Advice for regulatory approval of a new Ancestral DNA device

Challenge

Our client offered a genetic ancestry test in the form of a home kit that contained a buccal swab to collect customer DNA and an analysis service using a SNP array-based chip. Results were then returned to customers through an online interactive website.

The company wished to further develop it's service into providing nutritional, fitness and pharmacogenomics information to customers. Alacrita was asked to assess the feasibility of extending the platform and to identify any regulatory hurdles.

Solution

Alacrita provided support through our medical devices consultant in assessing the regulatory hurdles of the proposed applications and provided ongoing, ad hoc, advice and assistance with implementing the regulatory processes. Key analysis points covered:

• Where the product fell within the regulatory frameworks of the US, UK and Australia;
• What the simplest route was to ensure compliance with regulations;
• What was specifically required from the client in order to expand the product offering in these territories;
• What documentation was needed, who needed to produce this and how long would it take;

After analysis of the above points our regulatory consultant concluded that the proposed platform development would not be a viable option due to high competition and regulatory hurdles owed to it's likely classification as an IVD. As a result the company deprioritised the project.