July 25, 2016)

FDA Approves At-Home DNA Tests For 10 Diseases | NBC Nightly News (April 7, 2017)