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How to successfully launch a direct-to-consumer microbiome test

Published 3 October 2023

Demand for consumer microbiome testing is growing

A far greater understanding of the human microbiome has brought with it a high demand for consumer microbiome testing. Thus, rich market opportunities exist for offering consumers tailored solutions according to their specific needs.

From the consumer point of view, the process seems simple enough: the consumer receives a microbiome testing kit in the post and makes the microbiome sample in the comfort of their own home, before mailing it to the lab for analysis. But what things must a company consider when launching a direct-to consumer microbiome testing service in order to make the process as quick, cost-effective and informative as possible?

1. Determine the features and technical specifications for your sample collection kit

The sample collection kit plays a pivotal role in the success of a microbiome testing service. It not only needs to be user-friendly, encouraging consumers to collect and return samples promptly, but it must also effectively preserve the microbial profile from the moment of collection until it reaches the laboratory possibly days later.

The use of an industry-leading sample collection kit can streamline the collection and transportation process of microbiome samples. Thankfully, due to the DNA/RNA Shield™ sample preservation reagent, which inhibits microbial growth, safeguards nucleic acids, and deactivates pathogens, it has become common practice for microbiome testing companies to transport samples at room temperature. DNA/RNA Shield™ is a core component of Zymo Research's innovative SafeCollect™ sample collection devices. These devices, such as the DNA/RNA Shield™ fecal collection tubes (DX), are designed to be spill-proof and user-friendly, facilitating safe at-home sample collection.

One common challenge with at-home sample collection is the potential for user errors, such as spills or ingestion of the sample preservation reagent. SafeCollect™ devices mitigate these risks by sealing the reagent until a foil cover is punctured during sample addition. Furthermore, Zymo Research manufactures its own kits and reagents, ensuring you won't face customer losses due to supply chain delays. These kits are also entirely customisable, allowing you to maintain consistency with your brand.

2. Select the type of microbiome analysis you are offering

A pivotal decision in launching your microbiome testing service is the type of analysis you'll provide to customers. Typically, individuals expect access to next-generation sequencing analysis, either targeted or shotgun sequencing, as it offers a more comprehensive view compared to traditional culturing or even PCR-based methods.

With targeted 16S rRNA gene sequencing, you can potentially offer customers the following insights:

  • Assessing taxonomic diversity of the microbiome, often used as an indicator of a "healthy" microbiome.
  • Quantifying beneficial genera or species for gut health, like lactobacilli and bifidobacteria.
  • Profiling bacterial composition, ideal for samples primarily dominated by bacterial species, such as gut samples.

While targeted sequencing is cost-effective, shotgun sequencing may be worth considering if it adds substantial value through more precise interpretation or targeted recommendations. With shotgun sequencing, you can offer customers all the above benefits, along with:

  • Profiling bacterial composition with higher resolution, often down to the strain level.
  • Identifying antibiotic resistance genes.
  • Detecting fungi, DNA viruses, and parasites, particularly useful for comprehensive analysis and pathogen detection in sample sites susceptible to bacterial, fungal, and parasitic infections, such as vaginal samples.

3. Determine whether you will be outsourcing microbiome analysis

Microbiome analysis of direct-to-consumer tests can be performed either in-house or outsourced to an external provider. Establishing an in-house microbiome analysis lab, hiring necessary personnel, and obtaining certifications can introduce unexpected complexities that might delay the launch of your microbiome testing service or compromise service quality.

Timeliness can also be challenging for smaller labs, as the cost of sequencing runs may not be justified without a critical mass of customers. This can lead to difficulties in providing results within an acceptable timeframe.

Outsourcing microbiome sequencing to a trusted service provider, such as Zymo Research, offers cost savings and simplifies the end-to-end process. Zymo Research, with over 20 years of expertise, processes thousands of samples weekly using a high-throughput, automated process to ensure data consistency and reproducibility. Additionally, they offer quick turnaround times, delivering microbiome reports within two days of sample receipt for certain applications.

Using Zymo's microbiome service, your company sends sample collection kits to consumers, who send their samples directly to a Zymo Research lab for DNA extraction, next-generation sequencing library preparation, sequencing, and custom bioinformatic analysis. The resulting data is promptly forwarded to you, allowing you to provide results to consumers with minimal delay.

Zymo’s sample accessioning and tracking system ensures transparency, with barcoded samples being logged into the system upon arrival at the Zymo Research facility and tracked throughout the workflow. Zymo Research also places a high emphasis on data privacy and security, ensuring secure data transfer and allowing you sole discretion over data ownership.

4. Develop your education and results portal for consumer interpretation of microbiome analysis

For consumers, the true value of microbiome analysis lies in data interpretation, analysis, and recommendations. Raw microbiome data is often too complex for consumers to grasp without guidance. Therefore, your company can add significant value by presenting data in a digestible manner and offering practical recommendations.

Additionally, effective marketing of this test often involves educating potential customers about the significance of the microbiome in their health and wellness. Educational content can be delivered online, possibly through the same portal used for analysis results. Both educational information and results can be tailored to specific consumer groups, creating a memorable user experience that fosters loyalty.

Zymo Research's comprehensive bioinformatics and customised data reports can integrate into your portal. Your proprietary algorithms can then be applied to generate recommendations, helping consumers interpret their results and plan their next steps.

Four steps to a successful microbiome testing service

These four critical aspects significantly influence the success of a direct-to-consumer microbiome testing service, and require plenty of thought. The market is poised for specialised microbiome testing services, and it's likely that more will emerge in the coming years. In the ideal scenario, a direct-to-consumer company would put more focus on targeting specific consumer groups, while streamlining the process by selecting a fast, reliable service provider for laboratory microbiome analysis. Zymo Research serves as a trusted partner for direct-to-consumer microbiome testing companies, ensuring the best possible experience for end-consumers.

Original content written by Zymo Research. Read the original article.