Vaginal microbiome snapshot (VMS)

Case ID:
13-1141

Vaginal Microbiome Sanpshot; a Method for Diagnosing Bacterial Vaginosis and Other Vaginal Disorders  

WSU Tech#: 13-1141

Technology Summary:

Bacterial vaginosis (BV) is a disease of the vagina caused by an imbalance of naturally occurring bacterial flora and is often confused with yeast infection (candidiasis) or infection with Trichomonas vaginalis (trichomoniasis). 

 The main and unique feature of Lactobacillus Relative Content (LbRC) technology, is that it measures the level of dominance of Lactobacillus species relative to ALL BV-associated anaerobes in the vaginal mucosa.   It allows an assessment of the composition of the non-Lactobacillus populations, for correlation to all the risk factors associated with BV.  LbRC is based on quantitative PCR in the presence versus absence of inhibitors of Lactobacillus amplification, which otherwise dominates healthy, pre-BV, and post-BV vaginal populations.  Assesses the compositions (species or groups of species) with and without the Lactobacillus blockers, by comparing the amplicon melt profiles to known vaginal species.

Through WSU?s new LbRC technology, we have been able to predict, based on the make-up of microbiome, which patients respond to treatment and which patients are likely to recur from ineffective treatment, before it can be detected by other means

Competitive Advantages

 

There competing technologies in this space; however, they look for a specific non-lactobacilus bacteria to determine BV and are not predictive.

 

Examples:

 

?          BD Affirm Assay: Only good for detecting more than 10^7 cells, so it has low sensitivity.  Since the test predominantly tests for Gardnerella, which can be high even in woman without BV, the assay has a large number of false positive diagnoses.

 

?          BV Blue:  According to Dr. Sobel, this is a good test, but is not frequently used by physicians.  A downfall of this test is it relies on a protein secreted by the bacteria other than the bacteria itself.  The test is also not quantitative

 

Benefit Analysis:

 

Bacterial Vaginosis lifetime rates are 51% for African-American 32%, Mexican Americans and 23% for Caucasian women (23%).  About 85% of women with BV are asymptomatic.  The LbRC technology can be used as a screening tool for all women.  This market has yet to be defined.

Stage of Development: Clinical Trial

 

Patent Status:

 

Through the Office of Technology Commercialization at Wayne State University, we have filed an extensive and detailed PCT application to the USPTO office. This is a detailed composition of matter application with both specific and fairly broad claims, as well as some method elements.

Licensing Opportunity:

WSU is looking for a commercial partner interested in furthering the validation of this technology and bringing it to market.  WSU investigators would be happy to support SBIR/STTR funding sources and provide consulting support for the project.

Contact for Further Information:  

 Frank Urban, MS, CBA, BA.   email: frank.urban@wayne.edu   Phone (mobile): (734) 355-0730

Patent Information:
For Information, Contact:
John Shallman
Wayne State University
dd2514@wayne.edu
Inventors:
Robert Akins
Jack Sobel
Keywords: