Dear Customers,

As you’ve probably heard the FDA sent a new warning letter to 23andme demanding suspension of the operations.

The main issue that the FDA has is “Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these.”

This development has significant implications on Direct to Consumer genetic testing industry as the whole. We have expressed similar concerns with clinical validity of 23andme testing in our blogs and publications, including the commentary in Nature BioTechnology, which triggered harsh response from the company – see the attached response that will be published upcoming issue of the journal.

The DTC industry is being embraced by consumers, but is struggling to gain acceptance amongst medical professionals who are extremely skeptical about the clinical validity of DTC genetic testing. Excessive push to expand commercial genetic testing to swaths of consumers who do not understand the benefits and limitations of such testing nets customers who should have opted for clinical genetic diagnostic testing. Thus, we argued against non-selective marketing and predicted that 23andme would trigger a reflexive move by the FDA to protect consumers by restricting access to DTC testing.

23andme uses outdated technology that cannot provide robust disease and drug response predictions that could be used for planning clinical intervention. FDA is concerned about the negative consequences for consumers who do not understand the tests limitations and that positive findings of genetic predisposition to cancer can have harmful consequences. When knowledge of strong predisposition to cancer, such as in carriers of BRCA1/2 mutations, is available to physicians it allows for personalized disease prevention strategies reducing the rates of disease diagnosis at advanced stage of disease. Therefore genetic screening is a powerful tool for disease prevention, and the FDA announced approval of Next Generation Sequencing for disease diagnostic and predictive testing.

Here are a few reasons why the FDA letter does not endanger our chances of commercial success in the long term:

  1. Our PGx test is much more robust than 23andme because it analyzes many more rare variations thus reduces the risk of false negative reporting. We are undertaking a project with 1000 genomes data to demonstrate differences in the PillCheck test’s sensitivity and specificity.
  2. We use only FDA drug labels as a basis of our reports for genotype-drug response predictions.
  3. We are initiating clinical validation of PillCheck in collaboration with McMaster Pain Centre and Thornhill Medial which will be probably sponsored by the Ministry of Health and Genome Canada.
  4. For disease prediction we use NGS rather than genotyping and we validate mutations of clinical significance (such as BRCA mutations) in collaboration with clinical diagnostic laboratory at Kingston, and will continue to do so!

We hope that the FDA and Health Canada will take balanced approach and will evaluate each provider because genetic testing technologies and reporting varies between different providers, and irresponsible actions by single player should not endanger others. We will take even more visible and pro-active action to engage Health Canada to gain clinical approval for our testing offerings as we continue platform development and validation. Also please note that there are many more successful DTC genetic testing companies besides 23andme who are less arrogant and more grounded, so I’m sure the industry will continue to grow.

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