47% of women consider menstrual cycles as taboo to discuss.
Based on a 2024 Smart Design survey of 113 women.
Transforming monthly periods to diagnostic potential: An interview with Dr. Sara Naseri
Smart Design is proud to partner with female entrepreneurs who are transforming women’s healthcare through innovation and design. Today, we feature Dr. Sara Naseri, CEO of Qvin, a company shattering taboos and pioneering new ways to diagnose women’s health issues.
For millions of people who menstruate, the blood shed each month has long been dismissed as a mere byproduct. But recent research has revealed that this overlooked biological sample holds a wealth of information. It turns out, menstrual blood contains cells, immune factors, and proteins that can offer a non-invasive glimpse into a woman’s overall health [1|2].
Dr. Sara Naseri and her company, Qvin [pronounced kwɪn] are revolutionizing healthcare accessibility with the world’s first FDA-approved menstrual blood test. This innovative technology has the potential to monitor conditions like diabetes and endometriosis, and even aid in diagnosing cervical cancers. Plus, the collection methods are simple and familiar to women, using period pads. Menstrual blood analysis has the potential to be a game-changer for preventative and reproductive healthcare.
What is Qvin’s origin story?
Sara: I was in medical school when I got the idea for Qvin. I knew that the most important prognostic factor for any condition is time and catching things early. So I was very interested in how we can become more preventative. How can we know what’s going on in our bodies outside the doctor’s office, so we can catch things before symptoms arise? And we’ve seen in the last five years this explosion in medical devices that can tell us the information about our bodies, you can track your steps, and monitor your sleep, but I really wanted it to be clinically relevant. A lot of these things, at the time at least, were not directly clinically relevant. And so, blood being the most commonly used bodily fluid for diagnosis, it was sort of a natural thing to think about. How can we get access to blood non-invasively, regularly, outside the doctor’s office? And then all of a sudden, it just hit me that women bleed every month. Why is nobody using that? And, in many ways, it’s a very simple idea. I was shocked when I started looking into it, that little to no scientific research had been done on this. And that took me on a 10-year journey to understand the diagnostic utility of menstrual blood.
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The moment you ask a patient to collect at home, you're putting the responsibility of the collection in the patient's hands, it has to be very simple and bulletproof.
I started with the science of it, working at the Stanford University Hospital for a number of years and doing research on the clinical utility and potential of menstrual blood. Once that was established, then it became about, how do you build a product that really captures it in a simple way. The moment you ask a patient to collect at home, you’re putting the responsibility of the collection in the patient’s hands, it has to be very simple and bulletproof. The Q-Pad™ design has been through many, many, iterations. And now we have a product that certainly is very simple to use, consistently collects and keeps the integrity of the sample where it needs to be. And we’re very excited that we received FDA approval.
Why do you think it's taken such a long time for this type of technology to emerge?
Sara: There’s a couple of things that have surprised me throughout this journey. When we started Qvin, research had been done in urine and sweat, and even feces. It was shocking to me that menstrual blood had just been ignored. Early on, it was difficult to find labs that would work with us. We actually had to build our own and go through that entire process of getting certified. But I think when you look at women’s health as a whole, it has been very under prioritized and overlooked. Even though I went to medical school, I had not realized how bad it was. And then you take something like menstruation, which is not only tied to women’s health but in some cultures and historically, [also] something that is a taboo and stigmatized, and for a lot of women still feels like a shameful thing to share.
But as we’ve been publishing and showing the data that there is clinical utility in menstrual blood, that removes the emotion a little bit, and I think the conversation [about menstruation] has changed because of that. Now the conversation is more about, how can this be helpful for patients? And that’s really where the conversation should have been all along.
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Menstruation is not a waste product, but in fact, an incredible opportunity for women to gain insights about their health.
Why do you think Qvin is so important for women?
Sara: Not every woman around the world, and even here in the US, has access to an Ob-Gyn. Even if you have access, an Ob-Gyn can be hours away from where people live.. And that makes it very hard for part of the population to get access to screening. We have a solution, to give women who are bleeding every month, access to healthcare. It’s the idea that menstruation is not a waste product, but in fact, an incredible opportunity for women to gain insights about their health. And that’s the purpose of the company.
Our first priority is for women to get proactive about their health by providing them regular insights about their health by monitoring a number of biomarkers [def, A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease4]. We have a number of them that we can monitor now. One biomarker that I’m very excited about and we’ve done two studies on is cervical cancer screening. We have very good data suggesting that the Q-Pad™ can actually screen for cervical cancer, which of course, would be an incredible, incredible step forward for women.
Our second priority is to use the information we get from collecting blood on a regular basis to enhance women’s health as a whole, and close the gender data gap that exists in healthcare. We are able to biobank some of the data, if women consent to it being used for research. There’s still so much we don’t know about regarding women’s specific conditions and so we need women to participate in research and engage with clinical trials. That’s the only way we can study female biology and start to close that gender data gap. With the Q-Pad™, because it’s so easy to collect the samples, we hope that women will be willing to participate in clinical trials.
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What's even more shocking is that we are studying conditions that are primarily affecting women on male biology, which makes absolutely no sense to me.
Are there any data points about women's health that have surprised or motivated you to keep going?
Sara: One thing is that women have not been included in clinical trials, equally. But what’s even more shocking is that we are studying conditions that are primarily affecting women on male biology, which makes absolutely no sense to me. An example is chronic pain. 70% of chronic pain patients are female but 80% of clinical trials to find solutions are conducted on males. So the drugs coming out of that may not be as effective as they should be for women. That shocks me. The consequences in my mind are pretty significant because what drugs were not approved? Or never made it to phase two of trials because they were not effective on males but could have been effective for females, had they been studied on? We are behind on women’s health and we really have some catching up to do. [3].