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Use Cases

The primary use case for our device is for individuals with recurrent Bacterial Vaginosis (BV). Measurements of their vaginal microbiome over time would be invaluable information for themselves, and their doctors in developing treatment plans, identifying specific triggers, and overall preventing recurrences before they begin.

In addition to recurrent BV, our device can aid in gathering information on the vaginal microbiome and BV through research pathways. The ability for optical fluorescence detection, pH and biogenic amine testing allow for longitudinal data collection. This type of data characterizing the vaginal microbiome over time has not yet been widely researched, and thus leaves a critical gap in our understanding of women’s health.

Furthermore, our device could be used in a temporary setting, given to a patient by a doctor for short-term use in monitoring vaginal health. Our device could inform the doctor of the patient’s symptoms without the patient needing to come into the clinic for frequent testing.

Future Plan

We have investigated several competitors in the market of diagnostic tools for BV, and identified the critical flaws in their business models. First is Evvy, a current product on the market that offers metagenomic sequencing of a user’s vaginal swab. Evvy recommends the user send in swab samples every 3 months, totaling 4 tests per year. Each test is expensive, and the quarterly sequencing is not frequent enough to track daily vaginal fluctuations.

Second are simple pH tests, which are widely available at convenience stores like CVS or Walgreens. These pH tests are affordable and indicative of general vaginal health, and can often be used as prescreening before a doctor appointment. However, these pH tests lack the specificity of any individual disease, as the pH of the vaginal microbiome is affected by countless factors.

These competitors are all striving towards making women's health more accessible, which is an admirable goal that we also share. We believe our product offers significant advantages in terms of affordability and usability – two aspects that are increasingly important in today’s era. Our product, FloraDX, provides daily monitoring of the vaginal microbiome. While the initial price point is similar to that of a single test from Evvy, we offer higher value and return on investment for our customers. This value manifests in the additional data that our product provides. Daily monitoring ensures 365 data points a year versus 4 from another product for the same price, demonstrating our device’s capability of being competitive in the market, while also filling an unmet need for continuous health data.

Integrating our insights from Human Practices, we compiled a list of future actionables to expand the scope of our project:

  • Examine the relationship between BV and flare ups caused by HPV
  • A preliminary check to test for human specimen before reading the putrescine and pH data
  • Work on a faster, easier way to transfer data from device to mobile
  • Investigate the importance of sialidases in BV monitoring to provide additional tracking
  • Understanding the co-occurance of BV with other disease to better strengthen our diagnostic predictions
  • Introduce modifications to make it applicable for a research setting as well
  • Ensure that BV is the issue that is occurring, rather than another vaginal condition. To do this, introduce more biosensors for multiple biomarkers
  • Creating a more robust method of data analysis, allowing for more personalized, adaptable tracking. This would be a more complex machine learning approach.
  • Using data from self identifying triggers correlated with flare ups in BV to inform predictions for other individuals with similar demographics.
  • Reducing cost of material to improve accessibility

Challenges

Like all initial prototypes, FloraDX still has some unmet challenges. While the one time purchase of the device is environmentally conscious, the weekly hydrogel disks that must be shipped poses environmental concerns. To improve upon this, we could look into making the discs reusable, or recyclable after decontamination. An alternative method could be to improve upon the longevity of the biosensor in a hydrogel. If this longevity was improved, the discs would be shipped less frequently, thus reducing environmental burden.

Speaking to the biological aspects of our device, it is critical to consider the biosafety of our device. A kill switch or toxin-antitoxin system may be useful for improving containment of our biosensor. Alternatively, we could investigate the potential for developing a cell-free system, thus limiting the concerns associated with whole-cell biosensors.