[elil17]

It seems really weird to me that you're selling a "non-diagnostic" early access test but also claiming on your website that "Bristle analyzes your oral microbiome to detect oral diseases." I've seen early access in video games, but never before in a medical device. I'm sure you have lawyers who told you this was okay, but I feel like the whole reason that you have to do clinical trials before selling a product (the spirit of the law, so to speak) is that many consumers will believe that the test you're giving them is producing valid results, even if you have a fine print disclaimer saying that it is for "medical purposes." If someone took this test and wrongly assumed that the results meant they were safe from oral diseases, that could have a really negative impact for them.

[david_l_lin]

Thank you for your input, that's completely understandable. We're describing in our website the product that is undergoing clinical validation, but want to provide consumers an opportunity to gain insight into their oral microbiome, as there are no equivalent comprehensive oral microbiome tests. The "early access" test is a limited offering that provides novel data to users.

We are making it clear to users during on-boarding and in the microbiome report that our test is currently for educational and research purposes only. You are right, there are health implications behind results of the test, and we hope that the data we provide empower users to make impactful positive decisions around their oral health.

We are on-boarding early access users off the wait-list in small batches in the hopes of discussing the product 1:1 with each of them. Our assay is currently undergoing regulatory approval and we anticipate to have a diagnostic offering by the end of 2021.

Our goal is to make sure users up front know what they are receiving with the early access test, so if you have other suggestions or concerns we'd love to chat with you - feel free to email us at [e-mail]