Meet SmartJane!

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:

Vaginal conditions

Bacterial vaginosis
Aerobic vaginitis
Sexually transmitted infections

HPV and associated conditions

HPV infection
Cervical cancer
Squamous intraepithelial lesions
Genital warts

Other

Cervicitis
Idiopathic infertility
Pelvic Inflammatory Disease

Why self-sampling?

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:

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.

Thank you!

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.

Further Reading

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/

Bacterial Functions, Diversity Score, And A Hallowe’en Treat

What are your bacteria actually doing in there?

We’re proud to announce some exciting new additions to the uBiome website:

1. Bacterial functions. How well do your bacteria process caffeine compared to other people? What do your carbohydrate and fat metabolism capacities look like? We’ve added 106 bacterial functions for you to explore in your gut microbiome data, and we’re giving everyone this new feature for free.

Login at http://app.ubiome.com and let us know what you think!

2. Diversity score. Is your gut microbiome more or less diverse than all other samples in the uBiome dataset? The chart below shows my actual data. In the gut, bacterial diversity is generally positive, so I guess I’m in good shape, diversity-wise.

And finally, we’d like to wish you and your bacteria a very happy Hallowe’en! All uBiome kits are 50% off until midnight on the 31st, so be sure to claim your treat, whether you dress up yourself, or just your bacteria do. (And it’s actually 100 trillion trick-or-treaters, thanks to a sharp reader for noticing!)

Hope you enjoy the new features. We’d love to hear your feedback.
Bugs and hisses,
Alexandra

Fall Colors Sale – 5 For 2

The season has changed. See how this affects your bacteria!

By popular request from many of you, we’re bringing back our 5-site offer.

Thanks for asking, we’re happy to oblige!

With the change of season, it’s a good time to check in with all the bacteria living in your gut, mouth, nose, skin, and genitals. How are they doing?

Starting today, we’re offering our 5-site microbiome testing kits for just $178 instead of the usual $399.

Offer valid until Friday (or until 1,000 kits are scooped up.)

Use discount code HAPPYFALL when you checkout at ubiome.com.

We wish you and your bacteria a warm, cozy day.

Love,
Your friends at uBiome

uBiome Launches First Microbiome App Using ResearchKit; Initial focus is on Relationship Between Gut Bacteria and Weight Loss

iPhone users can now explore their gut bacteria, and also contribute to research about the relationship between the microbiome and human body weight with the launch of a ground-breaking app launched by the microbiome-testing company uBiome, which uses the ResearchKit framework designed by Apple. The app itself is free, and the first 1,000 users will also qualify for free microbiome testing, usually priced at $89.

www.indiegogo.com/ubiome
SAN FRANCISCO, CA (PRWEB) OCTOBER 09, 2015

Leading microbial genomics startup uBiome today launched the first-ever microbiome app, in tandem with a study that aims to better understand the relationship between weight management and the microbiome. The study uses the ResearchKit framework, designed by Apple, to gather data more frequently and more accurately from participants using an iPhone app.

The uBiome app is available as a free download from the App Store. The first 1,000 users to complete the app’s questionnaire and share a link to the app on social media will receive a free uBiome microbiome testing kit, usually priced at $89. After these free kits have been distributed, users of the app will qualify for a 50% discount.

uBiome is the first biotech company to launch a microbiome-focused app on the ResearchKit framework, following in the footsteps of prestigious clinical trailblazers such as Mt. Sinai, the Dana Farber Cancer Institute, Sage Bionetworks, Massachusetts General Hospital, and Stanford Medicine. From asthma, breast cancer and Parkinson’s disease to diabetes and heart health, existing ResearchKit apps are contributing to scientific understanding of serious health conditions around the world.

“Being able to see how research participants compare to each other is critical to a deeper understanding of human health and the role played by the microbiome,” says Jessica Richman, co-founder and CEO of uBiome. “Participants have already been incredibly eager to contribute to this exciting new branch of science, and we look forward to this opportunity for greater participation.”

uBiome anticipates rapid adoption of its ResearchKit app. Stanford Medicine, one of the first users of the platform, recruited as many research participants in 24 hours as it usually would in a year, with more than 11,000 people signing up within one day. Nearly 75 percent of mobile subscribers in the United States own smartphones and Health & Fitness is the fastest growing app category.

Dr. Zachary Apte, CTO and co-founder of uBiome, explains that processing microbiome data has only become possible because of the company’s powerful high-throughput DNA sequencing technology. “uBiome’s free iPhone app connects the phone in your pocket to our powerful technology in the lab, enabling users to directly contribute to enhancing human health through better understanding of the human microbiome.”

The human microbiome contains around ten times as many cells as the entire body, and an individual’s bacteria is responsible for between three and six pounds of their weight. To place this in context, an average human brain weighs three pounds. The bacteria, which live in and on the body, play critical roles in human health. Although some kinds of bacteria can be responsible for a host of problems such as autoimmune disorders, diabetes, heart conditions, Inflammatory Bowel Disease and skin conditions, the right types of “friendly bacteria” assist us with digestion and the synthesis of vitamins among other important biological activities.

To download the free uBiome ResearchKit iPhone app visit: https://itunes.apple.com/US/app/id998772157.

About uBiome

Technologists from UCSF, Stanford, and Cambridge launched uBiome in 2012 after a crowd-funding campaign raised over $350,000 from citizen scientists, roughly triple the initial goal. uBiome is now funded by Andreessen Horowitz, Y Combinator, and other leading investors. The company’s mission is to use big data to understand the human microbiome by giving consumers the power to learn about their bodies, perform experiments, and see how current research studies apply to them.

Contact:

Orli Kadoch
orli(at)ubiome(dot)com
Ph: +1 415-691-7291

uBiome Co-Founder Jessica Richman Scoops Top Prize At IVY Awards, uBiome Is Finalist In MedTech Innovator of 2015

Screen Shot 2015-10-01 at 9.15.18 AMuBiome, the San Francisco-based company behind a fast-growing, self-sampling microbiome testing service, has been celebrated in two major national competitions, both focusing on technology and innovation. uBiomeʼs CEO and co-founder, Jessica Richman, was announced overall winner of the IVY Innovator Awards presented by Cadillac, in San Francisco on September 30th. And Richmanʼs company is one of a shortlist of four finalists for the MedTech Innovator 2015 competition which will be awarded on the basis of a panel of judgesʼ decision and audience votes at AdvaMed 2015 on Wednesday October 7th in San Diego.

The microbiome is the rich diversity and prodigious volume of bacteria that live in and on the human body. We have ten times as many microbial cells living in this balanced ecosystem than we do in the entire human body, and its weight amounts to between three and five pounds, enough to fill a soup can – an equivalent weight to the human brain. Bacteria in the gut play a supporting role in digestion and the synthesis of vitamins, however pathogenic bacteria are associated with a range of conditions such as autoimmune disorders, diabetes, heart conditions, Inflammatory Bowel Disease and skin conditions. There may even be bacterial connections with anxiety and depression.

uBiome uses DNA sequencing to identify the types and amounts of bacteria in an individualʼs sample, which may be collected from one of five sites – gut, mouth, nose, skin, or genitals. Users can freely explore their results online, comparing their own microbial makeup with others. The species of bacteria in an individualʼs microbiome have only recently become identifiable thanks to a $115 million project by the NIH Human Microbiome Project. uBiome builds on this pioneering work, enabling the cost of microbiome sequencing to be cut from millions of dollars ten years ago to just $89 today, making it accessible to all.

The IVY Innovator Awards, in their second year, recognize outstanding achievement in the fields of technology, film, and design. Jessica Richman has picked up the top prize in the technology section. To do so she needed to convince the judging panel of her suitability in five ways: potential to impact the entrantʼs field; expansiveness of personal vision; uniqueness of innovative endeavors; approach to creativity and innovation; and dedication to building lifelong collaborative bonds.

IVY is a collaborative community of 10,000 thought-leaders and innovators in New York City, Los Angeles, San Francisco, Washington D.C., Boston and Chicago dedicated to creating a better world through its belief that everyone has limitless potential. Its mission is to unlock potential through creative collaboration, camaraderie and inspiration.

MedTech Innovator of 2015 is a competition and virtual accelerator designed to identify and mentor outstanding, innovative early-stage medical technology companies. Over the past two years, MedTech Innovator has produced five successful medtech innovation competitions and two innovation scholarships, with submissions from more than 700 early-stage medtech companies worldwide.

AdvaMed Accel and AdvaMed 2015 have partnered with MedTech Innovator to provide best-in-class start-ups access to a virtual accelerator and to support AdvaMed members developing innovative and transformational medical technologies. AdvaMed represents 80% of medtech firms in the U.S., producing nearly 90% of the health care technology purchased in the U.S. each year.

Jessica Richman and her co-founder Dr. Zachary Apte founded uBiome in November 2012 with a crowdfunding campaign which raised over $350,000. Following an angel round, their startup was accepted into Y Combinator in Summer 2014. Almost immediately they raised a Series A from Andreesen Horowitz. Prior to founding uBiome, Richman worked for Google, McKinsey, Lehman Brothers, the Grameen Bank, and top-tier Silicon Valley venture firms. She attended Stanford University, studying economics and computer science, and Oxford University, where she studied on a fellowship after college graduation.

Jessica Richman says: “Itʼs an honor to win the IVY Innovator Award, and to also know that uBiome is a finalist alongside three other worthy businesses in MedTech Innovator is the icing on the cake. Actually the credit should really go to a couple of groups of remarkable people. One is our incredible uBiome team, without whom we wouldnʼt exist. Theyʼre talented, devoted, and just as eager as Zac and I are to change the world through microbiome testing. The other is our fabulous community of citizen scientists who send us their samples, enabling us to work together to help them explore their microbiomes. Many of them helped get the company off the ground in the first place by supporting our enormously successful crowd-funded launch.”

Zachary Apte adds: “Iʼd add a third group of important people to Jessicaʼs list, and theyʼre our fabulous investors, whoʼve supported the building of our world-class laboratories where we already do some amazing gene sequencing work, and are soon to introduce clinical testing. The people whoʼve invested are some of the brightest folks Iʼve ever met. They totally get what we do, and get that it has vast game-changing potential in the provision of health services.”

For more information on the IVY Innovator Awards, click here: https://www.ivy.com/awards

And for background on MedTech Innovator, see here: http://medtechinnovator.com/2015

 

What Do Your Results Mean? Go In Depth With A uBiome Data Scientist.

Some of you might be wondering…

What do my results mean?
What can I learn from this test?
What is a firmicutes, anyway?

At long last, here’s your chance to find out.

Book your exclusive 20-minute Skype or phone session with one of our data scientists here at uBiome to help you understand the specifics of your microbiome test results.

For example, you could be talking one-on-one with:

We look forward to answering your questions and helping to make meaning from your data! We’re offering this for a limited time at $149.

Schedule your spot now at http://ubiome.com/products/data-help