Jun 17, 2016 | By Alec

Are needles the most efficient way to draw blood from a patient? If you have a crippling fear of needles or live in a remote region where medical supplies are hard to come by, you could probably use an alternative. That’s why one Harvard-backed startup called NextGen Jane is tapping into a blood source that is easily accessible in half of the world’s population: menstrual blood. With their smart tampon accessories, users can test themselves for STDs and other reproductive illnesses without ever having to face the needle. While still under development, their first 3D printed tampon accessory prototype is already finished.

NextGen Jane has been founded by Harvard graduate Ridhi Tariyal and her former research colleague Stephen Gire. As Tariyal explained, the test’s origins can be found in fertility research. “I was trying to develop a way for women to monitor their own fertility at home, and those kinds of diagnostic tests require a lot of blood. So I was thinking about women and blood. When you put those words together, it becomes obvious. We have an opportunity every single month to collect blood from women, without needles,” Ridhi Tariyal, told the New York Times.

The need for such a test became apparent in 2013, when Tariyal was denied fertility tests because her insurance wouldn’t cover the costs unless she already failed to conceive. “It was clear to me then that our health care system was a reactive paradigm. I really thought women should have information that’s theirs — without going to a doctor and without having a random arbiter decide whether they were ready to have this data,” she recalls.

The great thing about menstrual blood is that it contains a lot more than just blood. Among others, it contains cells from the ovaries and the uterus, and therefore provides information on whether or not the patient has chlamydia, the human papilloma virus (which causes genital warts and cervical cancer) and a lot more. Among others, they are also looking into testing for the polycystic ovarian syndrome, uterine fibroids and for endometriosis, which is currently diagnosed through far more invasive laparoscopic surgery. “You’re in pain, you feel bloated, so you don’t really think of it as an opportunity,” Tariyal explained. “But it’s such a rich biological matrix that you’re shedding every single month.”

This provides a fantastic and non-invasive way to test for a large variety of diseases. For thousands of women are living with numerous treatable infections that are left unaddressed. Over time, these complications – which might not even be noticeable yet – can lead to significant damage to a woman’s fertility. “It shouldn’t be like this,” Tariyal argued. “The intent is to help you manage your health, from menarche to menopause.”

Teaming up with close friend and infectious disease specialist Stephen Gire, she started a mission to get actionable health information into women’s hands as easy as possible. Their research was made possible through the Blavatnik Fellowship in Life Science Entrepreneurship, which enables graduates to start a company. As Curtis Keith, the chief scientific officer of the  Blavatnik Biomedical Accelerator recalled, Tariyal had an excellent concept. “She was completely different. She knew exactly what she wanted to do with her life. It wasn’t just the [women’s health] idea itself. I thought, ‘There’s something special about her.’ She was very confident,” he revealed.

During early stages, they considered making a smart tampon filled with diagnostic chips that send updates to an app, but the concept creeped her out. How many women would use such a high-tech device? They therefore ultimately decided to set up medical testing outside of the body through a special flow capturing tool. Over the past year or so, the duo has already been using a 3D printed prototype that extracts liquid from a tampon, to show the concept to investors and commercialization specialists. It is simple enough for a woman to use in her own bathroom.

To realize their 3D printed prototype, the NGJ team started working with 3D printing specialists and product developers FATHOM. As the scientists revealed, this partnership was absolutely crucial for their success. “The NGJ team has minimal design experience, but we are scrappy, and we were able to create a prototype from our initial concept. But we needed guidance from professional engineers and designers to get our product where we wanted it,” they said on the FATHOM website. 

What’s more FATHOM did a lot more than just press print, as they closely collaborated with NextGen Jane during all steps of the design process. “FATHOM’s expertise allowed NGJ to quickly improve upon the design of our device, which included engineering for fluid dynamics, manufacturing, and integration into existing medical infrastructures. We used FATHOM’s 3D printing services to quickly iterate on the design and functionality,” the makers say. Once the design was finished, FATHOM also developed injection mold tools to produce large batches suitable for clinical trials, and helped with media outreach.

But despite their potent smart product and backing from Harvard, the duo have found themselves fighting an uphill battle. STDs and menstruation are not trendy topics – even though quantified self-knowledge (such as sleeping cycles) are. “The amazing thing about the ‘quantified self’ is that it’s talked about,” said Gire. “If you can do that with reproductive health and get it to the point where people talk about it at work or over cocktails, then it reduces the stigma, allowing women to be more proactive.”

Most meetings were ‘very disheartening’, in part because the concept grossed people out. Even a blue-tinted water alternative did not create more positive responses. “Someone told us that the product would only help women, and women are only half the population — so what was the point?” Tariyal said. Fortunately, gene-sequencing specialist Illumina was interested in the test, especially for its ability to extract a lot more than just blood. They are exceptionally interested in using tampons to test for endometriosis, a painful uterine tissue disease.

The researchers are now able to devote themselves to NextGen Jane full-time, and their blood and biomarker extracting unit is making rapid progress. Especially with the help of the Illumina Accelerator program, they have been able to go deeper into the diagnostic possibilities. “We saw an explosion of differentially regulated genes that correlated to known hormonal shifts in the menstrual cycle,” said Gire.

The startup is currently conducting clinical trials with their 3D printed prototype. Among others, they are seeking healthy female volunteers to contribute samples for endometriosis studies. “You can be part of our trial, and it’s as simple as giving us a tampon,” Tariyal said. “Something that you would otherwise throw away can actually push science further.” A final (presumably non-3D printed) product is expected to be completed next year.



Posted in 3D Printing Application



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