The State of Pre-natal Testing in the Post-Roe World

Chris Wolski:
Welcome to Clinical Lab Chat, part of the MEDQOR Podcast Network. I’m Chris Wolski, Director of Business Intelligence for CLP. And today I’ll be speaking with Saman Askari about prenatal testing in the post-Roe world. Now, Saman is the Co-Founder and CEO of Mitera, an at-home testing company within the reproductive health space, with roots in Telehealth and genetic testing.

Chris Wolski:
Now, in the wake of the US Supreme Court’s overturning of Roe v. Wade, which I’m sure we’re all aware of, there’s been a lot of focus on how it’s affecting the delivery of healthcare to women. And I think rightly so. But one area that hasn’t been as focused on is what this decision means for prenatal testing, and how labs and providers of tests need to be navigating what is becoming, to put it mildly, some pretty fraught waters.

Chris Wolski:
So Saman, welcome. And I’m hoping you’ll be able to help me and CLP’s listeners to take our first steps in these very uncertain times of reproductive rights. So first, tell me a little bit about what Mitera does, for those who might not be familiar with it, and how you do it.

Saman Askari:
Yeah. Absolutely, Chris. And thanks for having me on. So Mitera was started early in 2020 as a maternal fetal medicine and genetic counseling telehealth company. We provided video consultations for people that needed expertise within our fields. And that included the field of maternal fetal medicine, which is a subspecialty of OB-GYN that deals with pregnancy complications and reproductive genetics. Soon after we launched, we got structured to be able to provide our services in all 50 states. We got medical licenses everywhere and we structured the company as well. And it made a lot of sense for us to launch our own genetic tests. We were already doing a lot of pre-test and post-test genetic counseling for genetic tests that are related to reproductive health, and we saw a big gap in the market to be able to extend access to these technologies in a responsible manner.

Saman Askari:
And to that end, we launched two at-home genetic tests. One of them is an expanded carrier screening, which is a saliva-based test that screens a person’s DNA for 421 genes. And it would tell you whether you’re a carrier of any one of those genes, and would tell you the risk of you passing that along to your child. And if you do that alongside your reproductive partner, for example, and if you find out that you’re both carriers of conditions such as cystic fibrosis or sickle cell anemia, then there’s a high risk that your child can come down with that condition. And that information is very powerful in the sense that you can plan ahead and you can take certain steps to mitigate that risk.

Saman Askari:
The other test that we launched is a non-invasive prenatal test, commonly known as an IPT. And this test is a first of its kind in the sense that it’s the first time somebody can order this from their comfort of their home. Get it administered at-home, and also be able to see a genetic counselor about their results. And that test screens the fetus. It’s done at around 10 weeks of pregnancy. And it’s a blood test, it’s a blood sample from the mother. And it screens the fetus for Down Syndrome and Trisomy 13, Trisomy 18, as well as fetal sex and any sex chromosomal abnormalities.

Chris Wolski:
All right. And these both go back to a lab, is that correct? These home tests?

Saman Askari:
These are home tests. We send you an at-home kit and we provide you the tools to be able to provide the sample. And you ship that back to the lab, yes.

Chris Wolski:
Okay, great. And the way you’re describing this, and the way I understand it, really, what you’re doing is you’re giving women and their partners, depending on which tests they’re using or if they’re using both of them, the facts about their potential reproductive health and the health of the fetus.

Chris Wolski:
And so you touched on this a little bit, but can you talk a little bit more about the benefits of having this knowledge? I mean, is this simply being able to make more informed decisions? Which is always great. Or is it about a broader issue maybe, of having personal choice and autonomy about your reproductive health?

Saman Askari:
The ultimate goal here is to provide our patients with information that would allow them to make the best decision for themselves as far as their reproductive health goes. So this type of information that these tests provides were not available to people even 10, 15 years ago. As DNA sequencing technology has advanced, it has become very cost effective to be able to have these tests done. And our goal, essentially is to demystify the genetic testing landscape, in the sense that we make sure that every patient that goes through our system and through our intake process is provided information around what these tests can do and what these tests can’t do. And we show them a video and they thoroughly understand what they’re going to go through. And we take them through an informed consent process and so on.

Saman Askari:
And the reason for that is that the type of expertise that allows for people to understand these tests thoroughly and understand their results is lacking in vast areas of the country. They’re only about 1500 or so internal fetal medicine experts in the country. There’s also a shortage of genetic counselors. So by using telehealth technologies, we’ve centralized that expertise and are able to provide a process by which patients are responsibly taken through the process and get the most out of the results.

Chris Wolski:
So you’re also … there’s something that I’ve also talked a lot about on the show and in our magazine and on our website about access. So this is also about access, as well. You’re giving people access, convenience, a lot of those things that come with a home testing regimen.

Saman Askari:
Yes, correct. We are extending access to the expertise that we have in-house, because of the reason I mentioned earlier, there’s lack of expertise across the country for this particular test. Many people, actually about a third of pregnant individuals today get noninvasive prenatal tests done already. But it’s very rare that somebody sits down with them and thoroughly explains the capabilities of the test and what their results mean.

Saman Askari:
So part of our goal is to make sure that these tests are delivered in a very responsible manner. And of course, the tests being at-home means that there’s a lot of convenience and privacy that come along with the process as well.

Chris Wolski:
Right, for sure. And this leads into … one thing we discussed in the pre-interview was how there is no judgment in what you present to the patient. You are presenting just the facts, which I think was one of the most refreshing things I’ve heard in a long time. Particularly today when everything is … and the issue of reproductive rights particularly, is so driven by ideology and emotion. And how important a role do you think companies like Mitera, and labs in general are in helping to get ideology and emotion out of what is at root, a very ideological and emotional issue for people, their reproductive health?

Chris Wolski:
I mean, how important is it for you to … and this might be an obvious thing. But how important was it for you to really just … for those who are maybe listening who remember this old TV show. This just the facts approach. That Dragnet, just the facts approach to providing this information?

Saman Askari:
Yeah. That makes a lot of sense. So we specifically devised our process in a way where we’ve taken judgment and value-based guidance completely out of the equation. And the way we do that is that we have made the process into an autonomous process in the sense that things are very clearly laid out. The patient, first of all, is educated on what the information … what the test can tell them. So they make the decision upfront whether they want to have access to that information or not. And the way we convey that information is through genetic counseling sessions that we offer to patients. And genetic counseling, by nature is non-directed in the sense that just presents the information. Here are your options, here are the pros and cons.

Saman Askari:
And the entire goal is to empower patients to make the best decision possible based on their own values. So it’s a little bit different than a patient doctor relationship, where a doctor can be a little bit more directive and say, okay, I suggest, or I recommend you do this. We steer clear from that and we strictly present the information to the patient. And part of the reason that’s doable is because we have made protocols and processes around our telehealth process to allow for that. So the automation makes the whole process very autonomous and allows for that kind of information to be dispersed to the patients.

Chris Wolski:
Right. And I could see a critic coming out and saying, well, you’re just pushing some sort of an agenda and something of that sort. You are not telling anyone, you should not have children or you should have an abortion, or anything of that sort. You are just laying out what the results of these tests are. Is that the case here?

Saman Askari:
Absolutely. We’re not in the business of doing any of that. The whole process is very de-personalized and it’s around providing the patient information about their own health, about their own DNA, about their fetus. And yeah, the entire thing is very de-personalized in that way.

Chris Wolski:
But it’s not … I mean, it’s de-personalized in the fact that it’s factual. But if you tell someone that both the partners have a recessive gene that could result in a very serious illness for the child, or a condition, there’s emotion involved there. I’m sure that when you’re telling a patient that, that can have a little bit of emotional content there. How do you handle that part of it? I mean, is that part of what the genetic counseling aspect of it is that you provide?

Saman Askari:
Absolutely. So, yeah. These are very important emotional decisions for people. And what we do is that we do provide them with options, but we make sure that we present the options in a very non-personalized way. We don’t want to pass along any value judgements, and we leave the value-based decision making to the patients. We provide them with the options and say, here are the pros, cons, limitations, and this is what you can do with this information. And now it’s up to you to make that decision.

Chris Wolski:
Okay. Well, I mean that’s how you’re working with patients in general. Let’s talk a little broader now, and how are you, that is Mitera, navigating the myriad of new laws coming out regarding reproductive health? You mentioned at the beginning of the podcast that you are licensed in all 50 states. So you have to navigate … I mean, it’s like in some cases today, navigating 50 different countries.

Chris Wolski:
I mean, do you foresee a trickle down effect as well for Mitera and labs happening as more laws limiting reproductive rights or access are added to the books? How is this affecting a company like you, that’s just handling the testing aspect of it?

Saman Askari:
That’s a great question. We have made it a point to keep things separate in the way that we deal with things. We are a genetic testing company at the end of the day. So we gather certain information from the patient’s genome and we pass that along to them. And in our own way, we’ve tried to … and that’s a separate area than some of the laws that have been passed.

Chris Wolski:
Right, sure.

Saman Askari:
And in our own way, we’ve tried to enable the patients and empower them through our process by allowing for more privacy and by allowing for more autonomy and convenience. And we feel like what we do is … even though it’s related to a lot of the laws that have passed. But we see it as a separate practice of medicine. Where we utilize certain technologies to, at the end of the day, give patients health information.

Chris Wolski:
Okay, sure. But I mean, it’s interesting, you’re talking about the at-home aspect of this. And I know … that’s becoming, I think a big part of the debate. At least on the divide here. Do you see home prenatal testing and reproductive testing as critical to preserving that personal autonomy, that privacy that we’ve been touching on a little bit here?

Chris Wolski:
And do you think this might be … maybe this is an overly dramatic way of putting it. But a bulwark against some of the, frankly, draconian laws that we’ve seen enacted or coming up the road since the Roe v. Wade decision was overturned?

Saman Askari:
Yeah, I think so. I think there’s been a movement toward at-home care, and it’s been spurred on by COVID, as we all know. Most people are now familiar with telehealth and a lot of the visits to their doctor have been converted to telehealth. So this is in line with a lot of that. And certainly, the autonomy and the privacy and the access to technology that we’ve extended across the country is a way for us to be able to empower patients to overcome some of the limitations that have been placed on them now.

Saman Askari:
Obviously, at the end of the day, we don’t want to step outside the bounds of the law. And we want to respect the patient’s decision to undertake such testing in the first place. So it is all in the patient’s hands, whether this is something that makes sense for them or not.

Chris Wolski:
Right. Okay. Well, unfortunately, we’ve reached the end of our time today. I do think we’ve covered some really fascinating ground. And I’m grateful that testing is still available for women and their partners to make informed rational decisions that are right for them. So thanks, Saman, and the team at Mitera for providing that to women and their partners out there. And also, thanks, Saman, for taking part in what I expect will be an ongoing discussion about reproductive rights in our country. So maybe you can come and join us again in the near future and we can talk a little bit more about this as things become clearer, either for the positive or negative side of this.

Chris Wolski:
I also want to thank you, the laboratory audience, for listening. And look for more episodes of Clinical Lab Chat in the future. And visit us online at clpmag.com and on all the major social media platforms until next time.

Saman Askari:
It was a pleasure, Chris. Thanks for having me on.