A couple of weeks ago, we announced SmartJane™— the world’s first doctor-ordered, sequencing-based, at-home vaginal health test.
SmartJane is the first test to combine human papillomavirus (HPV) genotyping, sexually transmitted infection (STI) testing, and microbial risk factors for common conditions like bacterial vaginosis and aerobic vaginitis. The test can also be used by trans and non-binary individuals who need to care for their vaginal health.
NOTE: The test is not intended to replace traditional Pap smears or well-woman visits and does not diagnose or treat any disease. SmartJane is only available with a valid lab test order from a healthcare provider. uBiome can work with your doctor or connect you with an independent external clinical care coordination network to review your test request.
Why did we make SmartJane?
Women’s health is important. We think it’s silly to even ask this question — why shouldn’t we make a test that will help women take better care of their health? Dozens of female scientists, engineers, and laboratory staff on our team (and some men too) have worked hard to make a product that would help women (and others with vaginas) to work with their doctors to better screen for HPV, STIs, and vaginal flora implicated in bacterial vaginosis and other conditions.
What’s new in SmartJane?
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 four STIs as well as HPV and vaginal flora balance: Chlamydia trachomatis (chlamydia), Neisseria gonorrhoeae (gonorrhea), Treponema pallidum (syphilis) 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.
SmartJane includes testing for risk factors for ten conditions:
Sexually transmitted infections
HPV and associated conditions
Squamous intraepithelial lesions
Pelvic Inflammatory Disease
Self-sampling is common in most of the developed world. We’ve done a review of global self-sampling protocols (here in pre-print), and have found some really interesting facts:
- In 2016, the Netherlands was the first country to start a new screening program, where women will be able to self-collect samples for HPV testing (RIVM 2017; Rozemeijer et al., 2015).
- The National Cervical Screening Program in Australia is recommending to switch to self-sampling under medical/health care supervision (National Cervical Screening Program Renewal). The Finnish Cancer Registry has declared that self-sampling tests for HPV detection are reliable for cancer screening purposes.
- Other countries have started trials with self-sampling to evaluate incorporation of this methodology in official national cervical cancer programs, including the UK (Lim et al., 2016), Norway (Enerly et al., 2016), Denmark (Tranberg et al., 2016), Switzerland (Viviano et al., 2017), and Italy (Georgi Rossi et al., 2015).
How do I SmartJane?
Patients can request the test from your regular doctor or OB/GYN, or from an external clinical care coordination network through our website. Once the doctor order is placed, we’ll send you a kit.
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.
If you are a healthcare provider, please click here.
How does it work?
uBiome’s proprietary methods have exceptional sequencing accuracy for the detection of HPV infection (see our pre-print paper). 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. Samples are processed in our CLIA-licensed and CAP-accredited laboratory in California.
SmartJane was made possible by citizen scientists who helped us make this groundbreaking test. We are so grateful to all of you and are very excited to make this test a reality with your help!
For those who also have gut issues…
SmartJane is the second in a series of ground-breaking clinical tests that are available through healthcare providers. The first in the series, SmartGut, the world’s first sequencing-based clinical microbiome test, was launched in the fall of 2016.
A new sequencing-based women’s health assay combining self-sampling, HPV detection and genotyping, STI detection, and vaginal microbiome analysis
Elisabeth M. Bik, Sara W. Bird, Juan P. Bustamante, Luis E. Leon, Pamela A. Nieto, Kwasi Addae, Victor Alegría-Mera, Cristian Bravo, Denisse Bravo, Juan P. Cardenas, Adam Caughey, Paulo C. Covarrubias, José Pérez-Donoso, Graham Gass, Sarah L. Gupta, Kira Harman, Donna Marie B. Hongo, Juan C. Jiménez, Laurens Kraal, Felipe Melis-Arcos, Eduardo H. Morales, Amanda Morton, Camila F. Navas, Harold Nuñez, Eduardo Olivares, Nicolás Órdenes-Aenishanslins, Francisco J. Ossandon, Richard Phan, Raul Pino, Katia Soto-Liebe, Ignacio Varas, Nathaniel A. Walton, Patricia Vera-Wolf, Daniel E.Almonacid, Audrey D. Goddard, Juan A. Ugalde, Jessica Richman, Zachary S. Apte
bioRxiv 217216; doi: https://doi.org/10.1101/217216
Self-Sampling for HPV Testing: Increased Cervical Cancer Screening Participation and Incorporation in International Screening Programs
Sarah Gupta, Christina Palmer, Elisabeth M. Bik, Juan P. Cardenas, Harold Nuñez, Laurens Kraal, Sara Bird, Jennie Bowers, Alison Smith, Nathaniel A. Walton, Audrey D. Goddard, Daniel E. Almonacid, Jessica Richman, Zachary S. Apte
Preprints 201711.0199: https://www.preprints.org/manuscript/201711.0199/