Dr. Sara Naseri: Menstrual blood as a diagnostic tool

NIALA BOODHOO: From postpartum health to menopause, women's health companies are innovating.

DR. SARA NASERI: We are at this point in time really just have just scratched the surface of what I think is possible.

NIALA: One doctor wants to give women the tools to close the gender data gap in medicine.

SARA: One goal is to change the conversation around menstrual blood, from being this stigma, taboo, to actually: this is an incredible opportunity terms of information about what's going on in our bodies.

NIALA: I'm Niala Boodhoo. From Axios, this is 1 big thing.

Mainstream headlines about women's health over the last few years have been dominated by developments in the courts and statehouses: Alabama's IVF battle, the Supreme Court on abortion, and ensuing state-led efforts to restrict or change access to reproductive care.

So you'd be forgiven for not seeing some of the business and science leaps that are happening right now… even--as Axios senior healthcare editor Adriel Bettelheim told me--women's health remains...

ADRIEL BETTELHEIM: ...underfunded. It's estimated only 1 percent of medical research spending goes toward female specific conditions that aren't related to cancer. Groups like the Bill and Melinda Gates Foundation are trying to narrow the gender gap and harness some of the scientific and technological advances that are occurring in other areas of health care.

New types of contraceptives like once a month pills or injectable contraceptives that last six months and that could find great utility in poorer nations. AI enabled portable Ultrasound machines that are being developed to identify high risk pregnancies or estimate gestational age.

And there's just a lot of work now in collecting and harmonizing data and modeling. Increasing female representation in medical studies and using technologies like organs on a chip to personalize treatments across a lifetime. The Biden administration in November announced a White House initiative on women's health research to push for new diagnostic tools and treatments to manage conditions including menopause, endometriosis and cardiovascular disease. Some people think the pace will pick up with more female investors reshaping the male oriented venture capital world and putting more resources into what's traditionally been viewed as kind of a niche market. Startups focused on women's health. There are estimates that by the end of this decade, the women's health market could be worth over a trillion dollars with new diagnostics and digital platforms designed for women's needs.

NIALA: Adriel Bettelheim is Axios' senior healthcare editor.

The woman behind one of the health companies making strides in 2024, is Dr. Sara Naseri, who's working to reframe menstrual blood as a diagnostic tool, rather than waste. She says that's valuable for how we talk about women's health, and could transform women's healthcare.

Dr. Naseri first started down this road while in medical school, where as she saw patients, she kept having the same thought over and over…

SARA: Oh, I wish you'd come in earlier.

And if I had to boil down the seven years I spent in medical school to kind of what my experience was, it was very much about reactive care, so to speak. Very little time was spent on early, early detection and early diagnosis and prevention. And so I really was sort of thinking through, well, how can we get information about our bodies when we're outside the doctor's office regularly? Non-invasively?

NIALA: Some 70% of healthcare decisions rely on lab tests--that's according to the CDC. And while there's some debate over that precise number, there's no question that blood tests play a major role in disease prevention and treatment.

SARA: And then one day it just sort of hit me. And I actually remember the moment pretty vividly because it was sort of like, hold on a minute. Women bleed every month. Why has nobody looked at that? Right?

And the next couple of months following that, sort of shocking honestly to learn how little information had been published by the clinical and scientific community on the utility, the clinical utility of menstrual blood.

NIALA: So Dr. Naseri founded a company in 2014 called Qvin, that received FDA clearance in January of this year for a new kind of blood test.

SARA: We've built a way for women to get insights about their health regularly. Non-invasively, using blood that comes every month, the menstrual blood. It's essentially a modified menstrual pad that collects a small volume of blood that we can test for various clinically relevant health markers.

NIALA: I sat down with her to understand how this works.

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NIALA: Dr. Sarah Naseri is the CEO and co-founder of Qvin. Sarah, welcome.

SARA: Thank you very much. And thank you for having me, Niala.

NIALA: So what kind of markers, what kind of information can you get out of this blood?

SARA: There is a lot of clinically relevant information in this bodily fluid that comes every month. And so as of today, we have the Q-Pad itself, is FDA cleared as a medical device and can test for A1C, hemoglobin A1C, which is, your average blood sugar. It's a marker that diabetics, people that live with diabetes, have to monitor often. It's how we diagnose diabetes, Women also use it for general wellness to kind of understand where the blood glucose is. On top of that, we have looked at a number of different biomarkers and have validated. Those in a clinical lab, and it's biomarkers such as thyroid hormone, it's fertility hormones, inflammation markers, hemoglobin.

And then what, one of the things that I'm really, really excited about, I think, you know, as a team, we are really passionate about is we have done bigger trials on cervical cancer screening and the idea that we can bring screening to women in a very convenient way by just having women wear this specific menstrual pad and we can screen for, for what, the strains of viruses that cause cervical cancer. And really make that convenient and accessible. So, so these are examples of things that we've looked at that we have validated. And I, again, really do believe that this is just the beginning of what will become a very big opportunity in women's health, hopefully.

NIALA: So you said when you started this journey you couldn't find much research to help you?

SARA: In fact, there was only one paper on the proteomics of menstrual blood, which was done by the forensic department in New York. And so that took me there. And I met with the professor who did the first study looking at the proteomics. And it was just this crazy story, Niala, of there was this murder case, essentially. And the suspect said, this dried blood on the couch is menstrual blood, and we had no sort of really good way to sort of prove the difference in that, and so they did the first study looking at the proteomics to understand how it's different so that that could help solve this forensics case and others that have come since then.

And so they're actually working on putting together a standard to differentiate. And in parallel, we're working on in the same kind of field, but obviously for us, it's not about solving forensic cases, but it's about how do we make healthcare more accessible to women? How do we utilize this incredible opportunity that menstrual blood really is for women in gaining and obtaining health information and becoming preventative about their healthcare.

NIALA: What's proteomic?

SARA: It's basically, the forensic department looked at all the proteins, the different markers you may find in menstrual blood and compared that to systemic blood, to venous blood that you get, you know, when you get a needle poked in your arm. And sort of understood what are the differences there. And then what we did following that was sort of to say, okay. So if I take something like your cholesterol or your, let's say your thyroid hormone or average blood sugar for that matter.

And I monitor that in a menstrual sample. And then I also do a blood draw and I compare the two. What is the correlation? That's some of the work that we've done over the past many years to understand, you know, how can we utilize this from a clinical perspective? And you know, to some extent I'm not, to some extent, you know, it's blood, right? So, so a lot of these markers do correlate very, very well. And that's, what made the Q-Pad, the product that we've built, sort of, that started that process once we had sort of determined that there is certainly clinical utility.

NIALA: Is menstrual blood as clinically relevant as blood that you draw from your arm or a finger stick or any other method?

SARA: Yeah. So what we've shown and, you know, partly going through an FDA clearance process, you know, what we had to show, particularly with something like A1C as an example, is that exactly what you're asking: is this the same as if you were to go down and get a venipuncture? And the answer is yes, it is.

NIALA: And you actually- the FDA had to create a new product category for this? Why is that?

SARA: You know, I think we are the first diagnostic menstrual pad ever to get cleared by the FDA. And so in that way, it is so novel, and there's just nothing that exists out there just like the Q-Pad.

So that's why they had to create this new, new category. And here we have this incredible opportunity that frankly has never been looked at or regarded as something positive. And, part of what we hope to do with Qvin is, you know, one, to, of course, provide relevant information regularly to women, help them become more proactive about their healthcare. We think not just about how this is an incredible opportunity for women who are, you know, busy with their lives, important in our workforce, busy with family life, but want to stay on top of their health, but also for women who live in more rural areas of America and frankly, the world, right, where there is nobody there to do something like a pap smear, and it's the inconvenience and the cost and the time associated with getting information about our bodies.

It's just a very big barrier for a lot of women and that should not be the case in 2024. So that's one goal. The other goal is to use that information that we finally can collect very easily, to actually enhance women's health and an area of healthcare that has been overlooked.

And then lastly, it is to change the conversation around menstrual blood from being this. stigma, taboo, to some extent still in many areas shameful event to actually, this is an incredible opportunity and what this can provide in terms of information about what's going on in our bodies. And that's the conversation we hope to change for the future generations to come.

NIALA: That reaction, sort of the disgust or shame around menstrual blood, did you encounter that in the scientific community when you were developing this?

SARA: You know, early on, absolutely. I even recall one of my colleagues who was doing, about to do a PhD in sort of doing feces analysis, sort of look at me like, you're traveling to the U.S. to do menstrual blood studies...That's really kind of gross, right? And I was like, hey, you are doing feces analyses every day. What do you mean it's gross? But, but I think absolutely we did, we, we did get a lot of that and I do contribute that to some of the reasons, not all, of why this hasn't been done before. It has been looked at as sort of a stigma and a waste product and gross. I will say, Niala, which I am sensing this and I'm excited about this, I do think that the conversation is changing. It's no longer about opinion, it's about the data.

NIALA: In a moment – more with Dr. Sara Naseri. This is 1 big thing, from Axios.

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Welcome back to 1 big thing from Axios – I'm Niala Boodhoo. Dr. Sara Naseri is the doctor and researcher behind Qvin, a women's health company whose diagnostic menstrual pad just got FDA clearance earlier this year.

While she tells me other tests will be available soon, so far, the pad is only publicly available for testing hemoglobin A1C – useful in tracking diabetes and pre-diabetes.

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NIALA: You grew up in Denmark, you're doing this research here in the U. S. As we talk about the stigma of menstruation again, sort of the backdrop of women's health and a lack of data for a lot of things, how do you think the U.S. compares to other countries?

SARA: That is a good question. I think as a whole, women's health, unfortunately, has been overlooked. I think, you know, even when I think back on my experience in medical school and some of the, pretty basic things like heart attacks and what we were taught to look for. We know today that, you know, the symptoms for heart attacks are different in females and males, but that's, I didn't, that was not made part of my clinical training. I think that's coming. The fact that you and I are having this conversation today and more conversation around that there is a gender data gap, and that's a real issue that we need to, we need to close that.

And I think the Nordics, Scandinavian countries in general, I think my experience is that, you know, talking about periods perhaps is a little bit more accepted in some ways, but I think women's health as a whole is as far behind as it is in America.

NIALA: You mentioned the gender data gap. Can you explain a little bit more about what that looks like?

SARA: Yeah, it's the fact that women haven't been included in clinical trials sort of historically. And even, you know, up until recently when big pharma do drug development. And they are testing phase one and they're testing many different kinds of drugs to see what should we take to a phase two process. A lot of those studies were done on male rodents. And because women's bodies and female biology, you know, is different, that is potentially excluding opportunities that women could have had that would have worked better for female biology. Or putting, you know, solutions out there that frankly doesn't fit perfectly or even remotely to a female biology.

And I'll give you an example of, chronic pain is, is you know, majority of chronic pain patients are female. But when you look at the clinical trials and the inclusion of women in those clinical trials, they are predominantly studied on male biology. I believe it's 20% only that are women being included. Now that's a problem, right? And so that's the gender data gap that I'm referring to here, is that the studies we've done and the conclusions we've drawn and the diagnostics that we've, you know, have out there and the drugs that we've developed, there is a lack of female representation in those studies. And I think. It is very important and one of the things that I'm very passionate about, you know, we hope women will use the Q-Pad, not just for their own health, but because we can sort of collectively start to actually close the gender data gap and understand women's health better.

And so that's one of the big things that we hope to do it, you know, at Qvin. And I think, we've been doing trials for 10 years, frankly, and I think we are not going to stop that. We are going to continue doing that even as we sort of offer this commercially, which we of course really excited about in the- with the recent FDA announcement, we are still going to continue to run trials because there is so much that we don't know about female biology and women's health. And that's not going to stop anytime soon.

NIALA: Sara, there's data suggesting that women feel like they aren't always heard in medical contexts -- or even that their test results are interpreted differently. What are you hearing from women about their experiences, and how are you trying to adapt for those?

SARA: You know, I think one of the things that I was surprised by as we've been having conversations with women about their health journeys, about their health experience, and asking them what a product like the Q-Pad, why that would be exciting for them, what they would want to monitor even, right? What about their health would they want to have more information about? And one of the words that came up, which for me was surprising because in my mind, of course, the Q-Pad solves barriers such as I don't have to drive anywhere to get my information. It's at the comfort of my own home. I can pick up my kids while I'm doing it. People wear the Q-Pad while they're sleeping and you know, no needles, you know, that was the things that I thought women would be, would be talking about. But actually one of the most oftentimes things that we heard women would say was, was, was around the, the notion of control. I want to take control of my own health. I want to be empowered that when I want to know what my iron level is, and I want to monitor that or my cholesterol level, I don't want to have to go and ask permission to do that. And that's sort of interesting.

We have also heard from women who have, been, been raped or molested that you know, for them to go in and get a speculum exam is incredibly invasive. And so we, we have heard from, from women that have experienced this, this horrific thing that this would be a way for them to get that information and get screened for something like cervical cancer without having to experience the speculum exam. And we hope to be able to do that for these, for this, for this group of women.

NIALA: Sara, we've talked so much about women, women's health, and how women are reacting to all of this. What do you want everyone listening to this conversation to come away from it with?

SARA: I do believe, and I strongly feel like, we need both women and men to, rally behind the idea that this is not gross. You know, one of the most impactful things that I thought about quite a bit was we had this panel at some point and there was a man that actually stood up in the audience and his daughter was disabled. And for her to go in and get something like a pap smear done is very, very difficult. So he said, as a man and as a father, this is something I'm, very excited about. I hope to see in the world because it will, it would be a massive help for them and a way to get her care, health care more easily. And so that actually, it stuck with me that, you know, this is not about women only standing behind this, but it's about men and women acknowledging that female biology is important. You know, we are seeing that more women's health solutions are coming out there. All of that is important and it's important that we all have that conversation, together and not just sort of one, one sex.

NIALA: Sarah Naseri is the CEO and co founder of the women's health company, Qvin. Thank you for taking the time to speak with us.

SARA: Thank you so much for having me.

NIALA: And that's it for this week's edition of 1 Big Thing.

The 1 big thing team includes Supervising Producer Alexandra Botti and Sound Engineer Jay Cowit. Alex Suigura composed our theme music. Aja Whitaker-Moore is Axios' Executive Editor, and Sara Keuhalani Goo is Axios' Editor in Chief.

I'm Niala Boodhoo. Thanks for listening, stay safe, and we'll see you back here next Thursday.