uBiome Launches SmartJane™ - Revolutionary Test for Women's Health

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uBiome launches SmartJane™. A revolutionary, doctor-ordered, at-home, clinical precision-sequencing™ women's health test to combine screening for multiple strains of HPV+STIs+vaginal flora and risk factors to get the answers you need.

What we are doing is making novel tests to help support doctors and patients in the area of women's health, said Dr. Jessica Richman, CEO and Co-founder of uBiome


uBiome’s Combined HPV, STI, and Vaginal Risk Factors Test Lets You Test at Home — And It’s Covered by Health Insurance

uBiome, the leader in microbial genomics, launches SmartJane™— the first sequencing-based at-home women’s health test. SmartJane™ is the first test to combine human papillomavirus (HPV) genotyping, sexually transmitted infections (STI) testing, and microbial risk factors for HPV infection, bacterial vaginosis, cervicitis, idiopathic infertility, pelvic inflammatory disease, bacterial vaginosis, and aerobic vaginitis. Patients can sample in the comfort of their own home. The test is not intended to replace traditional Pap smears or well woman visits. SmartJane™ is only available with a valid lab test order from a healthcare provider.

SmartJane™ can tell doctors and patients which type of HPV strain they have (genotyping), and how the microbiome interacts with HPV to increase or decrease risk. SmartJane tests for 14 high-risk HPV types which are associated with cervical cancer, squamous intraepithelial lesions, and cervicitis. SmartJane also tests for 5 low-risk HPV strains.

In a combined approach, SmartJane™ tests for three common STIs as well as HPV and vaginal flora balance: Chlamydia trachomatis (chlamydia), Neisseria gonorrhoeae (gonorrhea), and Mycoplasma genitalium. Mycoplasma genitalium is a common STI that can be a cause of unexplained infertility. This bacterium has been recently implicated in cervicitis, pelvic inflammatory disease, and infertility in women. Mycoplasma genitalium was recently found to have a prevalence at least as high as that of Chlamydia trachomatis and Neisseria gonorrhoeae, but has not been included in standard STI tests, until now with SmartJane™.

“Our mission focuses on using the most advanced technologies to understand the human microbiome. SmartJane™ uses our proprietary precision sequencing technique to test for eleven strains of high risk HPV as well as common STIs, and microbial co-factors associated with HPV and other conditions,” said Dr. Jessica Richman, co-founder and CEO of uBiome. “This is a great step forward for women’s health and an exciting addition to uBiome’s line of sequencing-based lab developed tests.”

Collecting the sample is simple and takes just two minutes at home. Once the sample is collected, it is then placed in a prepaid mailer and dropped in the mailbox for return to the uBiome CLIA-licensed (Clinical Laboratory Improvement Amendments) and CAP-accredited (College of American Pathologists) laboratory in San Francisco. After the sample is processed, uBiome sends a link to its HIPAA-compliant website. Here the patient and prescribing doctor can access the test report, which can then be used as a valuable resource for further treatment planning.

Dr. Zachary Apte, co-founder and CTO of uBiome and Adjunct Professor of Biochemistry and Biophysics at the University of California, San Francisco adds: “Our vast dataset collected over five years, with hundreds of thousands of samples, along with our patented analytical techniques and peer-reviewed methods, allow us to create revolutionary new assays.

One of these is SmartJane™, the world’s first sequencing-based clinical test for the vaginal microbiome.”

uBiome’s proprietary methods have exceptional sequencing accuracy for the detection of HPV infection, according to a paper in preparation for submission to peer review. On average, the sensitivity, specificity, precision, and negative prediction value for the microorganisms of the vaginal microbiome included on the test are 99.3%, 100.0%, 98.1%, 100.0% for the species, and 97.0%, 100.0%, 99.9%, 100.0% for the genera, respectively.

SmartJane™ is the second in a series of ground-breaking clinical tests that uBiome has developed. The first in the series, SmartGut™, the world’s first sequencing-based clinical microbiome test, was launched in the fall of 2016.

About uBiome:
Founded in 2012, uBiome is the world’s leading microbial genomics company with a mission to explore important research questions about the microbiome and develop reliable, accurate products and services, focused on the microbiome. uBiome is funded by Y Combinator, Andreessen Horowitz, 8VC, and other leading investors. uBiome’s mission is to transform the science of the microbiome into useful ducts and services that improve people’s lives.

PR Contact: uBiome.com Lisa.micarelli(at)ubiome.com

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