On November 22, 2013, the FDA issued a Warning Letter to 23andMe instructing the company to halt sales of its genetic tests due to failure to obtain regulatory clearance. 

23andMe claims in its company literature that it collects DNA directly from consumers, analyzes those samples for over one million SNPs across the entire genome and provides risk information back to the consumer on more than 240 conditions and diseases, including several cancers, Alzheimer’s disease, and other major medical conditions. 

The Food and Drug Administration (FDA) has repeatedly stated that it has the authority to regulate laboratory-developed tests, or LDTs, but has generally exercised enforcement discretion in not otherwise regulating LDTs that are validated by and performed only in a high complexity CLIA certified laboratory. Although there are thousands of genetic tests offered as LDTs, the vast majority have not been submitted to or reviewed by the FDA. An example is Myriad’s BRCA1 test for breast and ovarian cancer risk. In response to the increased availability of genetic tests offered directly to consumers, the FDA has indicated for the past few years that it was reviewing the regulatory requirements that it would apply to LDTs. In July 2010, FDA held a public meeting in which FDA officials including those from the Office of In Vitro Diagnostic Products, now the Office of In Vitro Diagnostics and Radiological Health (OIR), within the Center for Devices and Radiological Health (CDRH) announced its intention to develop a regulatory framework for LDTs that would be based on the risks posed by such tests. In particular, FDA officials stated that LDTs offered directly to consumers would no longer be subject to enforcement discretion, that is, they would require FDA review and clearance. 

On November 1, 2010, we met with the director and staff members of the OIR to present information on our Inherent Health brand of genetic tests sold directly to consumers (DTC) and to discuss how our tests might fit within their stated objective to develop a risk-based process for reviewing genetic LDTs. At FDA’s request, we submitted in December 2010 a plan to provide materials on our Inherent Health DTC tests for OIR’s review, and we requested a follow-up meeting to obtain feedback on the plan from OIR personnel. As of December 2, 2013, we have had no further communications from the FDA regarding our DTC products. 

In March 2011, FDA convened an expert advisory panel to discuss and make recommendations on scientific issues concerning DTC genetic tests that make medical claims. The panel expressed a variety of concerns regarding DTC genetic testing and recommended that certain tests not be permitted to be sold DTC. We submitted a position paper to the FDA in advance of the meeting and presented testimony to the panel at a public meeting on March 8, 2011. After that meeting, the OIR director publically stated that FDA would likely take a case-by-case approach with respect to which types of genetic tests may be offered DTC. He also stated that OIR planned to issue three guidance documents addressing oversight of LDTs. However, he did not provide a timeframe for OIR’s release of these documents. The FDA issued a draft guidance for industry and FDA staff entitled, “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” containing non-binding recommendations on benefit-risk assessments on March 28, 2012. That guidance, however, does not specifically reference genetic LDTs, and no other relevant guidance has been released. 

The FDA’s warning letter to 23andMe indicates that FDA is concerned that 23andMe reports risk for several life-threatening diseases, including multiple cancers, which could lead an individual to incorrectly take life changing actions without direct guidance by a physician. The FDA’s letter also noted that its previous communications with 23andMe failed to resolve its concerns and that 23andMe has been unresponsive to requests for further information on their tests. 

Interleukin Genetics has taken a focused approach to the development of our tests, conducting clinical validity studies as appropriate and targeting only risk for conditions that may be reduced or in some instances be avoided completely with certain low risk actions by the individual. Interleukin Genetics offers the following LDTs, some of which are available only through licensed healthcare providers and others that would be classified as DTC. Our tests have been developed by and are processed only through our CLIA-certified lab. 

  • Tests only available to licensed healthcare providers:
    • PerioPredictTM — risk for severe periodontitis
    • Osteoarthritis progression test— not yet commercially available 
  • Tests available directly to consumers: 
    • Inherent Health Weight Management test 
    • Inherent Health Heart Health test 
    • Inherent Health Bone Health test 
    • Inherent Health Nutritional Needs test 

Our PerioPredict test for severe periodontitis has strong analytic and clinical validity, as documented in the literature; is only available from a licensed dentist; and in our view provides minimal risk to the patients since it is indicated for use in stratifying prevention frequencies in the dental office or need for more intensive maintenance care to prevent progression of pre-existing periodontitis. We have never received any communications from the FDA relative to our PerioPredictTM periodontal disease test, and there has been no indication from the FDA that they plan to exercise their authority to review LDTs that are available only through licensed healthcare providers. 

Our Inherent Health DTC tests are lifestyle tests intended to guide an individual’s self-management of health-associated practices, including diet modifications; and they provide clear, specific and actionable guidance that consumers can readily understand and implement. Accordingly, we believe, based on the FDA’s public statements and actions over the past three years, that OIR will ultimately introduce a risk-based approach for the review of DTC genetic LDTs and in the interim will take action on a case-by-case basis where they deem an individual genetic LDT as potentially high risk. Interleukin Genetics provided OIR with information on our Inherent Health tests in December 2010, and we have received no further inquiries from the FDA. If the FDA provides a plan for risk-based review and clearance of DTC genetic LDTs, Interleukin Genetics will cooperate with the OIR to comply with any new guidelines.