You’ve probably noticed that Viome’s services were temporarily suspended. This is because we are acquiring the rigorous CLIA certification. In this article, we are going to dive into exactly what that means for you but if there’s one major take away, it’s this. The CLIA certification will not affect your current annual service.
In the most recent app update, you’ll see some of your results missing – this isn’t to say they won’t be back. The full review process is happening in phases and as results are approved, they will appear in your Viome app in a series of updates.
Let’s take a closer look at the CLIA certification itself, your recommendations, and your results.
What Does the CLIA Certification Mean?
The newest Viome update is a reflection of CLIA certification standards. CLIA stands for Clinical Laboratory Improvement Amendments of 1988 regulations and are federal standards for US laboratories that test human specimens for health assessment or to diagnose, prevent, or treat disease. The CLIA certification is supported by the Centers for Disease Control (CDC), the Federal Drug Administration (FDA), and Centers for Medicare & Medicaid Services (CMS).
CLIA examines the accuracy and reproducibility of laboratory analysis and ensures protocols meet their standards. Before the CLIA certification, we were already operating our laboratory following their guidelines.
If you’d like to dig into the nitty-gritty behind the CLIA certification, (we’re talking laws, history, and the rigorous standards applied) you can check out the CDC’s website here.
What Does CLIA Certification Mean for Viome’s Recommendations & Results?
First things first, your scores have not changed – only the presentation is changing. While we understand this can be frustrating, we see obtaining a CLIA certification as an investment in our customer’s future. This is because the CLIA certification gives us the ability to work with health insurance companies and doctors more readily. With the CLIA certification, physicians will be able to prescribe Viome as a service to their patients. Also, all of our testing, and results will be third-party approved, meaning an there’s oversight – this is good news for all Viome customers.
What You Need to Know About the December 2018 Update
Your new results are now CLIA approved. When you log into your app, you’ll notice that your results have the biggest changes. But don’t worry, we are working on adding result scores back in.
Let’s take a closer look at the 8 changes you’ll see on the December 2018 Update.
1. For now, only 3 scores are displayed:
- Microbial Richness
- Metabolic Fitness
- Inflammatory Activity
2. Cohorts and microbe activity levels are no longer available. These will be available after they’ve been reviewed by CLIA. We will be sure to keep you posted on when you can expect these in future updates.
3. Top beneficial microbes have been replaced with top probiotic organisms. This is interesting because it helps you track if you are creating a more hospitable environment in your gut for probiotics to thrive.
4. Enhanced explanations. This is one of our favorite updates! You’ll find clear scientific references and thorough explanations throughout. For everyone who’s been asking about the viruses in your results, you’ll find more information on this in the new update.
5. Personal sample data. Now you have a section with your sample information, including the collection date. From now on, when a new sample is collected you’ll need to make a note of when you collected it.
6. Debranding supplement recommendations. To make sure you are getting the best supplement possible, we’ve made it very clear what to look for. You can simply copy and paste your specific recommendations into a web browser and find suitable options.
7. You can filter your microbes. Many of you have asked for the ability to sort your microbes, and now you can. You’ll be able to sort your microbes by type, which makes discovering what’s in your microbiome more straightforward.
8. You can now generate your PDF right from your app. There is now an option on your app to create your personalized PDF report, which is emailed directly to you.
Viome’s Standard for Excellence
As you know, Viome’s mission is bold – it means we aim to be here for the long haul. For us to achieve such a mission, we must continue to make decisions as a company that is in the best interest of our customers for the long run. This means holding ourselves to the highest standard of excellence even if we must pause services.
Thank you so much for being patient during this time as we take our testing to the next level. The passion of our customers is unmatched and we are honored you’re part of the Viome team.